Regulatory
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Biopolitics With Allan Shaw
11/24/2024
The notion that political influence has no place in biology appears poised for a test it hasn’t studied for. Trump administration nominations, from RFK, Jr. to HHS and Vivek Ramaswamy to the newly-proposed DOGE, are driving speculation over the implications for biotech and other life sciences industries. How should biotech builders be obviating? On the Business of Biotech, we’re joined for some reflection by none other than Allan Shaw.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.