Regulatory

31. 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.

32. 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.

33. 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.

34. 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.

35. Biosimilars And Complex Medicines For All With RNA Therapeutics' Sarfaraz Niazi, Ph.D. 4/9/2026

    On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes.

36. 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.

37. 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.

38. Preparing For The Clinic With Amolyt Pharma's Dr. Thierry Abribat 3/8/2021

    Amolyt Pharma is developing a therapeutic peptide program targeting rare endocrine and metabolic diseases including hypoparathyroidism and acromegaly. Fresh on the heels of its lead candidate's foray into phase 1 clinical trials, we're joined by the company's founder and CEO, Thierry Abribat, Ph.D., for a deep dive into Amolyt Pharma's pre-clinical preparation, including his financing, talent acquisition, and clinical study strategies.

39. Psychedelics For Mental Health Disorders With atai's Srinivas Rao, M.D., Ph.D. 5/28/2025

    On this week's Business of Biotech episode, Dr. Srinivas Rao, co-founder and CEO at atai Life Sciences, explains how his engineering background led him to the development of psychedelic compounds for treating depression, anxiety, and other mental health disorders. Internal drug development efforts at atai are focused on short-duration psychedelics that can work within existing healthcare infrastructure, with the potential to transform the treatment of mental health disorders.

40. 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.