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

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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

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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

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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

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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

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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

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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

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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

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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

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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

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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.

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