11.01.21 -- BridgeBio's Approach To Gene Therapy, The CDMO Capacity Crunch And More

Check out the latest episodes from Cell & Gene: The Podcast and Business of Biotech. As a member of the Life Science Connect community, you have access to content beyond our weekly newsletters including our podcast series. Don’t forget to subscribe so you never miss an episode!

BridgeBio's CEO of gene therapy, Dr. Eric David, explains the company's gene therapy programs for Canavan disease and congenital adrenal hyperplasia, their manufacturing plans, and the platform underpinning their approach to gene therapy.

Spark Therapeutics' clinical development lead, hematology, Dr. Tiffany Chang, explains the company's data from its ongoing Phase 1/2 clinical trial of investigational SPK-8011 for hemophilia A, the largest gene therapy trial in this disease to date, as well as the misconceptions and unknowns about the disease.

This episode tackles the CDMO capacity crunch from every angle in a spirited discussion with Discovery Labs & Center for Breakthrough Medicines cofounder, Audrey Greenberg, Iovance SVP of commercial manufacturing, Sumit Verma, and the CEO of Project Farma, Anshul Mangal.

The clinical trials status quo is a roadblock. They're slow, they're inefficient, and they're expensive. Friend and frequent guest Allan Shaw shares some strong opinions on what's wrong with clinical trials, and what the industry (read: you) and the FDA need to do to make them right. 

AltruBio VP of technical development, Gene Lee, Ph.D., joins us for a deep dive into the importance of chemistry, manufacturing, and controls (CMC) developability assessments, covering the key points they must address, when to begin them, how to go about them efficiently, and why they're integral to early milestones and rapid entry into Phase 1 clinical trials.

Inspired to develop a treatment for infantile Krabbe disease, the founders of Forge Biologics picked a unique but strategic approach to funding the initiative. Cofounder, president and CEO, Timothy J. Miller, Ph.D., joins us to discuss the strategy, why it was a no-brainer given the white-hot market for contract development and manufacturing space, the state of the biologics manufacturing capacity crunch, and what companies such as Forge are doing about it.

Eric Ostertag, M.D., Ph.D., is founder and CEO at Poseida Therapeutics, a company that's doing things never seen before in the field of CAR T-cell and gene therapies for multiple myeloma and prostate cancer. Here, Dr. Ostertag gives us a tour of the architecture supporting Poseida's unique three-tiered development and manufacturing platform.