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Mobile in Clinical Trials is joined by the FDA who will provide updates on the draft guidance issued December 2021 that provides recommendations for clinical trial sponsors, investigators, sites on using DHTs to collect data remotely from clinical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

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.patientsaspartne

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

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

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

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 b

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

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

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

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.  

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

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

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