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by Ben Comer
The Business of Biotech is the pod dedicated to leaders of emerging biopharma firms. 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.
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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, 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 al...
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 adap...
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...
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 collaboratio...
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 manufact...
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 growt...
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 in...
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), a...
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The Business of Biotech is the pod dedicated to leaders of emerging biopharma firms. 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.
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