1. Pink Sheet

Gene Therapy Safety Issues Reflect Pushing Of The Scientific Envelope – FDA’s Marks

 
• By Sue Sutter

Recent adverse events are ‘speed bumps’ that need to be worked around, biologics center head Peter Marks says; Morgan Stanley’s Peter Hwang asserts high-profile safety issues have added to unpredictability of gene therapy development, dampening investor enthusiasm for the field.

Speed bump
CBER director Peter Marks believes recent safety issues with gene therapy products are merely speed bumps and overcoming them will advance the science. • Source: Alamy

Recent high-profile adverse events with gene therapy products suggest the industry is appropriately pushing the envelope on the science and this ultimately will help advance the field, representatives from the US Food and Drug Administration and industry said during a BIO Digital panel on challenges and opportunities in the sector.

Center for Biologics Evaluation and Research director Peter Marks pointed to exciting developments in the space in the past year

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