Business Of Biotech

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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.  

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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.  
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Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

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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.  
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Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

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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.  
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Get in touch with guest and topic suggestions: [email protected]

Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

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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.  
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Get in touch with guest and topic suggestions: [email protected]

Find Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/