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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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