Regulatory

  1. 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.

  2. 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.

  3. 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.

  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. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Dissecting Spesolimab's Approval With Boehringer Ingelheim's Carine Boustany 1/2/2023

    Join Matt Pillar for a conversation with Carine Boustany, PharmD, Ph.D. and SVP, US Research Site Head and Global Head of Immunology and Respiratory Diseases at Boehringer Ingelheim. On this episode of the Business of Biotech, we walk through the story leading up to the recent approval of spesolimab. In September 2022, spesolimab was approved in the USA for the treatment of generalized pustular psoriasis (GPP) flares in adults. Dr. Boustany shares the antibody's fortuitous discovery, the challenges her team faced on the path to approval, and how those challenges were overcome.