PharmaTalkRadio

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

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

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

Speakers:

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

Mobile in Clinical Trials is joined by the FDA who will provide updates on the draft guidance issued December 2021 that provides recommendations for clinical trial sponsors, investigators, sites on using DHTs to collect data remotely from clinical trial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

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

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

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

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.

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