Regulatory

1. Dissecting Spesolimab's Approval With Boehringer Ingelheim's Carine Boustany 1/2/2023

   Join Matt Pillar for a conversation with Carine Boustany, PharmD, Ph.D. and SVP, US Research Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. On this episode of the Business of Biotech, we walk through the story leading up to the recent approval of spesolimab. In September 2022, spesolimab was approved in the USA for the treatment of generalized pustular psoriasis (GPP) flares in adults. Dr. Boustany shares the antibody's fortuitous discovery, the challenges her team faced on the path to approval, and how those challenges were overcome.

2. 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.

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. Biopharma Regulatory Requirements With Bluebird Bio's Scott Cleve 4/26/2021

   Scott Cleve brings an entire career dedicated to the mastery of global biopharma regulatory standards to his role as Vice President of Regulatory Operations and Compliance at bluebird bio. Join Cleve, host Matt Pillar, and Erin Harris, chief editor at Cell & Gene, for a candid discussion on the regulatory trends shaping the advance of bluebird's pipeline of gene therapies for the treatment of serious, life-altering diseases including Cerebral Adrenoleukodystrophy, Multiple Myeloma, Transfusion-Dependent β-Thalassemia, and Sickle Cell Disease.

5. Biopolitics With Allan Shaw 11/24/2024

   The notion that political influence has no place in biology appears poised for a test it hasn’t studied for. Trump administration nominations, from RFK, Jr. to HHS and Vivek Ramaswamy to the newly-proposed DOGE, are driving speculation over the implications for biotech and other life sciences industries. How should biotech builders be obviating? On the Business of Biotech, we’re joined for some reflection by none other than Allan Shaw.

6. CMC Considerations For In-Human Studies With Drs. Edith Perez And Nathan Ihle 9/23/2020

   Bolt Biotherapeutics CMO Dr. Edith Perez and VP of CMC & Quality Dr. Nathan Ihle bring a unique combination of patient and production process expertise to the table for an enlightening conversation on preparing chemistry, manufacturing, and controls for an IND and ensuing first in-human studies.

7. BoB@JPM: Kasper Roet, Ph.D., QurAlis 3/12/2025

   On this episode of the Business of Biotech, Life Science Leader's Ben Comer joins to co-host a conversation with Dr. Roet that goes deep on his company's genetic medicine approach to ALS, and even deeper into his opinions on, and growing influence over, the regulatory environment.

8. The Clinical Trials Conundrum With Allan Shaw 10/18/2021

   The clinical trials status quo is a roadblock. They're slow, they're inefficient, and they're expensive. On this episode of the Business of Biotech, 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.

9. Drug Delivery Differentiators with Syncromune's Eamonn Hobbs 7/7/2024

   Syncromune's Sync-T solid tumor therapeutic platform is, in a word, complex. The company's three phase 1 programs combine T-cell science with a proprietary drug delivery device to target solid tumors, specifically metastatic breast, non-small-cell lung, and castrate-resistant prostate cancers. But, while orchestrating a successful drug/device combination therapy presents unique regulatory challenges and requires a diverse array of in-house skillsets, President and CEO Eamonn Hobbs is confident. Why? He's done it before.

10. How To Apply For BTD And Win It With Drs. Ira Gupta & Shanthi Ganeshan 8/23/2021

    Everyone in the business is looking for breakthroughs, but only a select few win breakthrough therapy designation from the FDA. Under the guidance of Ira Gupta, M.D. and Shanthi Ganeshan, Ph.D, GSK has a few BTDs under its belt. Dr. Gupta is VP of Medicine Development at GSK and Dr. Ganeshan is formerly VP of Global Regulatory Affairs there, having recently joined Gilead as Head of Regulatory for Oncology. On this episode, we go deep on how to apply for--and win--breakthrough therapy designation with two women who couldn't be more qualified for the discussion.