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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):

  • 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