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. 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. 

3. 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.

4. Keeping Cell Therapy Clinicals On The Rails With Brian Culley 2/1/2021

   Like most biotechs, Lineage Cell Therapeutics faced some significant challenges as it navigated multiple clinical trials, one of them in an aging, at-risk population, during a global pandemic. On this episode, CEO Brian Culley tells Erin Harris and Matt Pillar how he kept the company's programs for OpRegen® (dry AMD with GA) and OPC1 (acute spinal cord injury) running on time despite the disruptions.

5. The Editors' Roundtable: A Midyear Look At The 2026 Life Sciences Industry 6/5/2026

   On this week's episode of the Business of Biotech, Tyler Menichiello, chief editor at Bioprocess Online, host of the Better Biopharma podcast, and my Life Science Connect (LSC) colleague, convenes the broader LSC editorial team once again for a midyear discussion on what's happening now in the life sciences industry, and what's to come in the second half of the year.

6. Improving Cardiovascular Outcomes With Immediate Therapeutics' Atul Deshpande, Ph.D. 8/27/2025

   On this week's Business Of Biotech episode, Atul Deshpande, Ph.D., CEO at Immediate Therapeutics, talks about partnering with American cities to conduct clinical trials during ambulance rides to the hospital, with the goal of preserving heart function and reducing mortality related to acute cardiovascular events, including heart attacks.

7. 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. 

8. T-Cells For The Win With Adaptimmune's Adrian Rawcliffe 11/17/2024

   In August of this year, the first TCR cell therapy to be approved for use in the U.S. was greenlighted by the FDA for patients with unresectable or metastatic synovial sarcoma who have previously received chemotherapy. It marked the first new treatment for those patients in more than a decade; a win for those patients, and a win for Adrian Rawcliffe, who’s had a hand on the wheel at Adaptimmune, the therapy’s developer and manufacturer, since he joined the company as CFO in 2015.

9. 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. 

10. 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.