Regulatory

1. 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.

2. 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.

3. 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. 

4. 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. 

5. 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.

6. 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.

7. 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.

8. 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.

9. Obesity Tx End-Around With Skye Bioscience's Punit Dhillon 10/20/2024

   While the trend toward CB1 inhibition for obesity took a small hit with the release of Novo Nordisk's small molecule oral cannabinoid receptor (CB1) inverse agonist monlunabant last month, Skye Bioscience Chairman and CEO Punit Dhillon is shaking it off. He's confident that his company's antibody-based approach to CB1 inhibition will make a moot point of the neuropsychiatric side effects that put a damper on Novo's data. On this episode of the Business of Biotech, we're digging into the uber-hot business of weight loss therapeutics.

10. 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.