Business Of Biotech

Hosted by Ben Comer

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Episodes

311

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Jun 2026

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About the show

The Business of Biotech is the pod dedicated to leaders of emerging biopharma firms. SUBSCRIBE to our new newsletter at www.bioprocessonline.com/bob. We bring you insight into organizational, finance and funding, HR, clinical, manufacturing, regulatory, and commercial challenges you’ll face as you navigate your company from an idea to success in the clinic and beyond. Each episode features guest commentary and best practices from accomplished founders and biopharma industry luminaries. The Business of Biotech is produced by Life Science Connect.

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June 15, 2026Episode 31055 min

Drug Launch Success In A Changing Commercial Landscape With ACMA's William Soliman, Ph.D.

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, William Soliman, Founder and CEO of the Accreditation Council for Medical Affairs (ACMA), and Founder and CIO of White Manna Capital Partners, talks about why biotech drug launches so often miss expectations, and how to build an integrated commercialization plan that holds up with physicians, patients, and payers. William also describes the evolution in medical affairs, why standards and certification matter, and how AI and new media channels are reshaping how drug information reaches patients and prescribers. 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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

June 8, 2026Episode 3091 hr 24 min

The Editors' Roundtable: A Midyear Look At The 2026 Life Sciences Industry

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Tyler Menichiello, chief editor at Bioprocess Online, host of the Better Biopharma podcast, and my Life Science Connect (LSC) colleague, convenes the broader LSC editorial team once again for a midyear discussion on what's happening now in the life sciences industry, and what's to come in the second half of the year. Topics include AI manufacturing regulations and navigating supply chain pressures, outsourcing trends and onshoring, biotech market signals and IPOs, clinical development's slow shift to digitization, the move toward organoids and non-animal models (NAMs) in discovery, RNA modality growing pains, 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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

June 1, 2026Episode 30849 min

Derisking CNS Drug Development With Tortugas Neuroscience's Jeff Jonas, M.D.

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Jeff Jonas, M.D., CEO of Tortugas Neuroscience, talks about the company's April 2026 launch and how in-licensed development assets were chosen. Jeff explains his strategy of chasing fast proof of safety and efficacy in humans, not animals, and talks about what product differentiation looks like in brain disorders, from adjusting indication targets to conducting head-to-head trials. He also reflects on the opportunity with psychedelics, RFK Jr.'s quest to curb SSRI prescriptions, the payer landscape in CNS disorders, 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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

May 25, 2026Episode 30755 min

Rare Disease Drug Commercialization With Zevra Therapeutics' Neil McFarlane

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Neil McFarlane, CEO at Zevra Therapeutics, talks about transitioning to a focused rare disease company through acquisitions, and building out a commercial organization. Neil explains the importance of working with rare disease patient advocacy groups, using AI to analyze electronic health records and claims data to identify and diagnose patients with Niemann-Pick disease type C, and adapting to regulatory inconsistencies around rare disease drug approval frameworks in the U.S. and Europe. 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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

May 18, 2026Episode 30650 min

Scaling Manufacturing For Personalized Cell Therapies With Cellino's Marinna Madrid, Ph.D.

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Marinna Madrid, Ph.D., Cofounder, Board Member, Chief Product and Regulatory Officer at Cellino, talks about scaling up an automated manufacturing process she co-invented for personalized autologous induced pluripotent stem cell (iPSC) therapies using laser-activated substrates and AI. Marinna describes her work with industry groups to improve regulatory guidelines, Cellino's partnership strategy, the implications of receiving FDA's Advanced Manufacturing Technologies designation, and the future of iPSC therapies. 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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

May 11, 2026Episode 30554 min

Building A New Antibody Discovery Platform With Infinimmune's Wyatt McDonnell, Ph.D.

We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Wyatt McDonnell, Ph.D., cofounder and CEO at Infinimmune, talks about how single-cell biology and computational rigor led to the formation of Infinimmune, and a new way to discover human-derived antibody drugs. Wyatt explains Infinimmune's 'discovered in humans' antibody discovery platform, how the company was launched and initially funded, and how Infinimmune landed a Merck collaboration worth up to $838 million. 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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

May 4, 2026Episode 30455 min

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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

April 27, 2026Episode 30347 min

Implementing A New CEO Strategy With NervGen's Adam Rogers, M.D. And Rich Macary

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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

April 20, 2026Episode 30246 min

The Impact Of FDA Risk On Biotech Rewards With CFO And Board Director Allan Shaw

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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

April 13, 2026Episode 30158 min

Biosimilars And Complex Medicines For All With RNA Therapeutics' Sarfaraz Niazi, Ph.D.

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: ben.comer@lifescienceleader.comFind Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/