2023 BIO Clinical Trial Diversity Roundtable

BIO hosted this roundtable on January 31, 2023.

Speaker biographies are available at this link. If a speaker shared slides, a link to that presentation is below the person's name in the agenda. Not all speakers presented slides.

Please send any questions or feedback to scireg@bio.org referencing this event in the subject line.

2023 BIO Clinical Trial Diversity Roundtable: Analyzing the Data We Have Today, Enhancing Data Sources and Infrastructure for the Future, and Building a Diverse Workforce

AGENDA

Moderator: Winston Kirton, JD, Partner, BakerHostetler

Time (ET)	Session Topic
10:00 AM	Welcome —Cartier Esham, PhD, Chief Scientific Officer, Biotechnology Innovation Organization (BIO)
10:05 AM	Introductions & Call to Action
	*“Call to Action”* —Eric Dube, PhD, President and Chief Executive Officer and a Director of Travere Therapeutics (on the Board of Directors and Executive Committee for BIO) no slides *“Legislative Perspective: The Depict Act and the Omnibus”* —Aisling McDonough, Chief of Staff, U.S. Rep. Anna G. Eshoo (CA-16) no slides *“Diversifying Clinical Trials: Challenges and Opportunities”* —Joy Buie, PhD, MSCR, RN, Lupus Foundation of America presentation slides
10:45 AM	Panel 1: Regulatory Perspectives on Improving Representation in Clinical Trials
	*“Regulatory Perspectives: OMHHE”* —RDML Richardae Araojo, PharmD, MS, Associate Commissioner for Minority Health and Director of the Office of Minority Health and Health Equity (OMHHE), FDA no slides *“FDA Draft Guidance on Diversity Plans”* —Lola Fashoyin-Aje, MD, MPH, Deputy Director, Division of Oncology, Gastrointestinal, Cutaneous Sarcoma; Associate Director, Science and Policy to Address Heal Disparities, Oncology Center of Excellence, FDA no slides *“Regulatory Perspectives: CDER”* —Karen Hicks, MD, FACC, Deputy Director, Office of Medical Policy, CDER, FDA presentation slide *“Regulatory Perspectives: CBER”* —Diane Maloney, JD, Associate Director for Policy, Office of the Center Director, CBER, FDA no slides Q&A
11:20 AM	Break
11:25 AM	Panel 2: Industry Perspectives on Improving Representation
	*“Inclusive Research Tactics to Improve Patient Diversity”* —Alexandra Goodyear, MD, MS, Global Development Lead, Roche-Genentech presentation slides *“Building a Framework for Setting Enrollment Goals to Ensure Trial Participant Diversity: Insights & Challenges”* —Leo Russo, PhD, Vice President and Head of Global Medical Epidemiology, Pfizer Inc. presentation slides *“Challenges to Defining and Achieving Enrollment Goals”* —Leah Peters, BS, Senior Clinical Operations Lead, Patient Access & Inclusive Research Community/Clinical Operations, Roche-Genentech presentation slides Q&A
12:15 PM	Panel 3: Industry Perspectives on Improving Representation
	*“Leveraging a Data-Centric Approach (qual & quant) to Improving Representation in Clinical Studies”* —Denise Bronner, PhD, Director, Diversity, Equity & Inclusion in Clinical Trials, Johnson & Johnson presentation slides *“AbbVie Workforce Diversification”* —Kim Ribeiro, MLS (ASCP)CM, MS, Head of Diversity & Patient Inclusion, AbbVie presentation slides *“Achieving Diverse Representation in the Covid-19 COVE Trial”* —Brittany Gerald, BS, Senior Manager, Clinical Trial Diversity and Inclusion, Moderna presentation slides Q&A
1:05 PM	Lunch Break
1:45 PM	Panel 4: Overcoming Challenges to Improve Representation
	*“Case Study: Leveraging an Affective Trust Framework to Enhance Clinical Trial Diversity”* —Camille Pope, PharmD, Chief Medical Lead, Acclinate presentation slides *“Flipping the Discussion about Trust: a Perspective from the AAMC Center for Health Justice”* —Heather Pierce, JD, MPH, Director of Policy, Center for Health Justice, Association of American Medical Colleges (AAMC) presentation slides *“Training Community Clinicals to be Principal Investigators”* —Gary Puckrein, PhD, President and Chief Executive Officer, National Minority Quality Forum (NMQF) presentation slides Q&A
2:35 PM	Break
2:45 PM	Panel 5: Overcoming Challenges to Improve Representation
	*“Rethinking Clinical Trials: How Better Data Can Improve Health Equity”* —Laurent Grosvenor, Chief Diversity Officer, Institute for Health Metrics and Evaluation (IHME) presentation slides *“How AI is Meaningfully Moving the Needle in Improving Diversity in Clinical Trials”* —Arnaub Chatterjee, BS, MHA, MPA, Senior Vice President, Medidata AI, a Dassault Systèmes company; Alliance for Artificial Intelligence in Healthcare (AAIH) presentation slides *“Setting Diversity Goals and Measuring Success—Lessons Learned and the Path Forward”* —Rachael Fones, Director, Government & Public Affairs, IQVIA; Chair, Diversity & Inclusion in Clinical Trials Committee, Association of Clinical Research Organizations (ACRO) presentation slides *“Perspectives from MRCT”* —Willyanne DeCormier Plosky, DrPH, Program Manager, Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard presentation slides Q&A
4:00 PM	Closing Remarks