Regulatory

31. 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.

32. 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.

33. 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.

34. 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.

35. 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.

36. Bringing Curative Cell Therapies To Market with Kite Pharma's Cindy Perettie 2/6/2026

    On this week's episode of the Business of Biotech, we're speaking with Cindy Perettie, Executive Vice President and Global Head at Kite Pharma, a Gilead-owned company focused on curing cancer with cell therapies.

37. 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.

38. 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.

39. Engineering B Cells With Immusoft's Sean Ainsworth 12/5/2025

    On this week's episode of the Business of Biotech, Sean Ainsworth, CEO and Chairman at Immusoft, talks about transitioning from the research bench to entrepreneurship, his M&A experiences as a biotech founder, and why engineered B cell therapies offer a better, more patient-friendly administration for lysosomal storage diseases currently treated with enzyme replacement therapies.

40. 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.