BioCentury This Week BioCentury

It sounds obvious, but still needs saying, says Ysios Capital's Karen Wagner. “How do you rise above the noise? By having the most spectacular data.” In conversation with Editor in Chief Simone Fishburn on The BioCentury Show, Wagner discussed the theme of the upcoming Bio€quity Europe conference — rising above the noise: in a sea of competition where companies vie for attention among investors and pharmas, what are the characteristics that allow them to differentiate? Wagner explains what she and her team looks for in a biotech before investing, and also discusses the role of ESG policies, including diversity, in companies. “We have absolute certainty that ESG is important."

The BioCentury Show is now available as an audio podcast. The Show, featuring BioCentury one-on-one with an industry KOL, is available on Apple, Spotify and wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.

View full story: https://www.biocentury.com/article/652294

00:00 - The BioCentury Show Podcast
02:12 - Spain’s Biotech Ecosystem
10:06 - Investment Criteria
15:03 - ESG, Diversity
28:29 - AI in Drug Development

Next week's Bio€quity Europe conference in San Sebastián will focus on how European biotechs can rise above the noise to attract investors, partners and talent. McKinsey & Co.’s Alexandra Zemp and Paula Olazábal of Ysios Capital joined BioCentury to outline the opportunities and challenges faced by Spain’s biopharma ecosystem and preview some of the conference’s networking events, fireside chats and panel discussions. EBD Group's Claire Macht also joined to detail what to expect in terms of attendees and one-on-one partnering meetings at the event. Bio€quity Europe 2024 is sold out, but space on the waitlist remains, and digital passes are available. See the conference website for more information.

View full story: https://www.biocentury.com/article/652371

00:00 - Intro
03:27 - Spanish Biotech Ecosystem
08:13 - McKinsey's Insights
12:08 - Event Preview
17:26 - BioЄquity Europe C-Level Attendees

One of the big themes of this week’s ASGCT meeting will be CAR T cells in cancer and beyond. On the latest BioCentury This Week podcast, BioCentury’s editors preview the American Society of Gene and Cell Therapy’s annual meeting. Much of the CAR T field has reoriented from cancer to autoimmune diseases over the past year. Now, researchers are looking even farther afield. According to abstracts released ahead of ASGCT, the engineered T cell modality may have new benefits to offer patients with asthma, Duchenne muscular dystrophy or HIV.
The editors also discuss a study aiming to quantify the benefits accelerated approval has had for cancer patients, and what’s next for the Biosecure Act and similar legislation seeking to rein in Chinese CDMOs and genomics companies. This week’s podcast is sponsored by Nxera Pharma.

Don’t miss BioCentury’s new podcast, The BioCentury Show, featuring BioCentury one-on-one with an industry KOL. It’s available wherever you listen to your favorite podcasts and in video podcast format on BioCentury’s YouTube channel.

View full story: https://www.biocentury.com/article/652335

00:01 - Sponsor Message: Nxera Pharma
01:43 - ASGCT Preview
10:37 - BioCentury Show Podcast
14:21 - Accelerated Approval 
19:48 - Biosecure: What’s Next

Led by CBER Director Peter Marks, FDA is moving forward with policies that aim to improve access to gene therapies for patients with rare diseases. On the latest BioCentury This Week podcast, BioCentury’s editors discuss how FDA plans to use regulatory policies to overcome barriers that are slowing gene therapy, as well as how Pfizer hopes to ensure access to its newly approved hemophilia gene therapy. The editors also assess the $2.4 billion acquisition of Massachusetts oncology company Deciphera by Japan’s Ono as it seeks to diversify its pipeline beyond Opdivo and expand its global footprint. They also discuss the $1 billion launch of AI-guided therapeutics developer Xaira. Finally, BioCentury’s Joshua Berlin joins the podcast to preview BioCentury’s upcoming conference Bio€quity Europe, which kicks off May 12 in San Sebastián. This week’s podcast is sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/652273

0:01 - Sponsor Message: Jeito Capital
1:55 - Energizing Gene Therapy
6:28 - Pfizer Hemophilia Approval
11:36 - Bio€quity Europe Preview
18:03 - Arch & Foresite's AI Biotech Build
19:32 - Ono's Deciphera Takeout

A “drive-by analysis of accelerated approval is intellectual malpractice,” argues Washington Editor Steve Usdin on the latest BioCentury This Week podcast. Usdin and his BioCentury colleagues explain why a paper on the expedited regulatory pathway written by researchers at the Program on Regulation, Therapeutics, and Law (PORTAL) at Brigham and Women’s Hospital misleads the public about the value of drugs granted accelerated approval. The paper also fails to grasp the pathway’s purpose, which is “to allow risk-taking when there’s evidence that a therapy is reasonably likely to benefit patients who are suffering from a serious condition,” Usdin writes in the Editor’s Commentary.
BioCentury’s editors also discuss how an FDA advisory committee’s support for a myeloma metric makes the broader case for endpoint innovation; why a group of biotechs is delisting from U.K. stock exchange AIM; and the launch of well-funded obesity play Metsera Inc. For more of BioCentury’s coverage of obesity therapeutics, see our Hot Topics page. This week’s podcast is sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/652185

0:01 - Sponsor Message: Jeito Capital
1:54 - Defending Accelerated Approval
8:44 - Endpoint Innovation
12:55 - Challenges for U.K.'s AIM
18:16 - Obesity Launch: Metsera

Vertex Pharmaceuticals' acquisition of Alpine Immune Sciences will bolster a growing kidney disease franchise that could help diversify Vertex’s business beyond its blockbuster cystic fibrosis franchise. On the latest BioCentury This Week podcast, BioCentury’s editors discuss what attracted Vertex to Alpine and why it believes its newly acquired therapy can outshine others for IgA nephropathy. The editors discuss how Goldman Sachs aims to scale private biotechs via its venture strategy and the likely key factors for CMS as it determines prices for the first cohort of drugs in Medicare drug price negotiations under the Inflation Reduction Act. They also preview BioCentury’s first R&D conference — Grand Rounds — which will focus on the biotech industry’s interface with academia, bringing together decision-makers and the next innovators in Nashville, Sept. 9-11. This week’s podcast is sponsored by Jeito Capital.

View full story: https://www.biocentury.com/article/652107

0:01 - Sponsor Message: Jeito Capital
1:30 - Introducing BioCentury's Grand Rounds
3:59 - Vertex’s Alpine Takeout
9:38 - Goldman’s Venture Strategy
14:33 - Reading the IRA Tea Leaves