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    Natural Sciences

    PharmaTalkRadio

    PharmaTalkRadio is an internet radio podcast platform organized and supported by the Conference Forum to give easy and free access to industry professionals, patient advocacy and students in medicine development. PharmaTalkRadio features industry insiders on the latest strategies, business models, and new innovations to advance clinical research with emphasis on clinical trials, patient- centricity, drug delivery, Immuno-oncology, digital, mobile and other technologies as well as leadership topics and emerging biotech challenges. Also featured on PharmaTalkRadio are podcasts covering a wide range of topics from Conference Forum events.

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    Latest Episodes:
    Incorporating Quantitative Values of Patient Perspectives into Trial Design Oct 25, 2024

    For more information, visit theconferenceforum.org

    Accessing a Novel Source of Patient Experience Data to Improve Clinical Research Oct 24, 2024

    For more information, visit theconferenceforum.org

    Empathy and Behavioral Science in ePROs to Increase Data Collection Adherence Oct 23, 2024

    For more information, go to theconferenceforum.org

    Antiviral Drug Development: Overcoming Challenges to the Current Model Oct 11, 2024

    As viruses evolve to resist vaccines and therapeutics, new targeted approaches to deliver broad-spectrum antivirals are needed. In this podcast, Anil Diwan, President and Executive Chairman of NanoViricides Incorporated, explains some of the shortcomings of the current model of antiviral drug development and how NanoViricides developed a nanotechnology with a different approach to develop and deliver antiviral drugs. Anil also presents an overview of the scientific and clinical development of NanoViricides lead program, NV-387 as well as potential applications in different indications. For more information about NanoViricides Incorporated, visit NanoViricides.com. For more information about the annual PODD drug delivery conference, please visit Drug-Delivery.org.

    Strategies to Empower Clinical Sites, Streamline Trials and Enhance Patient Care Oct 09, 2024

    For more information, visit theconferenceforum.org

    Unlocking Pre-Enrollment Data to Help Sponsors Recruit and Enroll More Patients Oct 09, 2024

    For more information, visit theconferenceforum.org

    The History of Tumor Vaccines, and Why the Newest RNA Cancer Vaccines Might Work Oct 07, 2024

    For more information, visit immuno-oncology360.org.

    What Biotech CEOs Need to Know about Developing a Commercialization Roadmap Oct 04, 2024

    For more information, visit theconferenceforum.org.

    Simplicity in Technology Delivery for Clinical Trials Sep 20, 2024

    For more information, visit theconferenceforum.org

    Micromachines, Biologic Approaches and New Tools Pushing the Boundaries in Oral Sep 19, 2024

    To learn more about the PODD: Partnership Opportunities in Drug Delivery Conference, please visit PODDConference.com.

    Combining AI and Empirical Science to Advance Cancer Immunotherapies Sep 13, 2024

    For more information, go to theconferenceforum.org

    The Personal Impact of a Clinical Trial Sep 12, 2024

    For more information, go to theconferenceforum.org

    The Future of Patient-Centricity: Advancing Frameworks to Achieve Greater Impact Aug 08, 2024

    For more information, visit patientsaspartners.org.

    Using AI to Accelerate the Next Generation of Oncology Immunotherapies Aug 07, 2024

    For more information, go to IO360summit.com.

    Immuno-Oncology Cell Therapy Data Analytics: What and How to Measure Jul 29, 2024

    For more information, visit theconferenceforum.org.

    What to Expect at CRAACO: Clinical Research as a Care Option 2024, in 5 Minutes Jul 25, 2024

    Summary: The 2024 CRAACO: Clinical Research as a Care Option conference is a unique opportunity for pharma, healthcare and patients to come together and address how we can integrate healthcare and clinical research to improve patient access to clinical trials. In this short podcast, Valerie Bowling, Executive Director of the Conference Forum, outlines the key themes and sessions for the 9th annual meeting.

    How to Enhance Clinical Trial Participation in Diverse Linguistic Backgrounds Jul 23, 2024

    For more information, visit patientsaspartners.org.

    Patient Engagement Advocate on Collaborating Successfully with Pharma Jul 16, 2024

    For more information, visit theconferenceforum.org.

    What to Expect at DPHARM 2024, with DPHARM Directors Jul 09, 2024

    For more information, visit DPHARMconference.com.

    Astellas Head of Patient Centricity on Patient-Centric Medicine Development Jul 08, 2024

    For more information, visitpatientsaspartners.org

    Preferences in Decentralization and Digitalization of Pediatric Clinical Trials Jun 24, 2024

    For more information, visit theconferenceforum.org.

    How CMOs Build a Network of Consultants Jun 07, 2024

    To learn more about the Chief Medical Officer Summit 360° and its associated editorials, podcasts and webcasts, please visit CMO360.org

    What CMOs Need to Know about Partnering with Hospitals & Clinical Research Sites Jun 07, 2024

    To learn more about the Chief Medical Officer Summit 360° and its associated editorials, podcasts and webcasts, please visit CMO360.org

    CMO Insights and Advice on Tailoring Your Pitch to Investors Jun 06, 2024

    To learn more about the Chief Medical Officer Summit 360° and its associated editorials, podcasts and webcasts, please visit CMO360.org

    Transitioning from Early Stage to Registrational/Pivotal Stage Development Jun 06, 2024

    To learn more about the Chief Medical Officer Summit 360° and its associated editorials, podcasts and webcasts, please visit CMO360.org

    Discoveries from the Clinic that Help Inform IO Cell Therapy Moving Forward Jun 05, 2024

    For more information, visit IO360summit.com.

    Using Sustainability to Empower Patient Engagement Goals in Medicine Development Jun 05, 2024

    For more information, visit patientsaspartners.org.

    The CMO as a Translational Scientist Jun 04, 2024

    To learn more about the Chief Medical Officer Summit 360° and its associated editorials, podcasts and webcasts, please visit CMO360.org

    Maximizing Regulatory Interactions Jun 04, 2024

    To learn more about the Chief Medical Officer Summit 360° and its associated editorials, podcasts and webcasts, please visit CMO360.org

    Optimizing the Integration of Mobile and Patient-Facing Tech in Clinical Trials May 02, 2024

    For more information, visit patientsaspartners.org.

    Delivering Exceptional Clinical Trial Experiences for Patients May 02, 2024

    For more information, visit DPHARMconference.com.

    ctDNA Potential for Prognostic Stratification, Tumor Insights & Drug Development May 01, 2024

    For more information, visit IO360summit.com.

    What to Expect at the 2024 Patients as Partners EU Conference Apr 23, 2024

    Valerie Bowling, Executive Director of the Conference Forum, discusses what attendees can expect at the 8th annual Patients as Partners EU conference, including keynotes, key topics, and the wide breadth of pharma companies present. For more information about the upcoming event, full agenda and speakers, visit https://patientsaspartnerseu.com/

    Taking Lessons from Manufacturing Immunotherapies to Accelerate Development Apr 12, 2024

    For more information, visit IO360summit.com.

    Enhancing Solubility with Novel Excipient Technologies Apr 08, 2024

    As new drugs in development have poorer solubility and bioavailability, there is a need for novel solubility enhancing polymers to improve drug loading and improve patient adherence. In this podcast, Nick DiFranco explains some of the shortcomings of traditional solubility enhancers as well as key considerations for novel technologies. Nick also presents an overview of Lubrizol’s Apinovex™ polymers for oral solubility enhancement and Apisolex™ polymers for injectable solubility enhancement. For more information about Lubrizol Life Science, visit Lubrizol.com. For more information about the PODD Conference, please visit PODDConference.com.

    Measuring the Value of DCTs and Hybrid Models Apr 02, 2024

    For more information, visit DPHARMconference.com.

    Navigating and Adopting Innovation in a Post- Pandemic World Mar 29, 2024

    For more information, visit DPHARMconference.com.

    Turning a Search for Lung Cancer Biomarkers into a Patient Empowerment Community Mar 15, 2024

    Summary: In this podcast, Terri Conneran tells the story of how her cancer diagnosis and a search for relevant biomarkers turned into KRAS Kickers, a cancer research advocate community. For more information on PharmaTalk Radio podcasts, visit theconferenceforum.org.

    Engaging All Stakeholders for Clinical Trial Patient Engagement and Value Mar 12, 2024

    For more information, visit theconferenceforum.org.

    Optimizing Medicine Development for Real-World Efficacy in Patients Feb 26, 2024

    About the episode: It's estimated that only 20% of health outcomes are due to clinical care, with the remaining 80% as a result of social determinants of health. Medicine development leaders must understand the broader context of patient lives in order to create therapies with real-world efficacy. In this podcast, Noël Theodosiou tells us how she's working with life science companies, to understand and contextualize the real world that patients live in to create therapeutics that fit in the environment to deliver actual impact. Noël argues that taking an approach that combines biology, psychology and sociology provides companies with decision-making capabilities that connects good business practices with life science's social contracts with patients. About the Speaker: Noël Theodosiou is principal, founder and CEO of Luminous, which empowers organizations in the life sciences with insights, strategies, and capabilities that lead to better outcomes for patients, business, and society. Using proven methods such as behavioral science, culture and discourse analysis, and cutting-edge methodologies such as biosemiotics, we identify and address the myriad factors that influence health outcomes. www.luminouseffect.com. For more information on PharmaTalkRadio podcasts, visit theconferenceforum.org.

    How CMOs can Support the Overarching Process of a Fundraising Jan 30, 2024

    To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

    Prioritizing Development Programs that Align with Fundraising Catalysts Jan 30, 2024

    To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

    Interacting with Different Types of Investors as a CMO Jan 29, 2024

    To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

    Developing Internal and External Communication Strategies Jan 29, 2024

    To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

    What CMOs Need to Know About Medical Affairs Jan 28, 2024

    To learn more about the Chief Medical Officer Summit 360°, please visit CMO360.org.

    Achieving Targeted Delivery of Gene Editing Therapies Jan 09, 2024

    To learn more about the PODD: Partnership Opportunities in Drug Delivery Conference, please visit PODDConference.com.

    The Promise and Challenges of Ultrasound-Mediated Delivery Jan 09, 2024

    To learn more about the PODD: Partnership Opportunities in Drug Delivery Conference, please visit PODDConference.com.

    The Future of Digital Technology in the Connected Device Space Jan 08, 2024

    To learn more about the PODD: Partnership Opportunities in Drug Delivery Conference, please visit PODDConference.com.

    New Approaches in CNS/PNS Delivery Jan 08, 2024

    To learn more about the PODD: Partnership Opportunities in Drug Delivery Conference, please visit PODDConference.com.

    Delivery Challenges from the Oncology Pipeline Jan 07, 2024

    To learn more about the PODD: Partnership Opportunities in Drug Delivery Conference, please visit PODDConference.com.

    Precision Ophthalmic Delivery Jan 07, 2024

    To learn more about the PODD: Partnership Opportunities in Drug Delivery Conference, please visit PODDConference.com.

    Overcoming Barriers to Adoption of Transdermal Delivery Jan 04, 2024

    To learn more about the PODD: Partnership Opportunities in Drug Delivery Conference, please visit PODDConference.com.

    Novel Nasal Products and Formulations Jan 04, 2024

    To learn more about the PODD: Partnership Opportunities in Drug Delivery Conference, please visit PODDConference.com.

    Evolving US Clinical Trial Infrastructure for Better Trials & Emergency Response Dec 20, 2023

    To learn more about the DPHARM: Disruptive Innovations to Modernize Clinical Research conference, visit DPHARMconference.com.

    Addressing the Clinical Operations Workforce Gap Dec 20, 2023

    Learn more about the DPHARM: Disruptive Innovations to Modernize Clinical Research conference, visit DPHARMconference.com.

    Patients on How R&D Organizations Can Better Operationalize Trials for Patients Dec 14, 2023

    Learn more about Patients as Partners in Clinical Research at patientsaspartnersconference.com.

    Community Organization Perspectives on Improving Clinical Trial Initiatives Dec 14, 2023

    For more information on Patients as Partners in Clinical Research, visit patientsaspartnersconference.com.

    How Henry Ford Health Integrated Clinical Trials into Clinical Care Oct 26, 2023

    Learn more about CRAACO: Clinical Research as a Care Option, at CRAACOevent.com

    Novartis’ Approach to Making Patients Feel Valued in Clinical Research Oct 26, 2023

    Learn more about CRAACO: Clinical Research as a Care Option, at CRAACOevent.com

    Reimbursement Challenges with Clinical Trials Oct 25, 2023

    Learn more about CRAACO: Clinical Research as a Care Option, at CRAACOevent.com

    Democratizing Access: Enabling All Care Locations to be Research Locations Oct 25, 2023

    Learn more about CRAACO: Clinical Research as a Care Option, at CRAACOevent.com

    Strategies for Building a Successful Clinical Research Team in the Care Setting Oct 24, 2023

    Learn more about CRAACO: Clinical Research as a Care Option, at CRAACOevent.com

    How to Optimize Inventory and Sample Management for Clinical Trial Health Oct 04, 2023

    In this Episode: As clinical trials become more complex, sampling schemes keep pace. That makes proper sample and inventory management so crucial. Slope's Hope Meely and Kyle Baker shed light on the intricacies and the complexities related to clinical inventory management and sample management. Listeners can learn more about clinical inventory involved for biospecimens, the challenges experienced in executing clinical trials and how these issues can be resolved. Speakers: Hope Meely, Chief Clinical Officer, Slope Hope Meely is the Chief Clinical Officer at Slope, the industry-leading provider of a clinical trial execution platform for highly complex, sample-intensive clinical trials. Hope has spent the entirety of her 25-year clinical research career supporting several sponsors and CROs in leading clinical operations teams in the execution of their clinical trial programs. Most recently, she spent 3 years in a growing biotech leading operations for a robust early phase oncology pipeline. Kyle Baker, Content Marketing Manager, Slope Kyle Baker is a former project manager in the central lab space. In his most recent role before joining Slope, Kyle spent nearly 2 years supporting sample management and inventory management for various trial sponsors. By leveraging his clinical trial background and his passion for storytelling to create content for Slope, Kyle marries his understanding of site- and sponsor-specific challenges with his belief that the industry needs a more comprehensive solution for clinical trial execution. For more information about disruptive innovations to modernize clinical trials, click here.

    Ensuring That Sites Are Set Up for Trial Success, Using Data and Technology Aug 29, 2023

    About the Episode: For those of us who work in clinical trials, we know all too well that the majority of sites don't hit recruitment targets, resulting in costly delays and burnout from sites and patients. Tegan Mead and Julie Mansson, both at Javara, describe how they are applying data and technology to identify the right fit and make sure that sites are set up for success, advising sponsors on making trials less burdensome for patients, and keeping physicians in the loop on trials for their patients, to make clinical trials more successful in more places, for the benefit of patients. About the Speakers: Tegan Mead, Executive Director of Operational Excellence, Javara Tegan Mead began her career in clinical research in 2014, working as a Clinical Operations Manager at PMG Research. She has served in various roles across the site enterprise, including operational leadership, feasibility management and operational excellence, with most of her career centered on clinical operations execution, development, and growth. Julie Mansson, Associate Director, Project Strategy, Javara Julie Mansson has over 24 years of clinical research experience primarily focused on trial implementation, study startup, and site operational development. For the last two and a half years she has served in several roles on Javara’s Project Strategy team, supporting cross-functional teams on trial feasibility and project optimization. For more information about clinical research as a care option, click here.

    Innovating Patient Recruitment: A Conversation with BBK Worldwide Founders Aug 07, 2023

    Innovating Patient Recruitment: A Conversation with BBK Worldwide Founders Joan F. Bachenheimer and Bonnie A. Brescia The Conference Forum moderates a webcast featuring Joan F. Bachenheimer and Bonnie A. Brescia, the founders of BBK Worldwide, who walk us through the evolution of patient recruitment and engagement, the connection to the women’s and consumer healthcare movement, the need for changes in communication and the rise of the patient voice. They also address the impact of scientific advances on patient recruitment and the importance of preparing to meet the evolving changes. The timing of the webcast coincides with the company’s 40-year anniversary. Guests: Joan F. Bachenheimer, Founder, Chief Executive Officer, BBK Worldwide Bonnie A. Brescia, Founder, Chief Development Officer, BBK Worldwide Moderated by: Valerie Bowling, Executive Director, Conference Forum For more information on BBK Worldwide, visit www.bbkworldwide.com For more information on the Conference Forum, visit www.theconferenceforum.org

    10th Annual Mobile Tech in Clinical Trials: What to Expect in under 10 Minutes Jul 28, 2023

    Directors, Valerie Bowling and Kate Woda, discuss what to expect at the upcoming 10th annual Mobile Tech in Clinical Trials conference taking place on September 19, 2023 in Boston, MA.

    CRAACO Director's Note Podcast on What to Expect in Under 6 Minutes May 10, 2023

    Director, Valerie Bowling, reviews what to expect at the upcoming Clinical Research as a Care Option (CRAACO) conference taking place on May 22-23 at the Sheraton Imperial Hotel in Raleigh-Durham, NC.

    Current Challenges in Vaccine Delivery and Distribution Jan 23, 2023

    In this podcast, you will hear a panel discussion moderated by Paul Jansen from the 2022 PODD Conference regarding the biggest challenges as well as future solutions to vaccine administration and distribution. Panelists include: Jeffrey T Blue, MerckDerek O’Hagan, PhD, GSK To learn more about the PODD Conference, please visit PODDConference.com.

    Providing the Right Level of Value to the Patient that Creates Value Jan 20, 2023

    In this podcast, you will hear a panel discussion moderated by Mark DeStefano, Teva, from the 2022 PODD Conference regarding balancing the level of connected activity with user needs, determining how broadly or specifically to use connectivity and slowly implementing connectivity to provide good user acceptance. Panelists include: Kevin Deane, Phillips-Medisize, a Molex CompanyDavid Harrison, UCBLilly StairsBrad Womble, JabilAndrei Yosef, Eitan Medical To learn more about the PODD Conference, please visit PODDConference.com.

    Enhancing the Interferon Pathway to Attack Cancer Jan 19, 2023

    Why is enhancing the interferon pathway an attractive approach for treating cancer?What are the novel therapeutic approaches being investigated to harness the innate immune system to enhance the interferon pathway to treat cancer?What are the translational approaches being applied to better study therapeutics that activate the interferon pathway against hematologic and solid tumors and identify the patients who may respond better to these therapeutics? Christine Ward, PhD, Head, oncology Precision and Translational Medicine, Takeda Pharmaceuticals Learn more about the IO360° Summit at www.io360summit.com

    Innovative CRISPR-based Editing to Create Off-the-shelf Immune Cell Therapies Jan 18, 2023

    In this talk, first recorded at the 2022 IO360° Summit, Dr Rachel Haurwitz, CEO, Caribou Biosciences, addresses the big picture view of where the cell therapy field is going and how innovative CRISPR-based editing will help with the treatment of hematologic and solid tumors. Key topics include: Approach that requires highly specific and efficient multiplex genome editingWhat are some of the potential stumbling blocks?What are the tools for solving those challenges?Tackling solid tumors as the next frontier for cell therapies Rachel Haurwitz, PhD, President & CEO, Caribou Biosciences Learn more about the IO360° Summit at www.io360summit.com

    Investment Trends in IO Jan 17, 2023

    Moderated by: Axel Hoos, MD, PhD, CEO, Scorpion Therapeutics Panelists: Jonathan Fassberg, Vice Chairman of Healthcare Investment Banking, OppenheimerIrina Margine, PhD, Principal, Biotech Private Equity, Wellington ManagementAsthika Goonewardene, MBA, Managing Director, Senior Biotech Analyst, Truist SecuritiesGraig Suvannavejh, PhD, Managing Director, Equity Research Biopharmaceuticals & Biotechnology, Mizuho Securities USA Learn more about the IO360° Summit at www.io360summit.com

    Investment and Collaboration Strategies in Cell and Gene Therapy Jan 16, 2023

    This panel, first recorded at the 2022 IO360° Summit addressed: What are the risks and implications of investing in cell/gene therapy companies who have no clinical data from programs available?Venture company perspectives on what they are investing in and why? • What science needs to be seen in order to invest in either a startup or IPO?What are investors/pharma partners looking for and how does that inform what people should be doing?How do we think about partnerships between organizations? Moderated by: Michael Polansky, CEO, Parker Group Panelists: Mark Bonyhadi, PhD, Senior Advisor, Qiming Venture PartnersElaine Cheung, SVP, Corporate Strategy & Business Development, Lyell ImmunopharmaArjun Goyal, MD, MPhil, MBA, Co-founder and Managing Director, Vida Ventures Learn more about the IO360° Summit at www.io360summit.com

    Mechanisms of Immune Evasion Mediated by Hypoxia- Inducible Factors Jan 14, 2023

    In this session, first recorded at the 2022 IO360° Summit, Dr Semenza will talk about how his work is impacting cancer immunotherapy. Dr Semenza’s groundbreaking discovery of hypoxia-inducible factors paves the way for the development of drugs that could kill cancer cells by cutting off the oxygen supply tumors need to grow and improve the response to immunotherapies. Key areas addressed include: Regions of intratumoral hypoxia are a common feature of advanced cancersHypoxia-inducible factors increase the expression of multiple proteins that mediate immune evasionHIF inhibitors stimulate anti-tumor immunity and improve the response to immune checkpoint blockade Gregg Semenza, MD, PhD, Director, Vascular Program, Institute for Cell Engineering and Professor of Genetic Medicine, Johns Hopkins University School of Medicine Learn more about the IO360° Summit at www.io360summit.com

    Neoadjuvant Immune Checkpoint Blockade: A Window into Treatment Response and Pri Jan 13, 2023

    Neoadjuvant (pre-surgical) immune checkpoint blockade may prevent cancer relapse and progression.This treatment approach is now FDA-approved for resectable triple-negative breast cancer, and hundreds of clinical trials in other cancers are ongoing.Surgical resection specimens collected after several weeks of neoadjuvant ICB offer vast opportunities for predictive biomarker discovery and understanding ICB response/resistance. Suzanne Topalian, MD, Associate Director / Professor of Surgery, Bloomberg~Kimmel Institute for Cancer Immunotherapy / Johns Hopkins University Learn more about the IO360° Summit at www.io360summit.com

    Regeneron’s Approach to Strategic Collaborations, Licensing and Business Dev. Jan 12, 2023

    Nouhad Husseini, MBA, SVP, Business Development and Corporate Strategy, Regeneron Pharmaceuticals with Allan Shaw, CFO / Founder & Senior Managing Director, Portage Biotech / Shaw Strategic Capital, LLC Learn more about the IO360 Summit at www.io360summit.com

    Panel: Targeted Radiotherapy and the Impact on IO Jan 11, 2023

    What is the impact of targeted radiotherapy on the immune system?What are the implications for combination IO?Current approaches and future direction Moderated by: Michael Groaning, PhD, Global Medical Affairs Lead, Genitourinary, Amgen Panelists: Charles Glaus, PhD, Sr Director, Radiomics & Radiology Biomarkers, Bayer US-PharmaceuticalsJeff Legos, PhD, MBA, EVP, Global Head of Oncology & Hematology Development , NovartisMatthew Silva, PhD, CEO , InvicroOhad Ilovich, PhD, Senior Director, Translational Sciences, Curie Therapeutics Learn more about the IO360° Summit at www.io360summit.com

    What’s Next on the IO Radar? Top 10 Recommendations from Dr Andrew Baum, Citi Jan 10, 2023

    Learn more about the IO360° Summit at www.io360summit.com

    KEYNOTE FIRESIDE CHAT with Dr Robert Langer and Dr Ester Caffarel-Salvador Jan 10, 2023

    In this podcast, you will hear a keynote fireside discussion with Dr Robert Langer, MIT, and Dr Ester Caffarel-Salvador, Chiesi USA, from the 2022 PODD Conference regarding current projects in the Langer Lab, how COVID affected the lab’s dynamics and collaborations, challenges in the drug delivery space, and exciting technologies in the pipeline, To learn more about the PODD Conference, please visit PODDConference.com.

    Panel: Role of China in the BD Process Jan 09, 2023

    This panel, first recorded at the 2021 Immuno-Oncology 360° Summit, will bring together chinese biotechs to share how they are partnering with additional IO companies to advance cancer treatments for patients. This will include partnering strategies and decision making. To learn more about the IO360° Summit visit, www.io360summit.com

    Gaining “Hard-to-Reach” Patients’ Input During the Global COVID Pandemic Jan 06, 2023

    In this session, GSK shares how they delivered on patient and caregiver engagements, especially with communities experiencing the highest COVID burden. They gained insights on study designs, educational pieces and captured patient experiences to enhance HCP/public COVID awareness. GSK will discuss: Value of COVID engagements Novel approaches and mechanisms for finding patients who don’t belong to an organized patient community Overcoming challenges How this initiative could be modeled to help find future patients when the pathway is not clear Patient Perspectives-In their own words Susan Burriss, Patient Engagement Lead, GSK Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    How Janssen is Collaboratively Working with Patients and Sites to Advance DCTs Jan 05, 2023

    In this session, Janssen shares how they are collaboratively working with patients and sites to advance DCTs and will share engagement methodologies, what they have learned from the perspective of participants and sites, and the direction this has taken them in DCTs. Alyson Gregg, Director Patient Insights, GMA Commercial Operations, Janssen Morgan Wooten, Investigator & Patient Engagement Program Team Leader, Janssen Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    How Merck is Partnering with Communities to Support Clinical Research Jan 04, 2023

    Merck’s iLab53 (a modular 39-foot mobile unit) was used to bring clinical research into community settings as an effort to increase clinical trial awareness and engagement. More specifically: How the iLab53 was created and implemented How Merck is continuing to work to help build trust within communities, and provide increased access to clinical research Challenges, learnings and successes to date How this initiative can be scaled and adapted Susan Manoff, MD, MPH, Executive Director, Office of the Chief Patient Officer, Merck Kai Bode, Director, Digital Innovation and Patient Strategy, Global Digital Analytics & Technologies Team, Merck Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    Sanofi’s New Initiatives Firmly Embedding Patient Experience & Perspectives Jan 03, 2023

    In this session, Sanofi shares how they created and implemented an end-to-end fully integrated patient informed R&D organization that works directly with patients as advisors in 100% of development staged programs from discovery and supporting research pipeline prioritization to registration. Key topics include: Aligning with the patient community’s most pressing needs Gaining insights that established clinical programs and studies and reshaped clinical trial designs and logistics Prioritizing early diversity & inclusion planning Generating patient relevant data that supports improved patient experience Victoria DiBiaso, MPH, BScN, Global Head, Patient Informed Development & Health Value Translation, Sanofi R&D Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    Reflections on Alnylam and Conquering Delivery Jan 03, 2023

    In this podcast, you will hear a keynote presentation from Dr John Maraganore from the 2022 PODD Conference regarding lessons learned from his 19 years as CEO of Alnylam Pharmaceuticals, leading a team that conquered some very difficult drug delivery challenges. To learn more about the PODD Conference, please visit PODDConference.com.

    Patient Involvement Legal Barriers to Be Aware of and Pathways to Overcome Them Jan 02, 2023

    Legal barriers exist for many good reasons, but can block our pathway in making the changes needed to help patients in the current climate. The panel addresses: Protocols that require approval from legal and complianceR&D and compliance, breaking down the silos and working jointly for patient needsHow to bring the patient voice to legal and compliance initiatives that impact patients?What are the next steps? What initiatives could legal/compliance be a part of with patient engagement to gain an understanding of the impact and urgency of their approvals? Led by: Marilyn Metcalf, PhD, Senior Director, Patient-Focused Development, Global Medical, GSK Panelists: Roslyn Schneider MD, VP, Scientific, Medical and Patient Affairs, Theravance Biopharma USParthena Psyllos, Senior Corporate Counsel, Clinical Development Legal, PfizerSue Gregory, Former Managing Counsel/Executive Director, GSKCandace Lerman, Patient Advocate and AttorneyKate Harr-Sponsler, Associate General Counsel – Global Commercial, Spark Therapeutics Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    Next Generation Immune Checkpoints: Deciphering Key Roles in the TME Jan 02, 2023

    Learn more about the IO360° Summit at www.io360summit.com

    Merck Reporting on Site Monitoring, Performance and Database Lock Dec 31, 2022

    In this session recorded at DPHARM 2021, Merck shares about their proprietary Site Monitoring and Reporting Tool (SMART), an iOS Apple iPad technology that enables “monitoring and deviation management” before, during and after COVID-19. Merck talks about how they got SMART. Merck developed a real-time “scorecard” for sites called Site Health Check, which allows them to see how they are performing in absolute and relative terms compared to other sites. Merck addresses how this really helped in COVID-19. Merck has engaged in project RESTART to help sites and to lock databases (~300 locked in 2020 and none missed in 2020 and 2021). Merck shares with the DPHARM audience how this worked. Speakers Andrew Onikepe, Director, Monitoring Excellence – North America, Global Clinical Trial Operations (GCTO), MerckMerle Schneider, Director, Monitoring Excellence Innovation, MerckKatherine Taylor, MBA, Head, Risk Evaluation and Adaptive Integrated Monitoring (REAIM), Global Clinical Trial Operations (GCTO), Merck

    The Role of RWD in the Development of Remdesivir Dec 30, 2022

    In this session from DPHARM 2021, Gilead shares how they designed, developed and obtained Emergency Use Authorization and Full Approval for Remdesivir for the treatment of COVID-19 in record time. Key topics: How they built new capabilities at an extremely accelerated pace to design and execute the remdesivir trialsThe role of Real World Data (RWD) in remdesivir trials to understand the natural history of the disease, to inform study design and conduct, and support real world effectivenessManaging compassionate use programs and communicating with regulators at the peak of the global pandemicLessons learned and the impact on other therapeutic areas Speakers: Matthew Bryant, MBA, Head of Technology & Innovation Global Development and Clinical Operations, Gilead SciencesAnand Chokkalingam, PhD, Senior Director, Clinical Research, Gilead SciencesHassan Kadim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS

    De-risking Combination Product Development Involving L Volume Sub Formulations Dec 30, 2022

    In this podcast, you will hear a presentation with Peter Skutnik, BD Medical-Pharmaceutical Systems and Wendy D Woodley, BD Technologies & Innovation, from the 2022 PODD Conference regarding challenges in combination product development, patient-centric device development considerations, as well as case studies in large volume subcutaneous formulations. To learn more about the PODD Conference, please visit PODDConference.com.

    How Regeneron Got an FDA Approved Therapy for COVID in Record Time Dec 29, 2022

    In this session from DPHARM 2021, Regeneron's Bari Kowal sits down with Craig Lipset to discuss: Driving greater efficiencies in a pandemicA fresh look at solving problemsPrioritizing priorities Speakers: Bari Kowal, Senior Vice President, Head Development Operations & Portfolio Management, RegeneronCraig Lipset, Advisor and Founder, Clinical Innovation Partners

    Remote Monitoring to Improve Transitioning Home and Reducing Risk of Readmission Dec 28, 2022

    In this session recorded at DPHARM 2022, Memorial Sloan Kettering Cancer Center shares about their Connected Care protocol. Digital monitoring of patients has the potential to better the delivery of cancer care through improved patient-provider communication, enhanced symptom and toxicity assessment and management, and optimized engagement across the cancer continuum. Remote monitoring is especially crucial when patients are at high risk for experiencing symptoms or toxicities from treatment. During these episodes, patients and clinicians benefit from routine assessments of electronic patient-reported outcomes (ePROs) to identify symptoms early and prevent adverse outcomes. The Connected Care protocol provides remote monitoring to medical oncology patients for 10-days post hospital discharge as this is a high-risk period for patients due to a lingering symptom burden and a need for enhanced patient-clinician communication as symptom management shifts from the inpatient to outpatient team. Specifically, Dr. Daly will discuss: The feasibility and acceptability of remote monitoring in the post discharge setting for patients with cancerPatient perspectives for remote monitoring post hospital dischargeePRO versus device and challenges with implementationThoughts on the right data to collect and at what intervals Speaker: Robert Daly, MD, MBA, Assistant Attending Medical Oncologist, Department of Medicine, Thoracic Oncology Service, Memorial Sloan Kettering Cancer Center

    The Pfizer Pledge: Getting to 60% Remote Clinical Trials in 2022 Dec 27, 2022

    In this session recorded at DPHARM 2022, panelists from Pfizer discuss: Understanding the key steps Pfizer is taking to make remote clinical trials a reality for patientsExploring the cross functional team approach to scaling remote clinical trials across all therapeutic areasExamining the impact of adopting the light speed mindsetReviewing the key learnings and what the voice of the patient data reveals to date Speakers: Tim Joy, Executive Director, Head of Strategic Solutions, PfizerDaniela Graham, Clinician, Pfizer

    Benchmarking Clinical Operations for Digital Maturity Dec 26, 2022

    This session was recorded at DPHARM 2022. As the life sciences industry’s focus on digital transformation advances at a rapid pace, the opportunity to understand how well your organization stacks up to the rest of the industry around digital maturity in clinical operations can be highly valuable. This session examines a new benchmarking effort to help pharmaceutical companies rank their digital capabilities in clinical operations, codify specific terms that are used readily and leverage insights to drive strategic priorities. Specifically, this session will: Discuss the study purpose, methodology and areas being ranked for digital readinessExamine the value for companies participatingConsider how the study with greater industry participation could evolve into an innovation index and generate industry digital maturity metrics Moderated by: Craig Lipset, MBA, Founder, Clinical Innovation Partners Speakers: Hassan Kadhim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMSTim Joy Executive Director, Head of Strategic Solutions, PfizerAman Thukral, Head of Digital Operations and Clinical Systems, AbbVieBrandon Maggio, Director, Digital & Process Optimization, GSK

    Innovative Trial Designs to Reduce Patient, Site and Investigator Burden Dec 23, 2022

    This is a session recorded from DPHARM 2022. As the competition to recruit patients for clinical trials increases and sites are burdened by staffing shortages, technology shifts and more, how can innovative trial designs reduce patient, site and investigator burden? Designing for patient centricity – reducing the burden for patients, sites and investigatorsAddressing organizational implementation challengesEngaging in collaborative partnerships and innovation to operationalize and deliver innovative trials designs Speakers: Victoria L. Chiou, MD, Head of Clinical Excellence and Innovation, AstraZenecaSheryl Jacobs, VP, Global Development Operations, AmgenCamilla Richmond, MD, MA, Medical Director, Translational Medicine, TakedaDaniel Millar, MBA, Senior Director, Strategic Business Transformation, Janssen Research & Development, LLC

    Addressing the Lack of Structured, Clean Patient Data Dec 22, 2022

    In this session recorded at DPHARM 2022, moderated by Pfizer's Amy Cramer, the panelists discuss patient data. Often the elephant in the room that hinders the advancement of innovation in clinical trials for the benefit of patients in the lack of structured, clean patient data. R&D executives know the ability to garner greater data value from all data sources [clinical trials, EHRs, claims data, etc] is critical to supporting the future of drug development. The continued conundrum is that data is too often unstructured, incompatible, incomplete and unreliable and leads to an output of a research-intensive, operational bottlenecks. We have a unique group of panelists who will prioritize the critical issues first, provide potential solutions and address what to do about pending issues to be resolved. Speakers: Amy Cramer, Global Product Development Strategic Partnerships, PfizerXiaoying Wu, MD, MS, VP, Data Science Data Platform & Privacy, The Janssen Pharmaceutical Companies of Johnson & JohnsonPaul Bleicher, MD, PhD, Executive Partner, Arden EquityLekan Wang, Head, Machine Learning Services, Parexel

    Fireside Leadership Lessons: Driving Innovation to Support Patients and Sites Dec 21, 2022

    In this session recorded at DPHARM 2022, Pfizer's Judy Sewards is joined by Patient Advocate Barry Nelson. Judy Sewards was one of the top 30 leaders who played a critical role in the success of Pfizer’s Covid-19 vaccine clinical trial program. In her role, she led patient and site communications and engagement. She was responsible for Pfizer’s relationships with the over 150 trial sites who conducted the Covid-19 vaccine clinical trials. She also helped create awareness about the clinical trials and worked with community, and government partners to elevate the importance of participation in the trial by diverse communities and organized services to make clinical trial participation more convenient and sustainable for patients. In this fireside keynote chat, Judy will discuss leadership lessons needed to drive innovation and specifically, how to better support patients and sites. Speakers: Judy Sewards, VP, Head of Clinical Trial Experience, PfizerBarry Nelson, Patient Advocate

    Why Rare Disease Therapeutics Need Early Market Access Planning Dec 21, 2022

    About The Episode When developing and bringing a therapeutic for a rare disease to market, sponsors should think with the end in mind and plan for payer requirements early in protocol design. The economic and clinical value evidence required by payers for market access differs from the clinical efficacy and safety evidence demanded by regulators. Securing approval but lacking market access results in unrealized revenue and, most importantly, patients left untreated. But how do we price and how do we gain access on the promise of long-term value when we don’t have the long-term data? Join Sangeeta Budhia, VP and Global Head, Pricing and Market Access, and Wyatt Gotbetter, Worldwide Head, Access Consulting, of Parexel, to discuss early market access planning, including inclusive data collection, payer models and the impact of new regulations and innovative trial design on data collection and ongoing evidence provision. About the Speakers: Sangeeta Budhia is VP and Global Head, Pricing and Market Access, at Parexel. Her role is to ensure that global strategies including pivotal clinical trials, long-term data collection studies, real world evidence generation plans and HEOR strategies are prepared for the reimbursement challenges that each product will face. Wyatt Gotbetter is SVP & WW Head of Access Consulting, leading all facets of Parexel's Access Consulting business with a focus on helping customers position products for market success. With more than 25 years of industry experience, he brings unique insights to guide Parexel's strategy as we invest in this segment of the business to further our patients-first focus. Sangeeta and Wyatt can be contacted at Sangeeta.Budhia@parexel.com & Wyatt.Gotbetter@parexel.com.

    Effective Concentration for a Longer Period with Long Acting Injectables Dec 20, 2022

    In this podcast, you will hear a presentation from Dr Liping Zhou, AstraZeneca, from the 2022 PODD Conference regarding formulation techniques and developability considerations for LAI peptide delivery, with a case study example. To learn more about the PODD Conference, please visit PODDConference.com.

    Moderna on Innovating Clinical Trial Partnerships to Expand Access Dec 20, 2022

    In this session recorded at DPHARM 2022, Moderna discusses its recent partnership with CVS Health to bring its clinical trial closer to patients and expand patient access into more communities. Review the complexities of forming a new partnership and developing a model for implementation and executionExamine the model in terms of investigator strategy, shipping and logistics approach and overall quality & monitoringOperationalizing each part of the model – key considerations, digital platforms, possibilities for scalingLessons learned moving forward Speakers: Jessica Perry, Director, Patient Centricity, Clinical Innovation, ModernaJosh Rose, VP, Head of Decentralized Trials, Site Solutions and Strategy, CVS Health

    Regeneron and Novartis on Innovating to Accommodate Growing Pipelines Dec 19, 2022

    In this session recorded at DPHARM 2022, Bari Kowal, SVP & Head, Development Operations and Portfolio Management, Regeneron, moderates a panel discussion on: Examining how modernizations like the implementation of AI/ML, RWE, DE&I, DCTs impact the need for more flexibility clinical trial designBuilding protocols in tandem with study design and re-envisioning methods to execute trials Panelists include: Henry Wei, MD, Head of Development Innovation, RegeneronRinol Alaj, MBA, Senior Director, Head of Clinical Outcomes Assessment & Patient Innovation, RegeneronBill Illis, Global Head, Collaboration and Technology Strategy, Clinical Development & Analytics, Novartis

    Development of the Lipid Nanoparticles Dec 19, 2022

    In this podcast, you will hear a keynote presentation from Dr Peter Cullis, UBC, from the 2021 PODD Conference regarding the path of discovery and innovation that led to the lipid nanoparticle delivery system driving one of the most successful vaccines against COVID-19. To learn more about the PODD Conference, please visit PODDConference.com.

    Targeting TGF Beta in IO: Mechanisms, Challenges and Opportunities Dec 14, 2022

    Learn more about the IO360° Summit at www.io360summit.com

    Biomarkers in IO: Challenges and Putative Benefits of Multi-omics Technologies Dec 12, 2022

    Evaluating single cell omics to understand the heterogeneity in immune and tumor cellsMulti-omic biomarkers for patient selection in solid tumor IO: is there a path to more personalized therapy?In an era of ‘targeted’ therapies against cell-intrinsic mechanisms (e.g. PARP, NTRK, BRAF) and surface molecules (Nectin-4, HER2), is there a path forward for pan-tumor biomarkers, or is multi-tumor more likely to be the dominant development mechanism? Moderated by: Theresa LaVallee, PhD, VP, Translational Medicine and Regulatory Affairs, Parker Institute for Cancer Immunotherapy Panelists: Jared Lunceford, PhD, Distinguished Scientist, Biostatistics and Research Decision Sciences, Merck Research LaboratoriesAngel A Rodriguez, MD, Oncology Medical Director, NateraSamik Upadhaya, PhD, Research Analyst, Anna-Maria Kellen Clinical Accelerator and Venture Fund, Cancer Research Institute (CRI) Learn more about the IO360° Summit at www.io360summit.com

    Chair’s Opening Presentation with Barbara Lueckel Summary Dec 12, 2022

    In this podcast, you will hear a presentation from Dr Barbara Lueckel, Roche Pharma Partnering, from the 2021 PODD Conference summarizing trends, approvals and pipelines within the drug delivery space. To learn more about the PODD Conference, please visit PODDConference.com.

    A Decade After Checkpoints- What Do We Know, What Do We Need to Know and Getting Dec 08, 2022

    Dan Chen, MD, PhD, Founder, Engenuity Life Sciences Learn more about the IO360° Summit at www.io360summit.com

    Achieving Diversity and Inclusion in Oncology Clinical Trials Dec 07, 2022

    This panel, first recorded at the 2022 IO360° Summit, reported on advances in achieving more diversity and inclusion in oncology clinical trials. Moderated by: Adrelia Allen, PharmD, Director, Clinical Trial Patient Diversity, Global Clinical Trial Operations, Merck Research Labs Panelists: Chétna Rao, PhD, Head of Site Strategy and Operations, BMSRobert Vonderheide, MD, DPhil, Director, Abramson Cancer Center, Perelman School of Medicine, University of PennsylvaniaKaren Peterson, Patient Advocate and Founder, Karen’s ClubMichel Reid, Sr. Director and Head, Global Demographics & Diversity, Global Clinical, Delivery, Global Clinical Operations, R&D, GSK Learn more about the IO360° Summit at www.io360summit.com

    How Long-Acting Implantables Are Taking Extended Drug Release to the Next Level Dec 07, 2022

    About The Episode With pharma’s focus on the extension of drug release windows, new technologies are needed that can lengthen that duration. Today, Zach Fletcher of Trelleborg Healthcare & Medical provides an insight into how the emerging field of long-acting implantables & polymeric drug delivery can address that need. He will be addressing: current applications of implantables and likely future applications, top concerns from pharma and assessing your portfolio for lifecycle applications, manufacturing and scalability challenges, likely conversations around reimbursement from payers. About the Speaker: Zach Fletcher, Business Development Manager - Implantable Drug Delivery & Combo Products at Trelleborg Healthcare & Medical Zach Fletcher is the Business Development Manager - Implantable Drug Delivery & Combo Products at Trelleborg Healthcare & Medical. In this role, he identifies, establishes and develops relationships with device organizations and pharmaceutical companies to deliver unique solutions and therapies to patients. Trelleborg is a world leader in engineered polymer solutions that seal, damp and protect critical applications in demanding environments. For more information on drug delivery news and partnership opportunities, click here.

    Advancements in CART for the Treatment of Glioblastoma Dec 06, 2022

    CAR T cells for solid tumors: Lessons learned from on-going clinical trials in glioblastoma.Interplay between CAR T cells and the endogenous immune systemNext-generation CAR designs to overcome barriers for solid tumor CAR therapy Christine Brown, PhD, Deputy Director, T Cell Therapeutics Research Laboratory, Beckman Research Institute, City of Hope Learn more about the IO360° Summit at www.io360summit.com

    From Carer to Trailblazer: One Man’s Fight to Impact Clinical Research Dec 06, 2022

    When Claas Röhl’s 12-year old daughter was an infant, she was diagnosed with Neurofibromatosis Type 1 (NF), a rare genetic disorder that causes tumors to form along nerves. With no prior background in research, Claas founded NF Kinder and became an advocate for his daughter and patients impacted by this rare disorder. Claas will discuss his involvement in research, how he helped set up the first pediatric department for NF at a major medical University in Austria, and his efforts to create a national registry of NF patients. He will share lessons learned and offer insights on how best to engage carers to impact clinical research. Claas Röhl, Chairman, NF Kinder, EUPATI Austria, NF PatientsUnited with: Renata Lazarova, MD, VP Development, Pediatric Programs, Noema Pharma Learn more about the Patients as Partners EU conference at www.patientsaspartners.org

    Cell & Gene Therapy: Current Landscape, Lessons Learned and Paths Forward Dec 05, 2022

    Where have we come over the past 5 yearsWhat are the approvals and approval activity over the past year?What are the challenges and issues?What have we learned?What are the real important technologies that are being developed that might help transform the cell and gene therapy spaceWhat are the key things we need to think about moving forward? Michael Kalos, PhD, Managing Director, Next Pillar Consulting Learn more about the IO360° Summit at www.io360summit.com

    What to Expect at the IO360° Summit in 6 Minutes Dec 05, 2022

    Kate Woda, IO360° Conference Director, gives a 6 minute overview on what you can expect at the 9th annual IO360° Summit taking place February 7-10 in Brooklyn, NY. Keynotes Include: Dr Carolyn Bertozzi, Stanford University on Bioorthogonal and Click Chemistries Impact on Advancing Cancer ImmunotherapyDr Marcela Maus, Massachusetts General Hospital on Mechanisms Driving CAR T CellsDr Isabelle Rivière, Memorial Sloan Kettering Cancer Center on Cell Therapy Manufacturing Progress Report and Novel Manufacturing ParadigmsDr Axel Hoos, Scorpion Therapeutics on Transformational Medicines & The Next Wave of IODr Andrew Baum, Citi on What’s Next on the IO Radar? Top 10 RecommendationsDr Arjun Goyal, Vida Ventures on Investor Perspective on the State of the Current Market and Impact on the IO Cell Therapy FieldOswald Peterson, Stage IV Lung Cancer Survivor who will share his extraordinary story from diagnosis through to immunotherapy treatments that saved his life Plenary Topics: Biomarkers / Assay DevelopmentDiscovery / PreclinicalImaging AdvancementsClinical OperationsBusiness DevelopmentsTranslational ScienceCell TherapyRNA TherapeuticsClinical Developments Learn more about the upcoming IO360° Summit at www.io360summit.com

    Solving for the Digital Divide: Building Trust with Mobile Tech for Patients Dec 02, 2022

    There are many reasons why patients don’t trust or feel comfortable using a digital/mobile device. Implementing mobile technologies in clinical trials can sometimes create barriers to participation amongst patients who struggle to access them, are digitally challenged and/or do not have the bandwidth to support the utilization. This session addresses the digital divide, the challenges of accessing and using mobile technologies and solutions to reduce these barriers. Patient and site perspectives on utilizing mobile/digital technologies in clinical trialsHow pharma is addressing access and equity from a digital perspectiveEducating, communicating and supporting patients through the use of digital/mobile technologies, reducing anxiety and building trustHow do we think about trial design to accommodate patients using digital/mobile technologiesHow are we addressing and tackling WiFI/Bandwidth connectivity challenges that are required with these technologies such as patient access? Speakers: Adama Ibrahim, VP, Digital Strategy and Change Management, Novo NordiskTina Aswani-Omprakash, Patient AdvocateMarieElena Cordisco MA, NP-C, APRN, AVP Clinical Trials, Research and Innovation, Nuvance HealthTimothy Joy, Head, Clinical Operations Strategic Solutions, PfizerJoan Severson, Chief Innovation Officer, Clinical InkAsh Rishi, CEO, COUCH Health

    How Moderna Built a Digital Organization to Transform How Clinical Research Gets Dec 01, 2022

    Moderna shares how they created and implemented their digital-first organizational infrastructure that has transformed the way clinical research is getting done. They will discuss their approach to agility, delivering value early and often. They will also specifically discuss the example of their COVID-19 vaccine trial. Key topics include: About Moderna’s Digital-first infrastructure that allows for rapid adoptionHow they built the infrastructure to support one of the biggest infectious disease trialsHow they built their medical information, safety capabilities to support adverse events, surveillance and capabilities to support launchAI as a major component in their safety organization and driving recruitment for clinical trialsBest practices for the industry to move the needle forward without innovation labs or huge transformations Speaker: Jean-Remy Behaeghel, VP, Digital, Moderna Therapeutics

    Roche’s Industry Overview on the Drug Delivery Landscape 2022 Nov 30, 2022

    Mark Schiebler, PhD, Global Search and Evaluation Lead for Research Technologies, Roche

    Leveraging Mobile Technologies in the Development of Novel Digital Endpoints Nov 30, 2022

    AbbVie’s Head of Digital Science, Michelle Crouthamel, joins Mobile Technologies in Clinical Trials to discuss how AbbVie has implemented digital health technologies to digitize measurements that can improve existing endpoints, uncover new endpoints and reduce the burden on patients by eliminating the need to travel to sleep labs. Key topics include: Early patient engagement to identify what is meaningful to themHow mobile technologies were implemented into a clinical study and the impactNavigating regulatory acceptance of digital tools for NDE implementation in a clinical trial Speakers: Michelle Crouthamel, Head, Digital Science, AbbvieAntoniu Fantana, PhD, Lead, Emerging Technology Strategy, Clinical Design, Delivery & Analytics, Eli Lilly

    How Mobile Tech is Enabling Smarter Trial Designs for Better Data and Access Nov 29, 2022

    Speakers: Sandeep Bhat, Senior Leader, Digital Health Partnerships and Digital Engagement, Global Clinical Operations, GSKDan Karlin, MD, CMO, MindMed

    FDA Update on Digital Health Technologies in Clinical Trials Draft Guidance Nov 28, 2022

    Mobile in Clinical Trials is joined by the FDA who will provide updates on the draft guidance issued December 2021 that provides recommendations for clinical trial sponsors, investigators, sites on using DHTs to collect data remotely from clinical trial participants. Following the discussion, the FDA representatives hold open Q&A. Topics include: Guidance updatesThe requirements to test all of these digital health technologiesEfforts the agency is putting in place to harmonize the requirements across the boardGuidance to the industry in terms of how we create the harmonization. What do we need to disclose? And in what timeframe?FDA update on approval of additional clinical measures Speakers: Lauren Oliva, PharmD, Director, Global Regulatory Policy, Lead, Digital Health Regulatory Policy, BiogenAnindita Saha, Assistant Director, Digital Health Center of Excellence, Center for Devices and Radiological Health (CDRH), FDALeonard Sacks, MD, Acting Deputy Director, Office of Medical Policy, Center for Drug Evaluation and Research (CDER), FDAElizabeth Kunkoski, Health Science Policy Analyst, Center for Drug Evaluation and Research (CDER), FDA

    Taking Patient Involvement in Clinical Publications to New Heights Nov 28, 2022

    For many years, Pfizer has been a leader in the writing of plain language summaries. Now they’re partnering with diverse patient advocates to develop guidance on how to co-author scientific publications that are relevant to patients and written in language they can understand. Hear how Pfizer is working with patient advocates to co-develop this internal process and what the impact has been so far in involving patients in this new way. Angela Sykes, Director, Team Leader, Publications Management Team, PfizerTrishna Bharadia, Health and Patient Engagement Advocate & Consultant Learn more about the Patients as Partners EU conference at www.patientsaspartners.org

    Partnering with Your Compliance Teams to Advance Meaningful Collaboration Nov 21, 2022

    Compliance with rules and regulations in patient engagement while necessary can also be an impediment to meaningful collaboration. We’ll hear from companies that have taken steps to work through compliance challenges internally and the efforts by associations such as ABPI to enable more collaboration. More specifically: Where do the problems still exist in contracting with patient organizations?What are solutions we can match to some of the problems?What are some case studies of successful collaboration between patients and pharma that we can learn from?What tools are available that can assist? Moderated by: Natalie Bohm, MD, PhD, UK Medical Director, External Engagement, Pfizer Panelists: James Read, Director, POlicy and Communications, MSDAlex Potlog, Legal Director, UK & Ireland, AbbVieJayne Spink, PhD, Translational Research Director, Prostate Cancer ResearchVictoria Bates, Patient Engagement Lead, ABPI Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    What Statisticians Wish They Could Tell Their Chief Medical Officers Nov 17, 2022

    About the Episode In this podcast, you will hear a panel discussion moderated by Dr Sheela Kolluri, Teva Pharmaceuticals, from the 2022 Chief Medical Officer Summit 360° regarding what CMOs need to know about statistics, strategies for clinical development, strengths and weaknesses of complex trial designs and how to maximize the use of your statisticians. Panelists include: Marcia Levenstein, ScD, MBE, VivliNatasha Mühlemann, MD, MBA, CytelJeffrey Bornstein, MD, Eledon Pharmaceuticals To learn more about the upcoming 2023 CMO Summit 360°, please visit: www.theconferenceforum.org

    Tackling the Manufacturing Complexity of Complex to Deliver Pipelines Nov 16, 2022

    In this podcast, you will hear a panel discussion moderated by Dr David Chen, Bill & Melinda Gates Medical Research Institute, from the 2022 PODD Conference regarding managing systems standards of new formulations and modalities and developing newer and improved methods of manufacturing complex delivery systems, such as LNPs. Panelists include: Julia Rashba-Step, PhD, PhosphorexMichael Schmidt, PfizerCornell Stamoran, PhD, Catalent Pharma SolutionsSathya Venkataramani, PhD, Amgen To learn more about the PODD Conference, please visit PODDConference.com.

    Misaligned Incentives: Physician Perspectives on the Integration of CRAACO Nov 16, 2022

    In this session, moderator Craig Lipset speaks with Dr Suzanne Steinbaum on: Patient preferences for learning about researchBarriers for physicians in exploring research as an option for their patientsPlaces where health systems can helpBarriers for diversity in research participationOvercoming implicit biases among providersHow COVID exposes the disparities in access to both care and research, as well as the lack of collaborationMaking research participation more accessible for providers and for patients Speakers: Craig Lipset, MBA, Founder, Clinical Innovation PartnersSuzanne Steinbaum, DO, FACC, FAHA, President, SRSHeart, Inc, / Spokesperson, Go Red for Women, American Heart Association

    Rewriting the Way We Work Together to Integrate Clinical Care and Research Nov 15, 2022

    Dr Simeone, the national PI leader on the adaptive platform trial on metastatic pancreatic cancer, Precision Promise, share her vision on embarking upon and building a new clinical-trial ecosystem. Speaker: Diane M Simeone, MD, Perlmutter Professor of Surgery and Pathology, NYU Langone, Director of the Pancreatic Cancer Center, NYU Perlmutter Cancer Center

    Volunteering for a Vaccine Trial, Tackling Racial Disparities in Healthcare Nov 14, 2022

    University Hospital’s Chief Strategic Integration and Health Equity Officer, Dr Chris Pernell, participated in the Moderna COVID vaccine trial. Dr Pernell tells us what we can do to improve health equity in care and research. Speakers Sharon Hanlon, Group Director, Clinical Trial Engagement & Enrollment, Bristol-Myers SquibbChris Pernell, MD, MPH, FACPM, Chief Strategic Integration and Health Equity Officer, University Hospital

    How Amgen is RISING Above with Clinical Trial Diversity Nov 14, 2022

    Amgen leadership joins Patients as Partners to discuss their RISE (Representation in Clinical Research) Initiative that is transforming clinical trial diversity at Amgen. Key topics include: The development of RISE, what it took to get off the ground Working with internal global development operations and other key groups by diversifying investigators and collaborating with those who serve diverse patient areas at clinical trial sites Collaborations with non-profits in communities that can help remove barriers to participation in clinical trials Partnering with influential community leaders to regain trust within communities Key learnings to help other stakeholders adapt, adjust and build on their current diversity and community engagement initiatives Ponda Motsepe-Ditshego, MBChB, VP, Global Medical Therapeutic Area Head, General Medicine & Global Chair, Amgen Black Employee Network (ABEN), Amgen Jude Ngang, PharmD, Executive Director, Representation in Clinical Research (RISE), Amgen Moderated by: Hassan Kadim, Director, Head of Clinical Trial Business Capabilities, Global Development Operations, BMS Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    A Vision for the Integration of Clinical Research and Care Nov 11, 2022

    Drs Janet Woodcock and Laura Esserman discuss why integrating clinical research and care is so critical and explore how we can get patients more access to clinical trials. Together they address: What is missing for the vision of integrating care and researchReal world dataPlatform trials and adaptive design solutionsHarmonizing data collectionNew models for covering costDeveloping a centralized IRBSimplifying the trial activation processIntegrating data collection with clinical care help from community settingsEarly endpoints and their ability to drive de-escalation and escalationWorkforce developmentMindsets, models, tools and more Speakers: Laura Esserman, MD, Professor of Surgery & Radiology, University of California, San Francisco / Director, UCSF Carol Franc Buck Breast, Cancer CenterJanet Woodcock, MD, Acting Commissioner of Food and Drugs, FDA

    Addressing Barriers to Patient Community Access through Non-Profit Partnerships Nov 10, 2022

    Non-profits can influence the community in a way that sponsors and site organizations cannot. In this session, Javara and Greater Gift present a partnership case study and show how they were able to achieve community access as a team. Speakers: Amanda Wright, Co-Founder & Chief Development Officer, JavaraJennifer Byrne, Founder, Greater Gift / CEO, JavaraKushal Gohil, MBA, SVP, Corporate Strategy & Innovation, Parexel

    Educating Patients and Non-Research Physicians on Navigating Clinical Research Nov 09, 2022

    In this session, panelists share best practices in raising awareness for clinical trials and improving patient satisfaction by educating patients and non-research physicians on the clinical trial process. Speakers: Lora Black, RN, MPH, OCN, CCRP, Executive Director, Clinical Research, Sanford HealthRobert Loll, SVP, Business Development & Strategic Planning, PraxisIrfan Khan, MD, Founder & CEO, Circuit Clinical

    Long Acting Injectables for Biologics Nov 09, 2022

    In this podcast, you will hear a panel discussion moderated by Dr Cindy Wu, AbbVie, from the 2022 PODD Conference regarding opportunities for long acting injectable biologics, stability, manufacturing processes, storage, release periods, and new delivery technologies including conjugate-based delivery. Panelists include: Brent A Buchine, PhD, Windgap MedicalFrederic Dargelas, PhD, MBA, DelSiTechMarc Hendriks, PhD, DSM BiomedicalMatthew O’Brien, PhD, Genentech To learn more about the PODD Conference, please visit PODDConference.com.

    Where and How DCTs Can Truly Enable and Close the Gaps between Research and Care Nov 08, 2022

    In this session, panelists from pharma and healthcare share perspectives on innovations in decentralized clinical trial technologies that have and have not worked during and throughout COVID. They also discuss: How we are bringing forth trial options to people on their own terms and getting patient inputCreating flexible systems that don’t increase undue burden on hospitals and sitesWhat hasn’t worked and whyManaging cost and spend Speakers: Sharon Hanlon, Head, Clinical Trial Engagement & Enrolment, Bristol Myers SquibbChristina Brennan, MD, MBA, VP, Clinical Research, Northwell HealthJamie Harper, MHA, CCRP, Director, Site Engagement & Relations, WCG ClinicalRamita Tandon, Chief Clinical Trials Officer, Walgreens Health, Walgreens Boots AllianceSusan Wong, PA, Principal Quality & Compliance Manager, gRED, Genentech

    Partnering with Health Systems to Enhance Diverse Patient Access in Trials Nov 07, 2022

    Using specific trials as examples, Dr Chetan Karyekar shares how Janssen Immunology is partnering with academic and community health systems to enhance diversity in clinical trials through recruitment strategies, outreach to local institutions, engaging in market research and building trustworthiness. Speaker: Chetan Karyekar, MD, PhD, VP, Clinical Development — Rare Diseases & Rheumatology, Janssen

    Novartis’ Approach to Patient Engagement Nov 07, 2022

    Marc Boutin, JD, Global Head, Patient Engagement, Novartis Moderated by: Sarah Krüg, CEO/Founder, Cancer101/Health Collaboratory Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    Workforce Planning & Reducing Churn to Support and Promote CRAACO Nov 04, 2022

    In this session, panelists share challenges and new initiatives to support building the clinical researcher workforce, workforce planning and flexibility. They address: Efforts to train new clinical researchersMaintaining a remote vs in office hybrid work environment to allow for work/home life balance strategies to reduce churn Speakers: Suzanne Rose, MS, PhD, CCRC, FACRP, Executive Director of Research, Stamford HospitalBrian Sevier, PhD, Sr. Assoc. Director of Research Operations, Yale Center for Clinical InvestigationJennifer Sheller, MPH, Associate Vice President – Global Clinical Trial Operations, MerckSusan Landis, Executive Director, ACRP

    Guest Keynote Connecting Communities with the CEO of Etsy Nov 03, 2022

    In this fireside discussion, Josh Silverman shares the story of how Etsy built a platform to connect sellers and consumers to diverse, local and global communities and the impact on equal access and the democratization of talent. He shares some practical ideas the clinical research industry can integrate to do the same. Speakers: Josh Silverman, CEO, EtsyJohn Potthoff, PhD, CEO, Elligo Health Research

    Making Institutional Change to Offer Clinical Research Options in Health Systems Nov 02, 2022

    In this session recorded at CRAACO 2022, Dr Byrd shares insights on how to provide a wider offering of clinical research options to diverse populations by developing workstreams and policies addressing upstream issues including clinical researcher and physician outreach and systemic blockers that prevent DE&I. Speaker: Goldie Smith Byrd, PhD, Professor of Public Health Sciences & Director of the Maya Angelou Center for Health Equity, Wake Forest School of Medicine

    Microgravity to Develop Crystalline Monoclonal Antibodies for Subcutaneous Nov 02, 2022

    In this podcast, you will hear a presentation from Dr Robert Garmise, Bristol-Myers Squibb, and Dr Paul Reichert, Merck, from the 2022 PODD Conference regarding developing molecules in space to benefit subcutaneous drug delivery including case studies of work done in the International Space Station, the potential of crystalline suspensions and future opportunities. To learn more about the PODD Conference, please visit PODDConference.com.

    CMO-CEO Fireside Discussion on Working Through Challenges Nov 01, 2022

    In this fireside chat recorded at CMO Summit 2022, Drs Alise Reicin and Marcella Ruddy discuss what makes their collaboration work and advice on what not to do as an MD CEO and CMO. Speakers: Alise Reicin, MD, CEO & President, Tectonic TherapeuticMarcella Ruddy, MD, CMO, Tectonic Therapeutic

    Building Trust to Ensure Diversity, Equity, Inclusion in Clinical Research Oct 31, 2022

    Community engagement is a massive challenge when it comes to diversity, equity and inclusion. This session will evaluate what has not worked and focus on the learnings so pharma/biotech can more successfully engage with under-represented communities long term. Key topics include: How can pharma have more of a presence in the community and what does that mean to patients?What are the best ways to build trust and gain community insights from patients where studies are implemented?What will lead patients to embrace it and utilize it and make this whole effort more sustainable?What does community engagement look like for different stakeholders (patients, advocacy, pharma)?What are those institutions that might already be there that can be built upon?How have community centers of excellence been able to recruit racial, ethnic minority populations to successfully get input into studies? Moderated by: Adrelia Allen, PharmD, Director, Clinical Trial Patient Diversity, Global Clinical Trial Operations, Merck Research Labs Panelists: Tesheia Johnson, MBA, Deputy Director and Chief Operating Office, YCCI and Director, Clinical Research, Yale School of MedicineKaren Peterson, Patient Advocate, Karen's ClubEbony Scott, Director, Lupus Therapeutics, an affiliate of Lupus Research AllianceAsh Rishi, CEO, COUCH HealthAngela Rochelle, Account Director, Head, Diversity Initiatives in Clinical Trials, Langland Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    Drug Delivery Pipeline and Technologies, a Year in Review Oct 26, 2022

    In this podcast, you will hear a presentation from Kurt Sedo of PharmaCircle at the 2022 PODD Conference summarizing trends, approvals and pipelines within the drug delivery space. To learn more about the PODD Conference, please visit PODDConference.com.

    How Eli Lilly is Diversifying and Engaging Patients Using DCT Capabilities Oct 24, 2022

    Craig Davenport, Senior Director, Site Engagement, Eli Lilly Moderated by: Marilyn Metcalf, PhD, Senior Director, Patient-Focused Development, Global Medical, GSK Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    Advice for Partnering Between Innovator Drug Delivery Companies and Big Pharma Oct 19, 2022

    In this podcast, you will hear a panel discussion moderated by John Merhige, Credence MedSystems from the 2022 PODD Conference regarding implementable guidance for both pharma companies and delivery companies looking to partner including: The similarities and differences when collaborating on device vs. formulation delivery technologiesDifferent pathways and mechanisms available for different stages of innovative technology, from pure innovation to proven technologiesKey criteria Pharma is looking for in the technology and the innovator company AND advice on how to present to PharmaThe roles of procurement, business development and other functional groups in scoping, structuring deals and negotiation Panelists include: Deborah Bitterfield, PhD, Lindy BiosciencesMichael Cucolo, Bristol-Myers SquibbVincent Ling, PhD, TakedaSarah Tao, PhD, Sanofi Partnering To learn more about the PODD Conference, please visit PODDConference.com.

    Fighting to be a True Stakeholder in Clinical Care and the Impact on Diversity Oct 17, 2022

    We are honored to open Patients as Partners with Karen Peterson, patient #1 in a metastatic triple-negative breast cancer immunotherapy combination trial at NYU Langone Cancer Center. In this fireside chat, she provides personal insights on her trial journey, which has led her to her advocacy work to raise clinical trial education and awareness in underrepresented communities. Karen Peterson, Patient Advocate, Karen's ClubDeirdre BeVard, R&D Strategic Operations, CSL Behring Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    The First 90 Days as a CMO Oct 14, 2022

    As each CMO role is different, it is critical for both first-time and seasoned CMOs to identify the role and develop a plan to ensure a successful transition. In this session recorded at CMO Summit 2021, panelists explore: What to look for in a companyIdentifying the position and taking your placePrioritizing responsibilities and first hires Speakers: Laurie Halloran, BSN, MS, President & CEO, Halloran Consulting Group, IncJames “Terry” Ferguson, MD, CMO, Matinas BiopharmaBecker Hewes, MD, CMO, Blueprint MedicinesRoger Waltzman, MD, MBA, CMO, Molecular Templates

    R&D Veteran on Leading a Biotech through Founding, IPO and Acquisition Oct 14, 2022

    Dr Viney joine the CMO Summit 360° in 2021 to share her incredible journey in drug discovery and development, founding and leading Pandion Therapeutics and joining the advisory boards of multiple biotech companies. Speakers: Jo Viney, PhD, President and CEO, Seismic TherapeuticZain Kassam, MD, MPH, Co-Founder, CMO, Finch Therapeutics

    Building up a Company Through to Commercialization and Beyond Oct 13, 2022

    In this session recorded at CMO Summit 2021, hear from Dr Ron Cohen about his journey founding and building Acorda Therapeutics and leading the company as an MD CEO for 26 years. Dr Cohen also shares advice on how CMOs can best collaborate with their CEOs and add value to their companies. Speakers: Ron Cohen, MD, Founder, President & CEO, Acorda TherapeuticsKen Getz, MBA, Director and Professor, Tufts Center for the Study of Drug Development, Tufts University School of Medicine /Founder and Board Chair, CISCRP

    Best Practices for Cross Functional Communication Strategies for the CMO Oct 12, 2022

    It is vital for the CMO to have excellent communication awareness and skills to communicate externally with KOLs, investors, the scientific community and more. In this session, recorded at CMO Summit 2022, seasoned CMOs share their best practices and more specifically: How to sell a science story to scientists and non-scientists alikePreparing for and managing negative outcomes and weak signalsAligning communications from the CMO, CEO and Commercial Speakers: Cadmus Rich, MD, MBA, CMO & Head of R&D, Aura BiosciencesStephen Huhn, MD, CMO & SVP of Clinical Development, Pipeline TherapeuticsAnna Berkenblit, MD, MMSc, SVP, CMO, ImmunoGenMargaret Koziel, MD, SVP, CMO, Axcella

    Nicholas Warne Drug Delivery Industry Oct 12, 2022

    In this podcast, you will hear a zeitgeist fireside discussion with Dr Nicholas Warne, Pfizer, from the 2022 PODD Conference regarding what the drug delivery industry learned from COVID-19, his view of RNA and LNP technologies, and building on therapies with applications across oncology, rare disease and chronic disease. To learn more about the PODD Conference, please visit PODDConference.com.

    Managing the Partnership Between Big and Small Pharma Oct 10, 2022

    This session recorded at CMO Summit 2022 addresses the role of the CMO in how to best manage the relationship between your biotech and big pharma. More specifically: What are the leadership skills needed?Where are the friction points and how do you avoid them or fix them? Speakers: Joanne Lager, MD, CMO, iTeos TherapeuticsThomas Davis, MD, CMO, Genocea BiosciencesMilan Zdravkovic, MD, PhD, CMO, SNIPR BiomeEric Crombez, MD, CMO, Gene Therapy & Inborn Errors of Metabolism, Ultragenyx

    Infusing Patient Perspectives Across All of Pfizer Oct 10, 2022

    Pfizer’s VP, Patient Advocacy, Emma Andrews, joins Patients as Partners US to provide her insights on the following: Internal and external collaborations to advance patient-focused programs across the enterprise Patient centricity within clinical trial design, research and development, and health equity efforts Pfizer’s deep focus on health literacy Emma Andrews, PharmD, VP, Global Patient Advocacy, Pfizer Cindy Geoghegan, Patient Advocate Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    The Changing Environment Around Accelerated Approvals and Regulatory Pathways Oct 07, 2022

    In this session recorded at CMO Summit 2022, panelists share strategy trends and opportunities around accelerated approvals and regulatory designations. Additionally, they discuss: How to approach the FDA based on the different types of meetingsHow these trends and pathways affect trial designImplications after approval based on the pathway Speakers: Edith Perez, MD, CMO, Bolt BiotherapeuticsJeffrey Bornstein, MD, CMO, Eledon PharmaceuticalsAmy Blawas, PhD, Principal Consultant, NDA Group

    Positioning Yourself For Board Roles and What to Expect as a CMO in Biotech Oct 06, 2022

    In this session recorded at CMO Summit 2022, Board members share their experiences and discuss how CMOs can think about Board role opportunities including: Knowing why you want a seat on a Board and what you bring to the tableThe skills needed to succeed and excel in the role of development representation on a Board, both private & publicWorking with your current CEO and Board while advising another companyIdentifying the reality of what you are getting into Speakers: Julie Hambleton, MD, Biotech Executive & Independent Board Member, Public and Private Biotech CompaniesAoife Brennan, MB, BCh, BAO, MRCPI, CEO, SynlogicHolly Schachner, MD, CMO, Double Rainbow BiosciencesJeffrey Humphrey, MD, CMO, Magenta Therapeutics

    Biotech Financing Options and Their Implications Oct 06, 2022

    In this session recorded at CMO Summit 2022, the panel discusses: What CMOs need to know about series funding, crossover and IPOHow to think about when to engage in these financing options based on the company stage, milestones, and budgetHow CMOs can best support the decision-making and fundraising processes Speakers: Nerissa Kreher, MD, MBA, CMO, Entrada TherapeuticsGeoff Meyerson, MBA, Co-Founder & CEO, Locust WalkTariq Kassum, MD, CEO, Celsius TherapeuticsAnn Barbier, MD, PhD, CMO, CAMP4 Therapeutics

    Building a Work Culture that Attracts and Retains Talent in Biotech Oct 05, 2022

    In this session recorded at CMO Summit 2022, the panel discusses: How to onboard hires who don’t have industry experienceRetaining talent and managing expectationsThe role of flexible working models, title inflation, non-monetary incentives, etc. in this process Speakers: Debora Barton, MD, CMO, Carisma Therapeutics, IncPatrick Burnett, MD, PhD, FAAD, CMO, Arcutis BiotherapeuticsDonna Higgins, CEO, The Higgins GroupBarbara Day, Principal, Pharmaceutical Practice, Penfield Search PartnersJames Lewis, Executive Director, Barrington James

    Exploring Ways to Reduce Costs of Developing & Manufacturing Drug Delivery Tech Oct 05, 2022

    In this podcast, you will hear a panel discussion moderated by Dr Mahesh Chaubal, Baxter International, from the 2022 PODD Conference regarding opportunities to lower costs of development and manufacturing of drug delivery technologies through working with regulatory bodies, reformulating drugs to be more cost effective and analyzing the role of lifecycle management to reduce cost of goods. Panelists include: Ryan Doxey, KymanoxWenlei Jiang, FDA CDER/OGD/ORSRaymond Knox, Lyndra Therapeutics To learn more about the PODD Conference, please visit PODDConference.com.

    Taking on the CMO Role at Moderna and Looking to the Future of Biotech R&D Oct 04, 2022

    In this session recorded at CMO Summit 2022, Dr Paul Burton shares his experience leading Moderna as CMO since June 2021: Transitioning from pharma to biotechLeveraging data science and digital technologies to reimagine medical engagementThoughts on the future of clinical trial innovationLessons LearnedQ&A Speaker: Paul Burton, MD, PhD, FACC, MRCS, CMO, Moderna

    What CMOs Must Know About How Patient Engagement Supports the Entire Biotech Oct 03, 2022

    This session recorded at CMO Summit 2022 gives CMOs an update on current views on patient-centric medicine development, what it really means and the benefits for both the patient and trial. More specifically: Achieving timely recruitment by better selecting sites and writing good protocolsWorking with patient advocacy groups to integrate patient voice in trial design and drive better enrollmentAchieving enrollment when there is so much competition for patients Speakers: Jodie Gillon, MPH, SVP Corporate Affairs & Patient Advocacy, PeptilogicsBarry Ticho, MD, PhD, CMO, Stoke TherapeuticsRolf Benirschke, Patient Advocate & Former NFL Player, Legacy Health StrategiesRoger Waltzman, MD, MBA, CMO, Molecular Templates

    Operationalizing the Integration of Patient Insights Oct 03, 2022

    Boehringer Ingelheim shares their initiatives on systematically operationalizing patient engagement within their drug development lifecycle. Case examples will be shared that demonstrate: • How they are building patient insights into their development and commercial programs • How patient perspective differs based on region culture, and how they incorporate those considerations Hilary Wilson, Director, Patient Engagement, Boehringer Ingelheim Learn more about the Patients as Partners in Clinical Research conference at www.patientsaspartners.org

    How Sites Using Their Own Technology for Research Benefits All Stakeholders Sep 29, 2022

    About The Episode As technology advances in clinical research manage operational workflows, others arise as research sites juggle non-integrated technology systems deployed by sponsors and CROs, slowing operations and duplicating work. In this podcast, Stuart Cotter, VP of Product Strategy and Innovation at Advarra, will explain the work being done to allow sites to bring their own tech to research studies when they are working with sponsors and CROs. This episode addresses: sponsor concerns around site technology being fit-for-purpose; the pain points sites currently face on a daily basis; and Advarra’s Site-Sponsor Consortium that brings together stakeholders to brainstorm and problem-solve this issue. About the Speaker: Stuart Cotter, VP, Product Strategy and Innovation, Advarra Stuart Cotter is the Vice President of Product Strategy and Innovation at Advarra. In this role, he collaborates with current customers and the research community to understand their challenges and translates those challenges into solution-based enhancements to our product offerings. Cotter also leads the Advarra Site-Sponsor Consortium, helping to seamlessly connect site and sponsor technology by addressing key data and process inefficiencies across the clinical research ecosystem. Prior to joining Advarra's strategic team, Cotter worked as a Product Manager for Advarra eRegulatory Management System, and as Product Support Specialist on Allegro CTMS, where he worked alongside dozens of small- to mid-sized research sites to help them overcome their operational hurdles. For more information on disruptive innovations in clinical research, click here.

    Adjusting Your eCOA Strategy For Patient Centricity: Expert Advice Sep 26, 2022

    About The Episode As patient-centricity influences every part of the clinical trial process, sponsors may be surprised at how they impact eCOA strategy. On this episode, THREAD Research's Chris Watson and Rebecca Tomalty share their expertise and experience, strategizing and developing patient-centric eCOAs to avoid surprise costs and delays. Listeners will learn: when to start thinking about eCOA implementation, the unexpected hurdles that can pop up, the ways that patient-centricity has impacted future eCOA planning, and the questions to be asking of your eCOA partners. About the Speakers: Chris Watson, Director, Consulting, THREAD Chris has over 27 years of experience in product and service development within regulated industries across multiple markets. The last 13+ years have focused on Clinical technologies, including tools and platforms to engage, educate and retain participants (and their families) in clinical studies. Chris is a recognised subject matter expert in eCOA and patient engagement, with a proven ability in the technical domain. Rebecca Tomalty, Director of eCOA and Translations, THREAD Rebecca has 20 years of industry experience, primarily in Operations. After several years of experience as a Project Manager, she moved to Clinical Outcome Assessment management in the form of scale management (eCOA Licensing and copyright management and Translations) and, most recently, eCOA design and oversight. As Director of eCOA and Translation Services, she has operational oversight for these two key areas of engagement. For more information on disruptive innovations in clinical research, click here.

    Sandoz's Chief Operating Officer Discusses the New Initiative Act4Biosimilars Aug 31, 2022

    About This Episode: What is in the future for biosimilars? In this episode, Pierre Bourdage, Chief Operating Officer at Sandoz, lays out the promise and potential of biosimilars, and the important role they play in healthcare system sustainability. We also hear about the new initiative Act4Biosimilars which addresses the challenges of biosimilar approvability, accessibility, acceptability and affordability, with the goal of increasing the global adoption of biosimilars by at least 30% in 30+ countries by 2030. Key Takeaways: How biosimilars can fuel competition, innovation and generate savingsThe lasting impact on access for patientsHow Act4Biosimilars works to support biosimilar adoption and access About the Speaker: Pierre Bourdage is the Chief Operating Officer of Sandoz, a division of Novartis, driving high quality off-patent medicine accessibility and affordability for millions of patients. He is a member of the Sandoz Executive Committee. His previous roles at Sandoz include Global Head, Biopharmaceuticals Business Unit and Global Head, Sandoz Biopharmaceuticals Strategy and Portfolio. For more information about innovations in clinical research, click here.

    A Natural Language Collaboration That Helps Cancer Patients Navigate Treatment Aug 31, 2022

    About This Episode: DataArt's engineering capabilities with xCures' oncology expertise created a Natural Language Processing tool. This collaboration tackles the difficult task of ingesting a patient's health records, parsing free-text cancer notes, in order to help patients navigate their options for oncology treatments. This Conversation Specifically Addresses: The unique challenges facing xCuresHow DataArt and xCures began their collaborationThe ongoing conversations required to create something novel and get the finished product to the end user: the patient Plus how this technology could positively impact clinical trial matching About the Speakers: Jamie McCulloch is Vice President of Client Solutions at DataArt. DataArt is a global software engineering firm with over 25 years of experience, teams of highly-trained engineers around the world, deep industry sector knowledge, and ongoing technology research, to help clients create custom software that improves their operations and opens new markets. Mark Shapiro, Chief Operating Officer of xCures, is a management consultant and drug development expert with over 20 years of experience leading growth, innovation, and business transformation in clinical research and development. xCures is an AI-supported platform predicting top treatment options for cancer patients and creating RWE suitable for FDA submissions. Lia Parsenadze is a Data Scientist at DataArt, with professional interests revolving around AI/ML/DL, particularly in medical applications. For more information about cancer research, click here.

    12th Annual DPHARM in Under 10 Minutes Aug 06, 2022

    DPHARM Directors, Valerie Bowling and Tracey Kimball, provide a brief overview of what to expect at the 12th annual DPHARM: Disruptive Innovations to Modernize Clinical Research conference. Get 10% off with code TEML.

    Director's Notes on What to Expect at CRAACO: Clinical Research as a Care Option Aug 04, 2022

    In this 9 minute webinar, CRAACO® Conference Producer, Andrew Goldstein is joined by Executive Director, Valerie Bowling where they give a summary on what you can expect at the CRAACO: Clinical Research as a Care Option conference. Embedding clinical research in the care setting can lead to higher rates of clinical trial participation inside of a health system, better health outcomes, lower cost of care and more satisfied patients. CRAACO is a unique opportunity for pharma, healthcare and patients to come together and address how we can build a more integrated research ready platform to improve patient access to clinical trials. The conference takes place September 12, 2022 at the Westin Copley Place in Boston, MA. For more information please visit www.craacoevent.com

    What to Expect at Mobile Tech in Clinical Trials 2022 Aug 02, 2022

    Directors Valerie Bowling and Kate Woda provide a quick overview on what to expect at the 9th annual Mobile Tech in Clinical Trials in under 9 minutes. Get 10% off with code TEML.

    5 Minute Overview Podcast on What to Expect at PODD: Drug Delivery Jul 19, 2022

    In this podcast, Valerie Bowling, Director of the PODD: Partnership Opportunities in Drug Delivery conference gives a 5 minute overview on what you can expect at the 12th annual PODD taking place October 24-25 at the Westin Copley Place in Boston. Learn more about the upcoming conference at poddconference.com

    Key Role of Strategy and Media in Improving Clinical Trial Enrollment Diversity May 19, 2022

    Summary: Join us for an important discussion about the necessity to adjust and adopt media and research strategies to ensure clinical trial recruitment of diverse populations. PharmaTalkRadio’s Valerie Bowling speaks with BBK Worldwide industry experts Justin Jones and Gaby Grekin who will share specific strategies and approaches to apply at the research and media planning stage to achieve more balanced clinical trial representation. More specifically, our guests discuss: FDA expectationsStrategic media approaches to create a more diverse and inclusive clinical trial environmentWhat to do before initiating an enrollment or engagement campaignKey considerations for planning and executing an effective outreach campaign that engages and motivates diverse audiencesWhat to prioritize? This podcast will especially benefit study sponsors, site staff, PIs, CROs/CRAs, designers and planners of clinical studies, as well industry professionals who support these groups to aid in study recruitment and strategy. Guests: Justin Jones, Sr Director Media and Content, BBK Worldwide Gaby Grekin, Sr Director of Global Strategy, BBK Worldwide Moderator: Valerie Bowling, Executive Director, PharmaTalkRadio For more information about patient involvement, engagement and centricity, click here.

    How CMOs Can Evaluate Potential Outsourcing Partners Effectively May 02, 2022

    About the Episode: The number of biotech companies out there makes the struggle to find good talent and good outsourcing partners more difficult and more expensive. As a biotech CMO, working with a CRO more worried about delivering their margins than delivering on what you need leads to an insourcing problem of being inappropriately staffed and an outsourcing problem of not being serviced. In this podcast, Joe Arcangelo, Co-founder & Managing Partner, InSeption Group, and Dr Steven Zelenkofske, CMO, SwanBio Therapeutics discuss how the biotech and CRO industries have evolved and how you can identify the best partner for your needs. Key Takeaways: How to assess and select outsourcing partnersFocusing on the individuals assigned to your company as opposed to the entire CRODetermining when to outsource and what model to useIntegrating CROs while remaining nimble and flexible as a biotech

    Is the End of SDTM in Sight? May 02, 2022

    About This Episode: Dr Derk Arts, Founder and CEO of Castor, lays out what he views as the next phase of data presentation to regulatory agencies, moving away from the standard SDTM (study data tabulation model) into something that more accurately represents the diverse streams of data that are being generated. Potential impacts include: drug approvals based on quality of life, a step forward into precision medicine, and overall increase in patient centricity. Key Takeaways: How companies can prepare for a more data-friendly futureWorking groups at the FDA and their involvement in data submission What this direction means for precision medicine, remote monitoring and other innovations in clinical research About the Speaker: Derk Arts, MD, PhD, has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform that helps them maximize the impact of research data on patient lives. Dr Derk Arts believes the key to achieving lasting change in the industry is through scalability and standardization. Technology to run better trials and maximize the impact of data should be available to all researchers. Over the past 12 months, Castor provided pro-bono support to over 300 COVID-19 trials, and provided the entire infrastructure for the World Health Organizations’ Solidarity Trials. For more information about innovation in clinical research, click here.

    What Adapting During COVID-19 Taught Us About Innovating Drug Development Apr 27, 2022

    COVID-19 changed the clinical research landscape by proving the use and efficacy of DCTs, patient-centricity and adaptive designs. Dr Ubavka DeNoble, Executive Vice President of Biotech Operations and Senior Medical Officer of Parexel Biotech shares advice on how CMOs can think about leadership, change management and investing in new technologies such as artificial intelligence, improved data collection and system interoperability to improve patient recruitment and retention and drug development efficacy. Key Takeaways: How to lead with an eye on industry changes and flexibilityThe importance of rewarding innovation rather than standardizing a single approachObservations of successful change management throughout the COVID-19 pandemic

    A Vision for the Future of Drug Delivery: Patients Interacting Less with Disease Apr 15, 2022

    About This Episode: What is the future of drug delivery for patients, and how do we get there? In this episode, Dr Shawn Davis, who leads the Drug Delivery team of the Biopharmaceuticals Development organization at AstraZeneca, lays out a bold vision discussing how the future of drug delivery is patients interacting less with their disease, and what steps we can take to make that future a reality. Key Takeaways: How companies can de-risk drug delivery innovationsHow the current moment in drug delivery is shaping our long-term visionBalancing the competitive landscape, portfolio and patient needs About the Speaker: Shawn Davis, PhD is an Executive Director at AstraZeneca and leads the Drug Delivery team of the Biopharmaceuticals Development organization. The team improves patients’ lives by ensuring AZ’s therapies are as safe, effective, and convenient as possible using technologies that target the delivery of medicines to the site of action and optimizing their effective half-life. This requires the evaluation, development, and commercialization of drug delivery technologies across a wide range of modalities in the biopharmaceutical space. Areas of program delivery include: intracellular delivery of nucleic acids, controlled release of antibodies for less frequent dosing, novel routes of administration for therapeutic benefit, and co-delivery of multiple therapeutic molecules. Dr Davis also serves as the CMC leader for early stage assets in the portfolio. For more information about drug delivery, click here.

    How Listening Tech Disrupts Clinical Research to Create Patient-Centric Trials Apr 14, 2022

    About This Episode: Current efforts to source and disseminate patient insights in clinical trial planning are expensive and time-consuming. In this episode, Fabio Gratton, CEO and Co-Founder of InVibe, which was recently acquired by THREAD Research, discusses how patient voice listening technology is enhancing and disrupting clinical research by making it easier to collect and use patient responses. The result could be more patient-centric trials informed by the actual patient voice. Key Takeaways: How current listening technology can accurately capture and convey patient responses, emotion and perspectiveThe difference from current methods of sourcing patient feedbackNext steps in the journey of making trials more patient-centric About the Speaker: Fabio Gratton, Co-Founder and CEO of inVibe, part of THREAD Research, is a digital health entrepreneur. For over two decades he has adapted his early experience as a Hollywood scriptwriter with innate acumen in science and data to redefine how healthcare companies tell patient stories through technology. Of his many Fortune 5000 ventures, inVibe has transformed market research by enabling brands to supplement their efforts with flexible, scalable, and impactful voice-driven insights. For more information about innovation in clinical research, click here. For more information about mobile technologies in clinical trials, click here.

    On-the-Ground Perspective on Putting Decentralized Strategies in Clinical Trials Apr 14, 2022

    About the Episode: Creating options for patients with decentralized clinical trials can provide tremendous benefits for certain patients and indications. In this podcast, Labcorp’s Linda Ross, Associate Director of Commercial Strategy, Decentralized Clinical Trials, brings an on-the-ground perspective to the benefit of incorporating decentralized strategies into your clinical trial approach. Having worked on multiple sides of clinical research, Ms Ross is using her experience running clinical trials via flexible approaches to discuss how, after COVID, the industry can and should continue broader applications of flexible, decentralized clinical trials. Key Takeaways: How to convey the value of consistent DCT planning to sponsorsUnderstanding current attitudes and burdens around decentralizationThe next steps in wider adoption of flexible approaches About the Speaker: Linda Ross has over 20 years’ experience in the pharmaceutical industry and commenced work with Labcorp in Nov 2008 where she is currently employed as an Ass. Dir. Commercial Strategy, Decentralized Clinical Trials. Linda has worked in a variety of leadership positions across different therapeutic areas that have involved multiple countries in Asia Pacific as well as Americas and Canada. She has developed extensive experience in developing decentralized clinical trials strategies on projects from pre-award, during set up, as well as leading new initiatives for ongoing studies which have been faced with challenging circumstances. For more information about disruptive innovation in clinical research, click here.

    Biotech CEO Keynote, Dr Ron Cohen, from Chief Medical Officer Summit 360° 2021 Feb 17, 2022

    In this podcast, hear a keynote session from the 2021 Chief Medical Officer Summit 360˚ with Dr Ron Cohen on his journey founding and building Acorda Therapeutics and leading the company as an MD CEO for 26 years. Dr Cohen also shares advice on how CMOs can best collaborate with their CEOs and add value to their companies. Learn more about the 10th annual Chief Medical Officer Summit taking place April 4-5, 2022 here.

    R&D Veteran Keynote, Dr Jo Viney, from Chief Medical Officer Summit 360° 2021 Feb 17, 2022

    Dr Viney joined the CMO Summit 360° in October 2021 to share her incredible journey in drug discovery and development, founding and leading Pandion Therapeutics and joining the advisory boards of multiple biotech companies. Learn more about the 10th annual CMO Summit 360° taking place April 4-5, 2022 here.

    10th Annual Chief Medical Officer Summit 360º in a Nutshell Feb 15, 2022

    Conference Producer, Andrew Goldstein, walks through what you can expect to learn and who you'll hear from at the upcoming Chief Medical Officer Summit 360º taking place April 4-5, 2022 in Boston, MA, including: Clinical development and operationsRelationships within the C-suite and team buildingThe role of the CMO in biotech financingExternal communicationsProfessional development For more information, click here.

    The Case for Sites Using Their Own Tech to Accelerate Research and Reduce Burden Jan 20, 2022

    About the Episode: In this podcast, we discuss the topic of clinical sites shifting to using the own technologies in sponsored trials and how it can advance (and maintain the pace of) clinical research. Our guest, Bryan Spielman, Chief Growth Officer at Advarra lays out the current burden being faced by performing sponsor trials. Mr Spielman also talks about the work Advarra has led in bringing together sites, CROs and sponsors to brainstorm new solutions, and the path forward to encourage wider conversation, acceptance and adoption. Key Takeaways: Identifying current burdens faced by sitesUnderstanding current attitudes towards site-owned technologySteps forward to benefit both sides of clinical research About the Speaker: Bryan Spielman, MBA, is Chief Growth Officer at Advarra and is responsible for driving Advarra’s corporate strategy, mergers and acquisitions, strategic partnerships, and corporate marketing. Spielman brings over 25 years of business development and corporate strategy experience from leading technology companies including those with a focus on life sciences. For more information about innovation in clinical research, click here.

    5 Talks to Watch (and Why) at IO360º 2022 with Strategic Advisor Dr Dan Chen Jan 18, 2022

    About the Episode: Daniel Chen, MD, PhD, Immuno-Oncology 360º 2022 Strategic Advisor, Physician Scientist, Cancer Immunotherapy and Board of Directors, Society for Immunotherapy of Cancer (SITC) and co-author of the Cancer Immunity Cycle, discusses five talks he is excited for, and why, at the upcoming Immuno-Oncology360 conference. The 2022 summit will be held March 16th through the 18th, 2022 at the New York Marriott Brooklyn Bridge. For more information, and the full agenda, visit www.io360summit.com. 5 Top Topics To Watch from Dan Chen: ctDNA Guiding Adjuvant ImmunotherapyClinical Data on PSMA BiTeNovel Approaches to Expand the Therapeutic Index of T cell EngagersSynthetic BiologyIO360° Debate: NK-Cars vs T cell- CARs

    8th Annual Immuno-Oncology 360° Summit: What to Expect in 7 Minutes Jan 02, 2022

    This 7 minute podcast summarizes what you can expect at the 8th annual Immuno-Oncology 360° conference. IO360˚convenes stakeholders spanning the science and business communities to report on the latest data impacting immuno-oncology to fight a wider range of cancers. Keynotes include: Dr Gregg Semenza, Johns Hopkins University School of MedicineDr Rachel Haurwitz, Caribou BiosciencesDr Christine Brown, City of HopeDr Suzanne Topalian, Johns Hopkins UniversityDr Andrew Baum, Citi Key topic areas include: Discovery/Preclinical ScienceCell & Gene TherapyTranslational ScienceBispecificsClinical DevelopmentsNeoadjuvant/Adjuvant DataEmerging BiomarkersCytokinesClinical OperationsIO CombinationsImaging AdvancementsBusiness Developments The conference takes place February 16-18, 2022 at the New York Marriott Brooklyn Bridge, New York City, NY. For more information please visit www.io360summit.com or contact us at service@tcfllc.org

    Patients as Partners EU 2022 in 5 Minutes Dec 17, 2021

    Conference Producer, Mark Scherzer, talks through what to expect at the upcoming Patients as Partners EU virtual conference taking place 24-25 January 2022. The 6th annual conference will bring together pharma, biotech, CROs and technologists to figure out how to advance patient involvement in medicines development. Experts from Novartis, Pfizer, Merck, EMD Serono, Janssen, Johnson & Johnson, GSK, Ipsen, UCB, Takeda, AbbVie, Noema Pharma, Gilead Sciences, and Pierre Fabre will gather with patient advocacy to address: Outcome measures that matter most to patients Patient Experience Data for regulatory submissionsCompliance barriers to advance patient involvementIncreasing diversity in clinical researchPatient involvement in Turkey and Eastern EuropeImpacting clinical research through carer InputPatient involvement in the design and execution of platform trialsPatient access to research through digital innovation

    How Artificial Intelligence Is Creating Better Clinical Trials, with Saama Dec 03, 2021

    About the Episode: How can artificial intelligence maintain the pace of clinical trials from the COVID-19 pandemic to bring therapeutics to patients faster? Suresh Katta, CEO and founder of Saama Technologies, sits down to discuss exactly how artificial intelligence can be utilized to design better trials from the start, reduce costs and benefit patients and pharma in the long run. Key Takeaways: How to create broader adoption and change management of new technologiesCreating the best protocol design from the start, without pricey and time-consuming amendmentsHow AI can reduce costs, as well as timelines About the Speaker: Suresh Katta founded Saama Technologies in 1997, well before the collective global corporate conscience was aware of the extraordinary opportunities – and significant challenges – inherent in big data. He is a frequent contributor to industry publications and a featured speaker at industry conferences. He earned his M.S. in Computer Engineering at the University of Southwest Louisiana, and his B.S. in Electronics Engineering at the University of Bangalore. For more information: About disruptive innovations in clinical research, click here. For more information about PharmaTalk Radio, visit theconferenceforum.org.

    Making the Leap from IV to Subcutaneous, with Halozyme's ENHANZE® Technology Nov 23, 2021

    About the Episode: How can therapeutics like biologics and small molecule drugs evolve in their delivery? Finn Doyle, SVP and General Manager of ENHANZE® at Halozyme, sits down to discuss exactly how these innovative therapeutics can be delivered subcutaneously where they have previously only been administered via IV, the impacts of doing so, and the keys to successful drug delivery collaborations. Key Takeaways: How switching to a SC delivery model impacts patients, healthcare providers and drug development companies Keys to successful partnerships and collaborations How Halozyme's ENHANZE® technology enables the shift from IV to SC About the Speaker: Finn Doyle joined Halozyme in May of 2021 as the Senior Vice President and General Manager of ENHANZE®. She is responsible for overseeing Halozyme’s ENHANZE® drug delivery technology, including responsibility for the annual operating plan and long-term growth strategy for the franchise. Ms Doyle will oversee the alliance management, ENHANZE® business development, regulatory and safety, and project management functions within Halozyme. Ms Doyle received a B.S. in Biochemistry from Trinity College in Dublin (Dublin University) and a degree in International Business and Marketing Ireland and did postgraduate research at MIT/Harvard. For more information: About drug delivery and partnerships, click here. For more information about PharmaTalk Radio, visit theconferenceforum.org.

    J&J Vision on Progress in Eyecare and Meeting the Needs of Future Patients Oct 21, 2021

    About the Episode: What does the future of eyecare look like? How does a global company stay innovative? Listen to this podcast to hear Dr Xiao-Yu Song, Johnson & Johnson Vision, providing the latest information on J&J Vision's new products, and her approach to innovation. Key Takeaways: How to encourage innovation in a large, global company What the current and future eyecare needs are How Johnson & Johnson Vision is expanding and innovating their products, including a first-in-class drug delivery contact lens About the Speaker: Xiao-Yu Song is the Global Head of Research & Development for Johnson & Johnson's eye health business. She has overall R&D responsibility for new product development and life cycle management support as well as portfolio management and innovation governance across all platforms in Johnson & Johnson Vision. Xiao-Yu earned her Ph.D. in Biology from the University of North Carolina at Chapel Hill, her M.S. in Biochemistry and Medical Degree at China Medical University, and completed postdoctoral training in autoimmunity and immunology at the U.S. National Institutes of Health. For more information: About disruptive innovation in clinical research, click here. About drug delivery and partnerships, click here. For more information about PharmaTalk Radio, visit theconferenceforum.org.

    Flexible Data Collection and Best DCT Strategies: Advice from an Expert Oct 18, 2021

    About the Episode: As the COVID-19 pandemic encourages the widespread adoption of decentralized clinical trial models, there are opportunities to optimize existing processes to make clinical research easier for sites and sponsors to conduct, and for patients to participate. Jonathan Andrus, Clinical Ink, discusses his advice as a flexible data collection expert, thoughts on wider adoption of DCTs and where he thinks the future is headed. Key Takeaways: The role of regulatory guidance, how-to's and industry examplesShifting from a "surviving" to "thriving" mentality in regards to DCTsNext steps for the industry About the Speaker: Jonathan Andrus is Chief Strategy Officer of Clinical Ink. He is responsible for driving the corporate strategic vision, communicating the plan with all those involved, executing the business initiatives, and sustaining implementation efforts. This includes driving important internal initiatives, identifying potential targets for acquisition, and other partnership opportunities to help drive the business forward. About Mobile in Clinical Trials: Mobile in Clinical Trials is the meeting place for digital R&D operations leaders who are seeking solutions to apply mobile-digital tools into clinical research. Each year, we bring forward the latest experience-based case studies while presenting fresh ideas to advance fit for purpose, adoption and scale of remote digital solutions. For more information, click here. For more information about PharmaTalk Radio, visit theconferenceforum.org.

    Building a Successful Relationship with your Development Partner Oct 05, 2021

    While the idea that trust between sponsors and development partners is integral to success is well known, actually building that relationship requires real effort and empathy from both groups. Today, Dr Skip Sands, Senior Vice President and Senior Medical Officer of Parexel Biotech, discusses practical examples of how to build and maintain that relationship of trust and navigate challenges that arise based on his experience on both sides of the sponsor and CRO partnership. Key takeaways: How to choose the right development partnerBuilding the relationship infrastructure from the bid process through clinical developmentCommunicating and managing expectations between sponsors and CROs Guest: Earl “Skip” Sands, MD, MBA, Senior Medical Officer, Parexel Biotech Prior to joining Parexel Biotech as Senior Medical Officer in 2019, Dr Sands served as the Chief Medical Officer for Selecta Biosciences (2015-2019), Targacept (2014-2015) and Plasma Surgical (2013-2014). From 2011 to 2013, he was a consultant to biotechnology, pharmaceutical, and health care companies, leading protocol development and execution for Phase 1-4 studies in areas including women’s and men’s health, oncology, neuroscience and gastroenterology. From 2003 to 2011, Dr Sands was with Solvay Pharmaceuticals/Abbott Laboratories (following its acquisition of Solvay) in a series of roles of increasing responsibility culminating as Executive Vice President, Market Access and Senior Vice President of Research and Development. Earlier in his career, he worked with Procter & Gamble Pharmaceuticals, founded a medical education company, and was a managing partner in a medical practice. He earned his Medical Doctor Degree from Hahnemann University School of Medicine in Philadelphia, PA, and has completed courses in the Executive MBA program at Emory University in Atlanta, GA.

    9th Annual Chief Medical Officer Summit 360° Overview in 5 Minutes Aug 27, 2021

    In this podcast, Conference Producer, Andrew Goldstein, reviews what to expect at the 9th annual Chief Medical Officer Summit 360°. The conference will take place October 14-15, 2021 in Boston, MA also with virtual attendance options. Learn more about the conference taking place October 14-15, 2021 at theconferenceforum.org

    10 Year Review on Drug Delivery Aug 17, 2021

    In this podcast, first presented at the PODD: Partnership Opportunities in Drug Delivery 2020 conference, you will hear Dr Barbara Lueckel, Roche Pharma Partnering provide her annual review on the drug delivery industry including notable highlights and partnerships that occurred over the past ten years. To learn more about the 2021 PODD: Partnership Opportunities in Drug Delivery conference please visit www.poddconference.com

    8th annual Mobile in Clinical Trials in 5 Minutes Aug 04, 2021

    In this podcast, Conference producer, Mark Scherzer, reviews what to expect at the 8th annual Mobile in Clinical Trials conference. The conference will take place September 27, 2021 in Boston, MA also with virtual attendance options. Learn more here.

    PODD 2021 in 7 Minutes with Director, Valerie Bowling Jul 27, 2021

    In this podcast, Valerie Bowling, Director of the PODD Drug Delivery conference gives a run down summarizing what is being featured at the 11th annual event. Learn more about the conference taking place October 28-29, 2021 at poddconference.com

    Ferring on Creating a First-in-Class Microbiome-Based Therapeutic Jul 19, 2021

    Disruptions in the microbiome are increasingly being linked to an associated risk for serious illnesses, opening up vast potential to create a new category of innovative microbiome-based live biotherapeutics to help people live better lives and advance current standards of care. Today, Dr James Tursi, Chief Scientific Officer of Ferring Pharmaceuticals, discusses study results of Ferring’s Phase III Trial for their microbiome-based live therapeutic (RBX2660), used in the treatment of recurrent C Difficile, and how to harness the potential of the the fast-emerging world of microbiome-based therapeutics. Key takeaways: Why now is the right time to tackle the microbiomeResults and impact of Ferring's RBX2660 treatmentNext steps for the industry About the speaker: Dr James Tursi is Chief Scientific Officer, Ferring Pharmaceuticals, responsible for US Clinical Development, Pharmaceutical Development, Medical Affairs, Pharmacovigilance, Project Planning and Regulatory Affairs. Prior to joining Ferring, as EVP, R&D, Chief Medical Officer for Antares Pharmaceuticals, he created patent extension and portfolio opportunities, was the medical-clinical-PV lead for commercial and business development activities and designed the medical/clinical commercial strategies. Before joining Antares, James held positions of increasing responsibility at Aralez Pharmaceuticals, Auxilium Pharmaceuticals, GlaxoSmithKline, and Procter & Gamble Pharmaceuticals. His therapeutic expertise includes reproductive health, urology, endocrinology (including pediatric), gastroenterology, cardiology, vascular surgery, oncology and neurology. For more information about PharmaTalk Radio, visit theconferenceforum.org.

    DPHARM in 10 Minutes with Director Valerie Bowling Jul 12, 2021

    DPHARM Executive Director, Valerie Bowling gives a 10 minute run down on what you can expect from DPHARM 2021. Learn more about the conference taking place Septmeber 28-29, 2021 at DPHARMconference.com.

    The Biotech Incubator Helping Entrepreneurs Launch Companies to Advance Health Jul 07, 2021

    This PharmaTalk Radio episode features Dr Shawn Carbonell, CEO and co-founder of Brazen Bio. In this conversation, Dr Carbonell describes how the Brazen Incubator, a turn-key biotech startup incubator, hopes to help fledgling entrepreneurs, the common hurdles that prevent startups from getting off the ground, and recruiting underrepresented founders. Dr Carbonell started the incubator, based in Los Angeles, with cofounder Dr Brent Witgen. About Dr Carbonell and Brazen: In 2009, Dr Carbonell quit neurosurgery residency to found the clinical stage biotech startup, OncoSynergy, Inc, a UCSF spinout. Brazen Bio, which launched in May 2021, is solving the problem Dr Carbonell had over a decade ago when founding his company. Launching a biotech startup requires laboratory access, specialized equipment and other resources. The Brazen Incubator provides the basic infrastructure to founders, including 24/7 laboratory access, resources and housing. For more information about our PharmaTalk podcasts, you can visit theconferenceforum.org. For more information about our Chief Medical Officer 360˚ summit, click here; and for more information about our Immuno-Oncology 360˚ conference, click here.

    How and When to Pursue Decentralized Clinical Trials: Conversation with Experts Jun 15, 2021

    In this conversation between two decentralized clinical trial experts, John Reites, CEO of THREAD, and Andy Iverson, Clinical Outcomes Solutions lead at Medtronic, are discussing decentralized clinical trials: where they don’t work yet and how that might change, the considerations for disease indication and trial type, what technology to use, and what an adoption journey could look like. Key Takeaways: When DCTs don’t work (yet) Technology, operations and knowledge perspectives What a phased approach looks like Identifying the key stakeholders Speakers: Andy Iverson is the Clinical Outcomes Solutions lead on the Evidence Optimization Center of Expertise team at Medtronic. In this role he functions as a subject matter expert and project team leader for initiatives related to artificial intelligence, decentralized clinical trials, and interoperability. His career includes 10+ years working with provider and payer systems and data. Andy serves as the Co-Chair of HL7s Biomedical Research and Regulation workgroup and is on the Operations Committee of the HL7 Vulcan FHIR Accelerator. He received a BA in Healthcare Management at Concordia College and an MS in Data Science at Northwestern. John Reites is CEO of THREAD. Executive intrapreneur turned digital health entrepreneur, his career includes 18 years leading global drug development, clinical trials, decentralized studies and clinical research innovation. As CEO of THREAD, he’s led the company’s efforts to change the way clinical research is conducted, focused on decentralized approaches and enabling the use of their platform to conduct modern research studies while supporting partnerships with their customers.

    How to Utilize Technology to Truly Increase Diversity in Clinical Trials Apr 15, 2021

    Learn lessons from a healthcare communications and clinical trial recruitment expert about addressing health disparities in racial and ethnic minorities, utilizing technology to precisely raise awareness, and bridging the digital divide, and how to: Leverage technology to raise awareness and engage post-trialChange practices to address mistrust amongst typically underserved populationsUse technology to recruit more diversely and representatively in the pandemic Speaker: Becky Johnson, PhD, Director, Global Diversity & Inclusion in Clinical Trials, IQVIA: Becky has 20 years of experience in the biopharmaceutical industry and is a subject matter expert in healthcare communications and clinical trial recruitment with a focus on diversity, equity and inclusion. Becky leverages her expertise to inform the strategic direction and initiatives to support pharmaceutical company sponsors with their efforts to achieve more racially and ethnically diverse trial populations. Becky has a Master’s in Public Health and a PhD in Health Sciences. Her doctoral dissertation research focused on facilitating access to clinical trials for racially and ethnically diverse patients. For more information on PharmaTalk podcasts, click here. For more discussions and updates on innovations in clinical trial operations and the use of devices in research, visit theconferenceforum.org to learn about the Patients as Partners in Clinical Research conference.

    Insights from CRAACO 2020 and Looking to the Future Apr 09, 2021

    In this podcast, Roger Boutin, VP of Communications at SCORR Marketing discusses the results of an audience survey from the 2020 CRAACO: Clinical Research as a Care Option Conference. The poll focused on the areas of: Patient Input and EngagementDealing with COVID and Patient OutreachDiversity and Collaboration Around Clinical TrialsAccelerating the CRAACO Movement

    The Practical Implementation of Sensors in the Changing Drug Development World Jan 22, 2021

    In this conversation, you'll learn lessons of how to implement sensors for the most impact in your clinical trials. Join three sensor experts as they discuss: What phases of clinical trials are more suited for sensor useHow to select and integrate the deviceHow to ensure compliance Speaking: Keith Wenzel, Senior Director, Parexel’s Scientific Data Organization: Keith's areas of subject matter expertise include electronic clinical outcomes assessment, patient sensors and a broad range of eClinical technology used within clinical drug trials.Julia Lakeland, Solutions Architect and Program Director, Parexel: Julia is responsible for selection and implementation of real-world scientific data sources and wearables for clinical trial use. Her background is in product management, operational delivery and support of phase III/IV clinical trials. Thomas Wells, CEO, Precision Digital Health: Thomas is currently focused on bringing innovative big data solutions to market to support real-world evidence research and clinical trial research that scale to meet the shear volume and diversity of data sources with evolution of digital health and precision medicine. For more information on PharmaTalk podcasts, click here. For more discussions and updates on innovations in clinical trial operations and the use of devices in research, visit theconferenceforum.org to learn about the upcoming DPHARM: Disruptive Innovations conference, held September 28-29, 2021, and the Mobile in Clinical Trials event, held September 27, 2021.

    Patients as Partners Europe 2021 Overview in 5 Minutes Jan 11, 2021

    Patients as Partners Europe conference producer, Mark Scherzer, provides an overview of the upcoming virtual conference agenda to take place 25-26 January 2021. Hear about the sessions, keynotes, interactive opportunities, and what you will walk away with, including: A range of examples of patient engagement ideas in the early stages of research to advance clinical outcomesAn understanding of how to design hybrid trials around patient preferences to drive better enrollment and retentionHow to increase diversity in clinical trialsHow to manage the issues that arise when implementing new approachesHow to influence organizational change to support patient engagement and clinical research awareness strategiesExpand your professional network by connecting with peers who can provide a wide range of insightsLearn directly from patient advocates who bring a broad spectrum of ideas to the conversations Learn more about the conference here.

    Innovations & Novel Approaches in IO Imaging & Assessing Responses Dec 27, 2020

    In this podcast, you will hear a panel discussion moderated by Dr Annette Schmid, Takeda Pharmaceuticals from the 2020 IO360° Summit regarding innovations and novel approaches in IO imaging and assessing responses. Panelists inclue: Gregory Goldmacher, MD, PhD, MBA, MerckS. Peter Eggleton, MD, FFPM, Merck KGaARon Korn, MD, PhD, Imaging EndpointsMatthew Silva, PhD, Invicro To learn more about the upcoming 2021 IO360° Summit please visit www.io360summit.com

    HLA Loss and the Impact on Immunotherapy Dec 27, 2020

    Loss of the HLA locus impairs presentation of tumor antigens and is frequently found in advanced cancers. This talk presented by Dr Lee Albacker, Foundation Medicine and first recorded at the 2020 IO360° Summit, will describe the landscape of HLA loss and other response biomarkers in a dataset of 90,000 solid tumor samples and highlight the effect of HLA loss on checkpoint inhibitor response. To learn more about the upcoming IO360° 2021 Summit please visit www.io360summit.com

    Cell & Gene Therapy Debate: Intrinsic Editing vs Systemic Combination Dec 27, 2020

    In this podcast first recorded at the 2020 IO360° Summit, Dr Aiman Shalabi, GSK, moderated a cell and gene therapy debate on intrinsic editing vs systemic combination Participants included: Mark O’Hara, MD, University of PennsylvaniaSaul Priceman, PhD, City of Hope To learn more about the upcoming IO360° 2021 Summit please visit www.io360summit.com

    Operational Dynamics of Implementing & Managing Basket Trials Dec 27, 2020

    In this podcast, first recorded at the IO360° 2020 Summit, Dr Millie Schultz, Seattle Genetics, discusses operational dynamics of implementing and managing basket trials. Discussion points include: What are the operational complexities of basket trials? How do they differ from standard IO trials?How do you identify the right institutions who can handle basket trials? What goes into that decision making?How do you set up your protocol in an open ended way so that you can add a cohort or make adjustments based on signals you received?How do you set up your database to be able to manage all the different tumor types and different types of case port forms. To learn more about the upcoming IO360° 2021 Summit please visit www.io360summit.com

    Overcoming Site Regulatory Issues to Optimize Clinical Quality Dec 11, 2020

    How two companies collaborated on a master trial to drastically improve site startup speed, reduce delays and optimize CRA productivity. In this podcast, Rick Arlow, Complion, and Dr Len Rosenberg, Leukemia and Lymphoma Society, discuss their collaboration on a LLS master trial, and how adopting Complion’s a purpose-built design optimized site functions and reduces startup time. Some specific discussion points included: The challenges sites face today with arduous manual tasksHow to pick the right point solution technology for your studyWhat the impacts of their collaboration have been on study progressHow this all benefits patients For more information about optimizing clinical research for the patient benefit and for improving care, visit the Clinical Research as a Care Option webpage. The 2021 Clinical Research as a Care Option event will be held April 26-28, virtually.

    Evolution of Regulatory Policy For Cell/Gene Therapy Nov 03, 2020

    In this podcast, first recorded at the 2021 IO360° Summit, Dr Peter Marks, Center for Biologics Evaluation and Research (CBER), FDA, moderated a panel on the evolution of regulatory policy for cell/gene therapy. Discussion points include: What are the greatest challenges to the expeditious development of cell and gene therapies at this time?How does the existing regulatory framework mesh with the current state of development of cell and gene therapy products?What adaptations or adjustments to the regulatory framework that might further advance manufacturing or clinical development of these products?Are there scientific developments coming that will require further adaptation or adjustment to the regulatory framework? Panelists include: Jeff Allen, PhD, Friends of Cancer Research Anne Chew, PhD, University of Pennsylvania Alberto Santagostino, Lonza Pharma & Biotech To learn more about the upcoming 2021 IO360° conference, please visit www.io360summit.com

    Centralized vs Decentralized Manufacturing Nov 03, 2020

    In this podcast first recorded at the 2020 IO360° Summit, Michael Paglia, ElevateBio, moderated a cell & gene therapy debate on centralized vs decentralized manufacturing. Participants included: Boro Dropulić, PhD, Lentigen Patrick Hanley, PhD, Children’s National Medical Center/George Washington University To learn more about the upcoming 2021 IO360° Summit, please visit www.io360summit.com

    Next Generation Bispecifics in Solid Tumors Nov 02, 2020

    In this podcast, you will hear a panel discussion moderated by Dr Priti Hegde, Foundation Medicine, from the 2020 IO360° Summit regarding next generation bispecifics in solid tumors. Discussion questions include: What is happening in hematology bispecific programs compared to solid tumor bispecific programs?What do bispecifics look like in solid tumors and what is driving efficacy?What’s hindering efficacy in solid tumors compared to hematology?How can we improve on it?What should we be doing on the next generation bispecifics? Panelists: Julie Bailis, PhD, Amgen Dimitris Skokos, PhD, Regeneron Pharmaceuticals David Schaer, PhD, Pfizer Pablo Umaña, PhD, Roche To learn more about the 2021 IO360° Summit, please visit www.io360summit.com

    Ariella Chivil's Immunotherapy Trial Pathway Nov 02, 2020

    In this podcast, you will hear a fireside discussion from the 2020 IO360° Summit featuring cancer survivor and advocate, Ariella Chivil who walked the audience through her immunotherapy trial pathway alongside patient advocate, Cindy Geoghegan, who moderated the chat. To learn more about the 2021 IO360° Summit, please visit www.IO360Summit.com

    Insitu Vaccinations vs Systemic Neo-Epitope Vaccinations Oct 30, 2020

    In this podcast first recorded at the 2020 IO360° Summit, Asthika Goonewardene, SunTrust Robinson Humphrey, moderated a cancer immunotherapy debate on insitu vaccinations vs systemic neo-epitope vaccinations. Participants included: Charles Drake, MD, PhD, Columbia University Medical Center Karin Jooss, PhD, Gritstone Oncology To learn more about the upcoming 2021 IO360° Summit, please visit www.io360summit.com

    What Do Next Generation of Immunotherapies Need to Look Like to Move the Needle? Oct 30, 2020

    The frenzy of deals around IO programs and companies has led to what could be referred to as “BD outpacing science.” That might be said too of the combination trials that have displayed varied results, with a few showing clear benefit, some being outright failures and some promising but not definitive signs of efficacy. These results, while not exactly slowing the IO gold rush, have somewhat tempered enthusiasm and perhaps led to a certain maturing in dealmaking, as seen by the shifting to more back loaded terms. Which is all by way of framing the context of the macroenvironment, which now begs the question of where will the next big shift come from in immunotherapy. This podcast, recorded at the 2020 IO360° Summit, will tie together discussion on scientific, translational and business development considerations into the latest thinking on strategizing development in IO that will impact collaborations and investment decision making. Discussion points: Will it be innovative cell therapies, vaccines against neoantigens, or the next wave of oncolytic viruses?Will it be known targets with better approaches to modulating them like TGF-beta, A2AR/CD73, even CTLA-4?Will it be novel targets and pathways targeting transcription or hitting new TNF superfamily members, or new approaches to modulate the TME “bad actors” like MDSCs, CAFs, TAMs, TANs and Tregs? Moderated by: Jeffrey Bockman, PhD, Cello Health BioConsulting Panelists: Jennifer Buell, PhD, Agenus Bio Charles Drake, MD, PhD, Columbia University Medical Center Asthika Goonewardene, MBA, SunTrust Robinson Humphrey Michael King Jr, Fortress Biotech Emmett Schmidt, MD, PhD, Merck Research Labs To learn more about the upcoming 2021 IO360° Summit, please visit www.io360summit.com

    Using Sensor Technology to Deploy Decentralized Trials and Improve Patient Care Oct 29, 2020

    In this PharmaTalk episode, get guidance from patient innovation and technology experts about the proper ways of harnessing technology in order to deploy Decentralized Clinical Trials and improve patient care. Specifically, in this episode Rosamund Round and Julia Lakeland, both of Parexel, discuss: How sensors can be utilizedThe patient impact of COVID-19 and clinical trialsEfforts to support patient safety and trial continuityProtocol around assessments for data collection with sensors Interview Guests: Julia Lakeland, Solutions Architect and Program Director at Parexel, is responsible for selection and implementation of real-world scientific data sources and wearables for clinical trial use. Her background is in product management, operational delivery and support of phase III/IV clinical trials. Rosamund Round, VP, Patient Innovation Center, spends her time devoted to simplifying the patient journey in clinical trials. Focused on the reduction of geographical, financial and practical barriers to study participation, Rosamund is excited by the industry shift towards a truly patient centric approach. Ms Round will be speaking at the upcoming Patient as Partners Europe conference,

    Current Issues and Potential Solutions for Site Audit Readiness and Monitoring Oct 26, 2020

    In this PharmaTalk episode, learn what can be done to enhance site audit readiness and monitoring. Rick Arlow, CEO of Complion, recently spoke with DPHARM quarterly newsletter writer, Danny McCarthy, to discuss: Why he believes that the traditional model for site monitoring doesn't serve the industry anymoreHow a purpose-built approach could free up valuable CRA time and reduce costly delays and amendmentsWhat these new processes could mean for research moving forward, answering the question, "How do we make site monitoring better, not just digital?" About Rick Arlow: Rick Arlow is the CEO and founder of Complion, an eRegulatory and Document Management provider. Mr Arlow began his career in clinical research while participating in a NIH-funded MD/PhD medical scientist training program, and was shocked at how cumbersome operations and regulatory compliance were for the research sites and how much time was wasted on manual tasks and paper binders. Drawing on his engineering background, and inspired by his work in clinical research, Rick Arlow built the first version of the Complion software platform. Mr Arlow spoke at the DPHARM: Disruptive Innovations in Clinical Trials conference on September 22-23rd, virtually, about bridging sites and sponsors with innovations in site regulatory.

    5 Minute Overview of 8th Annual CMO Summit 360º Oct 19, 2020

    In this podcast, conference producer, Andrew Goldstein, provides a brief overview of what to expect at the 8th annual Chief Medical Officer Summit 360º. The 2020 program will attract the largest gathering of physicians in biotech on October 26-27, 2020. Although the program is primarily designed for CMOs of emerging biotech companies, large pharma CMOs and other R&D decision-makers also attend to exchange best practices in drug development and business management. Learn more about the 2020 Summit here.

    The Future of Clinical Research and the Innovation from the COVID-19 Pandemic Oct 07, 2020

    In this PharmaTalk podcast, Benjamine Liu, DPhil, CEO of TrialSpark, discusses the impacts of COVID-19 on the future of clinical research and the innovation being created as a result. Ben recently spoke at DPHARM: Disruptive Innovations to Advance Clinical Trials, moderating an R&D leadership fireside chat with Drs Mark Fishman and Michel Mina. In this podcast, he recently spoke with DPHARM writer Danny McCarthy about: Embracing powerful technology into trials, particularly for the benefit of at-home monitoringDiversity in clinical researchThe growing and potential impact of artificial intelligence on clinical research Ben will be demonstrating the value of OpenAI's GPT-3 natural language processing model and artificial intelligence at an upcoming webinar, October 22 at 1pm EST. For more information and to register to attend, go to theconferenceforum.org. Guest: Benjamine Liu, DPhil, is the co-founder and CEO of TrialSpark, a technology company that is reimagining drug development. TrialSpark partners with doctors to create FDA compliant trial sites within their existing practices (like Airbnb), unlocking the 99% of patients and doctors not involved in trials today and democratizing access to research treatments. TrialSpark runs trials out of these sites using a roaming cohort of research coordinators (like Instacart), optimized by software, data, and machine-learning.

    Connecting Care and Research for the Patient with a Decentralized Trial Model Sep 30, 2020

    In this PharmaTalk episode, John Potthoff, PhD, CEO of Elligo Health Research explains the benefits of decentralized clinical trials. He recently spoke with CRAACO quarterly news writer, Danny McCarthy to discuss why he believes that decentralized clinical trials can be more patient-friendly, how it epitomizes clinical research as a care option and how the model helps to access patients who have no other way of participating in trials. Dr Potthoff will be speaking at the CRAACO: Clinical Research as a Care Option conference on November 4-6th virtually. About John Potthoff, PhD: John Potthoff, PhD, is the CEO and co-founder of Elligo Health Research, which aims to accelerate the development of new pharmaceutical, biotechnology, medical device, and diagnostic products using their novel clinical technology.

    Remote Monitoring for Clinical Research in the Digital Age Sep 18, 2020

    In this PharmaTalk podcast, MaryAnne Rizk, PhD, of IQVIA, leads a multi-perspective panel discussion on monitoring in the digital age as data becomes the new currency. Together they discuss how AI and ML are empowering sponsors and sites to predict risk before it happens, how modernization is expanding remote monitoring capabilities and the waterfall impact of that on analytical roles, and how this technology can be leveraged to benefit patient engagement and data standards. Dr Rizk went into deeper detail on this subject at the 2020 DPHARM: Disruptive Innovations conference. Moderator: MaryAnne Rizk, Ph.D. - SVP Digital R&D, IQVIA Guests: Michael Mittleman – Patient Advocate Ray Reilly – VP, Clinical Operations, TG TherapeuticsRajneesh Patil – Head, Process, Technology & Analytics, IQVIA For more information about PharmaTalk podcasts, visit theconferenceforum.org. A special thanks to the team at IQVIA for their support in presenting this podcast.

    Solving for the Patient Retention Problem in Clinical Research Sep 09, 2020

    In this PharmaTalk episode, Thomas Klein, founder and CEO of Be the Partner, discusses how to implement new retention and engagement methods to stop patients from "vanishing" in the clinical trial process. Mr Klein sat down with PharmaTalk's Danny McCarthy to discuss potential solutions, including transparency of data, increasing communication before, during and after trials, and truly making patients "partners" in the research. Mr Klein presented at the 2020 Patients as Partners virtual conference. Guest: Thomas Klein is the CEO and founder of Be the Partner, a technology company that is focused on how patients can use their health data to improve outcomes for themselves and others around the world. For more information go to or contact www.bethepartner.com.

    IO Combinations 360° Overview in 7 Minutes Sep 08, 2020

    Kate Woda, IO Combinations 360° Conference Director, gives a 7 minute overview on what you can expect at the 5th annual IO Combinations 360° conference taking place October 1-2 virtually. 2020 Key Topics: Discovery / Preclinical ScienceBispecificsTranslational Science & BiomarkersNext Generation Cell TherapyClinical DevelopmentsOperationalizing CombinationsBusiness AspectsEmerging Technologies Keynotes Include: Ronald Germain, MD, PhD, National Institutes of HealthSteve Hamilton, Melanoma Cancer SurvivorEdward Tenthoff, Piper Sandler & Co. 2020 Strategic Leadership: Dan Chen, MD, PhD, IGM BiosciencesAxel Hoos, MD, PhD, GSKAlexandra Snyder, MD, Merck Research LabsOmid Hamid, MD, The Angeles Clinic and Research InstituteRaluca Verona, PhD, Janssen R&DJames Gulley, MD, PhD, National Cancer Institute, NIHTheresa LaVallee, PhD, Parker Institute for Cancer ImmunotherapyRoy Baynes, MD, PhD, Merck Research LabsMichael Kalos, PhD, ArsenalBio Learn more about the upcoming IO Combinations 360° virtual conference at www.iocombinations360.com

    Enabling Clinical Trial Continuity with Live Video Visits Sep 08, 2020

    In this PharmaTalk podcast, Kelly McKee of Medidata leads a multi-perspective panel discussion on the challenges and opportunities of adopting a decentralized model for clinical trials and ensuring clinical trial continuity with live video visits. Together they discuss lessons learned from the rapid adoption of technologies to allow for more decentralized trials, how incorporating multiple perspectives highlights areas of growth when utilizing a decentralized approach, and the possibility of hybrid trials becoming the new normal for the near future. Host: Kelly McKee is the Senior Director of Patient Recruitment and Registries at Medidata Guests: Anne Marie Mercurio is a patient and research advocate and caregiver. Rosamund Round is Vice President of PAREXEL’s Patient Innovation Center. Jeff Kingsley, DO, is the founder and CEO of IACT Health. For more information about PharmaTalk podcasts, visit theconferenceforum.org. A special thanks to the team at Medidata for their support in presenting this podcast.

    Roche's Dr Barbara Lueckel's Opening Remarks and the 2018 Year in Review Aug 26, 2020

    Chair of the Partnership Opportunities in Drug Delivery (PODD) event, Dr Barbara Lueckel, Global Head of Research Technologies Partnering at Roche, presents an annual year-in-review of the drug delivery landscape from 2018. Dr Lueckel’s opening remarks are a highlight of PODD every year, and we’re excited to have her return as program chair for the 2020 event, taking place virtually October 8-9, 2020. About Dr Lueckel: Barbara is the Global Head of Research Technologies Partnering and a member of the Roche Pharma Partnering leadership team since May 2019. In her role she is working closely with the two research and early development organizations at Genentech and Roche (gRED and pRED) to identify transformative science developed by biotechs around the globe and help set up partnerships with such biotechs to enable novel discovery programs with the goal to increase the number of medicines impacting patients’ lives. Prior to Roche, Barbara worked at Novartis for ten years both on formulation development of poorly soluble molecules as well as on evaluations of reformulation opportunities as potential line extensions based on external drug delivery technologies. She is trained as a pharmacist with a PhD from the University of Basel.

    How a Gene Therapy for Duchenne Muscular Dystrophy Came to Be Aug 25, 2020

    This podcast dives into the history of creating a gene therapeutic for Duchenne Muscular Dystrophy. Dr Richard Jude Samulski has been studying gene therapy and the use of the AAV vector for decades. Recently, preliminary results from Pfizer were published on a small gene therapy trial for Duchenne Muscular Dystrophy with promising results, and Pfizer is scheduling a larger trial for later this year. That gene therapy originated from Dr Samulski work and from AskBio, and uses an adeno-associated virus to carry a healthy copy of the dystrophin gene; the virus was injected into boys with DMD, broke into their muscle cells, and replaced their non-working gene. Dr Samulski sat down with PharmaTalk's Danny McCarthy to discuss the process of creating an AAV vector to carry the gene therapeutic, the mechanisms of the therapy in DMD and what the future of the gene therapy landscape might look like. Guest: R. Jude Samulski, PhD, is President, Chief Scientific Officer and Co-Founder of Asklepios BioPharmaceutical and Professor of Pharmacology in the UNC School of Medicine. Dr Samulski has worked with AAV for 40 years, and for 25 years, he was director of the University of North Carolina Gene Therapy Center. Asklepios Bio's Chief Medical Officer, Martin Childers, DO, PhD, will be speaking at the Chief Medical Officer 360˚ summit, October 26-27, 2020, virtually.

    How a Covid-19 Research Study was Formed with Oracle, Javara and Wake Forest Jul 27, 2020

    This podcast tells the story of how a community-based COVID-19 research study was formed from a partnership between Oracle Health Sciences, Javara Research and Wake Forest Baptist Health, with the end goal of using regional infection patterns to understand the virus and develop strategies to contain it. Kathy Vandebelt of Oracle sat down to talk about the partnership enhanced Oracle's Therapeutic Learning System, which was set up to track how physicians were treating individuals infected with the virus and making the information available for others to learn from, for a real-world surveillance study. The collaboration resulted in the addition of a new component for the platform, the Patient Monitoring System, which aided in collecting daily information across a large population of participants and offering them the potential to participate in regular testing. That technology is being used for multiple studies on local, regional, national and now global levels. In the conversation, Ms Vandebelt also discusses the unexpected collaborations that emerged across the research spectrum as a result of the pandemic, how the Oracle team adapted their technology to keep pace with an evolving on-the-ground situation, and how clinical operations might benefit from adopting more decentralized measures, ultimately giving patients more choices. Guest: Kathy Vandebelt is Global Head of Clinical Innovation for Oracle Health Sciences, where she uses the power of technology to introduce new experiences and expectations to make the clinical research ecosystem better for patients, healthcare providers, sponsors and regulators. For more information about Oracle's COVID-19 response, visit Oracle.com. For more information about PharmaTalk Radio podcasts, go to theconferenceforum.org.

    IO Biomarker Discovery & Personalized Cancer Therapy Development with Personalis Jun 19, 2020

    PharmaTalk Radio’s Kate Woda welcomes guest, Erin Newburn, Director and Field Applications Scientist at Personalis on the topic of IO Biomarker Discovery and Personalized Cancer Therapy and how Personalis is enabling this. Guest Bio: Erin Newburn, PhD joined Personalis as a Field Applications Scientist in 2013 with over 12 years of research experience in the areas of molecular biology, genetics, and biotechnology. As the Director of the Field Applications Scientist team, Dr Newburn’s group has the responsibility of providing both pre- and post-sale scientific and technical support for the Personalis ImmunoID NeXT Cancer Portfolio. Dr Newburn completed her postdoctoral training at the National Institute of Mental Health (NIMH) investigating candidate susceptibility genes for major psychiatric illnesses. Dr Newburn received her PhD from the Ohio State University in Integrated Biomedical Science as a Presidential Fellow. Information about Personalis, visit www.Personalis.com Information about upcoming conferences and podcasts on medicine development, visit theconferenceforum.org.

    The Impact of COVID-19 on Clinical Trials: Where are We? And Where are We Going? Jun 18, 2020

    As the country goes through the phases of reopening, what does that mean for the patient and site experience in clinical trials? PharmaTalkRadio’s Valerie Bowling discusses the future of clinical trials with Dr Ray Dorsey, Matt Kibby and Craig Lipset. Together they address lessons learned from the rapid adoption of technologies to allow for more decentralized trials and their impact on study participation design moving forward, what sponsors can do to set themselves up for success, and the possibility of hybrid trials becoming the new normal for the near future. Guests: Ray Dorsey, MD, is the David M. Levy Professor of Neurology and Director of the Center for Health & Technology at the University of Rochester. Matt Kibby is President, Principal of BBK Worldwide Craig Lipset is the founder of Clinical Innovation Partners and the former Head of Clinical Innovation and Venture Partner at Pfizer You can find all three of our guests speaking at either the upcoming Mobile in Clinical Trials conference or the 10th annual DPHARM conference virtually over September 21st-23rd. For more information about these conferences and other podcasts, visit theconferenceforum.org. For more information about BBK, visit BBKworldwide.com Dr Dorsey's book on Ending Parkinson's Disease can be found on Amazon. You can keep up with Craig Lipset at twitter.com/craiglipset A special thanks to the team at BBK for their support in presenting this podcast.

    7th Annual Mobile in Clinical Trials Overview in Under 5 Minutes Jun 18, 2020

    In this podcast, Mark Scherzer, producer of Mobile in Clinical Trials gives an overview of what to expect at the 2020 virtual conference. The 7th annual meeting is co-chaired by Bayer's Michelle Shogren and Healthmode's Dan Karlin and reports on the latest progress in applying mobile-digital tools and patient-facing technologies for flexibility while connecting and empowering patients. It will feature collaborative, experience-based case studies to help R&D move faster to provide more choices for patients and investigators while obtaining better outcomes in drug development.

    KPIs that Support Innovation for Patient-Engagement May 10, 2020

    In this podcast, first recorded at the 2019 DPharm: Disruptive Innovations conference, Takeda's Dr Andrew Plump and Dr Jessica Scott discuss how they have developed KPIs that support innovation for patient-engagement. Dr Plump leads Takeda's global R&D organization, where he provides strategic direction and oversights. He specializes in bringing and unwavering focus on patients and a deep commitment to innovation and positive change in the healthcare industry. Speakers: Andrew Plump, MD, PhD, President, Research & Development, Takeda Pharmaceuticals Jessica Scott, MD, JD, Head of R&D Patient Engagement, Takeda Pharmaceuticals The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

    Starbucks: Innovation for the End User Experience May 09, 2020

    In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Starbucks' Robert Mercer sits down with Eli Lilly's Joe Kim to discuss the end-user experience in mobile technology. This out-of-industry example covers how they approach innovation and in particular how they designed their mobile experience with the customer in mind. More specifically: Barriers and executive buy-inRolling out the mobile experienceBalancing the scale of new solutions across stores around the globe with the need to maintain existing operations and deliveryHow Starbucks engages with the customers to learn and develop innovative new solutions Speakers: Robert Mercer, Design Director, Global Digital products, Starbucks Joseph Kim, MBA, Sr. Advisor, Clinical Operations and Digital Registry, Digital Health Office, Translational Technology & Innovation, Eli Lilly & Co. The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

    Transparency and the Future of Patient Expectations May 09, 2020

    In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Healthgrades' founder Kerry Hicks sits down with Craig Lipset for a keynote discussion on transparency and the future of patient expectations. "Everyone likes progress and no one likes change." - Kerry Hicks Kerry Hicks is the founder of Healthgrades, which puts the power of transparency into millions of patients' hands on provider visit experiences. The discussion begins with his vision for Healthgrades, what it was like to build it, early fears, and unintended consequences. Also covering: the intersection of patient experiences, technology, and clinical research as well as Kerry's insights on why you must consider transparency with everything you build moving forward. Speakers: Kerry Hicks, MBA, Founder, Healthgrades Craig Lipset, MBA, former Head of Clinical Innvation, Pfizer The 10th annual DPharm: Disruptive Innovation is scheduled to take place on September 22-23, 2020. Learn more here.

    Turning Genes into Medicines: Gene Therapy for Genetic Disease May 08, 2020

    One of the goals of the Human Genome Project was to improve therapeutic options for those born with serious inherited diseases. Today gene therapy is beginning to realize this promise, with the ever-increasing level of clinical investigation in the space, and the first products coming to licensing in the last few years. In this podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, Dr Katherine High, Spark Therapeutics, reviews the current state of gene therapy, including the development of therapies for diseases that were previously untreatable, and, for diseases where therapeutics already existed, the development of therapies that greatly lessen the burden of treatment for the patient and the family. Hurdles in clinical development of gene therapy will be discussed. Examples will be drawn from already approved products and from investigational agents in late stage development. To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

    Formulation & Device Lifecycle Management for Biotherapeutics May 08, 2020

    Subcutaneous (SC) delivery has become the norm for treating diseases such as Rheumatoid arthritis and multiple sclerosis, and there remains great potential to offer home- or even self-administered SC delivery for several other biotherapeutics. Given that there are a number of products already on the market, they can be examined to understand what improvements and changes can be made to increase product development opportunities and also enhance the patient experience. In this podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, you will hear from clinicians (pharmacist and physician) and industry to gain insight into needs and preferences of future SC biotherapeutic formulations and devices. For example, panelists will address the issue of reducing costs and dose complexity, improving adherence, and also provide input on changes they would like to see in future SC biotherapeutic products. Moderated by: Dr Beate Bittner, Roche Panelists include: Dr Mary Nauffal, Brigham and Women's HospitalDr Manuel Sanchez-Felix, Novartis Institutes for BioMedical ResearchDr Anand Subramony, AstraZenecaDr David Ting, MGH Cancer Center/Harvard Medical School To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

    Future Outlook for Novel Drug Delivery May 07, 2020

    This podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference explores the value of drug delivery technologies both to patients and pharma with a focus on the future direction of the field. This will include a review of the state of the art for traditional modalities such as small molecules and biologics and then expand the conversation to the challenges for less common modalities such as peptides and nucleic acids. The panel members will discuss the potential scientific barriers for these future delivery technologies and the industry's willingness to invest to address these barriers. Moderated by: Dr Shawn Davis, AstraZeneca Panelists include: Dr Advait Badkar, PfizerAndré LaFreniere, BattelleMaria Teresa Peracchia, SanofiDr Julia Rashba-Step, PhosphorexTheresa Scheuble, Johnson & Johnson To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

    Modality Fluid Development: Evolving Pipelines and Drug Delivery Solutions May 07, 2020

    Merck has a long history of being open to utilizing a wide range of delivery technologies for both enabling and life cycle management. In this leadership keynote, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, Dr Allen Templeton, VP, Pharmaceutical Sciences, discusses how Merck's strategy of utilizing DDS has evolved and the role of enabling drug delivery technologies play in the Merck R&D pipeline. What emerging DDS technologies and modalities does Merck view as the most promising, and why. To learn more about the upcoming 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit, www.theconferenceforum.org

    MedTech Fireside Chat: The Journey of an Emerging Medical Device Company May 06, 2020

    In this podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, John Merhige, Credence MedSystems, Inc and Mathias Romacker, formly with Pfizer discuss the journey of an emerging medical device company from a blank piece of paper toward commercialization. Topics include: The early days: starting the company and inventing with implementation in mindThe importance of listening to the customer and incorporating feedback early - and why that can be difficultStaying in the long game - the mindset, endurance and approach to ensure you are ready when opportunity appearsCollaborating within the supply chain - why it's challenging and the right approach To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

    Case Study: Forming and Managing a Drug Delivery Alliance May 06, 2020

    Effective drug delivery collaborations combine a wide range of experiences and viewpoints with common goals to achieve successful clinical and regulatory outcomes. But the path to developing this eventual relationship is not without challenges, as partnerships that are not clearly defined upfront or effectively managed downstream can quickly derail the best of intentions. In this podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, BMS and Halozyme panelists will shed light on key considerations, challenges and lessons learned during the pre-deal courting process as well as their ongoing successful alliance. Moderated by: Jennifer Guzman, Halozyme Therapeutics Panelists include: Michael Cucolo, BMSBrian Davideit, BMSRenee Tannenbaum, Halozyme TherapeuticsTom Witt, Halozyme Therapeutics To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

    Supporting Business Models for Scaled Connected Health Drug Delivery Products May 05, 2020

    How are industry leaders looking to bridge the gap from pilot systems to scaled solutions in the market? In this podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, a panel of Connected Health leaders in the industry provide their views on how they are developing value propositions that resonate with internal and external stakeholders. Defining business and operational models that benefit patients and support evolving healthcare payment structures, while delivering strong returns to the business is central to this discussion. Moderated by: Kevin Deane, Phillips-Medisize Company Panelists include: Dhairya Mehta, TakedaPaul Upham, Roche/GenentechPaul Schultz, BrightInsightAmir Zur, Teva Pharmaceuticals To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

    Utilizing Digital Health Data to Improve Management, Prevention & Wellness May 05, 2020

    Given the increase in focus on digital health and connected device development to improve "patient centricity" and the user experience, there is a large amount of clarity and evidence needed on how to truly ladder in these efforts to achieve the uiltimate outcome for patients. The answer lies in leveraging the power of contextualized, extrinsic data that while readily available given the acceleration of technologies and tools available today, are not readily apparent to connected therapeutic ecosystems as a whole - patients, clinicians, and developers of products and solutions. This podcast, first recorded at the 2019 PODD: Partnership Opportunities in Drug Delivery conference, Dr Chris Kovalchick, Eli Lilly and Company, discusses examples from both inside and outside the drug delivery industry to demonstrate how interrogating the massive amount of environmental and background information readily available can be used to activate the seismic shift needed to move us all towars the ultimate goal for all of our customers - improved wellness and awareness. To learn more about the 10th annual PODD: Partnership Opportunities in Drug Delivery conference please visit www.theconferenceforum.org

    Understanding Jansen's Metaphyseal Chondrodysplasia May 05, 2020

    In the fourth episode of our series highlighting rare diseases, Conference Forum reporter Danny McCarthy sits down with Neena Nizar, EdD, Founder and Executive Director of the Jansen's Foundation, to discuss Jansen's Metaphyseal Chondrodysplasia. Jansen type metaphyseal chondrodysplasia is an extremely rare progressive disorder in which portions of the bones of the arms and legs develop abnormally with unusual cartilage formations and subsequent abnormal bone formation. The Jansen's Foundation goal is to speed up and fund the process of finding a cure and treatment for the rare disease. For more information: https://www.thejansensfoundation.org/ For more information about our podcasts and the upcoming Patients as Partners event: www.theconferenceforum.org

    The Collective Struggle to Evolve Data and Analytics Culture & Capabilities May 04, 2020

    In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Cellarity's Milind Kamkolkar presents on the collective struggle to evolve a drug development organization's data and analytics culture and capabilities. Including: The theory of going digital in drug developmentIdentifying hype from realityWhat is the program we are trying to solve?Take a big, complex organization and evolving it to be digitally modernWhat is the intended use of the data?Priorities, structure, culture and next steps Speaker: Milind Kamkolkar, Chief Data Officer, Cellarity The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

    Re-Thinking Clinical Development - Using Historical Data to Transform Trials May 04, 2020

    In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Genentech's Aaron Mann discusses the use of historical data to transform clinical trials and how to rethink clinical development. Speaker: Aaron Mann, Global Program Lead, Industry Collaborations Data Sharing Initiatives, Genentech, a member of the Roche Group The 10th annual DPharm: Disruptive Innovation event is scheduled to take place on September 22-23, 2020. Learn more here.

    The Evolution of Using Real World Data to Create Trial Readiness Cohorts May 03, 2020

    In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Johnson & Johnson's Dr Martine Lewi discusses the evolution of their use of Real-World Data in their clinical programs. Including: What is the state of the art in real-world data and how is patient data being used today?Innovation initiatives at J&JAccelerating the drug development cycle Speaker: Martine Lewi, PhD, MBA, Janssen Clinical Innovation, Scientific Director, Johnson & Johnson The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

    The PD-FIDI: Developing a Digital Endpoint for Parkinson's Disease May 03, 2020

    In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Sanofi's Laura Kling discusses developing a digital endpoint for Parkinson's Disease using wearables. Speaker: Laura Kling, Director, Digital Innovation, Sanofi The 10th annual DPharm: Disruptive Innovations event is scheduled to take place on September 22-23, 2020. Learn more here.

    Planning For and Addressing Missing Data in Mobile Clinical Trials May 02, 2020

    This podcast presents a session on planning for and addressing missing data form the 2019 Mobile in Clinical Trials conference. When a protocol dictates a set period of time for data collection, what happens when there's a gap in the data due to technical glitches or human error? What are the regulatory and operational implications? Discussion points include: How to prepare for missing dataHow do we handle missing data?How to rewrite protocols so that you avoid the trapForewarning and communicating with regulatorsRegulatory advice on how to address missing data Moderator: Jennifer Goldsack, MBA, Executive Director, Digital Medicine Society (DiMe) Panelists: Ariel Dowling, PhD, Associate Director of Digital Clinical Devices, Data Sciences Institute, Takeda Pharmaceuticals Marie McCarthy, MBA, Senior Director of Product Innovation, Information Technology, ICON plc Carrie Northcott, PhD, Project Team Lead, Early Clinical Development, Digital Medicine, Pfizer Shyamal Patel, PhD, Director of Data Science, Digital Medicine & Translational Imaging, Pfizer The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

    Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines May 02, 2020

    In this podcast, first presented at the 9th annual DPharm: Disruptive Innovations conference, Merck's Mark Travers presents a cornerstone discussion on Balancing Innovation with Solid Common Sense to Deliver Innovative Medicines. Merck is walking the walk in disrupting how to restore best practices for people, products, and productivity. With a clear vision on output, their remarkable team mapped a plan to an enterprise to change operational delivery. In this R&D Leadership session hear the story on how they are delivering what they promise: How to plan upfront once and do it properlyGetting the basics right and what do you need to disrupt to get thereSignificant changes on greatly improving monitoringThe use of iPad technology to monetize CRA visitsHow monitoring reports got reduced from 8 to 2Building a stable workforce with strong employee engagementBehavior, structure, systems and toolsScaling it Speaker: Mark Travers, PhD, MBA, VP, Head of GCTO Regions, Monitoring Excellence, Global Operations, Merck & Co. The 10th Annual DPharm: Disruptive Innovations conference is scheduled for September 22-23, 2020. Learn more here.

    Virtual Trials: What are We Striving for and Measurements of Success May 01, 2020

    This podcast presents a panel discussion from the 2019 Mobile in Clinical Trials conference on what we are striving for and measurements of success in virtual trials. Discussion points include: How is it getting our of pilotville?What is the barrier to adoption?Factors that impact success: Risks and Patient Preferences Moderator: Adama Ibrahim, EMBA, Associate Director, Performance Operational Capabilities, Global Clinical Operations, Biogen Panelists: Christopher Ceppi, Chief Product Officer, Science 37 Jamileh Jamison, MD, Head of Clinical Development, HealthMode Hassan Kadhim, Director, Clinical Trial Business Capabilities, GCO, BMS Casey Orvin, President, Society for Clinical Research Sites (SCRS) John Reites, Chief Product Officer, THREAD Research The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

    Escaping Pilotville: How to Scale Mobile / Digital Deployment in Clinical Trials May 01, 2020

    This podcast presents a session from the 2019 Mobile in Clinical Trials conference on Escaping Pilotville: How to Scale Mobile/Digital Deployment in Clinical Trials. Discussion points include: What KPIs are used to evaluate success/failure of a pilot?What are the barriers to scale, even when a pilot is a success?What are the operational models used by innovation teams to support deployment?Which models are working?Are study teams equipped to take on deployment efforts?What resources must be made available?How to position for scaleHow can industry remove the fear and transition from addition to the replacement of traditional efforts?Show good evidence of what works at scaleWhat should this include? Moderator: Michelle Shogren, Director of Innovation, Pharma R&D Clinical Operations, Bayer Panelists: Arthur Combs, MD, FCCP, FCCM, CMO, MC10 Ken Thoelke, EVP, Chief Scientific Officer, PRA Health Sciences The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

    Merck's Strategy to Mobilize Mobile Efforts and Engineer for Scale Apr 30, 2020

    This podcast presents a session from Merck on Mobilizing Mobile Efforts and Engineering for Scale at the 2019 Mobile in Clinical Trials conference. Mobile tool/device implementation has been widely accepted, tested, and piloted in clinical research. With the bar set, Merck looks to challenge it and create an ecosystem that continues to set the bar higher with a scalable model. In this session, Kai Bode walks the audience through their approach to coordinating and prioritizing digital efforts, building a prototype to test devices, mobilizing their mobile devices, mobile patient screenings, finding a workaround to perceived barriers and/or premature acceptance of timelines/processes and lessons learned. Speaker: Kai Bode, Director, Digital and Analytics Technologies, Merck The 2020 Mobile in Clinical Trials Conference will take place on September 21. Learn more here.

    What Does a Successful Digital Trial Look Like? Apr 30, 2020

    This podcast presents a panel discussion on What a Successful Digital Trial Looks Like from the 2019 Mobile in Clinical Trials conference. Including: What is a digital trial?Is a common definition needed in order to scale for success?What does success look like? Fully remote, data sharing, device/tool implementation?How do we measure success? And when?What about accessibility?patient/investigator experience?tool/device effectiveness?data quality and usability?did digital help answer the necessary clinical question?did it ensure representative patients in the study? Moderator: Craig Lipset, Former Head of Clinical Innovation, Pfizer Panelists: Jennifer Goldsack, MBA, Executive Director, Digital Medicine Society (DiMe) Jacob LaPorte, PhD, Co-founder & VP, Global Head of Novartis Biome, Novartis The 2020 Mobile in Clinical Trials event will take place on September 21. Learn more here.

    Advocating for People Managing Hermansky-Pudlak Syndrome Apr 29, 2020

    In the third episode of our series highlighting rare diseases, Conference Forum reporter Danny McCarthy sits down with Fernando Albertorio, PhD, to discuss Hermansky-Pudlak Syndrome. Dr Albertorio is co-founder of Sunu, Inc, which creates wearable, IoT and mobile technology that empowers independence for people who a blind and visually impaired. Dr Albertorio is also an advocate for increasing awareness and treatments for managing Hermansky-Pudlak Syndrome (HPS). HPS is an extremely rare autosomal recessive disorder, characterized by albinism, visual impairment, and a platelet dysfunction that results in prolonged bleeding. There are currently 10 known types of HPS. In the episode, Dr Albertorio mentions several websites for more information: HPSNetwork.org, GlobalGenes.org and Sunu.com.

    Maintaining Clinical Trial Patient Engagement in COVID with Be the Partner Apr 29, 2020

    The COVID-19 pandemic has meant that, more and more, clinical trials are being disrupted or interrupted completely. Without the continuous momentum and contact, trials will lose patients as gaps in studies lengthen. To combat that, Be the Partner designed “Bridge,” a new solution on their Patient Portal specifically for continuing secure, ongoing connectivity with trial patients during any temporary pauses in trials as a result of COVID-19. The end goal of “Bridge” is to maintain patient engagement throughout the trial’s indefinite pause and aid in a successful relaunch at the appropriate time. For more information go to or contact www.bethepartner.com.

    Setting Up Therapeutic + Vaccine Programs for COVID-19: Lessons Learned Apr 28, 2020

    PharmaTalk Radio's Valerie Bowling welcomes guest, Kent Thoelke, EVP and CSO at PRA Health Sciences on his experience in rapidly setting up both therapeutic and vaccine focused programs for COVID-19. More specifically, they discuss lessons learned, what the new normal will look like for clinical trials and serving the needs of thousands of people who are currently in clinical trials. Guest Bio: Kent Thoelke is Executive Vice President and Chief Scientific Officer at PRA Health Sciences. Mr. Thoelke provides corporate oversight and strategy for Scientific & Medical Affairs, Pharmacovigilance & Patient Safety, Therapeutic Centers of Excellence, Real World Data, Patient Access & Experience, Digital Health & Virtual Trials, and their integration into operational delivery. Information about PRA Health Sciences, visit PRAH.com Information about upcoming conferences and podcasts on medicine development, visit theconferenceforum.org

    Understanding Spinal Muscular Atrophy: A Chief Scientific Officer's Perspective Apr 14, 2020

    In the second episode of a three-part series dedicated to highlighting rare disease, Conference Forum reporter Danny McCarthy sits down with C Frank Bennett, PhD, of Ionis Pharmaceuticals, to discuss Spinal Muscular Atrophy. Dr Bennett is Executive Vice President and Chief Scientific Officer at Ionis Pharmaceuticals, and one of the founding members of the company. He is responsible for continuing to advance antisense technology and expanding Ionis drug discovery platform. Dr. Bennet is a co-recipient of the 2019 Breakthrough Prize in Life Sciences for his contributions to the discovery and development of SPINRAZA® (nusinersen). Spinal muscular atrophy is a genetic, degenerative neuromuscular disorder characterized by weakness and wasting in muscles used for movement. It is caused by a loss of specialized nerve cells, called motor neurons that control muscle movement. Dr Bennett includes two sources of information about Ionis and SMA: Ionispharma.com and Spinraza.com.

    Changing How We Treat Systemic Sclerosis Mar 19, 2020

    In this three-part series dedicated to the physician's perspective on living with a rare disease, Conference Forum reporter Danny McCarthy sits down with Tracy Frech, MD, to discuss Systemic Sclerosis. Tracy Frech, MD, is a rheumatologist at the University of Utah. At the university, she is the Director of the Systemic Sclerosis (SSc, scleroderma) Clinic at the University of Utah Hospital and the Director of Clinical Trials for the Division of Rheumatology. In her work, Dr Frech treats patients with, and runs clinical trials on, systemic sclerosis, a complex autoimmune disease characterized by pervasive inflammation and fibrosis, and can lead to progressive vascular and organ damage. Dr Frech talks about the disease, current treatment and taking a more holistic approach to treating SSc. In the interview, Dr Frech references the education resource TotalSSc.com., a new disease education campaign website for healthcare providers focused on the “totality in systemic sclerosis”.

    New Opportunities for Cell Therapy Combinations Mar 10, 2020

    In this podcast moderated by Dr Michael Kalos, Janssen Oncology, you will hear a panel discussion from the 2019 IO Combinations 360° conference. Topic points include: What are the new opportunities in cell therapy for combinations?What the challenges are going to be with the microenvironment?What is being done to engineer cell therapy?How do you develop CARs and TCRs that deliver payloads?How do you manufacture all of this beyond mouse models to figure out how to effectively do this in patients?How do you actually go about designing trials and testing hypothesis?How do you create the regulatory framework to do these types of studies?How do you engage with regulatory agencies to get these things moving? Panelists include: Sharon Benzeno, PhD, MBA, Adaptive BiotechnologiesChaohong Fan, MD, PhD, FDABruce Levine, PhD, University of PennsylvaniaMark Stewart, PhD, Friends of Cancer ResearchBahram Valamehr, PhD, Fate Therapeutics To learn more about the upcoming IO Combinations 360° conference please visit, www.iocombinations360.com

    PD1 Resistance with a Multi-Omic Approach Mar 10, 2020

    Anti-PD-1 therapy has transformed cancer care but most patients do not respond. It is increasingly clear that there will be no single biomarker of response to a PD-1, and that a multi-omic approach will be required. In this podcast, first recorded at the 4th annual IO Combinations 360° conference, Dr Danny Wells, Parker Institute for Cancer Immunotherapy will address: Orthogonality and correlation of response biomarkers across histologiesIntegration of multi-omic data sets for mechanistic insights into tumor immunobiologyThe translational approaches to PD1 resistance program at the Parker Institute To learn more about the upcoming IO Combinations 360° conference please visit, www.iocombinations360.com

    Updates on PARP Inhibition Mar 09, 2020

    In this podcast, first recorded at the 4th annual IO Combinations 360° conference, Dr Darren Hodgson, AstraZeneca presented updates on PARP inhibition. Topics include: Strategies to target homologous recombination repair deficiencyMonotherapy indications and current development landscapeScientific hypotheses being explored in olaparib combinations To learn more about the upcoming IO Combinations 360° conference please visit, www.iocombinations360.com

    Leveraging the Tumor Microenvironment for IO Therapy Mar 08, 2020

    First recorded at the 4th annual IO Combinations 360° conference, this talk provided by Dr Kenneth Hance, GSK addresses agonistic strategies, T and NK cell redirection and the use of genetic/phenotypic assocations to identify novel target space in IO. To learn more about the upcoming IO Combinations 360° conference please visit, www.iocombinations360.com

    Updates on Bintrafusp alfa/M7824 Clinical Data Mar 07, 2020

    In this podcast, first recorded at the 4th annual IO Combinations 360° conference, Dr Laureen Ojalvo, EMD Serono provides an overview of the moleculte Bintrafusp alfa/M7824. This molecule is an innovative, first-in-class bifunctional fusion protein composed of an anti-PD-L1 mAb fused with 2 extracellular domains of TGF-βRII (a TGF-β “trap”). The mechanism of action, pre-clinical and phase 1 studies of this molecule is discussed as well as an overview of the next wave of clinical development. To learn more about the upcoming IO Combinations 360° conference please visit, www.iocombinations360.com

    NKTR-214: Harnessing the IL-2 Pathway in Combination Immunotherapies Mar 06, 2020

    In this podcast, first recorded at the 4th annual IO Combinations 360° conference, Dr Willem Overwijk, Nektar Therapeutics discusses Bempegaldesleukin (NKTR-214): harnessing the IL-2 pathway in combination immunotherapies. Topics include: Bempegaldesleukin: Structure and function of an engineered IL-2 cytokine prodrug providing sustained IL-2Rβγ-biased signalingPreclinical PK, PD, MOA and combination with PD-1 checkpoint inhibitionClinical PK, PD, clinical response data and biomarkers in patients with melanoma and bladder cancerCombinations under investigation To learn more about the upcoming IO Combinations 360° conference please visit, www.iocombinations360.com

    Advancing Bispecifics for Combination Immunotherapy Mar 02, 2020

    First recorded at the fourth annual IO Combinations 360° conference, this panel moderated by Dr Daniel Chen, IGM Biosciences discusses advancing bispecifics for combination immunotherapy. This discussion covers the following topics: What are the types of bispecifics and what are the limitations?What are the toxicity related side effects?What are teh next steps/levels for bispecifics?What does the future hold for bispecifics? Panelists include: Julie Bailis, PhD, AmgenRajkumar Ganesan, PhD, Janssen Research & DevelopmentDavid Schaer, PhD, Pfizer To learn more about the 5th annual IO Combinations 360° conference please visit www.iocombinations360.com

    How AI, Machine Learning and Big Data are Used to Inform Combinations Mar 01, 2020

    In this podcast, you will hear a panel discussion from the 2019 IO Combinations 360° conference regarding how AI, machine learning and big data are used to inform combinations. Moderated by Matthew Albert, MD, PhD, Insitro Panelists: Edward Bowen, GSK Ryan Fukushima, Tempus Renée Deehan-Kenney, PhD, QuartzBio, part of Precision for Medicine To learn more about the 2020 IO Combinations 360° conference please visit www.iocombinations360.com

    Weighing Your Options in Considering Clinical Trials from a Patient Perspective Feb 20, 2020

    In this podcast, you will hear a panel discussion from the 2019 Clinical Research as a Care Option (CRAACO) conference with patients and advocates on weighing your care options and considering participation in a clinical trial. Some points include, Strategies and ideas to reduce the burden to patientsUnderstanding of clinical care with their physician?Communication, consent and data sharing Moderated by Cindy Geoghegan, Cancer Veteran, Patient Advocate Panelists: Allison Greiner Patient Advocate Sarah Larson, Director of Global Clinical Operations, Biogen and Cancer Veteran Kelly Piacsek, PhD, VP, Patient-Centered Research, Aurora Research Institute The 2020 CRAACO conference will take place on April 27-28 in Raleigh, NC. Learn more here.

    Understanding the Goals of Care vs Research Feb 19, 2020

    In this podcast, you will hear a panel discussion from the 2019 Clinical Research as a Care Option (CRAACO) conference on Understanding the Goals of Care Vs Research. The panelists explore points including, Goals for care vs goals for researchOversight and governanceIs there an ethical burden of breaking down the line between research and care?What is the hesitation behind embracing the blurring of this boundary?In areas like precision medicine, this is already blurring, how to manage?Hurdles stopping large companies from thinking about this– Is it practical? Ethical? Moderated by Jennifer Byrne, CEO and Founder, Javara Panelists: Greg Burke, MD, MSc, Chief Science Officer, Senior Associate Dean for Research, Wake Forest School of Medicine Amy Nordo, Director eSource Implementation, Pfizer The 2020 CRAACO conference will take place on April 27-28 in Raleigh, NC. Learn more here.

    6 Min Podcast on What to Expect at the 7th Annual Patients as Partners Feb 18, 2020

    This 6 minute podcast summarizes what you can expect during the virtual Patients as Partners conference. Key topic areas include: BioPharma Strategies on Applying Patient Engagement Initiatives and Demonstrating ImpactDirect-to-Patient Clinical Trials Next Milestones and Actions to Get ThereMeasuring the Impact of Patient Engagement and Patient Centricity in Clinical Research and DevelopmentCurrent Efforts for Educating and Enrolling Diverse Populations in Clinical TrialsProgress on Patient Data OwnershipCollaborating with Site Partners & CROs to Increase Efficiencies, Provide Greater Value to Patients and Clinical TrialsProgress on the National Health Council’s Patient Engagement Fair Market Value InitiativeFDA Reports on the Latest Guidance Updates and New Agency Efforts on Patient Engagement Keynotes include: Dr Dara Richardson-Heron, PfizerDr Joanne Waldstreicher, Johnson & JohnsonDr Darryl Sleep, AmgenBarry Greene, Alnylam PharmaceuticalsRonnie Sharpe, Cystic Fibrosis AdvocateKen Getz, Tufts CSDDJeff Borghoff, Alzheimer's Patient and AdvocateChip Bell, Customer Service Guru Patients as Partners takes place virtually, August 19-21, 2020. For more information please visit www.patientsaspartners.org

    How to Integrate Industry Sponsored Clinical Trials Into Your Health System Feb 18, 2020

    In this podcast, you will hear a session from the 2019 Clinical Research as a Care Option (CRAACO) conference on How to Integrate Industry-Sponsored Clinical Trials Into Your Health System to Give Patients the Best Options. Points include, How to build your programsHow to become an integrated care & research organizationHow to integrate clinical research into your care systemRoswell Park and TrialScout’s strategic partnership Speakers: Irfan Khan, MD, CEO and Founder, Circuit Clinical Doug Plessinger, Chief Clinical & Scientific Development Officer, Roswell Park/GBCT The 2020 CRAACO conference will take place on April 27-28 in Raleigh, NC. Learn more here.

    How Sanford Health Systems Increased Clinical Trial Participation to 10% Feb 17, 2020

    In this podcast, you will hear a case study presentation from the 2019 Clinical Research as a Care Option (CRAACO) conference on how Sanford Health Systems has increased their clinical trial participation from 3% to 10% over the last 8 years by integrating clinical care and clinical research. Points include, Creating a system for all providers to work seamlesslyEducational programs and continual training across all areas of care and specialties for trial offeringsIdentifying gaps in trial availabilityAttracting providers who are interested in clinical research for their patientsNCORP site The 2020 CRAACO conference will take place on April 27-28 in Raleigh, NC. Learn more here.

    Keynote: Surgeon’s Perspective on Integrating Clinical Care & Clinical Research Feb 14, 2020

    In this podcast, you will hear a keynote presentation from the 2019 Clinical Research as a Care Option (CRAACO) conference. Dr Laura Esserman, the architect behind the I-SPY 2 TRIALTM has achieved remarkable progress with this clinical trial in improving the outcomes of early stage, breast cancer for patients who are at high risk for early recurrence. I-SPY 2 is also impacting far beyond breast cancer by increasing efficiencies that promise to accelerate the development and delivery of more effective therapies for other cancer types and a range of other diseases. This would not be possible without the integration of care and research. In this keynote session, hear this surgeon’s view on the future of integrating care and research. Speaker: Laura Esserman, MD, MBA, Director, UCSF Carol Franc Buck Breast Cancer Center; Alfred A. de Lorimier Endowed Chair in General Surgery; Professor of Surgery and Radiology, UCSF The 2020 CRAACO conference will be taking place April 27-28 in Raleigh, NC. Learn more about it here.

    How Wilmington Health is Streamlining Integration of Clinical Research & Care Feb 13, 2020

    In this podcast, you will hear a session from the 2019 Clinical Research as a Care Option (CRAACO) conference. Jeff James, CEO of Wilmington Health, presented a case study on how they are streamlining the processes behind integrating clinical care and clinical research, including: Going from a fragmented patient journey to a streamlined oneHow to take the patient experience to “just making it another visit type”How to take study protocols and make them more native to EMRGeneral best practices for streamlining the process for patients and investigatorsWhat it took to actively normalize the flows and processes of clinical research The 2020 CRAACO conference will take place on April 27-28 in Raleigh, NC. Learn more here.

    Addressing Barriers Health Systems Face in Integrating Clinical Care & Research Feb 12, 2020

    At the 2019 Clinical Research as a Care Option (CRAACO) conference, a panel discussed Barriers Health Systems Face in Integrating Clinical Care & Research, including: Financial barriers – Speaking to administration’s bottom lineHistorical barriers – Who are the key stakeholders that need to be converted into believers of the CRAACO movement?Logistical issues – How can we make study startup a more streamlined process?Culture change – Onboarding an outside group nested into an existing infrastructureDoes adding the offering of clinical trials disrupt the ability of the physicians in the clinics to have appropriate patient flow?How do you offer patients the options of clinical research?Insight from the front line of physicians seeing patients Moderated by: Lora Black, Senior Director of Clinical Research, Sanford Health Systems Panelists: Greg Burke, MD, MSc, Chief Science Officer, Senior Associate Dean for Research, Wake Forest School of Medicine Adrian Hernandez, MD, MHS, Vice Dean for Clinical Research, Duke University School of Medicine The 2020 CRAACO conference will be taking place July 13-14, 2020 in Raleigh, NC. Learn more here.

    Effectively Democratizing Access to Clinical Trials for All Feb 11, 2020

    In this podcast, you will hear a discussion from the 2019 Clinical Research as a Care Option (CRAACO) conference on Effectively Democratizing Access to Clinical Trials. This panel covers how making clinical research a care option is the ultimate opening of access to clinical trials. Including points on: Current state of affairs: Gross underrepresentation of minorities 5-6% are represented in trials, but it should be closer to 40%What are the barriers to opening access?How can we educate underserved communities about clinical research?What are we doing to overcome this?Does offering these care options enhance access in a broad sense? Moderated by: Jennifer Sheller, MPH, Regional Head, North America, Merck Panelists: Jonathan Jackson, PhD, Director, CARE Research Center, Massachusetts General Hospital Cynthia Verst, PharmD, President, Design and Delivery Innovation, IQVIA The 2020 CRAACO conference will take place on July 13-14, 2020 in Raleigh, NC. Learn more here.

    Delivering an Innovative, Patient-Centric Delivery System Feb 06, 2020

    A new way of doing business was required to achieve the mission of serving patients suffering from rheumatoid arthritis. In this podcast, first recorded at the 2nd annual Drug Delivery West conference, William (Bill) Rich, Amgen and Daniele Fazio, Flex discuss how Amgen and Flex created an integrated, single team with co-executive sponsorship and overarching program management that enabled the successful development and launch of a novel combination product. To learn more about the 3rd annual Drug Delivery West conference happening May 17-18, 2021 in San Francisco, CA please visit www.drugdeliverywest.org

    Ophthalmology: Exploring Other Routes of Administration Feb 06, 2020

    In this podcast, first recorded at the 2nd annual Drug Delivery West conference, Dr James Cunningham, Allergan leads a panel on exploring other routes of administration for ophthalmology. Discussion points include: Barries/challenges associated with drug delivery to the back of the eyeProlonging delivery & reducing frequency of administrationAlternative/less invasive routes of administration for delivery to the back of the eyeDelivery for emerging modalitiesImpact of delivery system design choices on development/scalabilityHow to effectively assess novel delivery approaches Panelists include: Dr James E Chastain, Novartis Institutes for BioMedical Research, IncDr Susan Crowell, GenentechDr Viral Kansara, Clearside Bio To learn more about the 3rd annual Drug Delivery West conference happening May 17-18, 2021 in San Francisco, CA please visit www.drugdeliverywest.org

    Transforming Cardiovascular Treatment with Pulmonary Delivery Feb 05, 2020

    First recorded at the 2nd annual Drug Delivery West conference, Dr Carlos Schuler, InCarda Therapeutics discusses transforming cardiovascular treatment with pulmonary delivery. This podcast discusses: Pioneering a novel approach for treating cardiovascular conditions by the oral inhalation routeWill be the ONLY non-invasive, self administered product for acute management of Paroxysmal Atrial Fibrilation, providing rapid cardioversionIn Phase 2: Dose dependent conversion observedWorking on enhancements to greatly improve speed of delivery To learn more about the 3rd annual Drug Delivery West conference happening May 17-18, 2021 in San Francisco, CA please visit www.drugdeliverywest.org

    MRI-Guided Focused Ultrasound and the Delivery of Therapeutics to the Brain Feb 05, 2020

    In this podcast, first recorded at the 2nd annual Drug Delivery West conference, Dr Isabelle Aubert, University of Toronto, provides an introduction to MRI-guided focused ultrasound (MRIgFUS) and reviews applications in preclinical models of neurodegenerative disorders where therapeutic molecules, gene therapy vectors, and progenitor cells are injected intravenously and delivered from the blood to targeted areas of the brain with MRIgFUS. Dr Aubert will describe the seminal work of the Sunnybrook team on MRIgFUS-BBB modulation, without exogenous therapeutic, leading to glial plasticity, amyloid pathology reduction, hippocampal neurogenesis and improved cognitive functions in a preclinical model of Alzheimer's disease. To learn more about the 3rd annual Drug Delivery West conference happening May 17-18, 2021 in San Francisco, CA please visit www.drugdeliverywest.org

    Better Strategies to Inform Patients on Clinical Research & Trial Participation Jan 23, 2020

    Bringing clinical research as a care option to patients is arguably the greatest change we can collaborate on to give patients the best choices of care and to help make clinical trial options easier for providers to access. This panel, moderated by Dr Irfan Khan, TrialScout and recorded at the 6th annual Patients as Partners US conference, will explore how to collaborate to create better strategies to inform patients on clinical research and trial participation. Key talking points include: Demystifying physician/research burdens. What are physicians really up against?How to better inform physicians of clinical research and trialsHow can more physicians get involved in research and communicate the offering of clinical trials?Patient perspectives on clinical research as a care option Panelists include: Dr Alistair Lindsay, GSKLinnea Olson, Patient AdvocateDr Sanjay Sethi, University of BuffaloDr Kelly Wade, Children's Hospital of Philadelphia & CHOP Newborn Care at Pennsylvania Hospital/ University of Pennsylvania Perelman School of Medicine To learn more about the 7th annual Patients as Partners US conference happening June 29-30, 2020 in Philadelphia, PA please visit www.patientsaspartners.org

    Chief Patient Advocate/Officer: Driving Culture Change from the Top Down Jan 23, 2020

    In this fireside chat, moderated by Ken Getz, Tufts CSDD/CISCRP and recorded at the 6th annual Patients as Partners US conference discusses the following: How do you create a culture that enables new strategic, operating and organizational models to flourish?How do you drive a patient-centric organization while continuing to execute on business imperatives? How do you balance that?How do you drive a patient-centric agenda through the value chain?How do you engage your employees and empower them to implement patient involvement strategies? And, how do you enlarge the outlook of employees who are stuck in status quo? Guests include: Julie Gerberding, MD, MPH, MerckJayne Gershkowitz, Amicus Therapeutics To learn more about the 7th annual Patients as Partners US conference happening June 29-30, 2020 in Philadelphia, PA please visit www.patientsaspartners.org

    How Novartis Includes Patient Input into All Aspects of a Clinical Study Jan 22, 2020

    This case study presented by Thérèse Johnsen, Novartis and first recorded at the 6th annual Patients as Partners US conference, discusses how the patient perspective was included from the earliest planning of a clinical trial and how it impacted the design, trial sites and the patient experience throughout the study. To learn more about the 7th annual Patients as Partners US conference happening June 29-30, 2020 in Philadelphia, PA please visit www.patientsaspartners.org

    Patients as Partners in Clinical Research EU 5 Min Upcoming Conf Summary Jan 06, 2020

    This 5 minute podcast summary helps prepare listeners on what they can expect at the4th Annual Patients as Partners Europe event, taking place January 27th and 28th in London. The venue is the Millennium Gloucester Hotel. In a nutshell, Patient as Partners is the first conference in Europe dedicated to understanding how working with patients can drive greater clinical trial efficiencies throughout the entire medicines development process. It is ultimately about how to reduce risk in the development of hugely, costly clinical trials through working with patients. It is a wonderful opportunity for pharma and biotech and patient disease advocacy groups to come together and learn from each other. The 2020 Summit is chaired by Claire Nolan, of Charities Research Involvement Group, GSK’s Andrew Garvey and Parexel’s Rosamund Round. Our patient keynote guest is Lesley Gosden. Lesley is a Parkinson’s patient and advocate who participated in the GDNF clinical trial, which was featured on the BBC. For more information, visit the conferenceforum.org.

    Partnering with Patients on Clinical Development Protocols Dec 20, 2019

    Linda Kollmar, Executive Director, Scientific Medical Patient Perspective - Oncology, Merck, shares with the audience at the 6th annual Patients as Partners US conference, Merck's strategy for bringing on a patient, as an equal stakeholder of their clinical development team, to provide patient input in protocol development and trial design. Ms Kollmar walks the audience through how this was done, the role of the patient employee and the impact it has to date on the clinical development initiatives. To learn more about the 7th annual Patients as Partners US conference taking place June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org

    Improving Clinical Research and Trials Through Pharma/Advocacy Partnerships Dec 19, 2019

    This podcast moderated by Mary Murray, BMS and recorded at the 6th annual Patients as Partners US conference discusses Improving Clinical Research and Trials Though Effective Pharma/Advocacy Partnerships. Topics include: What are the key elements that make for an effective partnership between Industry and Advocacy Groups?What is not getting done or being left on the table to increase partnership value?In relation to clinical trials what can we and what must we learn from existing experiences in patient engagement that will help provide patients with the enhanced active role they deserve?From an industry perspective there are generally three key decision-making points: research priority setting, design of clinical trials, and early dialogue that can benefit from vaiours levels of patient engagement - are there other valuable areas we are missing hereFrom a patient advocacy group perspective in which areas should industry be improving its clinical research, trial development and planning? Panelists include: Ellen Miller-Sonet, CancerCareKristin Smedley, Curing Retinal Blindness FoundationTiffany Westrich-Robertson, International Foundation for Autoimmune & Autoinflammatory Arthritis (IFAA)Keri Yale, Boehringer Ingelheim To learn more about the 7th annual Patients as Partners US conference taking place June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org

    Engaging with Communities to Educate and Enroll Diverse Populations Dec 19, 2019

    This podcast, first recorded at the 6th annual Patients as Partners US conference and moderated by Jan Nissen, Merck discusses the complexities of diversity and waht actions we can take to raise clinical trial awareness and enrollment that is reflective of the demographics of the populations. This panel discusses: What are some examples of how industry has approached diversity such as developing partnerships, education and awareness to identify and address the barriers of diversity?Is industry and advocacy engaging on the community level? If so, how?How has advocacy helped with outreach, awareness and recruitment of diverse populations for clinical trials?How do we engage with patients who are without technology access or those globally whereby the latest technological advances are not the norm? Panelists include: Caroline Donovan, Lupus TherapeuticsLisa Fitzpatrick, The Community Wellness CollectiveKelly Franchetti, ICON plcDr Tara Hiley, GenentechPatricia Roselle, Sanofi To learn more about the 7th annual Patients as Partners US conference taking place June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org

    Mapping Out the Patient Decision Journey Dec 18, 2019

    If you truly want to bring patients in as stakeholders, we have to start at the beginning by understanding patients, their lifestyles and how the trial protocols are developed to reflect that. This session moderated by Dr Marilyn Metcalf, GSK and recorded at the 6th annual Patients as Partners US conference discusses understanding these dynamics and how they will help industry design appropriate initiatives that help meet its goals while aligning with patient's needs. This session addresses: What can we learn and what resources can we use to develop a baseline understanding of patient lifestyles?What can sponsors do throughout trial protocols that can help support patients, help alleviate their worries/concerns?What is the decision making process a patient goes through when considering treatment options?What do patients consider when determining to participate/not participate in a clinical trial?How can pharma help support/provide tools that will help patients while deciding which treatment pathway they choose?How can advocacy groups support this and how do they help inform patients? Panelists include: Robert Long, Uplifting AthletesLilly Stairs, Patient and AdvocateMary Stober Murray, BMSHannah Watson Eccard, InspireRobert Weker, Three Time Cancer Survivor To learn more about the 7th annual Patients as Partners US conference happening June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org

    FDA Patient Engagement Synergistic Efforts Dec 17, 2019

    This multi-center FDA podcast moderated by Anindita Saha, (CDRH) FDA and first recorded at the 6th annual Patients as Partners US conference, focuses on patient engagement and regulatory decision making. This podcast discusses: What is each center doing in terms of patient engagement?What initiatives are underway and what is the impact they will have?What are the synergistic efforts across the FDA centers?How are the patient involvement initiatives within the FDA moving the needle forward in order to create greater efficiencies and better outcomes for patients? Panelists include: Megan Moncur, (CBER) FDADr Michelle Tarver, (CDRH) FDAPujita Vaidya, (CDER) FDA To learn more about the 7th annual Patients as Partners US conference happening June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org

    The Democratization of Patient Data Ownership: Returning Results Dec 16, 2019

    In this series, first recorded at the 6th annual Patients as Partners US conference, is led by Craig Lipset, formerly with Pfizer discusses the ideas of patients 'donating' data, patient data ownership, data rights, and why this is a disruptive force in advancing clinical trials, we address the need to ensure we have the appropriate systems, security, and the ability to withstand a Facebook/Cambridge Analytica Scenario. Craig is joined by Mark Scrimshire, NewWave/CMS and Bray Patrick-Lake, Duke Clinical Research Institute. To learn more about the 7th annual Patients as Partners US conference happening June 29-30, 2020 in Philadelphia, PA please visit theconferenceforum.org.

    Cell & Gene Therapy Day Overview in 4 minutes Dec 04, 2019

    In this podcast, Kate Woda, Conference Director provides an overview of Cell & Gene Therapy Day in less than 4 minutes. Cell & Gene Therapy Day takes place on February 27, 2020 in New York City and convenes stakeholders spanning the science and business communities to report on the latest cell and gene therapy progress to fight a wider range of cancers beyond hematologic malignancies. Key Topic Areas: Landscape and Evolution to Marketplace: ProgressNew Scientific Frontiers in Cell Therapies for Solid TumorsCell Therapy Pivotal Developments for Solid TumorsCurrent and Future Innovations Toward GMP Manufacturing of CAR and TCR Engineered T CellsFDA Led Session on the Evolution of Regulatory Policy for Cell & Gene Therapy Cell & Gene Therapy Day is available as an independent one day program with a luncheon and networking reception, to learn more please visit theconferenceforum.org Alternatively, attendees can register for the three day IO360° program, which includes Cell & Gene Therapy Day. For more information on IO360°, please visit www.io360summit.com

    2020 Immuno-Oncology 360° Summit Overview in 10 Minutes Dec 04, 2019

    In this 10 minute podcast, Kate Woda, Conference Director for IO360°, walks you through what to expect at 2020 IO360° Summit happening February 26-28, 2020 in New York City. IO360°convenes stakeholders spanning the science and business communities to report on the latest data impacting immuno-oncology to fight a wider range of cancers. The 6th annual IO360° Summit features the following plenaries: Discovery/Preclinical ScienceImaging AspectsClinical OperationsBispecificsBusiness DevelopmentsCell & Gene TherapyTranslational ScienceEmerging BiomarkersIO Novel TechnologiesAI & Machine LearningClinical Developments Keynotes: Dr Carl June, University of PennsylvaniaDr Arie Belldegrun, AllogeneDr Andrew Baum, CitiDr Crystal Mackall, Stanford University School of Medicine Learn more at www.io360summit.com

    Fireside Chat with an R&D Veteran Dec 03, 2019

    Dr Jeffrey Chodakewitz, former EVP, Clinical Medicine and External Innovation, CMO at Vertex Pharmaceuticals, joins the Chief Medical Officer Summit for the first time to discuss his incredible journey as a CMO. Recorded at the 7th annual Chief Medical Officer Summit, Dr Chodakewitz sits down with Dr Julie Krop, AMAG Pharmaceuticals to discuss the following: The journeyPrioritizing resourcesSuccesses and failuresOvercoming hurdlesCareer decisionsTransitioning from large pharma to small biotechConsiderations for building your team in large and small companies Learn more at theconferenceforum.org

    Designing Clinical Trials for Gene Therapy - A Paradigm Shift Dec 03, 2019

    This session, recorded at the 7th annual Chief Medical Officer Summit and moderated by Dr Martin Childers, Asklepios BioPharmaceutical, discusses designing clinical trials for gene therapy. Topics covered include: How to utilize adaptive trial design within the specific context of a gene therapy - are there any unique aspects of development conducive to this approach?How to ensure flexibility when pushing for an accelerated pathway?Communicating pros and cons of development options and your recommendation to your CEODe-risk identifying the primary efficacy endpoint without a proof of concept phaseHow to interpret the current FDA guidanceFactors to consider around in-vivo and ex-vivo regulatory guidanceHow to use the guidance to direct the path of your programGlobal regulatory considerations and how to overcome them Panelists include: Edward Conner, MD, Sangamo TherapeuticsKathleen Reape, MD, Spark Therapeutics Learn more at theconferenceforum.org

    Case Study: Life of a Chief Medical Officer Pre and Post IPO Dec 02, 2019

    In this talk, first recorded at the 7th annual Chief Medical Officer Summit, Dr Tal Zaks, Chief Medical Officer, Moderna Therapeutics shares his experience and lessons learned through one of the biggest transitions a Chief Medical Officer can make in biotech: Expanding the role of the CMO to meet the requirements of a public companyInsights into the experienceManaging growthWhat role does the CMO have in articulating the data of clinical trials What role does the CMO have in business development opportunitiesWhat are the personal implications of being a CMO in a publicly traded companyLessons learned Learn more at theconferenceforum.org

    How the CMO of Sage Therapeutics Positioned a New Indication for FDA Approval Dec 02, 2019

    In this session recorded at the 7th annual Chief Medical Officer Summit, Dr Steve Kanes, Chief Medical Officer, Sage Therapeutics, discusses how a company considered as an "up and comer" in the Cambridge biotech sector navigated the development and approval of the first treatment specifically designed for postpartum depression. Learn more at theconferenceforum.org

    Addressing the Talent Gap in Biotech - Recruit and Retain Dec 02, 2019

    In an increasingly competitive market, there is a growing need for efficiency in attracting and retaining top talent. This session, recorded at the 7th annual Chief Medical Officer Summit, and moderated by Dr Julie Krop, AMAG Pharmaceuticals, addresses the following: How to source talent; pros and cons of recruiters versus word-of-mouthHow to make the work environment optimal to keep employees satisfiedHow to compete with the competition banging on the doorHow to ease or address relocation concerns of potential hiresWhen is a good time to have consultants or contractors filling the gapsHow to access the untapped talent in academia, do they know we exist?Benefit/risk of having non-MDs fill the gaps and guided by a physicianDoes the industry need to evolve to attract and retain talentHow do you decide whom to recruit firstHow to identify the right hire Panelists include: Kara Coluccio Bern, Perspective GroupJames Lewis, Barrington JamesChris Poshka, Govig Learn more at theconferenceforum.org

    How to Navigate the Development Path from CMO to CEO Dec 01, 2019

    First recorded at the 7th annual Chief Medical Officer Summit, this session provides insight in what it takes and how to navigate and what to expect in the CEO role. Moderated by Dr Zain Kassam, Finch Therapeutics, this panel discusses: How can a CMO position themselves as a corporate leader?How to build a network of advisors and who should it include? Panelists include: Aoife Brennan, MB, BCh, BAO, MRCPI, SynlogicGreg Fiore, MD, Sollis Therapeutics Learn more at theconferenceforum.org

    How do Patients Become Partners in the Sharing of Data to Advance Science? Nov 06, 2019

    In this podcast, hear a session from the 2019 Patients as Partners EU conference on How do Patients Become Partners in the Sharing of Data to Advance Science? How to encourage the sharing of suitably anonymized data to further medicines development for the benefit of patients?What are the barriers/issues? Public mistrust of pharma? Language, medical records versus coded data? Speakers: Natalie Banner, PhD, Understanding Patient Data Lead, Wellcome Trust Richard Stephens, Patient/Consumer Lead, Chair Consumer Forum, NCRI The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about the program and patient centricity in R&D, visit theconferenceforum.org.

    Best Practices for Pharma - Patient Advocacy Partnerships Nov 05, 2019

    In this podcast, hear a panel discussion presented at the 2019 Patients as Partners EU conference on Best Practices for Pharma - Patient Advocacy Partnerships. Pharma and advocacy representatives discuss: • Advocacy point of view on is what pharma is doing in clinical trials and medicines development truly patient-centric? • How can advocacy groups work with the pharmaceutical industry to improve the clinical trial process? • How can advocacy get their foot in the door at pharma? Pharma’s advice. • How can pharma and advocacy better work together? • Explore the value of pharma reps spending time at an advocacy office to better understand what they do • How can this partnership impact patients and medicines development? Moderator: Chris Macdonald, Head of Research, Pancreatic Cancer UK Panelists: Vanessa Pott, Director, Patient Advocacy & Strategic Partnerships, Merck KGaA Natasha Ratcliffe, PhD, Research Involvement Manager, Parkinson’s UK The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about the conference and patient centricity in R&D, visit theconferenceforum.org.

    Merck's Next Phase of Patient Centricity in R&D Nov 04, 2019

    In this podcast, hear a session from the 2019 Patients as Partners EU meeting where Merck's Vanessa Pott presented a case study on Innovative Medicines Development and Merck KGaA's next phase of Patient Centricity in R&D. The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about the program and patient centricity in R&D, visit theconferenceforum.org.

    Clinical update on AMG 420, an anti-BCMA BiTE® Nov 01, 2019

    In this talk, recorded at the 5th annual IO360° Summit, Dr Alex Minella, Amgen, provides a clinical update on AMG 420, an anti-BCMA BiTE® This talk addresses the: Summary of IND enabling preclinical studiesFirst-in-human trial designFirst-in-human trial data (safety, efficacy) Save the date for the 6th annual Immuno-Oncology 360° Summit on February 26-28, 2020 at the Crowne Plaza Times Square in New York City. Learn more at www.io360summit.com

    Connecting Employee-Centric Culture to Patient-Centric Culture Nov 01, 2019

    At the 2019 Patients as Partners EU meeting, Servier's Lode Dewulf presented a discussion on connecting employee-centric culture to patient-centric culture. This presentation covered the following points: • What impact can engaged employees have on positioning the company as the preferred partner for patients and other collaborators? • How can this be done? And for what purpose? • How do you engage your employees and empower them to implement patient involvement strategies? • Inspiring employees to make change? The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020. To learn more about patient centricity in drug development and R&D and the Patients as Partners EU program, visit theconferenceforum.org.

    Eliciting Patient Experience Data to Understand Medicines Benefits/Disadvantages Oct 31, 2019

    In this podcast, listen to a session from the 2019 Patients as Partners EU conference on Sanofi Eliciting Patient Experience Data During Clinical Trials to Better Understand Patient-Perceived Benefits and Disadvantages of their Drugs. Dr Aude Roborel de Climens, PRO/COA Lead at Sanofi discusses how they capture patient experiences during clinical research and the benefit of collecting direct patient feedback. More specifically, she presents how they evaluate and analyse qualitatively and quantitatively individual patient experiences of benefits and risks of drugs during clinical trials to better understand and support clinical results and help future design of patient support programs. The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about patient centricity in R&D and the Patients as Partners EU program, visit theconferenceforum.org.

    Understanding the Language of Patients - The Value of Health Literacy Oct 30, 2019

    In this podcast, hear a session presented at the 2019 Patients as Partners EU conference on the Process to Understand the Language of Patients and the Value of Health Literacy. Who is responsible for delivering the why and how of getting involved in medicines development? Pharma, regulators or advocacy groups?What practical goals can the industry set to effect change?How are we communicating the trial information to patients and care partners to help them understand and make informed decisions?How can we address the communication challenges faced by patients and care partners while navigating the systemConsiderations for language used in adverse events reporting, informed consent and clinical trial summaries Speaker: James (Jay) Duhig, PhD, Director, Patient Integration, Pharmacovigilance and Patient Safety (PPS), AbbVie The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about the Patients as Partners EU program and patient centricity in R&D, visit theconferenceforum.org.

    UCB and Parkinson's UK Collaboration Improve a Trial through Patient Involvement Oct 29, 2019

    In this podcast, hear a case study from the 2019 Patients as Partners EU conference on UCB and Parkinson's UK Working Together to Improve a Phase 2 Trial through Patient Involvement. In 2018, UCB and Parkinson’s UK co-developed a workshop to enable the UCB research team to work together with people affected by Parkinson’s to discuss and develop a potential phase 2 clinical trial. The aim of the workshop was to better understand people’s thoughts on clinical trials and get feedback on key features of the potential trial to maximise appropriateness, acceptability and success. In this session, attendees hear a multi-stakeholder perspective on the collaboration, including: • How the workshop was co-developed • Benefits and impact of patient involvement • Key challenges and solutions during the collaboration • Practical tips for industry and patient organisation collaborations Speakers: Natasha Ratcliffe, PhD, Research Involvement Manager, Parkinson’s UK Elaine Sutcliffe, Patient Advocate Kate Trenam, UK Patient Advocacy and Policy Manager, UCB The 4th annual Patients as Partners EU conference will take place on January 27-28, 2020 in London, UK. To learn more about patient centricity in R&D and the Patients as Partners EU program, visit theconferenceforum.org.

    Improving T Cell Therapies via Next Generation Technologies Oct 17, 2019

    The pipeline of adoptive T-cell therapies and other cell based immuno-oncology programs continues to expand with a number of modifications and improvements to the first generation programs. These platforms include improved spcificty and delivery - including non-viral platforms, targeting of multiple antigens, editing constructs, and a variety of strategies to address toxicity and the tumor microenvironment. This panel of experts, moderated by Dr Gbola Amusa, Chardan and recorded at the 5th annual Immuno-Oncology 360° Summit, will consider the major technical and clinical improvements to cell based IO therapeutics that will lead to more durable therapies and the ability to treat both liquid and solid tumors. Panelists include: Dr Robert Ang, Neon TherapeuticsDr Usman "Oz" Azam, TmunityMichael Dombeck, Precision BioSciencesDr Aiman Shalabi, GSK Save the date for the 6th annual IO360° Summit on February 26-28, 2020 at the Crowne Plaza Times Square in New York City. Learn more at www.io360summit.com

    Monetizing Science: Turning an Asset into Value through IPOs Oct 16, 2019

    This panel moderated by Dr Andrew Baum, Citi and recorded at the 5th annual IO360° Summit discusses the preparation of an IPO, straight licensing with the transition to a public company and decision making on prioritization within portfolios. Panelists include: David Epstein, Flagship PioneeringDan Passeri, Cue Biopharma Save the date for the 6th annual Immuno-Oncology 360° Summit on February 26-28, 2020 at the Crowne Plaza Times Square in New York City. Learn more at www.io360summit.com

    IDO Changes the T-cell Balance in the Tumor Microenvironment Oct 16, 2019

    In this talk recorded at the 5th annual IO360° Summit, Dr Charles Link Jr, Newlink Genetics, addresses how IDO changes the T-cell balance in the tumor microenvironment. This talk addresses how: IDO creates local immunosuppression by increasing T regulatory cellsIDO often works in concert with PDL-1 mediated immunosuppressionIDO mediated T-cell immunosuppression leads to poor prognosis in melanoma Save the date for the 6th annual Immuno-Oncology 360° Summit on February 26-28, 2020 at the Crowne Plaza Times Square in New York City. Learn more at www.io360summit.com

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