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 atpoddconference.com
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 recruitm...
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
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 submissionWhat 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.
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
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.
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 ...
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 redefi...
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.
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.