Regulatory

1. The Impact Of FDA Risk On Biotech Rewards With CFO And Board Director Allan Shaw 4/16/2026

   On this week's episode of the Business of Biotech, five-time public company CFO and seven-time public company board member Allan Shaw talks about why FDA decision-making feels less predictable, and how that uncertainty is reshaping clinical trial strategy, investor behavior, and the innovation ecosystem.

2. The FDA's Progressive Appeal ft. Allan Shaw 2/16/2021

   Allan Shaw rejoins the Business of Biotech with candid and deep commentary on the unprecedented pace of biopharma innovation, and how the FDA is doing in its equally unprecedented effort to keep pace. In particular, Shaw shares his take on the advance of cell and gene therapies, his observation on the outsized approval rate for orphan disease and oncology therapies, and much, much more. *Editor's note: the review of Biogen's Aducanumab, referenced here as taking place in the March timeframe, was extended shortly after this episode was recorded.

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. Biotech Story Time With Tal Zaks, M.D. (Part 1) 12/22/2024

   Tal Zaks, M.D. was Chief Medical Officer at Moderna before, during, and immediately following the company's headline role during the COVID pandemic. If that doesn't pique your interest about the stories he can tell, this episode of the Business of Biotech surely will. Tune in to the first installment of this two-part episode for insight from the early days of mRNA that you probably haven't heard before.

6. 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.

7. Manipulating Milestones In Pandemic Times With AGTC's Sue Washer 12/21/2020

   The COVID-19 pandemic continues to disrupt biopharma clinical trials, especially those conducted with at-risk patient populations. From patient recruitment to data collection, clinical trials execution became considerably more challenging in 2020. On this episode of The Business Of Biotech, AGTC CEO Sue Washer gives us a behind-the-scenes look at the creative measures her company took to serve a geographically dispersed clinical patient population and ensure her company met clinical milestones.

8. Facing NASH Therapeutic Skepticism With 89bio's Rohan Palekar 8/9/2023

   The non-alcoholic steatohepatitis (NASH) therapeutics market has proven to be an 11/10 on the difficulty scale. Despite billions of big biopharma dollars invested in therapeutic development, and a few close calls, no therapeutics has yet reached the finish line.

9. Transforming Chronic Kidney Disease With ProKidney's Bruce Culleton, M.D. 12/12/2025

   On this week's episode of the Business of Biotech, Bruce Culleton, M.D., CEO at ProKidney, talks about moving from academic research to industry and the role a key mentor played in his career path.

10. The Business Of CNS with Acumen's Jim Doherty, Ph.D. 1/26/2025

    The Business of Biotech welcomes Dr. Jim Doherty of Acumen Pharmaceuticals to discuss the challenges and advances in Alzheimer's treatment, including controversies around amyloid-targeting drugs and the role of biomarkers in personalized therapy.