From Partnered ASO Therapies To A Wholly-Owned Pipeline With Ionis's Brett Monia, Ph.D.

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Brett Monia, Ph.D., CEO at Ionis Pharmaceuticals, talks about how antisense oligonucleotides (ASO) graduated from a late-1980s lab concept to real RNA-targeting medicines, and why Ionis stuck with a difficult modality despite multiple setbacks. Brett describes the company's shift from a partner-first model to building a wholly-owned pipeline, commercial function, and an expanded manufacturing operation, and how he as a founding scientist-turned-CEO bridged a skills gap in finance and investor relations. 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] 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 talk with NervGen leaders Adam Rogers, M.D., and Rich Macary about NVG-291, a daily neuroreparative peptide designed to restore function in patients with spinal cord injuries. Adam talks about his strategy for the company after becoming CEO last July, including moving company trading from Canada's TSX Venture Exchange to the NASDAQ for better visibility, and making key hires for growth. Rich talks about his early work in RNA therapeutics as an advisor at Sarepta, cofounding Synaptica Therapeutics, and bringing Adam to NervGen. They also talk about engaging with the FDA on endpoints for NVG-291's Phase 3 trial, and the broader opportunity in neurotrauma. 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] 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, 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] 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] 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] 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] 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] 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] 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] 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] Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/