Regulatory

1. 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.

2. 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.

3. 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.

4. 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.

5. Novel Peptide Delivery With Revolo's Woody Bryan, Ph.D. 12/1/2024

   Revolo Biotherapeutics President and CEO Woody Bryan, Ph.D. is pushing the boundaries of peptide therapeutic delivery. On this episode of the Business of Biotech, we dig into Dr. Bryan’s transition to the CEO chair at the company and how that coincided with an aggressive strategic decision to alter the course of administration of its peptide candidates in allergic and autoimmune diseases.

6. Biotech Down Under with BiomeBank's Dr. Sam Costello 12/20/2023

   Merry Christmas, Business of Biotechers! On this Christmas Day release, we’re taking a trip to the land down under to visit with Dr. Sam Costello, managing director and co-founder at Adelaide, Australia-based BiomeBank. We covered some ground on this one, most notably the unique path BiomeBank took to chalking up the first donor-derived microbiome therapeutic approval of its kind, anywhere in the world. In a segment of biotech that’s been particularly battered of late, that’s a big, big win. 

7. Commitment To GMP With Dr. Shabbir Anik 9/13/2020

   Sutro Biopharma Chief Technical Operations Officer Shabbir Anik has contributed to 15 INDs and 10 NDA’s over the course of his distinguished career, making him a great choice to sit down for a chat about the mechanics of GMP and CMC strategy in new and emerging biopharma enterprises. Here, Dr. Anik shares stories from the front lines of Sutro's effort to move its antibody conjugate, bispecific antibody, and cytokine derivative candidates forward.

8. 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.

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. 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.