Regulatory

1. 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.

2. 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.

3. Gap Analysis With Dr. Pablo Valenzuela & Cristián Hernández-Cuevas 9/30/2020

   On the season finale of the Business of Biotech, we're joined by biopharma pioneer Dr. Pablo Valenzuela and a rising star in Chile's biotech scene in Cristián Hernández-Cuevas for a candid discussion on biopharma's compute power revolution, the influence of technology on gap analyses and next steps for emerging biopharma, and what's driving biotech growth in South America.

4. 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.

5. How To Be A Policy Advocate For Biotech With NewYorkBIO's Jennifer Hawks Bland 6/25/2025

   On this week's episode of the Business of Biotech, Jennifer Hawks Bland, CEO of NewYorkBIO, shares insights on New York State's life sciences ecosystem while reflecting on her journey from Capitol Hill to biotech advocacy.

6. 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.

7. 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. 

8. Regulatory Harmonization With Aurion Biotech's Dr. Daniela Drago 2/22/2022

   If you're taking a candidate into clinical trials that will be monitored by multiple international regulatory bodies, this episode is an absolute must-listen. Dr. Daniela Drago, Chief Regulatory Officer at Aurion Biotech, shares her encyclopedic knowledge of the dynamic regulatory harmonization landscape. Along the way, she offers concrete advice on creating multijurisdictional regulatory efficiencies that will smooth your journey through the clinic and beyond. Don't miss this one. 

9. Steering Through Setbacks with AVEO Oncology's Michael Bailey 8/18/2024

   For all the drug commercialization successes he's played a leading hand in during his tenures at GSK, Genentech, and ImClone — Androderm, Augmentin, necitumumab, and Erbitux among them — Michael Bailey concedes that he's likely better known for his failures. After hearing his stories on this episode of the Business of Biotech, I tend to disagree.

10. 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.