BioCentury This Week

• 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 #BioCenturyGrandRoundsEuropeReach 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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• Ep. 305 - FDA's Future; In Vivo CAR T Plays; Psychedelics; CDK2

  The Trump administration’s overhaul of FDA is still underway, but the agency has already veered away from its decades-long trajectory in ways that will profoundly reshape medical product development and the lives of U.S. patients. On the latest BioCentury This Week podcast, BioCentury’s analysts assess who the winners and losers are likely to be as FDA changes shape.The analysts discuss a pair of in vivo CAR T companies: Esobiotec, whose story offers a case study in product-focused strategy, and Capstan Therapeutics, whose in vivo CAR T platform for immunological disorders attracted a buyer in Abbvie. The team also analyzes why data from Compass Pathways for psilocybin therapy COMP360 disappointed investors despite hitting the endpoint, and how molecular glues could be the future of selective CDK2 targeting. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/656341#biotech #biopharma #pharma #lifescience #RandD #drugapproval00:01 - Sponsor Message: ICON Biotech02:26 - BioCentury Grand Rounds Europe05:02 - FDA's Future15:03 - Psychedelics22:53 - Esobiotech's Fast Exit31:37 - Molecular Glues and CDK234:43 - Abbvie's Capstan BuyTo 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. 304 - Syncona Reshapes Fund; Lilly's $1B Verve Bet; FDA's 2-Track Future

  Publicly traded U.K. investment firm and company builder Syncona is restructuring its fund amid ongoing market challenges in the biopharma industry. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss how the firm will steer its portfolio toward returns for shareholders, while aiming to build a new fund away from public markets. The analysts then assess Eli Lilly's takeout of cardiovascular base editing company Verve, and what Washington Editor Steve Usdin calls FDA’s new “two-track” future for evaluating new therapies for approval — those with clear-cut benefits and those with ambiguous efficacy safety and efficacy profiles — in light of the many departures of senior FDA staff. They also discuss NASDAQ’s largest biopharma IPO — by Caris —  in two years, the latest obesity readouts, FDA Commissioner Marty Makary’s priority pathway and Usdin’s Q&A with new BIO Chair Fritz Bittenbender. This episode of BioCentury This Week was sponsored by ICON Biotech.View full story: https://www.biocentury.com/article/656266#biotech #biopharma #pharma #lifescience #finance #CV #FDA00:01 - Sponsor Message: ICON Biotech02:14 - Syncona Restructures Fund10:08 - Lilly's $1B Verve Takeout21:45 - FDA's 2-Track FutureTo 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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