BioCentury This Week

Will bispecifics be the drugs to dethrone cancer’s biggest blockbusters? Akeso is the latest company with a bispecific to impress in a head-to-head study, this one for non-small cell lung cancer. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the latest data from Akeso’s ivonescimab, a VEGFxPD-1 bispecific antibody that went up against Keytruda pembrolizumab in one of its largest indications, first-line non-small cell lung cancer.
The editors also discuss data from  Vaxcyte that the infectious disease company parlayed into the year’s largest follow-on financing and a new initiative by FDA veteran Janet Woodcock to bolster quality in biopharmas’ manufacturing. This episode of BioCentury This Week was sponsored by Parexel Biotech.

View full story: https://www.biocentury.com/article/653507

00:01 - Sponsor Message: Parexel Biotech
01:39 - Akeso's Bispecific Challenge
08:22 - Vaxcyte Pneumococcal Vaccine
12:32 - Woodcock's Quality Initiative
14:48 - Recap: The BioCentury Show on Biosimilars

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In this year’s series of Back to School essays, BioCentury’s editors ask whether the era of human first, causal biology and personalized medicine can reshape drug discovery to solve the weakest link in biotech — translation to the clinic. On a special edition of the BioCentury This Week podcast, the three authors of BioCentury’s 32nd Back to School edition, Editor in Chief Simone Fishburn, Executive Editor Selina Koch, and Executive Director of Biopharma Intelligence Lauren Martz, discuss how industry can solve its biggest bottleneck.

The editors zero in on inflammation and immunology, specifically how immunoproteomics upstage genomics in I&I target discovery, and neurology, notably how neuroscience companies are reducing to practice the concept of human-first discovery. Finally, they discuss the thread that runs through it all — precision medicine — and how biomarkers can help validate targets while bringing precision medicine to I&I and neurology.

View full story: https://www.biocentury.com/article/653485


00:00 - Introduction
01:32 - Introducing Back to School
10:42 - Validation Tools
14:50 - I&I
21:00 - Neurology
27:19 - Precision Medicine

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A vote on the Biosecure Act in the U.S. House of Representatives early next week shines the spotlight back on legislation seeking to rein in Chinese CDMOs and genomics companies, as Congress returns to work. On the latest BioCentury This Week podcast, BioCentury’s editors handicap the legislation’s chances of passage in the House and Senate and assess what’s at stake for the law authorizing rare pediatric disease priority review vouchers.
They also discuss the results of BioCentury’s snap poll gauging the biopharma industry’s reaction to the IRA Medicare drug price negotiation program, recalling the latest trends among pharma’s deals with biotechs over the past 12 months. Plus, a preview BioCentury’s annual Back to School package, next week’s new Grand Rounds R&D conference and highlights from this month’s Distillery roundup of translational papers.

View full story: https://www.biocentury.com/article/653385


00:00 - Introduction
01:36 - Biosecure on Deck
04:33 - Priority Review Vouchers
08:11 - BioCentury IRA Survey
17:07 - Back to School: Target Discovery
19:49 - Translational Highlights

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Shaking up an underwhelming year for fresh biotech paper, a trio of biotechs filed to go public on NASDAQ last week. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the IPO filings by MBX and Massachusetts companies Zenas and Bicara. Washington Editor Steve Usdin returns to the podcast to provide updates on the Inflation Reduction and Biosecure acts, as well as the life sciences policies of presidential candidates Donald Trump and Kamala Harris. And Director of Biopharma Intelligence Karen Tkach Tuzman zeroes in on the latest trends among pharma’s deals with biotechs over the past 12 months and the latest start-up out of Versant Ventures, Borealis.

View full story: https://www.biocentury.com/article/653354

00:00 - Introduction
01:48 - Biotech IPOs
12:48 - Washington Update
20:39 - Versant, Novartis Newco
24:34 - Pharma-Biotech Deal Trends

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Grand Rounds is an R&D meeting that represents BioCentury’s latest initiative to create new networks linking academic discoveries with translational skills and the investors who will finance them, BioCentury co-founder, President and CEO David Flores said on a special edition of the BioCentury This Week podcast previewing the new conference. The meeting, on Sept. 9-11 in Nashville, focuses on whether biotech can write a more successful playbook for translating from target to product.
The podcast features three special guests who will be at the conference: McKinsey's Guang Yang, Candel Therapeutics' Paul Peter Tak, and Abby Trotter of Life Science Tennessee. There is still time to register for BioCentury Grand Rounds, which will take place Sept. 9-11 in Nashville. Network, partner and debate key bottlenecks in translation. See the conference website for more information.

View full story: https://www.biocentury.com/article/653324

00:00 - Introduction
00:13 - Spotlight Grand Rounds
02:03 - Conference Themes
08:40 - Nashville's Biotech Ecosystem
16:58 - Paul Peter Tak on I&I
25:22 - McKinsey Report Preview

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The Biden administration has disclosed what Medicare will pay for the first graduates of its drug price negotiation program but biopharma companies, biotech investors and patient advocates are still waiting for the government to reveal how those prices were determined — details that are critical to informing the decisions that will shape the future of medicine. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what last week’s disclosure tells us — and what information is yet to come.
They also discuss why psychedelics companies believe they can avoid the hurdles that tripped up Lykos Therapeutics as it sought approval of its MDMA program to treat post-traumatic stress disorder (PTSD), and preview this year’s BioCentury Back to School report, which focuses on whether biotech can write a more successful playbook for translating from target to product.

Take part in BioCentury’s Snap Survey on the IRA and Part D pricing. We’ll be publishing the results next week, which means we need your input now! All results will be anonymous.

View full story: https://www.biocentury.com/article/653298

00:00 - Intro
01:32 - Medicare Drug Pricing
11:38 - Psychedelic Setback
18:53 - Back to School Preview

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Pharmaceutical companies and some investors may have once again become wary of gene therapy, but the modality’s future is bright, according to Jim Wilson. On the latest BioCentury This Week podcast, BioCentury’s editors discuss takeaways from BioCentury’s exclusive interview with the AAV trailblazer, including Wilson’s prediction that the benefits of the therapies will extend beyond rare genetic diseases, and the rationale for his new therapeutics company, Gemma Biotherapeutics.
BioCentury’s head of corporate alliances & business development, Josh Berlin, then joins the podcast team to detail the challenges and opportunities for biotech in South Korea, and to preview some of the highlights of the upcoming Grand Rounds conference. The event, BioCentury’s first R&D conference, takes place Sept. 9-11 in Nashville, Tenn. and tackles the roadblocks in the translation of science into new medicines.

View full story: https://www.biocentury.com/article/653239

00:00 - Intro
01:31 - Wilson’s Vision for Gene Therapy
14:23 - Inside Korea's Biotech
21:45 - BioCentury's Grand Rounds

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A substantial part of the biopharma ecosystem involves deals between biotechs and academics, with smaller companies accessing assets to add to their pipelines and technologies to help solve problems. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the interplay of biotech and academia, including how deals between the groups often come outside the hubs of Boston and the Bay Area and what types of indications and technologies are common focus points. They also discuss new data in Alzheimer’s for Leqembi from Eisai and Biogen that provide insight into how to get the most out of anti-amyloid mAbs for the disease, and what’s next for James Wilson now that the gene therapy pioneer is moving on from the University of Pennsylvania.

View full story: https://www.biocentury.com/article/653174

00:00 - Intro
04:25 - Biotech-Academia Deals
12:04 - Leqembi's Latest Data
19:20 - What's Next for James Wilson

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Europe’s CHMP has again ruled in contrast to FDA for a neurology product, this time on Biogen and Eisai’s Leqembi for Alzheimer’s disease. On the latest BioCentury This Week podcast, BioCentury editors discuss the similarities and differences between Leqembi lecenamab and Aduhelm aducanumab, the first anti-amyloid mAb from Biogen and Eisai and what it means for the next in line from that class, Kisunia donanemab from Eli Lilly. The editors also break down last week’s ODAC meeting, which discussed trials in perioperative cancer for checkpoint inhibitors, and talk about the looming delay in reauthorization of the rare pediatric priority review voucher program. They also assess the implications of the investigation by the House Select Committee on the Chinese Communist Party into clinical trials run in Chinese military hospitals and the Xinjiang Uyghur Autonomous region, a story broken last week by Washington Editor Steve Usdin.

View full story: https://www.biocentury.com/article/653010

02:06 - CHMP Leqembi Decision
09:53 - Perioperative Cancer
17:45 - Pediatric Review Vouchers 
23:55 - Beyond Biosecure

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Alpha emitters are the latest trend in the hot radioligand space, but there’s debate about which isotope offers the best attributes for optimizing safety and efficacy. On the latest BioCentury This Week podcast, BioCentury’s editors discuss the benefits and challenges that come with developing radiopharmaceuticals using lead-212 versus its more well-known counterpart actinium-225. They also discuss Editor-in-Chief Simone Fishburn’s conversation with Susan Galbraith, EVP of Oncology R&D at AstraZeneca, the latest innovations in delivering lipid nanoparticles to specific tissues beyond the liver, and the most recent oral GLP-1 obesity data from Roche.

View full story: https://www.biocentury.com/article/653008

00:00 - Intro
05:36 - Radiopharma Alpha Emitters
12:18 - AZ’s Susan Galbraith
21:40 - Lipid Nanoparticles
25:22 - Oral GLP-1 Race

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