Regulatory

  1. IND For TIL Therapy With Obsidian Therapeutics' Paul Wotton, Ph.D. 10/25/2022

    On this episode of The Business of Biotech, 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 called OBX-115. Learn how the company navigated the regulatory path for a first-of-its-kind biologic therapy developed in partnership with the University of Texas MD Anderson Cancer Center that Dr. Wotton says, should it succeed, will eliminate the patient risk associated with concomitant IL2 therapy and improve clinical outcomes for certain patients with metastatic melanoma. We also get an update on outcomes from Obsidian's unique approach to solving COVID-19 challenges covered on episode 9 of the Business of Biotech.

  2. Data Quality & Master Files With Dr. Robert Hariri 9/6/2020

    If ever a biotech unwittingly begged for FDA scrutiny by virtue of its business model, it was Celularity. The company is working on a host of biologic therapies, the development of which is dependent on the large-scale collection of stem cells harvested from afterbirth in maternity wards across the globe. That's an approach that simply begs for FDA oversight, which is why Celularity founder Dr. Robert Hariri makes for an excellent discussion on the importance of data quality and complete master files for FDA submissions. 

  3. The FDA's Progressive Appeal ft. Allan Shaw 2/16/2021

    Allan Shaw rejoins the Business of Biotech with candid and deep commentary on the unprecedented pace of biopharma innovation, and how the FDA is doing in its equally unprecedented effort to keep pace. In particular, Shaw shares his take on the advance of cell and gene therapies, his observation on the outsized approval rate for orphan disease and oncology therapies, and much, much more. *Editor's note: the review of Biogen's Aducanumab, referenced here as taking place in the March timeframe, was extended shortly after this episode was recorded.

  4. How To Be A Policy Advocate For Biotech With NewYorkBIO's Jennifer Hawks Bland 6/25/2025

    On this week's episode of the Business of Biotech, Jennifer Hawks Bland, CEO of NewYorkBIO, shares insights on New York State's life sciences ecosystem while reflecting on her journey from Capitol Hill to biotech advocacy.

  5. Gap Analysis With Dr. Pablo Valenzuela & Cristián Hernández-Cuevas 9/30/2020

    On the season finale of the Business of Biotech, we're joined by biopharma pioneer Dr. Pablo Valenzuela and a rising star in Chile's biotech scene in Cristián Hernández-Cuevas for a candid discussion on biopharma's compute power revolution, the influence of technology on gap analyses and next steps for emerging biopharma, and what's driving biotech growth in South America.

  6. Steering Through Setbacks with AVEO Oncology's Michael Bailey 8/18/2024

    For all the drug commercialization successes he's played a leading hand in during his tenures at GSK, Genentech, and ImClone — Androderm, Augmentin, necitumumab, and Erbitux among them — Michael Bailey concedes that he's likely better known for his failures. After hearing his stories on this episode of the Business of Biotech, I tend to disagree.

  7. Biotech Story Time With Tal Zaks, M.D. (Part 1) 12/22/2024

    Tal Zaks, M.D. was Chief Medical Officer at Moderna before, during, and immediately following the company's headline role during the COVID pandemic. If that doesn't pique your interest about the stories he can tell, this episode of the Business of Biotech surely will. Tune in to the first installment of this two-part episode for insight from the early days of mRNA that you probably haven't heard before.

  8. Leading From Within with ISCT & Kiji's Miguel Forte, M.D. 8/11/2024

    He's been a big pharma executive. He's a multi-time biotech founder and current biotech CEO. He was once a regulator. He's a physician. He serves on multiple boards. And as of this summer, he's president of one of the most influential global organizations dedicated to the advance of cell and gene therapies (ISCT), and an executive member of another (ARM). Miguel Forte, M.D. simply can't stop finding places to apply his talents and energy to influence the advanced therapies landscape.

  9. What's Next For COVID Vaccines With Tonix Pharmaceuticals' Seth Lederman, M.D. 5/23/2022

    As COVID-19 cases climb yet again, the Business of Biotech catches up with Tonix Pharmaceuticals Chairman and CEO Seth Lederman, M.D. for a conversation on his company's multi-pronged strategy to advance vaccine and therapeutic candidates to address the disease and its variants. In addition to sharing on his journey from academia to industry, Dr. Lederman discusses his company's approach to grabbing its share of the highly competitive, and highly lucrative, vaccine market.

  10. An Unanticipated Biotech Startup With OS Therapies' Paul Romness 11/3/2024

    Becoming a biotech CEO wasn't on Paul Romness' bingo card. He'd forged his place in the biopharma industry as a foremost public and policy affairs expert. Thirteen years at J&J, more than 5 at Amgen, and half a dozen at Boehringer Ingelheim had earned him the right to coast into a consulting gig that would enable him to finish out his career on his terms. Then his daughter's best friend Olivia, a teenage girl and neighbor he'd watched grow up, was diagnosed with osteosarcoma.