BioCentury This Week

• Ep. 337 - FDA’s Moving Goalposts & China’s Innovation Arc

  A baffling decision by FDA to issue a complete response letter for a pediatric medicine the medical community stood behind is just the latest example raising concerns that the agency is shifting the regulatory goalposts amid a lack of transparency. On the latest BioCentury This Week podcast, Washington Editor Steve Usdin explains how the absence of advisory committee meetings at FDA is in part to blame for a lack of consistency in decision-making and divergence from decisions taken by other global regulatory agencies. VP and Editor-in-Chief Simone Fishburn then discusses the takeaways from Franck Le Deu’s guest commentary on how China’s biotech ecosystem is evolving, and whether government support for the sector is helping or hindering its overall health. BioCentury’s analysts also discuss whether conventional CRISPR therapies will ever be commercially successful, and what’s next for NLRP3 inhibitors to treat obesity following the first set of Phase II data for the class.We'd also like to invite our listeners to participate in our important survey about their experiences interacting with FDA. To take the survey, please go to BioCentury's FDA Sentiment Survey. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657698#FDARegulation #CRISPRTherapies #NLRP3Inhibitors #ChinaBiotech #DrugApproval00:01 - Sponsor Message: Voyager Therapeutics01:31 - FDA Sydnexis CRL07:36 - CDC Vaccine Claims09:55 - China’s Innovation Arc16:49 - CRISPR Commercial Viability 26:39 - NLRP3 for ObesityTo 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. 336 - Cautious Optimism and M&A Momentum

  There is cautious optimism around continued M&A momentum and the public equities markets as biotech heads into the New Year. On a special edition of the BioCentury This Week podcast recorded in London during London Life Sciences Week, BioCentury’s Simone Fishburn and Stephen Hansen were joined by a trio of guests to discuss their key takeaways from the week and expectations for next year, including trends in M&A and creative deal structures for business development.The group also discussed the potential for biotech venture investing to make a comeback as a key asset class for LPs, especially in the U.K., as the government continues to encourage pension funds to invest more broadly.The three guests joining BioCentury included Luciana Griebel from law firm Morgan Lewis, James Critchley from PJT Partners, and Carmine Circelli from the British Business Bank.The podcast was recorded Nov. 19 on stage at the Victoria House in London as part of the 3rd Biotech CEO & Investor Reception.BioCentury’s next recording “on the road” will take place on the sidelines of the annual J.P. Morgan Healthcare Conference in San Francisco in January at the 11th East West Healthcare Reception hosted by BioCentury, Panacea Venture and Maytech Global Investments.View full story: https://www.biocentury.com/article/657686#BiotechMandA #DrugDevelopment #VentureCapital #LifeSciences #LondonLifeSciencesWeek00:00 - Introduction02:24 - Market Recovery08:02 - Growth and Influence16:24 - Creative Dealmaking21:40 - Role of CVRs25:52 - Pension Funds and Venture Capital30:09 - AI Bubble34:17 - Accelerating Clinical TrialsMorgan Lewis has prepared its materials for this podcast for general informational purposes only. They do not and are not intended to constitute legal advice. This podcast was recorded on Nov. 19. Morgan Lewis does not guarantee the accuracy or timeliness of the information contained in these materials and disclaims any obligation to advise you of any changes in the law. You should always refer to original source documents for complete information and consult directly with an attorney for advice, including on the latest developments in this rapidly changing area of the law.To 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. 335 - Neurology's Coming Inflection Point

  Voyager CEO and former head of R&D at Biogen Al Sandrock is more optimistic than ever about the prospect of bringing clinically meaningful solutions to patients with Alzheimer’s disease and other neurodegenerative disorders. The threads of progress are finally coming together, he said in a special episode of the BioCentury This Week podcast. From the first disease-modifying therapies for Alzheimer’s disease, to a growing biomarker toolkit, to an expanding set of genetically validated targets in other neurodegenerative conditions — and, crucially, to delivery vehicles capable of broadly and deeply penetrating the brain — neurology drug development may be poised to accelerate. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657678#AlzheimersDisease #AAVGeneTherapy #BloodBrainBarrier #TauTargeting #Neurodegeneration00:01 - Sponsor Message: Voyager Therapeutics 03:41 - Voyager's Approach to Gene Therapy15:07 - Alzheimer's Disease25:25 - Big Biotech to Small Biotech29:21 - Neurodegenerative Diseases31:19 - FDA FlexibilityTo 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. 334 - Pazdur’s New FDA Role, SITC & China RNAi

  Richard Pazdur took the top job at FDA’s Center for Drug Evaluation and Research after receiving vows that he would be leading CDER free from political interference. On the latest BioCentury This Week podcast, BioCentury's analysts discuss the issues that could prove to be flashpoints between Pazdur and the heads of FDA and HHS, including personnel, RSV mAbs, puberty blockers and SSRIs.BioCentury's analysts assess bispecific innovation at the annual meeting of the Society for Immunotherapy of Cancer (SITC) and the growing field of companies pursuing RNAi, many of which have multiple unpartnered assets. Also featured in this week's episode: new funds from European VCs Medicxi and Sofinnova Partners, FDA’s new plausible mechanism pathway and the Trump administration’s “most favored nation” drug-pricing plan, which is turning out to be much more less onerous to drug companies than its original description suggested. This episode of the BioCentury This Week podcast is brought to you by Voyager Therapeutics.View full story: https://www.biocentury.com/article/657631#RNAiTherapeutics #BispecificAntibodies #CD3TCellEngagers #MechanismOfAction #ImmunoOncology #PlausibleMechanismPathway #RegulatoryScience #ClinicalTranslation00:01 - Sponsor Message: Voyager Therapeutics 03:08 - FDA's Richard Pazdur13:08 - Plausible Mechanism Pathway19:30 - Most Favored Nation23:12 - Takeaways from SITC28:05 - RNAi in China33:21 - European VCsTo 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. 333 - Is This Korea’s Biotech Moment?

  Today’s South Korean biotechs have a risk-on mentality, a willingness to partner, and strategies focused on globalization. On a special edition of the BioCentury This Week podcast recorded at Venture Café Cambridge, BioCentury is joined by a quartet of investors and executives with deep knowledge of Korea’s life sciences ecosystem to discuss Korea biotech’s push to globalize and the opportunities in the country for Western companies. The four guests joining BioCentury were Aram Hong, CEO of Korean start-up Apollon; investors Spencer Nam and Debra Peattie; and Boehringer Ingelheim GmbH's Andy Whittle.The podcast was recorded Nov. 6 on stage at the Venture Café Cambridge during the K-Blockbuster Night hosted by KHIDI, the Korea Health Industry Development Institute. BioCentury analyses discussed during the podcast include one on Asian deals and another on the speed of clinical trials in China. BioCentury returns to Asia early next year for the 5th East-West Summit, March 9-11 in Seoul. This episode of the BioCentury This Week podcast is brought to you by KHIDI.View Full story: https://www.biocentury.com/article/657558#KoreaBiotech #Globalization #LifeSciences #BiotechEcosystem #PharmaDeals #ClinicalDevelopment #Innovation #BiotechLeadership00:01 - Sponsor Message: KHIDI05:08 - Asia Deals and Korea's Role09:12 - Boehringer's Perspective13:51 - Apollon's Journey17:24 - Building Relationships23:20 - Investors' View To 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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