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Monday, October 28 • 3:15pm - 4:00pm
New Indications in the Approval of Medicines

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  • Consider how the FDA has begun to look at molecular pathway indications instead of indication by clinical diagnosis as treatment fields continue to evolve
  • Share opinions on whether the FDA should more formally consider when to utilize molecular pathway-based indications versus clinical diagnosis in the approval of medicines
  • Discuss the concerns of modifying a tried-and-true process versus the pros of change

avatar for Bola Akinlade, M.D.

Bola Akinlade, M.D.

Vice President, Head, General Medicine Therapeutic Area, REGENERON
Dr. Bola Akinlade is the Head and Vice President for Regeneron’s General Medicine Therapeutic Area. In his current role, he leads programs in pain, rheumatology, allergic disease and transplantation. Upon joining Regeneron in 2015, Dr. Akinlade led the immunology and inflammation... Read More →
avatar for Sabah Oney, Ph.D

Sabah Oney, Ph.D

Chief Business Officer, Alector
Sabah Oney, PhD, is Chief Business Officer at Alector, a clinical stage biotechnology company leveraging the immune system to cure neurodegeneration.Sabah joined Alector in 2016 and has been leading the company's fundraising, partnering, business development, finance, PR, and IT activities... Read More →
avatar for Craig L. Tendler, M.D.

Craig L. Tendler, M.D.

Vice President, Clinical Development and Global Medical Affairs, Oncology, JANSSEN RESEARCH AND DEVELOPMENT
Craig Tendler, M.D. is Vice President, Clinical Development and Global Medical Affairs for the Oncology Therapeutic Area at Janssen Research & Development, LLC, one of the Janssen Pharmaceutical Companies of Johnson & Johnson. In this position, he is responsible for creating robust... Read More →
avatar for Kyle Blankenship

Kyle Blankenship

Associate Editor, FIERCEPHARMA

Monday October 28, 2019 3:15pm - 4:00pm PDT