Leadership and Workgroup

A 50+-member, international, multi-stakeholder workgroup convened by the Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University (MRCT Center) developed this Guidance Document and accompanying Toolkit.  While every member contributed to the development of the Diversity Framework, the leadership of the MRCT Center is responsible for the final content.

The views and findings expressed in this document are those of the authors and do not imply endorsement or reflect the views or policies of the U.S. Food and Drug Administration or the affiliated organization or entity of any member who contributed to this work. Individuals have served in their individual capacity.
  • RADM Richardae Araojo, U.S. Food and Drug Administration (as of August 2018)
  • Barbara E. Bierer, MD, MRCT Center
  • Luther T. Clark, MD, Merck & Co., Inc.
  • Milena Lolic, MD, U.S. Food and Drug Administration (August 2019 – August 2020)
  • David H. Strauss, MD, Columbia University
  • Junyang Wang, MSc, U.S. Food and Drug Administration (until August 2019)
  • Sarah White, MPH, MRCT Center
  • John Whyte, MD, MPH, U.S. Food and Drug Administration (until August 2018)

MRCT Center staff:

  • Carmen Aldinger, Administrative & Training Manager
  • Hayat Ahmed, Project Manager
  • Laura Meloney, Program Manager
  • Joshua Smith-Sreen, Student Researcher
Name Organization
Maria Apostolaros Pharmaceutical Research and Manufacturers of America (PhRMA)
Abhijit Bapat* Novartis
Stacey Bledsoe* Eli Lilly and Company
Shari Bodnoff* Novartis
Racquel Bruton Biogen
Elizabeth Cahn Cancer Connection
Li Chen Amgen
Patrick Cullinan Takeda, currently BlueBird Bio
Liza Dawson* National Institutes of Health (NIH)
Maria De Leon* Parkinson’s Foundation
Theresa Devins Boehringer Ingelheim, currently Regeneron Pharmaceuticals
Anthony Edmonds Takeda
Rhonda Facile Clinical Data Interchange Standards Consortium (CDISC)
Rachael Fones IQVIA
Laura Gordon* Institute for Advanced Clinical Trials for Children (iACT)
Anya Harry GlaxoSmithKline (GSK)
Melissa Heidelberg Genentech/A Member of the Roche Group
Quita Highsmith Genentech/A Member of the Roche Group
Sharareh Hosseinzadeh Novartis
Lloryn Hubbard* Genentech/A Member of the Roche Group
Anne Marie Inglis* GlaxoSmithKline (GSK), currently Mallinckrodt Pharmaceuticals
Aarthi B. Iyer* Kinetiq, now Advarra
Becky Johnson* IQVIA
Tesheia Johnson Yale School of Medicine
Jonathan Jackson* Massachusetts General Hospital
Marcia Levenstein Vivli
Roberto Lewis Columbia University
Eldrin Lewis Brigham and Women’s Hospital, currently Stanford University
Jianchang Lin* Takeda
Erin Muhlbradt National Cancer Institute (NCI)
Isabela Niculae * Biogen
Latha Palaniappan Stanford University
Claude Petit Boehringer Ingelheim
Claire Pigula* Biogen
Melissa Poindexter* Advances in Health
Nicole Richie Genentech/ A Member of the Roche Group
Bryant (Abel) Riera* Population Council
Suzanne M. Rivera Case Western Reserve University
Frank W. Rockhold Duke University
Ricardo Rojo* Pfizer
Rosanne Rotondo* Novartis
Fabian Sandoval Emerson Clinical Research Institute
Richard Sax* IQVIA
Hollie Schmidt Accelerated Cure Project for Multiple Sclerosis
Karlin Schroeder Parkinson’s  Foundation
Mary Scroggins* Pinkie Hugs
Jessica Scott* Takeda
Lana Skirboll Sanofi
Steven Snapinn Seattle-Quilcene Biostatistics
Stacey Springs* Harvard Medical School
Sara Tadesse-Bell Genentech/ A Member of the Roche Group
Ann Taylor* Columbia University
Paul Underwood Boston Scientific
Junyang Wang* Food and Drug Administration (FDA)
Robert Winn* University of Illinois
Gerren Wilson* Genentech/ A Member of the Roche Group
Crispin Woolston Sanofi
Honghui Zhou* Johnson & Johnson


*involvement limited in time

  • Mark Barnes, Ropes & Gray and MRCT Center
  • Maria DeLeon, Parkinson’s Foundation
  • David Hawks, National Council of Asian Pacific Islander Physicians and Alliance of Multicultural Physicians
  • James H. Powell, Strategic Medical Associates
  • Matthew Rotelli, Eli Lilly and Company
  • William Tap, Memorial Sloan Kettering Cancer Center

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