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Past, Present, and Future: How Industry and FDA are Handling the Evolving Clinical Trial Diversity Regulatory Landscape
Session Chair(s)
Dylan Bechtle, MS
Associate Director, Regulatory Policy Lead- US
Johnson & Johnson, United States
This forum will include discussion among multiple sponsors sharing their first-hand, cross-therapeutic area experience on notable trends and challenges they have faced in preparing these early diversity plan submissions. Panelists will also address how they plan to adapt to more expansive categories enumerated within diversity action plan guidance and share reflections on recently released FDA guidances on this topic (i.e. diversity action plans, post market approaches to obtain data on underrepresented populations, collection of race and ethnicity data). Additionally, panelists will discuss what policy deliverables and clarifications they would like to see reflected in the final guidances. The panel will also include FDA’s perspective and reflections from 2 years of diversity plan submissions as well as any considerations as we look to the future.
Learning Objective : Describe best practices and regulatory feedback on diversity plan submissions.; Compare the perspectives of both FDA and sponsors about the current landscape of trial diversity-related guidances, including the latest diversity action plan guidance.; Discuss how by using an interactive audience feature where we seek others’ experience compiling and feedback from the FDA on diversity plan submissions.
Speaker(s)
Industry Update
Andrea Doyle
Sanofi, United States
GRA Head, Region North America, Global Advertising and Promotion
Industry Update
Del Smith, PhD, MS
Acclinate Inc., United States
Co-Founder and Chief Executive Officer
Industry Update
Stacy Holdsworth, PharmD
Eli Lilly and Company, United States
Associate Vice President, US Regulatory Policy & Strategy
FDA Update
Tamy Kim, PharmD
FDA, United States
Director, Regulatory Affairs/ Regulatory Policy, Oncology Center of Excellence
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