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We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, five-time public company CFO and seven-time public company board member Allan Shaw talks about why FDA decision-making feels less predictable, and how that uncertainty is reshaping clinical trial strategy, investor behavior, and the innovation ecosystem. We talk about FDA politicization concerns, modernization efforts like AI initiatives, and what biotech leaders can do to manage risk instead of being managed by it.  Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, we speak with Dr. Sarfaraz Niazi, Ph.D., about how biosimilar regulations have taken shape, from early FDA uncertainty to citizen petitions, lawsuits, and guideline changes. Dr. Niazi offers a behind the scene look at the way FDA policy gets made, and unmade, and his own role in key regulatory changes, and legislation such as the Biologics Price Competition and Innovations Act (BPCIA), and the Inflation Reduction Act (IRA). We also discuss Dr. Niazi's current company, RNA Therapeutics, and his quest to make new drug modalities accessible to patients around the world.      This episode of the Business of Biotech is brought to you by Cytiva.  Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Thijs Spoor, CEO at Perspective Therapeutics,  a company developing Pb 212 (lead)-based therapeutics, talks about why radiopharmaceuticals are surging again and why biodistribution is the make-or-break variable when your payload is a radioactive isotope. Thijs discusses the reasons behind Perspective's investment in a proprietary generator for therapeutic production, manufacturing and delivery strategy, workforce constraints, and building a clinical strategy around receptor positivity across tumor types.  Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Dan McHugh, head of the investment team at Yosemite, explains the San Francisco VC group's approach to investing in early-stage cancer therapeutics and funding academic research through unrestricted grants. Founded by Reed Jobs, son of Steve Jobs and Laurene Powell Jobs, Yosemite invests across drug modalities and supporting technologies in the oncology space. Dan talks about his path from bioengineering to biotech venture capital, meeting Reed Jobs on Stanford's fencing team, his CEO turn at Tune Therapeutics, and the current fundraising environment for innovative science.    Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech we're speaking with Alan Bash, President, Carvykti, at Legend Biotech, about how Carvykti became a blockbuster, category-leading CAR T therapy for multiple myeloma. Alan talks about manufacturing and delivering an autologous cell therapy at commercial scale, Legend Biotech's partnership with Johnson & Johnson, lessons he learned at Bristol Myers Squibb, Checkmate Pharmaceuticals, and ZielBio, and his strategy for growing Carvykti's patient footprint and facing new competitors in the market.   Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech we speak with Dr. Marc Hedrick, M.D., President and CEO at Plus Therapeutics, about the company's pivot from cell therapy to radiotherapeutics for brain cancers, and what's behind the choice of Rhenium-186 as the radioisotope for its lead development candidate, Reyobiq. We'll talk about Plus Therapeutics' diagnostic subsidiary, CNSide, and hear from Marc about recent FDA meetings and the agency's attitude toward novel radiotherapeutics.       Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech we speak with Rahul Aras, Ph.D., President and CEO at Iterion Therapeutics, about capital efficient drug development in oncology and progressing a novel therapeutic with relatively small funding amounts. Iterion is a clinical stage company developing cancer therapeutics targeting the Wnt/β-catenin pathway, a known signaling target in oncology, but one that has confounded drug development efforts for decades. Rahul talks about his path from academia to company building and early work in gene therapy, Iterion's partnership strategy, and operating a biotech in the Houston, Texas clinical hub.  Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, we're speaking with Thomas von Erlach, Ph.D., Cofounder and CEO at Vivtex, a company spun out of the Langer Lab at MIT that's focused on developing orally available biologics. The company announced a deal in late February '26 with Novo Nordisk for up to $2.1 billion to develop next-gen oral drugs for obesity and diabetes, bringing the total number of Vivtex's partnerships to 10. Thomas shares his experiences working in the lab with Dr. Robert Langer, Ph.D., starting up Vivtex around his co-invention (a "GI tract on a chip"), building trust externally and securing the right partnerships, and using a strategic stealth period to refine Vivtex's platform technology before scaling it out.  Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech we speak with Monika Sumra, Ph.D., about how leadership, culture, and performance emerge from the environment and conditions inside an organization. Dr. Sumra, Founder and Managing Partner at Bunka, Inc., a management consulting firm and advisor to manufacturing-based organizations globally, explains how anthropology, CPIs, and rapid ethnography make culture measurable and operations faster, safer, and more reliable. Deploying a unique lens built on biosocial anthropology, she offers guidance on creating environments for sustainable performance in the complex life sciences industry.  Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Jared Bauer, Cofounder and CEO at Seek Labs, talks about his adventures in company turnarounds, and setting up Seek Labs to improve patient diagnoses and to discover and develop new treatments for infectious diseases. Jared explains the technology convergence that was needed to build Seek Labs' AI diagnostic and CRISPR-based therapeutics platform, an African Swine Fever proof-of-concept study that reduced viremia in pigs, mapping pathogens for rapid target design, and engaging with the FDA and global regulatory agencies.        Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, we're speaking with Cindy Perettie, Executive Vice President and Global Head at Kite Pharma, a Gilead-owned company focused on curing cancer with cell therapies. Perettie talks about scaling cell therapies in the community setting, global manufacturing strategy, preparing for the launch of late-stage development programs in lymphoma and multiple myeloma, and working with partners like Arcellx. She also discusses cell therapy funding cycles and big pharma, the autologous versus allogeneic divide, why in vivo CAR-T therapies could be a game changer, what the FDA's focus on cell and gene therapies could mean for U.S. competition, and more.  Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Brian Hilberdink, President of U.S. Human Pharma at Boehringer Ingelheim, returns to the show during the J.P. Morgan Healthcare Conference, and following his departure from LEO Pharma (see episode 164). Brian talks about new opportunities in obesity, the benefits of private ownership in funding early science, Boehringer's deal strategy, using AI to improve commercialization efforts, and the FDA's selection of zongertinib (in patients with HER2-mutant NSCLC) for the Commissioner's National Priority Voucher program.     Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech -- on location at the J.P. Morgan Healthcare Conference -- we're speaking with Ron Cooper, CEO and Board Member at enGene, to unpack how he scaled Albireo from a small research shop to a global commercial company, and why he’s now betting on nonviral gene therapy at enGene to help patients with non-muscle invasive bladder cancer keep their bladders. Cooper talks about the importance of keeping development, financing, and hiring in sync as biotech companies grow, his experiences surviving near-death cash deficits, the importance of investing early in CMC, and what to expect in 2026.   Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. The Business of Biotech was back in San Francisco for the J.P. Morgan Healthcare Conference (January 12 - 15) and this week we sit down with Marc Salzberg, M.D., CEO, CMO, and Board Chair at Airway Therapeutics, a company developing a recombinant version of human surfactant protein D for several respiratory, inflammatory, and infectious diseases including bronchopulmonary dysplasia (BPD), which is currently in Phase 2b/3 trials. Brian talks about why he selected BPD as a lead clinical indication (a disease primarily affecting preterm infants), what he learned through founding and selling a CRO, how a private biotech funds a pivotal trial across continents, and offers an industry outlook for 2026.    Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, we're speaking with Kenneth Galbraith, CEO and Board Chair at Zymeworks, a biotech developing multispecific therapies internally and through partnerships with companies including Jazz Pharmaceuticals and BeOne Medicines (formerly BeiGene), J&J, Merck, Daiichi Sankyo, and GSK. Ken talks about Zymeworks' shift to a royalty model for development funding and value creation, lessons learned from platform deals and cross-border R&D, the benefits of strong royalty agreements and backloaded milestone payments over headline upfronts, and industry dynamics for the coming year. Ken also shares insights from his deep experiences as a biotech investor and corporate director, and explains why scientific primacy should always drive biotech business decisions.          Access this and hundreds of episodes of the Business of Biotech videocast under the Business of Biotech tab at lifescienceleader.com.   Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/