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Tuesday, October 19 • 1:30pm - 2:30pm
Panel | Promising therapies, real risk: Overcoming regulatory hurdles in gene therapy

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Gene therapies have great promise for human medicine, but lately have made headlines for all the wrong reasons. SOME therapies have slammed to a halt after serious adverse events arose in patients, while others encountered unexpected delays because of FDA concerns. How can gene therapy makers work with the FDA and other regulators to manage these risks?

Moderator
avatar for Annalee Armstrong

Annalee Armstrong

Senior Editor, Fierce Biotech
Annalee Armstrong is a senior editor for Fierce Biotech. Prior to joining Fierce in April 2021, Annalee was an associate editor for S&P Global Market Intelligence’s healthcare news team. Before that, she was the EPA reporter covering climate and energy policy on the Hill in Washington... Read More →

Speakers
avatar for Eric Crombez

Eric Crombez

Chief Medical Officer, Ultragenyx Gene Therapy
Dr. Crombez has extensive experience and expertise in the development and execution of clinical development programs for rare genetic disorders. He currently serves as chief medical officer, Ultragenyx Gene Therapy and Inborn Errors of Metabolism. He has held this position since Ultragenyx... Read More →
avatar for Janet Lynch Lambert

Janet Lynch Lambert

CEO, Alliance for Regenerative Medicine
Janet Lynch Lambert joined ARM in 2017 as the organization’s first CEO. With more than 25 years in public and private sector management, Janet is an experienced government relations and business professional with an extensive record of accomplishment. Janet most recently served... Read More →
avatar for Robert Pietrusko, PharmD

Robert Pietrusko, PharmD

Chief Regulatory and Quality Officer, Vor Biopharma
Dr. Pietrusko has directed the worldwide approval of more than 30 new products. He also led the submission and approval strategies for more than 30 new drug applications (NDAs), supplemental NDAs, biologics license applications and marketing authorization applications in multiple... Read More →


Tuesday October 19, 2021 1:30pm - 2:30pm EDT