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Panel Session [clear filter]
Tuesday, October 19

9:30am EDT

Panel | Future proofing production for the looming gene therapy wave
In the quest to bring cell and gene therapies to the fore, players of all sizes are clamoring for capacity, innovation and standardization. Making advanced therapies at scale is one of the biggest hurdles, with a shortage of viral vectors—the engineered viruses used to deliver gene therapies and CAR-Ts—already upon us. Now, as a wave of potential approvals threaten to crowd the bottleneck even more, the industry will need to pull out all the production stops to meet demand. Join us as we discuss the latest tactics to avoid process pitfalls in the field, from the upsized role of contract manufacturing to automation, flexible production and more.

avatar for Kevin Dunleavy

Kevin Dunleavy

Staff Writer, Fierce Pharma
Kevin Dunleavy is a staff writer for Fierce Pharma. He joined the Fierce team after working 26 years as a newspaper sportswriter. He compiles Fierce Pharma’s COVID Tracker and writes about manufacturing and other topics. Kevin is a longtime resident of Northern Virginia and a graduate... Read More →

avatar for Curran Simpson

Curran Simpson

Chief Operations and Technology Officer, Regenxbio
Curran M. Simpson is the Chief Operations and Technology Officer at REGENXBIO. Prior to joining REGENXBIO, Mr. Simpson was the Head of North American Supply Chain and Interim Chief Operating Officer and Integration Lead at GlaxoSmithKline and the Human Genome Sciences division... Read More →
avatar for Jerry Keybl, Ph.D.

Jerry Keybl, Ph.D.

Head of Cell and Gene Therapy Manufacturing, MilliporeSigma
Jerry Keybl heads the Cell & Gene Therapy Manufacturing business for MilliporeSigma. As part of a diverse science and technology company, Jerry is focused on products and services for cell therapy and viral vector manufacturing, with the potential to transform therapies to cures. Jerry joined MilliporeSigma... Read More →
avatar for Kim Raineri

Kim Raineri

Chief Manufacturing and Technology Officer, Avrobio
Kim has deep global experience in the cell and gene therapy industry, biologics and medical device spaces, with a distinguished track record of innovation and implementation of Good Manufacturing Practices (GMP). Prior to joining AVROBIO, he served as the vice president of operations... Read More →

Tuesday October 19, 2021 9:30am - 10:30am EDT

1:30pm EDT

Panel | Promising therapies, real risk: Overcoming regulatory hurdles in gene therapy
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?

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 →

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
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