Reimagining Clinical Trials: Learning from COVID-19

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REIMAGINING CLINICAL TRIALS: LEARNING FROM COVID-19

The MRCT Center is hosting 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 will explore 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) will  focus 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) will focus on regulatory flexibilities, international cooperativity, and governance. The meeting is open to all interested stakeholders and to the public.

REGISTER for the first meeting, June 16, 2021, 10 AM – 1 PM EDT

REGISTER for the second meeting, June 24, 2021, 10 AM – 1 PM EDT

 

June 16, 2021: 10:00 am - 1:00 pm EDT

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

June 24, 2021: 10:00 am - 1:00 pm EDT

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

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