FDA-AACR Workshop to Examine Under-representation of African Americans in Multiple Myeloma Clinical Trials

Date: 8 a.m. – 5 p.m. Feb. 13, 2020

Location: Washington Marriott at Wardman Park, 2660 Woodley Rd NW, Washington, DC 20008

RECORDED WEBCAST (SESSION AND INDIVIDUAL PRESENTATION YOUTUBE LINKS BELOW):

• Introduction and Session I: State of the Science & Clinical Implications
  • Margaret Foti, PhD, MD (hc)
  • Kenneth C. Anderson, MD
  • Lola A. Fashoyin-Aje, MD, MPH, and Nicole Gormley, MD
  • Laura Fernandes, PhD, and Bindu Kanapuru, MD
  • Kathleen Maignan, MSN, NP
  • Nikhil C. Munshi, MD
  • Shaji K. Kumar, MD
  • Ajay K. Nooka, MD
• Session II: Approaches to Improve Data on Outcomes in Racial and Ethnic Minorities Prior to Drug Approval
• Session III: Approaches to Using Postapproval Clinical Trial Data to Better Understand Effectiveness and Safety of Therapies in Racial and Ethnic Minorities
• Session IV: Approaches to Utilize Real-world Data to Understand Outcomes with Specific Therapies in Racial and Ethnic Minorities
• Session V: Conclusion and Future Directions

Workshop Objectives:

• Discuss biology and genetics underlying racial and ethnic differences in multiple myeloma.
• Characterize racial and ethnic data available from multiple myeloma registrational trials and real-world data sources.
• Discuss implications of limited clinical data in racial and ethnic minorities with multiple myeloma.
• Explore approaches to increase our knowledge of the safety and efficacy of anti-myeloma therapeutics in racial and ethnic minorities.

Workshop Cochairs:

• Kenneth C. Anderson, MD, FAACR, Program Director, Jerome Lipper Multiple Myeloma Center and LeBow Institute for Myeloma Therapeutics and Chief, Division of Hematologic Neoplasia, Dana-Farber Cancer Institute; Chair, AACR Regulatory Science and Policy Subcommittee
• Lola A. Fashoyin-Aje, MD, MPH, Acting Deputy Director, Division of Oncology 3, Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
• Nicole J. Gormley, MD, Acting Director, Division of Hematologic Malignancies 1, Office of Oncologic Diseases, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
• Paul G. Kluetz, MD, Deputy Director, Oncology Center of Excellence, U.S. Food and Drug Administration