
Modernizing Clinical Trial Operations With Merck's Jennifer Sheller
22.12.2025 | 55 min.
We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Jennifer Sheller, SVP and Head of Global Clinical Trial Operations at Merck talks about simplifying trial protocols and what she likes about Merck's hybrid functional service provider model for conducting trials in over 60 countries. Jennifer shares her experiences integrating Merck's acquisitions without breaking studies or losing people, using new technology to improve trial operations, and co-designing studies with trial sites for agility and speed. 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/

Transforming Chronic Kidney Disease With ProKidney's Bruce Culleton, M.D.
15.12.2025 | 55 min.
We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Bruce Culleton, M.D., CEO at ProKidney, talks about moving from academic research to industry and the role a key mentor played in his career path. Bruce discusses his experiences as a first-time CEO at ProKidney, a late-stage autologous cell therapy biotech focused on pioneering new treatments for chronic kidney disease (CKD), the benefits of FDA's Regenerative Medicine Advanced Therapy (RMAT) designation, how delaying or avoiding kidney dialysis would be a game-changer for CKD patients, 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] Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

Engineering B Cells With Immusoft's Sean Ainsworth
08.12.2025 | 53 min.
We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Sean Ainsworth, CEO and Chairman at Immusoft, talks about transitioning from the research bench to entrepreneurship, his M&A experiences as a biotech founder, and why engineered B cell therapies offer a better, more patient-friendly administration for lysosomal storage diseases currently treated with enzyme replacement therapies. Sean also discusses FDA pathways, incentives, and agency engagement, and offers thoughts on the regulatory outlook for cell and gene 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: [email protected] Ben Comer on LinkedIn: https://www.linkedin.com/in/bencomer/

Building A Cancer Pipeline In A Molecule With Actuate Therapeutics' Dan Schmitt
01.12.2025 | 51 min.
We love to hear from our listeners. Send us a message. On this week's episode of the Business of Biotech, Dan Schmitt, President and CEO at Actuate Therapeutics, talks about building a company around elraglusib, a GSK-3β inhibitor for cancer. Dan describes his fast-fail approach to early product testing and development, using basket trials to evaluate chemotherapy combinations, and choosing pancreatic cancer as a lead program. He also talks about surviving an IPO during a brutal funding cycle for biotech, building lean teams and efficient operations, and potentially onshoring API in response to changing U.S. policy. 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/

Biotech Collaboration Strategy With IGI's Cyril Konto, M.D.
24.11.2025 | 58 min.
We love to hear from our listeners. Send us a message. On this week's episode, Cyril Konto, M.D., president, executive director, and CEO at Ichnos Glenmark Innovation (IGI) talks about the promise of multi-specific antibodies, funding the company during the 'biotech winter,' closing a $700 million upfront licensing deal with AbbVie, the impact of China's rising biotech sector, and the keys to successful collaboration. Cyril also discusses IGI's focus on developing innovative therapies for emerging markets, and the shift from animal models to in silico modeling in preclinical research. 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/



Business Of Biotech