Moving the Needle on Clinical Trial Diversity and Navigating New FDA Requirements for Diversity Action Plans

July 26, 2023 3:00pm

Kellie Combs
Ropes & Gray LLP

Ronni Fuchs
Troutman Pepper Hamilton Sanders LLP

Jennifer Jones-McMeans, PhD
Divisional Vice President, Global Clinical Affairs

Katrina Long
Senior Director, Assistant General Counsel
Regeneron Pharmaceuticals, Inc.

  • Devising a clinicical trial diversity action plan: what can industry do in practice to improve diversity in clinical trials and overcome operational challenges and obstacles in this endeavor
  • Understanding the different roles of sponsors, patients, and investigators in conducting more equitable clinical trials
  • Examining the new FDA clinical trial diversity requirements set forth by the Food & Drug Omnibus Reform Act of 2022
    • Understanding what will be required in the development of Diversity Action Plans to improve the enrollment of racial and ethnic populations in clinical trials
    • Exploring FDA’s toolkit for encouraging study sponsors to meet diversity goals
  • Taking a look at specific strides life sciences companies are making to increase clinical trial diversity – what is working and what is not?