Regulatory

1. 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.

2. FDA Trials And Tribulations With Connect Biopharma's Barry Quart 6/19/2025

   On this week's episode of the Business of Biotech, Barry Quart, CEO of Connect Biopharma, weighs in on the current state of engagement between drug developers and the FDA, and how that key relationship continues to evolve under new leadership. Barry also discusses moving the company from China to San Diego, why a U.S. financial reporting structure helps attract investors, and how Connect is finding the white spaces in respiratory disease -- the company's lead candidate is a biologic drug targeting acute asthma and COPD exacerbations.

3. Taking ADCs Across The Finish Line 8/13/2020

   While Immunomedics CMO Loretta Itri, M.D. is no stranger to taking drugs across the commercial finish line in big pharma environments, her most recent win with TRODELVY was very, very different. On this episode, Dr. Itri shares insight on her small biopharma's first commercial launch, the manufacturing and regulatory approval challenges that were overcome to get there, and why antibody drug conjugates are coming of age.

4. 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.

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. 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.

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. The Business Of CNS with Acumen's Jim Doherty, Ph.D. 1/26/2025

   The Business of Biotech welcomes Dr. Jim Doherty of Acumen Pharmaceuticals to discuss the challenges and advances in Alzheimer's treatment, including controversies around amyloid-targeting drugs and the role of biomarkers in personalized therapy.

9. 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.

10. Regulatory Harmonization With Aurion Biotech's Dr. Daniela Drago 2/22/2022

    If you're taking a candidate into clinical trials that will be monitored by multiple international regulatory bodies, this episode is an absolute must-listen. Dr. Daniela Drago, Chief Regulatory Officer at Aurion Biotech, shares her encyclopedic knowledge of the dynamic regulatory harmonization landscape. Along the way, she offers concrete advice on creating multijurisdictional regulatory efficiencies that will smooth your journey through the clinic and beyond. Don't miss this one.