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Research, Development, and Regulatory Roundtable (R3) of the MRCT Center and Ropes & Gray LLP

Focus Area: Ethics, Conduct, and Oversight

Research, Development, and Regulatory Roundtable (R3) of the MRCT Center and Ropes & Gray LLP

The Research, Development, and Regulatory Roundtable (R3) is a neutral forum wherein policymakers, legal counsel, academicians, industry representatives, and global regulators may present, discuss, and deliberate pre-competitive issues in drug and device development, regulatory oversight of clinical trials, and human subjects research. The R3 is a cooperative endeavor coordinated by the MRCT Center and Ropes & Gray LLP.

R3 meetings are open to organizations that sponsor R3 and occur three times per year.  The meeting locations will rotate among the Ropes & Gray LLP offices in Boston, New York City, Chicago, San Francisco, and Washington, D.C. Each R3 meeting focuses on one or two timely discussion topics related to the domestic and global impact of new legislation, regulations, guidance, and policies on research community stakeholders. At the end of each R3 meeting, we will consider whether the topic warrants further discussion or development as a publication, position paper, case study analysis, or commentary.

In order to promote open dialogue, the meetings are run by ‘Chatham House Rule,’ by which commentary will not be attributed to any individual nor to their institutional affiliation. R3 meetings are open to organizations that sponsor the R3. Please contact Emily Statham (estatham@bwh.harvard.edu) if you are interested in sponsoring the R3.

The MRCT Center and Ropes & Gray LLP are grateful to the following R3 sponsors:

  • Advarra IRB
  • Baim Institute for Clinical Research
  • Dana-Farber Cancer Institute
  • Genentech, Inc.
  • Johnson & Johnson
  • Novartis
  • Pfizer, Inc.
  • Sanofi
  • Takeda Pharmaceuticals International, Inc.
  • Washington University in St. Louis

Current status: Active

Impact: Non-partisan forum for discussing the impact of laws, regulations, policies, and guidance on drug and device development and regulatory oversight of clinical trials

Objectives:

  • To engender open and collaborative discussion of non-proprietary issues in research and development
  • To promote a deeper understanding of the laws and regulations that influence therapeutic innovation, product approval, and the protection of human research participants on the global stage

Milestones:

  • July 2018: Inaugural Meeting of the R3: Application of the General Data Protection Regulation to Research: Legal, Practical, and Strategic Implications, Boston, MA; initiated Workgroup to draft a Code of Conduct for the EU GDPR
  • November 2018: Second Meeting of the R3: Right to Try vs. Expanded Access: Practical, Legal, and Regulatory Considerations

Project Manager: Emily Statham