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About: 

The outcomes for patients with multiple myeloma have improved with the introduction of new therapies and approaches to care. However, relapses are common and multiple myeloma remains a difficult disease to treat, so the need for new therapies remains.  Recent trial results and developments in the field of multiple myeloma necessitate a discussion of the current paradigm to facilitate future drug development and improve patient outcomes.

On November 8-9, 2022, the U.S. Food and Drug Administration (FDA) and the International Myeloma Society (IMS) will host a joint symposium, to provide a forum for open discussion among academia, industry, and regulatory agencies about clinical drug development in multiple myeloma. The event will be held in person and online.  This workshop will discuss trial design, patient population, and endpoints in the different multiple myeloma disease settings with an aim to advance the future of drug development. Ultimately, this meeting serves to engage stakeholders to discuss opportunities and challenges in designing trials applicable to the US patient population.

Goals and Objectives:

• Provide a forum for open discussion among academia, industry, regulatory agencies, and patient groups about clinical drug development in multiple myeloma.
• Discuss trial designs, patient populations and endpoints in different multiple myeloma disease settings.
• Discuss considerations for novel agent combinations and biomarker directed therapy in specific multiple myeloma groups.
• Engage stakeholders to discuss opportunities and challenges in designing trials applicable to the US patient population.

Who Should Attend:

This workshop is intended for stakeholders interested in exploring the issues of advancing clinical drug development in multiple myeloma, determining the gaps in knowledge, as well as identifying the future research questions. This workshop is intended for but not limited to academia, industry, regulatory agencies, consulting firms, health-technology assessment groups, and patient groups.

Registration: https://www.eventcreate.com/e/fda-imsjointsymposium

Contact:

If to IMS:

• Moira Hancock
  mhancock@myelomasociety.org
  857- 302-0146

If to FDA:

• Christine Lincoln
  FDA/Oncology Center of Excellence (OCE)
  Christine.lincoln@fda.hhs.gov