China is setting a new bar for the speed of clinical development and redefining the time it takes an asset to get to the clinic. On a special edition of the BioCentury This Week podcast recorded on stage at the 12th BioCentury BayHelix China Healthcare Summit in Shanghai, BioCentury's Simone Fishburn argued that China’s emerging new standard for swift entry to the clinic could upend the bottleneck of translational development and usher in a new paradigm that could have a “massive impact globally.”
Fishburn and her BioCentury colleagues Joshua Berlin and Jeff Cranmer were joined by a trio of cross-border KOLs — John Zhu, CEO of antibody-drug conjugate company DualityBio; Matt Hewitt, CTO of  Charles River Laboratories' manufacturing business division; and Bing Wang, CFO of Akeso — to discuss the speed of generating first-in-human data, Innovent’s $1.2 billion deal with Takeda, an evolving biotech talent pool, and the state of the financial markets.
“For me, it really feels like 2025 is the year that biotech globally woke up to China,” Fishburn said.

BioCentury returns to Asia early next year for the 5th East-West Summit, March 9-11 in Seoul. Register today as a delegate or apply to join the Presenting Company Class to take advantage of early bird rates.

#ChinaInnovation #DrugDevelopment #PharmaDeals #GlobalBiotech #PharmaInnovation #siRNA #BrainToVein

00:00 - Introduction
02:49 - China Speed
12:27 - Clinical Trails 
17:34 - Global Strategy
26:59 - Financial Markets IPOs
36:52 - Talent

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Novartis’ biggest deal in more than a decade gives the Swiss pharma three programs for muscular dystrophies that are close to the finish line. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the $12 billion deal for Avidity in the context of Novartis’ recent acquisitions and the antibody-oligonucleotide conjugate platform it is gaining.
The team dives into RNA versus DNA modalities, noting antisense and siRNA approaches appear to be gaining traction with major pharmas as traditional gene therapy and gene editing approaches hit rocky times. Still, they note hopeful progress among base editing therapies given the promising early track records of over a dozen base editors in the clinic. They also discuss BioCentury’s conversation with base editing inventor David Liu; Alkermes’ $2.1 billion acquisition of Avadel; and β-catenin data from Parabilis. This episode of BioCentury This Week is sponsored by Evotec.

View full story: https://www.biocentury.com/article/657412

#AntibodyOligonucleotideConjugates #RNAtherapeutics #BaseEditing #MuscularDystrophy #WntPathway #BetaCatenin #Orexin2Receptor #PrecisionMedicine

00:01 - Sponsor Message: Evotec 
02:04 - 12th China Healthcare Summit
08:11 - Novartis' $12B Deal
16:58 - Alkermes M&A
20:01 - David Liu Base Editing
25:02 - Parabilis' Data

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Next-generation platforms and technologies are getting closer to cracking one of biopharma’s biggest problems: delivering medicines, and mAbs in particular, to the brain. On the latest BioCentury This Week podcast, BioCentury’s Selina Koch details the latest innovations in blood-brain-barrier shuttles and how the technologies could transform the treatment of neurological diseases.
BioCentury’s Lauren Martz discusses her conversation with Tony Wood, CSO of GSK, which included the pharma’s strategy for indication expansion, why it prefers RNA modalities over AAV-based gene therapies, and how its quest for causal biology has evolved over the years.
Washington Editor Steve Usdin discusses the first set of FDA’s new commissioner’s national priority review vouchers, and why the voucher program is unlikely to function as an incentive capable of steering future behavior. Usdin also discusses the potential impact of FDA staffing reductions on the sector. This episode of BioCentury This Week is sponsored by Evotec.

View full story: https://www.biocentury.com/article/657326

#BloodBrainBarrier #Neurology #DrugDelivery #MonoclonalAntibodies #RNAtherapeutics #CausalBiology #FDA

00:01 - Sponsor Message: Evotec
01:57 - Brain Shuttles
13:57 - GSK Q&A
20:08 - FDA Vouchers

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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It’s been a tough year for cell and gene therapy — patient deaths, high-profile companies pulling out of the space, and sour investment sentiment. But the field has had some promising readouts in the clinic recently, and it continues to mature, showing steady progress despite challenging market conditions. On the latest BioCentury This Week podcast, Evotec’s Bernd Mühlenweg joins BioCentury’s analysts to give his view of the field and offer takeaways from this month’s Cell & Gene Meeting on the Mesa in Phoenix. This episode of BioCentury This Week is sponsored by Evotec. 

View full story: https://www.biocentury.com/article/657278

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Biotech’s fourth quarter began with a familiar feeling, with indicators pointing toward an improving public market even as political and regulatory uncertainty has buysiders reluctant to say industry has returned to sustainable growth. On the latest BioCentury This Week podcast, BioCentury’s analysts assess the state of biotech’s public markets. The analysts discuss the Senate’s move to limit access to Chinese CDMOs, the latest developments in the White House’s “most favored nation” drug pricing negotiations, and the U.K.'s attempt to win over pharma companies via adjusting thresholds at NICE. Finally, they analyze a pair of billion-dollar-plus M&A deals: the $4.7 billion deal by Novo Nordisk to acquire liver disease company Akero and the $1.5 billion takeout of in vivo cell therapy company Orbital by Bristol Myers. This episode of BioCentury This Week is sponsored by Evotec.

View full story: https://www.biocentury.com/article/657260

#biotech #biopharma #pharma #lifescience #drugpricing #MFN

00:01  Sponsor Message: Evotec
02:12  4Q Markets Preview
13:25  China CDMOs
24:35  Drug Pricing Deals NHS
31:22  Drug Pricing Deals M&A

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The short-term consequences for Pfizer from its “most favored nation” drug pricing deal with the White House are negligible, but the long-term effects on the industry could be profound and permanent.
On the latest BioCentury This Week podcast, BioCentury Washington Editor Steve Usdin discusses why the deal by Pfizer Inc. (NYSE:PFE) changes everything — and nothing — and what’s next in wrangling over drug pricing between industry and the Trump administration.
The analysts also discuss PDUFA negotiations between FDA and leaders of BIO and PhRMA, how multi-site IITs could help bridge the academia-industry gap, and how TCG X plans to deploy its new $1.3 billion fund. This episode of BioCentury This Week is sponsored by Evotec.

View full story: https://www.biocentury.com/article/657192

#biotech #biopharma #pharma #lifescience #financialmarkets #drugpricing #MFN

00:01  Sponsor Message: Evotec
03:31  Pfizer MFN Deal
16:05  PDUFA Reauthorization
20:31  Investigator-Initiated Trials

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Genmab's $8 billion acquisition of multispecifics company Merus is the Danish biotech’s largest step toward marketing its own pipeline. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the evolution of Genmab, which, for many years, relied on a partnership model that delivered blockbuster revenues but now is making a change as a patent cliff looms.
The analysts also assess the tenure of Emma Walmsley the longtime CEO of GSK, and what’s next for the U.K. pharma under incoming CEO Luke Miels. Turning to the U.S., Washington Editor Steve Usdin discusses President Donald Trump’s looming tariff threat on imports of branded drugs, which Usdin says would hurt small biotechs the most. Usdin also analyzes the response of multinational pharmaceutical companies to the president’s demand that they make “most favored nation” price concessions, now that Monday’s deadline has passed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/657131

#biotech #pharma #deals #FGF21 #MASH #Interleukin5 #asthma #PhRMA #PBM #tarriff #MFN

00:01 - Sponsor Message: IQVIA Biotech
02:26 - Genmab's Merus Buy
09:43 - CEO Switch at GSK
17:22 - Trump Tariff Threat
21:17 - MFN Drug Pricing

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AI is bringing sweeping changes to drug development, from how targets are discovered to optimizing clinical trials to maximize an asset’s chance for success. On a special edition of the BioCentury This Week podcast, IQVIA’s Greg Lever joins BioCentury’s analysts to discuss agentic AI’s short- and long-term prospects to help biotechs discover new targets, predict success in preclinical development, and enhance clinical operations. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/657086

#Biotech #Biopharma #DrugDevelopment #ClinicalTrials #TargetDiscovery #AgenticAI #GraphRAG #DeRisking

00:01 - Sponsor Message: IQVIA Biotech
01:22 - AI in Biotech
05:01 - Machine Learning
06:21 - Generative AI and Language Models
08:37 - Agentic AI
12:43 - AI in Target Discovery
23:44 - AI in Clinical Trial Design

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Is this the U.K.’s moment to capitalize on its biotech ecosystem? That was one of the primary themes discussed at the debut Grand Rounds — Europe conference last week in Cambridge, U.K. BioMarin's James Sabry and Astex's Michelle Jones joined BioCentury’s analysts on a special edition of the BioCentury This Week podcast recorded live at the event to discuss their key takeaways from the two-day conference.
Beyond the state of the U.K. biopharma ecosystem, the analysts discussed the meeting’s major science themes, including what’s next for DNA damage repair pathway targets, both inside and outside of cancer; whether obesity should be recast as a brain disease; and the cutting edge of small molecule design.

View full story: https://www.biocentury.com/article/657082

#UKBiotech #TranslationalMedicine #DrugPricing #GlobalCollaboration #Aging #Biologics #SmallMolecules #Biobanking

00:00 - Introduction
00:35 - Key Takeaways
02:14 - The State of the U.K. Biotech Ecosystem
09:01 - Scientific Highlights & Panel Takeaways
22:44 - Closing Remarks and Future Events

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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A takeout that could be worth as much as $7.3 billion has Pfizer back in the obesity drug development race. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss Pfizer’s acquisition of Metsera and its obesity assets. Plus: Editor in Chief Simone Fishburn gives a recap of BioCentury’s Grand Rounds — Europe meeting, which included a fireside chat with Patrick Vallance on the state of the life sciences ecosystem in the country. The BioCentury analysts also assess the state of hot-button policy issues in Washington, such as drug pricing and China. Finally, they analyze the state of play among therapies for narcolepsy on the heels of the World Sleep Congress in Singapore. Check out BIO Chairman Fritz Bittenbender’s conversation with BioCentury Washington Editor Steve Usdin on BioCentury This Week’s sister podcast, The BioCentury Show. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/657065

#ObesityDrugs #PharmaDeals #BiotechDeals #MergersAndAcquisitions #DrugDevelopment #Narcolepsy

00:01 - Sponsor Message: IQVIA Biotech
03:46 - Pfizer’s Obesity M&A
14:54 - U.K. in Focus
28:20 - U.S. Drug Pricing, China Policy
40:07 - Narcolepsy Pipeline

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Merck's announcement that it is moving its R&D out of the U.K. highlights concerns about the country’s life sciences policies. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the life sciences ecosystem in the U.K., including MHRA CEO Lawrence Tallon’s plans to create a world-class regulatory environment. They also discuss a bill passed by the U.S. House of Representatives that would end most U.S.-China academic research collaborations, and the recent success of 40-year-old biotech Insmed. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656997

#biotech #biopharma #pharma #lifescience #MHRA #China #RandD #DrugDevelopment

00:01 - Sponsor Message: IQVIA Biotech
01:25 - U.K. Biopharma
04:40 - Grand Rounds Cambridge
09:45 - SAFE Research Act
18:01 - Spotlight on Insmed
26:32 - Sen. Cassidy's Vaccine Callout

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Molecular biologist and Nobel Prize winner David Baltimore made foundational contributions to the biopharma industry and was the essential figure behind such research institutions as the Whitehead Institute for Biomedical Research and the Broad Institute. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the legacy of Baltimore, who passed away this past weekend at 87.
The analysts also discuss Atlas Venture’s new $400 million opportunity fund, the clinical development pipelines for metabolic-associated steatohepatitis (MASH) and chronic urticaria, and late-stage atopic dermatitis data from Sanofi. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656942

#biotech #biopharma #DavidBaltimore #ReverseTranscriptase #MASH #Rezdiffra #GLP1 #ChronicUrticaria #Dupixent

00:01 - Sponsor Message: IQVIA Biotech
03:19 - Remembering David Baltimore
06:26 - Atlas's New Opportunity Fund
09:22 - The Growing MASH Pipeline
16:03 - Sanofi's Atopic Dermatitis Data
18:57 - Exploring Chronic Urticaria Treatments

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Two veteran biotech leaders are launching a new company with ambitions in the cardiovascular disease space. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the debut of Corsera Health, a biotech led by John Maraganore and Clive Meanwell that is developing an AI-guided early risk assessment tool alongside dual-acting therapy that could stave off heart disease.
The team then discusses how FDA has been quietly positioning itself to disrupt the childhood vaccine schedule, as well as the effects of changes to the Medicare drug negotiation program that were included in the tax and budget bill Congress passed in July.

View full story: https://www.biocentury.com/article/656897

#Corsera #DiseaseInterception #CardiovascularHealth #HeartDisease #FDA #VaccinePolicy #Medicare #DrugPricing

00:00 - Introduction
01:26 - Maraganore, Meanwell Newco
09:17 - BioCentury's Back to School
14:51 - Vaccine Disruption at FDA
26:01 - Medicare Drug Negotiations

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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There’s been a rare IPO filing on NASDAQ as LB Pharma looks to test the market during a year that has seen little activity among U.S. biotechs even as green shoots continue to appear on the Hong Kong stock exchange. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss the market for biotech IPOs on NASDAQ and in Hong Kong.
The analysts then assess FDA’s about-face on Stealth BioTherapeutics' Barth syndrome therapy, putting the decision in the context of a changing regulatory agency; and a BioCentury Guest Commentary that argues that the university-industry engine that drives U.S. innovation is under attack. Also mentioned on this week’s podcast: BioCentury’s 33rd Back to School package, which reimagines FDA; the upcoming 12th China Healthcare Summit in Shanghai; the evolution of dealmaking in China; and Annalisa Jenkins’ take on MHRA and the U.K. biotech ecosystem on The BioCentury Show.

View full story: https://www.biocentury.com/article/656849

#Biotech #IPO #Pharma #FDA #RareDisease #Biopharma #DrugDevelopment #HealthcareInnovation #HongKongIPO

00:00 - Introduction 
02:48 – LB Pharma Tests IPO Market
07:01 – Hong Kong IPO Momentum
09:53 – China Summit Preview
13:40 – FDA Reversal on Stealth Bio
18:15 – Bayh-Dole Clash & Innovation Threats

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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BioCentury’s third annual analysis of pharma company deals finds that bispecifics and degraders are in, cell and gene therapies are out, and China is bringing much more than me-too assets to cross-border deals. On the latest BioCentury This Week podcast, BioCentury’s analysts assess a year’s worth of deals between pharmas and biotechs to tease out emerging trends.
The analysts also discuss last week’s FDA approval of a vector-based immunotherapy from Precigen to treat a rare respiratory disease and whether the decision will set a precedent of more flexibility for rare disease therapies. They then take stock of recent translational coverage in BioCentury, including a report by Denali of a way to avoid a key safety issue of anti-amyloid-targeting mAbs.
BioCentury’s Grand Rounds — Europe will take place in Cambridge, U.K., Sept. 17-19. The conference seeks to bridge academia, industry and investors for breakthrough innovation.

View full Story: https://www.biocentury.com/article/656802

#PharmaDeals #CrossBorderDeals #Bispecifics #TargetedProteinDegradation #RareDisease #Neurodegeneration

00:00 - Introduction
01:38 - Pharma Deals
10:41 - Precigen
14:40 - Denali's BBB Tech
25:20 - Grand Rounds Europe

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Dealmaking between Western and Chinese biopharmas has been one of the year’s bright spots, as a maturing biotech landscape in China converges with Western demand for innovative assets, driving record deal flow. At the same time, the Hong Kong stock exchange has emerged as the hottest market for biotech IPOs, at a time when the NASDAQ window remains shut.
These themes will be in the spotlight at the 12th BioCentury-BayHelix China Healthcare Summit Oct. 22-24 in Shanghai. On this special edition of the BioCentury This Week podcast, a trio of biopharma leaders join BioCentury’s analysts to discuss the landscape: McKinsey's Franck Le Deu, former BD executive Ji Li, and HBM Holdings' Mike Patten.
BioCentury, BayHelix and Insights Partner McKinsey & Company invite you to visit Shanghai for the 12th China Healthcare Summit at the St. Regis Shanghai Jingan. For more information, click here; to apply to join the 2025 Class of Presenting Companies click here.

View full story: https://www.biocentury.com/article/656773

#ChinaBiotech #CrossBorderDeals #HongKongIPO #BiotechInvesting #LifeSciencesFinance

00:00 - Introduction
02:09 – Key Trends
06:03 – View from McKinsey
13:36 – Evolution of Deal Landscape
20:24 – Learning from China
24:00 – China-China M&A & NewCos

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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Phase III data from Lilly’s orforglipron in obesity fell short of investor expectations, but they appear to be enough to obtain approval and wide use. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss why the first-in-class oral small molecule GLP-1R agonist’s clean safety profile and clear manufacturing advantage over oral peptides give the product a leg-up in the market.
They then discuss Vinay Prasad’s return to FDA after a brief hiatus, the revamped strategy of 32-year-old San Diego biotech Acadia Pharmaceuticals, and an attempt in the Senate to revive the Biosecure Act targeting China biotechs.
Finally, the analysts preview this year’s Back to School package, which reimagines FDA. At a time of unprecedented change in government agencies, BioCentury’s 33rd Back to School asks what FDA could look like if it were reorganized from the ground up to create the regulator patients deserve and industry needs.

View full story: https://www.biocentury.com/article/656727

#orforglipron #CBER #VinayPrasad #AcadiaPharmaceuticals

00:00 - Introduction
00:49 - Prasad
07:09 - Back to School
12:29 - Lilly Obesity
21:58 - Acadia's Comeback
28:50 - Biosecure Act

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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The ouster of Vinay Prasad after three months running FDA’s Center for Biologics Evaluation and Research could signal a reset is ahead for CBER. On the latest BioCentury This Week podcast, BioCentury’s analysts discuss what the latest shakeup at the regulatory agency says about what’s next for FDA.
The analysts also assess two leading European pharmas: obesity and diabetes company Novo Nordisk, which named a new CEO last week while cutting its 2025 forecast, and Bayer, which is gearing up for launches and is revamping its pipeline to restart growth. Finally, they discuss the promising clinical data that’s reviving interest in masking technologies that conditionally activate biologics.

View full story: https://www.biocentury.com/article/656649

#FDA #CBER #NovoNordisk #ObesityDrugs #Bayer

01:05 - Prasad's Ouster
14:59 - Novo's New CEO
21:14 - Bayer's Growth Strategy
26:05 - Masked Biologics

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A handful of encouraging signals is cause for cautious optimism for biotech headed into the second half of the year — companies have been able to parlay strong data into follow-on capital and M&A activity is picking up. That said, the IPO market continues to be closed and concerns about U.S. drug pricing and FDA stability continue to weigh on expectations for a robust near-term sector recovery.
Special guest Megan Hooton from IQVIA Biotech joins BioCentury’s analysts on a special edition of the podcast to discuss key indicators of progress for the biopharma sector. Hooton is president of IQVIA Biotech, which sponsored this episode of the pod.

View full story: https://www.biocentury.com/article/656614

#biotech #biopharma #pharma #lifescience #BiotechTrends #ClinicalTrials #GeneTherapy #CellTherapy

00:01 – Sponsor Message: IQVIA Biotech
02:37 – Biotech Markets
06:41 – Clinical Highlights
10:26 – Insights from Meg Hooton
23:10 – Advanced Therapies

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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This week’s deal between GSK and Jiangsu Hengrui is a prime example of how Western biopharmas have begun to recognize the innovation and opportunities being fostered in China — and how it’s no longer all about fast followers.
On the latest BioCentury This Week podcast, BioCentury’s analysts put the collaboration between GSK and Jiangsu Hengrui Pharmaceuticals, two of the most active cross-border dealmakers, into the context of East-West dealmaking over the past 30 months, assessing the innovation that is driving the rush to partner with biotechs in China, Japan, South Korea and beyond, and the types of companies looking to Asia for assets.
BioCentury’s analysts also discuss Steve Bates’ outsized role in building the U.K. biotech hub, as he readies to take on a new role in the U.K. government. They examine new VC funds from Omega Funds and Brandon Capital, FDA’s new national priority voucher pilot program, and fallout from how FDA and  Sarepta Therapeutics handled the deaths of four patients who had received the biotech’s gene therapies. This episode of BioCentury This Week is sponsored by IQVIA Biotech.

View full story: https://www.biocentury.com/article/656592

#biotech #biopharma #pharma #lifescience #EastWestDealmaking #ChinaBiotech #UKBiotech #FDAPolicy

00:01 - Sponsor Message: IQVIA Biotech
02:48 - Asia Deals Landscape
17:32 - Steve Bates & U.K. Biotech
25:46 - FDA's New Voucher Pilot
31:01 - New VC Funds
35:28 - Sarepta

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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 #Elevidys

00:01 - Sponsor Message: IQVIA Biotech
02:03 - Gene Therapy
17:59 - Leading CDER
27:00 - Venture Report

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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 #quantumcomputing

00:01 - Sponsor Message: IQVIA Biotech
04:43 - Q25 Financial Markets Preview
22:20 - Quantum Computing Impact on Biopharma
30:07 - Makary's First 100 Days

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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; Sally Mardikian, business development director, Astrazeneca; and Kristin-Anne Rutter, executive director of Cambridge University Health Partners.
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 #BioCenturyGrandRoundsEurope

00:00 - Introduction
01:53 - Grand Rounds Cambridge Themes
10:14 - Why Cambridge?
23:43 - Tough Love
28:02 - Join us at GlastonGeek

To submit a question to BioCentury’s editors, email the BioCentury This Week team at podcasts@biocentury.com.

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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_T

00:01 - Sponsor Message: ICON Biotech
02:30 - FDA Cancer Regulations
07:48 - Project Optimus
25:12 - CAR T REMS Removal

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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_T

00:01 - Sponsor Message: IQVIA Biotech
01:19 - Treg Inflection Point
10:57 - Biotech's Next Big Story
22:36 - Tax Bill Consequences

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