Regulatory
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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.
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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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IND For TIL Therapy With Obsidian Therapeutics' Paul Wotton, Ph.D.
10/25/2022
On this episode of The Business of Biotech, Obsidian Therapeutics CEO Paul Wotton, Ph.D. takes us behind the scenes to reveal what precipitated the FDA's clearance of its IND application for a novel, engineered tumor-infiltrating lymphocyte therapy called OBX-115. Learn how the company navigated the regulatory path for a first-of-its-kind biologic therapy developed in partnership with the University of Texas MD Anderson Cancer Center that Dr. Wotton says, should it succeed, will eliminate the patient risk associated with concomitant IL2 therapy and improve clinical outcomes for certain patients with metastatic melanoma. We also get an update on outcomes from Obsidian's unique approach to solving COVID-19 challenges covered on episode 9 of the Business of Biotech.
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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.
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The Clinical Trials Conundrum With Allan Shaw
10/18/2021
The clinical trials status quo is a roadblock. They're slow, they're inefficient, and they're expensive. On this episode of the Business of Biotech, friend and frequent guest Allan Shaw shares some strong opinions on what's wrong with clinical trials, and what the industry (read: you) and the FDA need to do to make them right.
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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.
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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.
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What's Next For COVID Vaccines With Tonix Pharmaceuticals' Seth Lederman, M.D.
5/23/2022
As COVID-19 cases climb yet again, the Business of Biotech catches up with Tonix Pharmaceuticals Chairman and CEO Seth Lederman, M.D. for a conversation on his company's multi-pronged strategy to advance vaccine and therapeutic candidates to address the disease and its variants. In addition to sharing on his journey from academia to industry, Dr. Lederman discusses his company's approach to grabbing its share of the highly competitive, and highly lucrative, vaccine market.
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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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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.