The AI Impact with Generate:Biomedicines' Mike Nally

We love to hear from our listeners. Send us a message. This week, it’s another “Business of Biotech-meets-Business-of-RNA” takeover with Circio CEO Erik Digman Wiklund, Ph.D. and guest co-host Anna Rose Welch of Advancing RNA.  While Circio’s legacy is in cancer immunology (it still boasts a cancer vaccine candidate targeting KRAS driver mutations), the company made a bold pivot, of sorts, when it committed headlong to the circular RNA future. Now, it’s in the throes of fine-tuning a platform for the development of novel circRNA medicines for rare disease, vaccines, and cancer. On this episode of the Business of Biotech, we go deep inside the story behind the pivot, we explore the RNA therapeutic platform-versus-product appetite among biotech investors, and Dr. Digman Wiklund shares insights into the challenges his company overcame to enable such a dramatic shift in focus. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Guest co-host Anna Rose Welch of Advancing RNA fame joins us on this week’s Business of Biotech podcast for a conversation with the leaders of RNA upstart Radar Therapeutics. The company’s co-founders, Eerik Kaseniit, Ph.D. (CSO & President) and Sophia Lugo (CEO), are making waves in the mRNA therapeutics space on the heels of the invention of a precision-expressed mRNA technology that laid bare the path to Radar’s inception. On this episode, we dig into that science, why it’s timely, and how it fits into today’s mRNA therapeutics landscape. We also go deep on how Kaseniit and Lugo went about navigating the complexities of biotech formation, leaning into their networks andbuilding up a team—and each other—along the way. Their work is paying off, as the fast-growing company is attracting gobs of investor and big bio attention. For more on the technology Radar is bringing to bear, read Kaseniit and Lugo’s recent byline at Cell & Gene. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. For all the drug commercialization successes he's played a leading hand in during his tenures at GSK, Genentech, and ImClone—Androderm, Augmentin, necitumumab, and Erbitux among them—Michael Bailey concedes that he's likely better known for his failures. After hearing his stories on this episode of the Business of Biotech, I tend to disagree. While he offers a transparent and instructive look at the failures themselves, I'd contend it's what he's done with those setbacks that defines his biopharma and biotech leadership legacy. Today, Bailey is CEO at Aveo Oncology, a company that saw its own set of challenges during the clinical development of now-commercial FOTIVDA (tivozanib) and ficlatuzumab. Tune in for Bailey's straight-shooting insight on how to turn biotech setbacks on their ear. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. He's been a big pharma executive. He's a multi-time biotech founder and current biotech CEO. He was once a regulator. He's a physician. He serves on multiple boards. And as of this summer, he's president of one of the most influential global organizations dedicated to the advance of cell and gene therapies (ISCT), and an executive member of another (ARM). Miguel Forte, M.D. simply can't stop finding places to apply his talents and energy to influence the advanced therapies landscape. The experiences he's amassed give him a unique perspective on the industry's path forward, how to navigate the regulatory gauntlet, the role of industry associations and alliances in a biotech's succes, balancing the demands of multi-point leadership, changing the ATMP accesibility paradigm, and more. On this episode of the Business of Biotech, Dr. Forte shares generously on all of it. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Kristin Yarema, Ph.D. thinks the progress of CAR T therapeutics is allogeneic. In fact, she says CAR T-cell therapies have to become a one-to-many proposition, if their early autologous success can possibly live up to the promise of offering widespread accessibility to life-saving treatments. Dr. Yarema is the newly-appointed CEO at Poseida Therapeutics, a company we first covered with founding CEO Eric Ostertag, Ph.D. On this episode of the Business of Biotech, we'll learn about Dr. Yarema, how she earned the company's reins, how Poseida is positioning itself to crack the allogeneic CAR T code, and how strategic collaborations with the likes of Astellas and Roche are fueling the effort. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Flagship Pioneering’s ProFound Therapeutics is on to something, and it could be something big. It began with a simple question:  What if more RNAs were being translated into proteins? Answering that question took ProFound deep into the translatome, where it’s now studying the full compendium of RNA sequences that are being translated into proteins. Along the way, the young company is gaining confidence that its research will reveal important insight into potential therapeutic protein targets and medicines. On this episode of the Business of Biotech, ProFound CEO and Flagship Pioneering CEO-Partner John Lepore, M.D. shares the company’s journey—and his—as a physician scientist-turned-founder.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. While organic chemistry lectures caused many of his peers at NYU to wring their hands, gnash their teeth, and question life choices, then-19-year-old Enrique Diloné ate those classes for lunch. They inspired him to earn a Seton Hall Ph.D. in chemistry, and to go to work as a big bio research scientist. Along the way, Dr. Diloné got bit by the biotech business bug. It wasn’t easy. A whole bunch of MBA and executive learning programs at Rutgers, MIT, and Harvard, and many years of experience later, he’s Chief Technology Officer at Immunity Bio, which he joined in advance of the company winning FDA approval of ANKTIVA, its IL-15 Receptor Agonist for BCG-Unresponsive Non-Muscle Invasive Bladder Cancer, in April '24. On this episode of the Business of Biotech, we follow Dr. Diloné’s path from the bench to the boardroom, and learn how valuable that rare bridge between CMC and the executive offices really is. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Data drives decision-making at Aulos Bioscience. It's also driven the career trajectory of its CEO. On this week's episode of the Business of Biotech podcast, we get an introspective walk through Aron Kinickerbocker's strategically-orchestrated career path, from his early days in the labs at Bristol-Myers Squibb and Genentech to his leadership of Aulos Bioscience, a company that boasts the first AI-generated antibody in human clinical trials. We explore Aulos' innovative IL-2 antibody and the role AI played in its highly-targeted and toxicity-reducing design, and we do it in pragmatic fashion — Aron's not about the AI hype, he's about the AI data — and in its Phase 1/2 clinical trial, the data is looking pretty good. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Syncromune's Sync-T solid tumor therapeutic platform is, in a word, complex. The company's three phase 1 programs combine T-cell science with a proprietary drug delivery device to target solid tumors, specifically metastatic breast, non-small-cell lung, and castrate-resistant prostate cancers. But, while orchestrating a successful drug/device combination therapy presents unique regulatory challenges and requires a diverse array of in-house skillsets, President and CEO Eamon Hobbs is confident. He's done this before, and Syncromune's lead candidate has just been fast-tracked by the FDA. On this episode of the Business of Biotech, Hobbs shares his perspectives on bringing novel drug/device combination therapies to market, and reflects on a career dedicated to the drug delivery craft and demonstrated by his leadership at Antares Pharma, Delcath Systems, AngioDynamics. Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/

We love to hear from our listeners. Send us a message. Built on the back of hepatocyte growth factor discoveries by Harvard Drs. Reza Dana and Sunil Chauhan, ClarisBio is rewriting the ophthalmology rulebook. CEO Clark Atwell acknowledges that it's not the first to bring topically-administered biologic therapies to the front of the eye, but if successful in the clinic, its Neurotrophic Keratitis candidate will vastly improve the patient experience. It will also prove unequivocally that there's biotech business value in front-of-the-eye therapeutics, as opposed to just parenterally-administered back-of-the-eye biologics. On this episode of the Business of Biotech podcast, Atwell shares the stories of his career focus on the cornea, Claris' founding and funding progress, and why there's big, multi-indication opportunity for the company's novel HGF therapeutics in corneal diseases.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com. Subscribe to our monthly Business of Biotech newsletter. Get in touch with guest and topic suggestions: [email protected] Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/