11.02.22 -- PDUFA VII Reauthorization, IND for TIL Therapy, Oncology Discovery Advances, and more podcast episodes for you!

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!

On the heels of Congress's reauthorization of the Prescription Drug User Fee Authorization (PDUFA) Act, BridgeBio's chief regulatory affairs officer, Adora Ndu, explains the commitment letter, the programs that may be rolled out under PDUFA VII, why right-sizing CBER will help the cell and gene sector going forward, as well as how sponsor companies can prepare for 2023 from a regulatory perspective.

Arrowhead Pharmaceuticals is a biopharmaceutical company based in Pasadena, CA, that develops medicines that treat intractable diseases by silencing the genes that cause them. Javier San Martin, Arrowhead's CMO, talks about the similarities and differences between RNAi and CRISPR. He also explains the roadmap for RNAi as well as the company's pipeline development strategy, which includes preclinical to Phase 3 trials.

Anat Binur, Ph.D., is leading an effort to reverse-engineer the proteins that induce immune response in people who suffer from food allergies. Her company, Ukko, leverages AI to analyze proteins taken from patients' blood to determine the specific attributes that trigger immune response. It then applies compute power and biology to identify and understand the changes it wants to engineer and predict the best possible designs.

4BIO managing partner Dmitry ‘Dima’ Kuzmin and Ray Therapeutics co-founder and CEO Paul Bresge share the recipe for a successful relationship between biotech VC firm and startup. Bresge offers insight into VC engagement strategy and pitch, while Kuzmin dishes on what investors look for in terms of "fundability" and what throws red flags.

AbbVie’s VP of oncology discovery, Steve Davidsen, Ph.D., is a living, breathing timeline of the company's cancer research and development efforts. He's charted the adoption of multiple advanced technologies that have contributed to the realization of dozens of molecular weapons in the fight against cancer. Davidsen shares the latest on AbbVie's adoption of computational biology and how it's contributing to discovery and development efficiencies.

Obsidian Therapeutics CEO Paul Wotton, Ph.D., takes us behind the scenes to reveal what precipitated the FDA's clearance of its IND application for a novel engineered tumor-infiltrating lymphocyte therapy. Learn how the company navigated the path to a first-of-its-kind therapy developed in partnership with the University of Texas MD Anderson Cancer Center.