Modernizing Clinical Trial Operations With Merck's Jennifer Sheller

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/

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/

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/

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/

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/

We love to hear from our listeners. Send us a message. Allan Shaw, Chief Financial Officer and Chief Business Officer at Create Medicines, is back on the Business of Biotech this week, with a temperature check on biotech funding and the IPO market. We discuss the implications of recent blockbuster acquisitions, strategies for managing the current funding environment for biotech, what to look for in the IPO market in the coming months, alternative financing opportunities, and what besides lower interest rates might bring generalist investors back into the sector. 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, Mardi Dier, CFO at Madrigal Pharmaceuticals, talks about building relationships in investment banking and investor relations before moving into business development and becoming a chief financial officer. Mardi describes how drug companies transition from an R&D focus to commercializing products, how to read IPO windows and manage expectations, pricing new drugs, and balancing commercial efforts with pipeline renewal and maintenance. 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 Bernard Ravina, M.D., CEO at Vima Therapeutics, a company that emerged from stealth in May with $60 million Series A financing to develop an oral candidate for dystonia, a movement disorder. Ravina talks about transitioning from government and academic medicine to industry, partnering with Atlas Ventures and defining the company's thesis, the reasons behind working in stealth mode and when to emerge, and the clinical plan and potential for VIM0423.  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 — the last of our four-part series focused on South Florida — we catch up with Rich Daly, CEO at Catalyst Pharmaceuticals, a member of Life Science Leader's editorial advisory board and Miami-based location host for our in-person series. Rich talks about Catalyst's rare disease strategy built on operational excellence (including how to select a rare disease special pharmacy), his criteria for selecting de-risked, differentiated, and accretive products for rare diseases, partnering outside the U.S., and what new incentives Florida politicians could create to help South Florida grow even faster as a life sciences 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 -- part three in a four part series recorded in-person at Catalyst Pharmaceuticals' Miami headquarters -- Anthony Japour, M.D., CEO at iTolerance, talks about his work as a physician treating infectious diseases, his CEO role in diagnostics at the height of the COVID-19 pandemic, what he learned working as a medical director at a large CRO, and iTolerance's work toward a cure for Type 1 diabetes that doesn't require chronic immunosuppression. Anthony also provides insights on overcoming CMC challenges and how to bypass avoidable detours, the funding climate for preclinical biotechs, and operating in South Florida. 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/