Business Of Biotech

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: [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, 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: [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, 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: [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, 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: [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, 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: [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, 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: [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, 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: [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 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: [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, 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: [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 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: [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, Thijs Spoor, CEO at Perspective Therapeutics,  a company developing Pb 212 (lead)-based therapeutics, talks about why radiopharmaceuticals are surging again and why biodistribution is the make-or-break variable when your payload is a radioactive isotope. Thijs discusses the reasons behind Perspective's investment in a proprietary generator for therapeutic production, manufacturing and delivery strategy, workforce constraints, and building a clinical strategy around receptor positivity across tumor types. 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 McHugh, head of the investment team at Yosemite, explains the San Francisco VC group's approach to investing in early-stage cancer therapeutics and funding academic research through unrestricted grants. Founded by Reed Jobs, son of Steve Jobs and Laurene Powell Jobs, Yosemite invests across drug modalities and supporting technologies in the oncology space. Dan talks about his path from bioengineering to biotech venture capital, meeting Reed Jobs on Stanford's fencing team, his CEO turn at Tune Therapeutics, and the current fundraising environment for innovative science.   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 Alan Bash, President, Carvykti, at Legend Biotech, about how Carvykti became a blockbuster, category-leading CAR T therapy for multiple myeloma. Alan talks about manufacturing and delivering an autologous cell therapy at commercial scale, Legend Biotech's partnership with Johnson & Johnson, lessons he learned at Bristol Myers Squibb, Checkmate Pharmaceuticals, and ZielBio, and his strategy for growing Carvykti's patient footprint and facing new competitors in the market.  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 speak with Dr. Marc Hedrick, M.D., President and CEO at Plus Therapeutics, about the company's pivot from cell therapy to radiotherapeutics for brain cancers, and what's behind the choice of Rhenium-186 as the radioisotope for its lead development candidate, Reyobiq. We'll talk about Plus Therapeutics' diagnostic subsidiary, CNSide, and hear from Marc about recent FDA meetings and the agency's attitude toward novel radiotherapeutics.      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 speak with Rahul Aras, Ph.D., President and CEO at Iterion Therapeutics, about capital efficient drug development in oncology and progressing a novel therapeutic with relatively small funding amounts. Iterion is a clinical stage company developing cancer therapeutics targeting the Wnt/β-catenin pathway, a known signaling target in oncology, but one that has confounded drug development efforts for decades. Rahul talks about his path from academia to company building and early work in gene therapy, Iterion's partnership strategy, and operating a biotech in the Houston, Texas clinical 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, we're speaking with Thomas von Erlach, Ph.D., Cofounder and CEO at Vivtex, a company spun out of the Langer Lab at MIT that's focused on developing orally available biologics. The company announced a deal in late February '26 with Novo Nordisk for up to $2.1 billion to develop next-gen oral drugs for obesity and diabetes, bringing the total number of Vivtex's partnerships to 10. Thomas shares his experiences working in the lab with Dr. Robert Langer, Ph.D., starting up Vivtex around his co-invention (a "GI tract on a chip"), building trust externally and securing the right partnerships, and using a strategic stealth period to refine Vivtex's platform technology before scaling it out. 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 speak with Monika Sumra, Ph.D., about how leadership, culture, and performance emerge from the environment and conditions inside an organization. Dr. Sumra, Founder and Managing Partner at Bunka, Inc., a management consulting firm and advisor to manufacturing-based organizations globally, explains how anthropology, CPIs, and rapid ethnography make culture measurable and operations faster, safer, and more reliable. Deploying a unique lens built on biosocial anthropology, she offers guidance on creating environments for sustainable performance in the complex life sciences industry. 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, Jared Bauer, Cofounder and CEO at Seek Labs, talks about his adventures in company turnarounds, and setting up Seek Labs to improve patient diagnoses and to discover and develop new treatments for infectious diseases. Jared explains the technology convergence that was needed to build Seek Labs' AI diagnostic and CRISPR-based therapeutics platform, an African Swine Fever proof-of-concept study that reduced viremia in pigs, mapping pathogens for rapid target design, and engaging with the FDA and global regulatory agencies.       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 Cindy Perettie, Executive Vice President and Global Head at Kite Pharma, a Gilead-owned company focused on curing cancer with cell therapies. Perettie talks about scaling cell therapies in the community setting, global manufacturing strategy, preparing for the launch of late-stage development programs in lymphoma and multiple myeloma, and working with partners like Arcellx. She also discusses cell therapy funding cycles and big pharma, the autologous versus allogeneic divide, why in vivo CAR-T therapies could be a game changer, what the FDA's focus on cell and gene therapies could mean for U.S. competition, 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, Brian Hilberdink, President of U.S. Human Pharma at Boehringer Ingelheim, returns to the show during the J.P. Morgan Healthcare Conference, and following his departure from LEO Pharma (see episode 164). Brian talks about new opportunities in obesity, the benefits of private ownership in funding early science, Boehringer's deal strategy, using AI to improve commercialization efforts, and the FDA's selection of zongertinib (in patients with HER2-mutant NSCLC) for the Commissioner's National Priority Voucher program.    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 -- on location at the J.P. Morgan Healthcare Conference -- we're speaking with Ron Cooper, CEO and Board Member at enGene, to unpack how he scaled Albireo from a small research shop to a global commercial company, and why he’s now betting on nonviral gene therapy at enGene to help patients with non-muscle invasive bladder cancer keep their bladders. Cooper talks about the importance of keeping development, financing, and hiring in sync as biotech companies grow, his experiences surviving near-death cash deficits, the importance of investing early in CMC, and what to expect in 2026.  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. The Business of Biotech was back in San Francisco for the J.P. Morgan Healthcare Conference (January 12 - 15) and this week we sit down with Marc Salzberg, M.D., CEO, CMO, and Board Chair at Airway Therapeutics, a company developing a recombinant version of human surfactant protein D for several respiratory, inflammatory, and infectious diseases including bronchopulmonary dysplasia (BPD), which is currently in Phase 2b/3 trials. Brian talks about why he selected BPD as a lead clinical indication (a disease primarily affecting preterm infants), what he learned through founding and selling a CRO, how a private biotech funds a pivotal trial across continents, and offers an industry outlook for 2026.   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 Kenneth Galbraith, CEO and Board Chair at Zymeworks, a biotech developing multispecific therapies internally and through partnerships with companies including Jazz Pharmaceuticals and BeOne Medicines (formerly BeiGene), J&J, Merck, Daiichi Sankyo, and GSK. Ken talks about Zymeworks' shift to a royalty model for development funding and value creation, lessons learned from platform deals and cross-border R&D, the benefits of strong royalty agreements and backloaded milestone payments over headline upfronts, and industry dynamics for the coming year. Ken also shares insights from his deep experiences as a biotech investor and corporate director, and explains why scientific primacy should always drive biotech business decisions.         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. This week's special holiday episode of the Business of Biotech brings seven chief editors from the Life Science Connect family together to talk about the life sciences industry topics, trips, and reporting that mattered most in 2025, and what each editor has planned for 2026. From the RNA, cell, and gene therapy space to small molecule manufacturing, bioprocessing, drug discovery, and outsourcing, the editors weigh in on key industry trends, new developments, and policy surprises from their respective coverage areas. Topics include biotech funding dynamics, FDA leadership, China's growing role, favorite holiday movies, and much, much more. Special thanks to Tyler Menichiello and the Better Biopharma podcast for hosting this roundtable discussion. Happy New Year!     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, Nick Manusos, CEO at Kenai Therapeutics, talks about his experiences building cell therapy spinouts from FujiFilm Cellular Dynamics, learning from big pharma decision-making processes, and dosing the first patient with Kenai's allogeneic neuron replacement cell therapy for Parkinson's disease. Nick also talks about funding an early-stage cell therapy company and forging key manufacturing and therapy administration partnerships. 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, 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/

We love to hear from our listeners. Send us a message. In this week's episode of the Business of Biotech -- part two in a four-part series recorded in-person at Catalyst Pharmaceuticals' Miami headquarters -- we're speaking with Daniel Teper, an entrepreneur and most recently, founder and CEO at NAYA Therapeutics. Based in South Florida, NAYA is developing NK-engaging bifunctional antibodies and Astatine-211 radiopharmaceuticals targeting hepatocellular carcinoma. Daniel discusses the company's decentralized manufacturing strategy, the current funding climate for early-stage companies, his plan to conduct clinical trials in China, and what's unique about the South Florida life sciences ecosystem.  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. The Business of Biotech is on location in Miami this week! For the first episode in this four-part series on the biotech scene in South Florida, Raquel Cabo, Founder and President of the Miami Biotech Collective, talks about her experiences as a member of the founding team at Ovid Therapeutics, why South Florida needed an organization to connect regional drug developers, what Miami offers to biotech companies and operators, and what gaps in the South Florida life sciences ecosystem still exist.  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, Rob Abbott, CEO of ISPOR, explains how startup and early-stage clinical drug development companies benefit from conducting health economics and outcomes research (HEOR), and not just with patients and commercial payers. HEOR, viewed as a strategic lever as opposed to a compliance exercise, can help answer investor questions about market differentiation, pricing pathways, and real world product validation. Abbott talks about the value of cost-of-illness studies, burden-of-disease analyses, and payer landscape assessments, and how AI, real world evidence, and patient-centered research can improve drug and trial design and accelerate market access.       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, Joel Latham, President and CEO at Incannex Healthcare, talks about developing cannabinoid and psychedelic combination therapies for conditions as diverse as sleep apnea, rheumatoid arthritis, and generalized anxiety disorder. Joel walks through his funding strategy for the publicly-traded company, his desire to lead in a new category of medicine, and what comes next. 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, Lyle Small, Founder and CEO at Lahjavida, a dye drug conjugate start-up, talks about creating the famous color-changing technology that turned the mountains blue on cold Coors Light beer cans, to launching a dye-drug conjugate startup developing targeted cancer therapies. Small talks through Lahjavida's early preclinical work and the ongoing animal studies he hopes will secure an IND filing by 2027, his experience with scaling up manufacturing of new technologies, and his approach to leadership and company culture.   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 the Business of Biotech this week, Sahir Ali, Ph.D., founder and general partner at Modi Ventures, a family office investing at the intersection of technology and biology, talks about adapting the Markowitz model to improve returns and balance risk, his concept of the "biostack" for making direct investments into life sciences companies, and the revolutionary potential of scientific super intelligence. Ali explains why Houston, Texas is an underrated ecosystem for life sciences, and what AI will mean for medicine and the future of healthcare consumption.  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, Atul Deshpande, Ph.D., CEO at Immediate Therapeutics, talks about partnering with American cities to conduct clinical trials during ambulance rides to the hospital, with the goal of preserving heart function and reducing mortality related to acute cardiovascular events, including heart attacks. Deshpande reflects on his previous experience developing and commercializing Dupixent at Sanofi, describes the history and mechanism of Immediate's glucose-insulin-potassium (GIK) candidate, IMT-358, and explains why there is more to intellectual property than just patents. 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, ex-handballer Vladimir Cmiljanovic, Ph.D., Founder and CEO at Swiss Rockets, talks about co-discovering bimiralisib with his sister Natasa Cmiljanovic, Ph.D. (and COO at Swiss Rockets), losing his company to a hostile takeover, buying the company back, and building out Swiss Rockets as an incubator with manufacturing capabilities and shared scientific expertise. Swiss Rockets' portfolio of companies is developing radioligand therapies, vaccines, and cancer treatments, including bimiralisib for actinic keratosis. Cmiljanovic also discusses U.S. expansion plans, partnering, and funding strategies for early-stage companies.       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, Milan Kalawadia, CEO, North America, Dr. Reddy's Laboratories, and Arun Swaminathan, Ph.D., CEO, Coya Therapeutics discuss their unique partnership to develop COYA 302, a novel dual-mechanism immunotherapy for the treatment of ALS. The partnership pairs Coya's scientific expertise with Dr. Reddy's manufacturing and commercialization capabilities, putting Coya in a financial position to advance development activities and commercialize COYA 302 upon FDA approval, and providing Dr. Reddy's -- a generics, biosimilars, API, and OTC manufacturer -- with an opportunity to pivot into innovative branded products. Kalawadia and Swaminathan discuss their pathways to the CEO role at each company, respectively, how the partnership came together, ongoing FDA engagement, and what COYA 302 could mean for patients with ALS. 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, Bill Holodnak, Cofounder and CEO of Occam Global, a life sciences executive recruitment firm (and occasional investor), shares insights from his decades of experience pairing executives with drug development companies, and talks about the psychology of successful biotech leadership. From building an advisory board to the sequencing of executive hires, such as CSOs, CMOs, CBOs, and CFOs, as a company grows, Holodnak offers specific tips to help founders and investors create leadership teams capable of winning the "slow motion roulette" business of biotech.   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, Oury Chetboun, co-founder and CEO of Seekyo, a French biotech, talks about the range of experiences that prepared him to lead a company focused on developing innovative solid tumor treatments that target functional proteins in the tumor micro-environment. Chetboun talks about raising money for preclinical research and navigating the valley of death between research and clinical development, accessing French innovation funding and angel networks, how click chemistry can produce therapies at a lower cost compared to antibody-drug conjugates (ADCs), and the potential use of drug combinations and umbrella trials for testing multiple cancer indications.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, Ebrahim Delpassand, M.D., founder, CEO, and chairman of the board at RadioMedix talks about his personal journey standing up and growing  a radiopharmaceutical company focused on oncology. Dr. Delpassand discusses the current trends in radiopharmaceutical drug development, the differences between alpha- and beta-emitting isotopes, overcoming manufacturing and supply chain challenges and restraints, and building strategic partnerships with companies like Curium, Fusion (now part of AstraZeneca), and Sanofi. He also offers specific advice to physician-entrepreneurs interested in building their own drug development companies. 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, Dr. Hernan Bazan, M.D., co-founder and CEO at New Orleans-based South Rampart Pharma, talks about building an ultra-lean drug development company to address an unmet need observed in his own patients as a surgeon: safe treatments for acute pain. Dr. Bazan explains his strategy for building value through small raises and no full-time salaried employees, co-founding the company with his father -- a scientist and director of the Neuroscience Center of Excellence at Louisiana State University Health Sciences Center -- and why the future of pain management will likely involve multimodal approached personalized to individual patients. This episode of the Business of Biotech is brought to you by Ecolab. 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, Roger Cone, Ph.D., Founder and Chair of the Scientific Advisory Board at Courage Therapeutics, talks about discovering obesity-related protein receptors in the brain, how he spun his academic discoveries out into a biotech company developing new obesity drugs, the need for obesity treatments with fewer side effects than currently available GLP-1 therapies, and the value of pairing scientific leadership with a strong business partner as CEO. This episode of the Business of Biotech is brought to you by Ecolab. 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. This week's episode is one from the road, recorded in front of a live audience in Boston's Seaport neighborhood during the BIO conference (special thanks to MasterControl for making it happen). Amber Salzman, Ph.D., CEO of Epicrispr Biotechnologies (aka 'Epic Bio') explains how epigenetic editing is revolutionizing genetic medicine by controlling gene expression, without cutting DNA like traditional CRISPR technologies. Amber talks about FSHD, a progressive muscular dystrophy, how the company raised $68 million in Series B funding despite challenging market conditions, her partnership with Springbok Analytics for AI analysis of MRI images, working with a CDMO to manufacture a new treatment modality, and navigating the FDA during a time of disruption. 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/