REIMAGINING CLINICAL TRIALS: LEARNING FROM COVID-19
The MRCT Center hosted a 2-part meeting to create a vision for new ways of conducting clinical research by building upon experiences from interventional, multi-site, multi-national clinical trials during the COVID-19 pandemic. The meeting explored learnings derived from the COVID-19 pandemic: what worked, what did not work, and what we need to analyze further.
The first meeting (June 16, 2021, 10AM-1PM EDT) focused on permissible flexibilities to study conduct and coordination, including site flexibilities, decentralized trials, and other changes, and the implications for the clinical research workforce in this new environment. The second meeting (June 24, 2021, 10AM-1PM EDT) focused on regulatory flexibilities, international cooperativity, and governance. The meeting was open to all interested stakeholders and to the public.
June 16, 2021: 10:00AM – 1:00PM EDT
Agenda
| TIME | TOPIC | SPEAKERS |
| 10:00 AM – 10:30 AM EDT | Introduction Keynote speaker: The Future of Clinical Trials | Barbara Bierer, Faculty Director, MRCT Center Esther Krofah, Executive Director, FasterCures |
| 10:30 AM – 11:30 AM EDT | First Panel: Useful and permissible flexibilities: A discussion of regulatory, protocol, and study conduct flexibilities that can and should be sustained in the future, that should be eliminated, and for which further experience is necessary | Lindsey Baden, Division’s Director of Clinical Research, Brigham and Women’s Hospital/ Dana-Farber Cancer Institute Penny Carlson, Vice President, Head of Global Development Support, Takeda Valen Keefer, Patient Advocate for polycystic kidney disease (PKD) and Organ Donation Isaac R. Rodriguez-Chavez, Head, Global Center of Excellence Strategy for Decentralized Clinical Trials, PRAHealthSciences Moderator: Paul Kluetz, Deputy Director, Oncology Center of Excellence, U.S. FDA |
| 11:30 AM – 11:40 AM | BREAK | |
| 11:40 AM –12:40 PM EDT | Second Panel: Implications for and need to re-imagine the workforce in a reimagined clinical research enterprise | Nicholas Brooke, Founder & Executive Director of The Synergist, Chief Executive Officer of Patient Focused Medicines Development (PFMD) Andrea Ferris, President and Chief Executive Officer, LUNGEvity Andrew (Andy) Lee, Senior Vice President, Head of Global Clinical Trial Operations, Merck Harpreet Singh, Director of Division of Oncology, U.S. FDA Moderator: Craig Lipset, Co-Chair of Decentralized Trials & Research Alliance |
| 12:40 PM – 1:00 PM EDT | Discussion and wrap-up | Moderators and: Barbara Bierer, Faculty Director, MRCT Center Sarah White, Executive Director, MRCT Center |
Speaker Information
View Speaker Biographies for June 16, 2021
June 16, 2021 Webinar Recording, Slides and Transcript
Webinar Proceedings
June 24, 2021: 10:00AM – 1:00PM EDT
Agenda
| TIME | TOPIC | SPEAKERS |
| 10:00 AM -10:45 AM EDT | Introduction Keynote speakers: Reimagining Clinical Trials: Learning from COVID-19 – Fergus Sweeney Aligning global clinical trial requirements – Ginny Beakes-Read | Sarah White, Executive Director, MRCT Center Fergus Sweeney, Head, Clinical Studies and Manufacturing Taskforce, European Medicines Agency (EMA) Ginny Beakes-Read, Executive Director, Global Regulatory and R&D Policy, Amgen |
| 10:45 AM -11:40 AM EDT | First Panel – Enabling regulatory flexibilities in a global context | Taras Carpiac, Executive Director, Innovation & Process Improvement, Amgen Lauren Hartsmith, Director of Regulatory Affairs, Advarra Richard Moscicki, Chief Medical Officer and Executive Vice President of Science and Regulatory Advocacy, PhRMA Névine Zariffa, Principal and Founder, NMD Group Moderator: Barbara Bierer, Faculty Director, MRCT Center |
| 11:40 AM – 11:50 AM | BREAK | |
| 11:50 AM -12:45 PM EDT | Second Panel – Regulatory cooperation and communication and issues of governance in a global pandemic | M. Khair ElZarrad, Deputy Director, Office of Medical Policy at Center for Drug Evaluation and Research (CDER), U.S. FDA Owen Fields, Vice President for Regulatory Strategy, Research and Development, Pfizer Steven Kern, Deputy Director of Quantitative Sciences, Bill and Melinda Gates Foundation Fergus Sweeney, Head, Clinical Studies and Manufacturing Taskforce, European Medicines Agency (EMA) Moderator: Mark Barnes, Faculty Co-Director, MRCT Center; Partner, Ropes & Gray |
| 12:45 PM – 1:00 PM EDT | Discussion and wrap-up | Barbara Bierer, Faculty Director, MRCT Center Mark Barnes, Faculty Co-Director, MRCT Center; Partner, Ropes & Gray |
Speaker Information
View Speaker Biographies for June 24, 2021
June 16, 2021 Webinar Recording, Slides and Transcript
Webinar Proceedings
Planning Committee
- Maria Apostolaros, PhRMA
- Ginny Beakes-Read, Amgen
- David Peloquin, Ropes & Gray
- Michele Russell-Einhorn, Advarra
- Shona Sanchita Pendse, Kowa
- Jessica Scott, Takeda
- Moke Sharma, Alexion
- Michael Steel, Novartis
- Fergus Sweeney, EMA
- Carmen Aldinger, MRCT Center
- Barbara Bierer, MRCT Center
- Sarah White, MRCT Center