BioCentury This Week

• Ep. 310 - Sarepta & What's Next for Gene Therapy. Plus: Leading FDA's CDER

  Last week’s public disclosure that a gene therapy from Sarepta had caused a third death led FDA to ask the company to stop distributing its DMD gene therapy Elevidys, a move the biotech has resisted. The deaths, and disputes between FDA and Sarepta, raise questions about the future of AAV gene therapies, as well as the future of FDA’s platform technology designation. On the latest BioCentury This Week podcast, BioCentury’s analysts unpack the events surrounding Sarepta’s gene therapies and discuss how FDA, industry and patient groups should come together to learn the lessons from the tragic, avoidable deaths.BioCentury’s analysts also assess Monday’s appointment of Stanford professor and biotech executive George Tidmarsh to lead FDA’s Center for Drug Evaluation and Research, and check in on the latest trends in venture financings. This episode of BioCentury This Week is sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656537#biotech #biopharma #pharma #lifescience #GeneTherapy #AAVTherapy #Sarepta #Elevidys00:01 - Sponsor Message: IQVIA Biotech02:03 - Gene Therapy17:59 - Leading CDER27:00 - Venture ReportTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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• Ep. 309 - 3Q Markets Preview; Quantum Computing; Makary’s First 100 Days

  Chinese biotech is the lone bright spot for the biopharma financial markets in 1H25, as macro concerns about the most favored nation (MFN) pricing policy and FDA weigh on the prospects for biotech elsewhere. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the positives — and negatives — impacting investor sentiment headed into the second half of the year. The team also discuss where the quantum computing revolution could have its biggest impact on drug development, and review the proposals and accomplishments of FDA Commissioner Marty Makary over his first 100 days in office. This episode of BioCentury This Week was sponsored by IQVIA Biotech.View full story: https://www.biocentury.com/article/656482#biotech #biopharma #pharma #lifescience #financialmarkets #FDA #quantumcomputing00:01 - Sponsor Message: IQVIA Biotech04:43 - Q25 Financial Markets Preview22:20 - Quantum Computing Impact on Biopharma30:07 - Makary's First 100 DaysTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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• Ep. 308 - Grand Rounds - Europe Preview

  Grand Rounds heads to Europe: first meeting Sept. 17 in Cambridge, U.K.There are many reasons why it may be the European biomedical ecosystem’s moment to shine, and advances at the academia-industry interface are a core part of that story, particularly in Cambridge, U.K. — the site of the inaugural BioCentury Grand Rounds – Europe conference.On a special edition of the BioCentury This Week podcast, BioCentury’s analysts are joined by four leaders in the Cambridge, U.K., life sciences community to preview the Sept. 17-19 meeting: Kathryn Chapman, executive director of Innovate Cambridge; Anne Horgan, partner, Cambridge Innovation Capital (CIC); Sally Mardikian, business development director, Astrazeneca plc (LSE:AZN; NASDAQ:AZN); and Kristin-Anne Rutter, executive director of Cambridge University Health Partners (CUHP).The BioCentury team and its Cambridge counterparts discuss the conference’s themes and how they relate to the region’s strengths, and offer both some tough love and a warm invitation to early-stage innovators looking for science-forward investors and partners.View full story: https://www.biocentury.com/article/656373#biotech #biopharma #pharma #lifescience #Discovery #Translation #BioCenturyGrandRoundsEurope00:00 - Introduction01:53 - Grand Rounds Cambridge Themes10:14 - Why Cambridge?23:43 - Tough Love28:02 - Join us at GlastonGeekTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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• Ep. 307 - How Cancer Regulation is — and isn’t — Changing at FDA

  Oncology regulation has been less affected by recent changes in FDA leadership than other parts of the agency. On a special sponsored edition of the BioCentury This Week podcast, BioCentury’s analysts assess what has and hasn’t changed at FDA when it come to regulating cancer therapeutics. Special Guest Liz O’Brien joins BioCentury’s analysts to discuss how biotechs can navigate FDA’s Project Optimus and EMA’s Joint Clinical Assessment as well as the differences between the two agencies. O’Brien is a former EMA regulator who is now therapeutic expert, oncology and women’s health, drug development solutions at BioCentury This Week sponsor ICON Biotech. View full story: https://www.biocentury.com/article/656371#biotech #biopharma #pharma #lifescience #FDA #cancer #CAR_T00:01 - Sponsor Message: ICON Biotech02:30 - FDA Cancer Regulations07:48 - Project Optimus25:12 - CAR T REMS RemovalTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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• Ep. 306 - Treg Inflection Point; Biotech's Next Big Story; Tax Bill Consequences

  Treg-based cell therapies are nearing a clinical proof-of-concept inflection point, but in an environment that has dramatically shifted with the advent of CAR T therapies for autoimmune diseases. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what these cell therapies need to show to be relevant in the fast-changing I&I world, and which types of indications may best suit the cells’ unique profile.The team also explores the biotech sector’s ongoing struggle to capture the interest of generalist investors, and what the next major theme might be to draw them back.The analysts then break down the key provisions in the recently passed U.S. reconciliation tax bill, highlighting the positive and negative developments, as well as the missed opportunities for the industry. This episode of BioCentury This Week was sponsored by IQVIA Biotech. View full story: https://www.biocentury.com/article/656376#biotech #biopharma #pharma #lifescience #CellTherapy #TregTherapy #CAR_T00:01 - Sponsor Message: IQVIA Biotech01:19 - Treg Inflection Point10:57 - Biotech's Next Big Story22:36 - Tax Bill ConsequencesTo submit a question to BioCentury’s editors, email the BioCentury This Week team at [email protected] us by sending a text

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