We love to hear from our listeners. Send us a message. Combined Therapeutics President & CEO Dr. Romain Micol is operating his company in a very noisy space, where hundreds of new biotechs have popped up on the coattails of a COVID-driven renewal of interest in mRNA vaccines. Micol recognizes that noise and the competition it brings for capital and mindshare. He's not only aware of it —  he  welcomes it. On this quick episode of the Business of Biotech podcast, Micol shares the unique approach Combined Tx is taking to distinguishing itself in the mRNA infectious disease and cancer vaccine space, from the delivery, safety, efficay, and business perspectives. 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. When it comes to landing and executing strategic partnerships, Regeneron puts on a clinic. Partnerships, acquisitions, licensing agreements, and other deals large and small with Intellia, Decibel Therapeutics, BARDA, Alnylam, and Sonoma Therapeutics are just a sampling of those making news this year alone. The man behind much of that dealmaking is none other than Nouhad Husseini, SVP and Head of Business Development and Corporate Strategy at Regeneron. He’s a guy who’s deftly married the art and science of biopharma dealmaking, and on this episode of the Business of Biotech podcast, we’re getting introspective with this legend in the making, who our friend Allan Shaw says “turns the deals he touches into gold.” Strategic dealmaking is central to the biotech business, and today’s episode offers a master class. 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. From his vantage point as an independent biotech journalist, Luke Timmerman has been watching the expansions and retractions of the industry for a couple of decades now. His unique perspective is hard to equal, and that perspective is, despite tough markets and tepid public sentiment, decidedly bullish. Luke's optimism is fed by sound logic gained from a career spent in observation mode, watching the development of purpose-built tools matched to address the fragility of human biology. Luke's tireless advocacy for the industry also stretches well beyond his professional coverage and punditry. Through his Timmerman Traverse initiative, he's figured out a way to weave his personal and professional passions into a tapestery that serves some of the philanthropic initiatives our industry cares about most. On this episode of the Business of Biotech, we'll get to know Luke personally, we'll learn about his philanthropic work, and we'll give you a healthy dose of optimism as we look ahead to the next decade in biotech. 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. Earlier this year, Shawn Davis, Ph.D. left a pretty comfortable position at AstraZeneca (and Amgen before that, and Milliken, and others, before that) to lead Liberate Bio. He brought along another industry notable in Merck/Intellia alumnus Walter Strapps,  Ph.D., who serves as CSO at Liberate. Why'd they do it? Because RNA delivery is such a crucial step toward  revolutionary genetic medicine, but it's tough science. They think they can change that.  On this episode of the Business of Biotech, Drs. Davis and Strapps share how they're applying automation and machine learning technologies to minimize the challenges associated with targeted delivery of genetic medicine and  overcome the limitations of AAV.  During our conversation, they both leaned hard into how their previous experiences have shaped the work they're doing, and the wide-open business opportunities Liberate Bio is creating. 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. Shortly after Thalidomide became a household word—albeit a very, very bad one—a biotech investor bought it for a couple hundred grand. Who on earth would want a drug pulled from the market for causing birth defects? Steve Gorlin did. Today, Thalidomide is  the foundation of cancer drugs worth billions of dollars. Gorlin doesnt own it anymore, but the story of how he got it is just one of the experiences that contributed to the codification of his "golden rules." Following those rules has paid off. SIx of the companies he's founded acieved valuations, or sold, for more than $1 billion each. This week, the Business of Biotech sits down with the legendary biotech investor Steve Gorlin, now CEO of CoRegen, for a conversation on his golden rules for picking winners. Gear up for an action-packed, LIVE, and INTERACTIVE Business of Biotech as we delve into the nitty-gritty of IP and legal considerations crucial for budding biotech entities.  Get your queries resolved straight from a seasoned professional, minus the lawyer's fees! YOU HAVE TO REGISTER FOR THIS ONE (no cost), so head to tinyurl.com/boblive23, or secure your spot for Business of Biotech Live! Legal & IP Protection For New Biotechs here. Join us on Monday, November 13th, at 11 am Eastern. You don't want to miss this!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. Register for Business of Biotech Live! Legal & IP Protection For New Biotechs here. Get ready to unravel the legal enigmas of the biotech world with me and Keir LoIacono, Esq. The CEO of Blue Sphere Bio, Keir is no stranger to high-stakes decision-making and legal conundrums in the biotech industry. Having served as the general counsel and VP of Corporate Development for Oncosec, lead in-house counsel and senior director for Advaxis, and intellectual property attorney at the leading biotech law firm Lerner, David, Littenberg, Krumholz, and Mentlick, Keir is a powerhouse of knowledge ready to share his insights.Gear up for an action-packed, LIVE, and INTERACTIVE Business of Biotech as we delve into the nitty-gritty of IP and legal considerations crucial for budding biotech entities.  Get your queries resolved straight from a seasoned professional, minus the lawyer's fees! YOU HAVE TO REGISTER FOR THIS ONE (no cost), so head to tinyurl.com/boblive23, or secure your spot for Business of Biotech Live! Legal & IP Protection For New Biotechs here. Join us on Monday, November 13th, at 11 am Eastern. You don't want to miss this!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. What constitutes a healthy, productive, and successful relationship between an emerging biopharma company and its contract develpment and manufacturing outsourcer (CDMO)?  Jenny Holt, Chief Development Officer at the biopharma company Ray Therapeutics has some opinions. So does John Maslowski, Chief Commercial Officer at the CDMO Forge Biologics. Think they align?On this episode of the Business of Biotech, we dig into the trust, technical expertise, and project timeline considerations that required of a successful partnership. We also broach the risks associated with emerging CDMOs, the right balance among cost, quality, and time, what you should ask when evaluating outsourcing partners, and a whole lot more. ***REGISTER for the first-ever, interactive Business of Biotech Live! Legal & IP Protection For New Biotechs here!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. On a road trip to Boston, the Business of Biotech caught up with podcast alum Dan Passeri, J.D., CEO at Cue Biopharma, and enjoyed a two-for-one with CSO & President Anish Suri, Ph.D. at Cue's headquarters just feet below the Auerbach Center. Among other things, we discussed the duo's complementary leadership approach as the company takes multiple candidates into the clinic, why Passeri leans into his biotech legal background almost every day he's at work, the successful navigation of outsourced manufacturing relationships, why Cue's discretely targeted IL-2 approach eliminates the absurdity of early IL-2 failures, and a whole lot more. Speaking of Dan's legal background, before you jump into today'sepisode, REGISTER for the first-ever, interactive Business of Biotech Live! Legal & IPProtection For New Biotechs here!Subscribe to the #BusinessofBiotech newsletter at bioprocessonline.com/bob for more real, honest, transparent interactions with the leaders of emerging biotech. It's a once-per-month dose of insight and intel that you'll actually look forward to receiving! Check it out at bioprocessonline.com/bob!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. Johanna Kaufmann, Ph.D.'s path to EVP, Oncology at Codagenix is part serendipity and part circumstance, but it's a much larger part hard work. On this week's episode of the Business of Biotech, Dr. Kaufmann gives us an intimate retrospective on her career to date, sharing stories about her rapid ascension from Scientist 1 to executive leadership. We dig into her wild ride through M&A, her time at GSK, and the personal professional and personal development regimens she subscribes to. We also catch up on the important work Codagenix is doing in the live vaccines and viral therapeutics arena. ***REGISTER for the first-ever, interactive Business of Biotech Live!  Legal & IP Protection For New Biotechs here! https://event.on24.com/wcc/r/4376909/58114AA2A39F50879AE1B6F0CD1F5B11Access 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. On this episode of the Business of Biotech, Leonard Mazur, co-founder, CEO, and chairman of Citius Pharmaceuticals, shares his rollercoaster ride to success in biotech, the founding story of Citius Pharmaceuticals, his engagement with the Department of Defense, and the effort to revive an antibiotic used on the frontlines.Leonard takes us into the complexity of investor relationships, and his personal investment that influences his leadership style. He reveals his strategies for constructing a successful biotech pipeline, underscoring the importance of a unique mechanism of action and the hurdles of resurrecting a retired product. Get ready for an intimate look at Leonard's decision-making process, and his insights into managing the financial aspects of a bio-pharma company. As we wrap up, Leonard offers an honest look at the evolution of the biotech industry, the financial challenges faced, and his advice on navigating these turbulent waters. He brings his experience with auction processes and drug hunting to light, preparing us for unexpected hiccups in the biotech world. Leonard also credits mentorship in shaping his approach to constructing a clinical pipeline. Join us for this inspiring exploration of resilience, determination, and success in the biotech industry.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. Don't be offended by the title of today's Business of Biotech podcast. Dr. Quin Wills' application of what's become known as "Wheaton's Law" (look it up) is central to the ambitious goals his company, Ochre Bio, is pursuing: pioneering the value of computational biology in large mol discovery and development, putting an end to the global liver disease epidemic, and changing the costly, high-risk approach to clinical trials. On this week's episode, Dr. Wills and I explore how those goals are being addressed despite the challenges they present, and how the company's three guiding principles, don't be a d*** being one of them, align the Ochre team with the mission at hand. 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. This week's guest on the Business of Biotech, EVQLV's Andrew Satz, says AI and ML in biopharma are like sex in high school. "Many of the people who say they're doing it really aren't, and the one who really are aren't talking about it," he says. So, when it comes to the computational biology buzz, what’s real? What’s hype? What’s yielding benefit and what’s merely vaporware? In our talks with the leaders of new and emerging biotechs over the past 12 to 18 months, we've seen a steep increase in the application of – or at the very least, interest in – machine learning, AI, and computational biology tools for drug discovery, development, and beyond. Even those who are using some "ultra-light" application of new computational technology are eager to talk about it, as it’s clearly become as en-vogue as tacking “bio” onto your moniker was a few years back – even among companies who aren’t actually developing biologics. On this episode, Satz offers his take on the reality of adoption and shares advice on the fundamentals of AI and ML in biotech.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. Orca Bio's Dan Kirby has played a hand in prepping more than a few approved biologic therapeutic candidates for commercialization. Equally important, he knows firsthand what makes or breaks post-approval commercial efforts, having played virtually every role there is to play in drug sales and marketing. He "carried the bag" for GSK in his early days, directed oncology marketing efforts at Amgen, and led marketing and U.S. commercial efforts at Juno, then Celgene after it acquired the former. Kirby joined Orca Bio in timely fashion back in 2020, as today the company ushers its first cell therapy into phase 3 clinical trials, with strategically-dispersed follow-up candidates spanning all phases back to R&D. On this week's episode of the Business of Biotech, we get a one-on-one commercialization preparation discussion with one of the best in the business, and the straight-talking veteran doesn't disappoint in the strategy and insight departments. 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. Core to the clinical-stage biopharma Life Bisociences belief set is that, "contrary to popular belief, aging is not caused by random wear and tear, but instead is caused by a discrete set of biological mechanisms that can be targeted therapeutically.” The fountain of youth might be a fantasy, but the biology of aging, and more specifically, the science behind the manipulation of that biology, is not only real, it’s become big business. Still, the challenge for serious and legitimate biopharmaceutical companies in the anti-aging space can sometimes have less to do with biology than it does perception. Does the biotech investment community understand and embrace the concept? Equally, if not more importantly, will the FDA and other regulatory agencies lean into the idea that aging itself might be viewed as an indication that warrants therapeutic review? And from a commercial perspective, how does a legitimate biopharmaceutical company, focused on combatting the physical deterioration marked by the advance in our years, separate and differentiate itself from the billions of dollars being poured into the consumer packaged anti-aging and cosmetic medical procedures markets? On this episode of the Business of Biotech, Matt sits down with Life Biosciences' CEO Jerry McLaughlin to address these questions and more. 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. Within about five minutes of conversation with Protalix CFO Eyal Rubin, I learned that he doesn’t bite his tongue about the rigors of biotech business and finance management, which is precisely why I’m eager to talk with him on today’s episode of the podcast. From commercialization deals with big pharma to being about $50 million underwater to swatting away the day trading armchair quarterbacks on Stocktwits, Rubin’s seen a few things and he’s developed more than a few opinions. On this episode of the Business of Biotech, you'll get a front-row seat to a discussion with a biotech CFO who knows how to put on the blinders, shut out distractions, right the ship and set the course to favorable financial waters. Bringing his years of experience in the CFO role at Teva Pharmaceuticals, Brainstorm Cell Therapeutics, and now, Protalix Biotherapeutics, we bring you Eyal Rubin for a story on big biopharma fiscal recoveries. 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. In many respects, bringing an established foreign biopharma company to the U.S. market is not unlike starting one up from scratch. In other respects, it's even harder; long-held cultural norms and management styles, region-specific market dynamics, payer system nuance, and political influence must all be re-navigated and re-negotiated without encumbrance. The job's not for the faint of heart, which might be why the Danish company LEO Pharma tapped veteran biopharma leader Brian Hilberdink to lead its U.S. operations. On this episode of the Business of Biotech, Hilberdink shares loads of biopharma-specific leadership intel and advice as we discuss the task he faces and the course he's charting. 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. Since we last spoke in the Spring of 2021, Nevan Charles Elam, JD has managed to advance both of small-but-mighty Rezolute Bio's candidates onto the next phases of their journey. This year, on the back of a $130 million investment, Rezolute Bio is prepping its RZ358 candidate, a monoclonal antibody for congenital hyperinsulinism, for a pivotal phase 3 trial. On this week's epsiode of the Business of Biotech, we're settling in for an interrogation of Elam on the management principles of maintaining multi-candidate clinical momentum among highly disparate candidates and raising big dollars as a small biotech. 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. The non-alcoholic steatohepatitis (NASH) therapeutics market has proven to be an 11/10 on the difficulty scale. Despite billions of big biopharma dollars invested in therapeutic development, and a few close calls, no therapeutics has yet reached the finish line. On this episode of the Business of Biotech, 89bio CEO Rohan Palekar gives us the insider's perspective on the the challenges that heave beset the field, from a rigorous FDA approval process to poorly designed clinical trials and a wary investor base. Palekar also expresses optimism in his explanation of how, through a focus on safety, convenience, and cutting-edge testing technology to aid patient recruitment, 89bio is positioning itself to break the tape.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. It’s been said that clinical trials are where emerging biotechs go to die. If the science doesn't kill quickly, poor cash management will slowly. And, even when good data opens the cash floodgates, post-round cash management savvy isn't necessarily intuitive to academic and scientific founders. Cash runway preservation is, however, ingrained in the cerebral cortex of one of our favorite mavens of biotech finance markets and management, Mr. Allan Shaw. He joins us on this week’s episode of the Business of Biotech for a conversation on post-financing fundamentals for new and emerging biopharmas.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 Horizon Therapeutics has made plenty of waves in the biotech news cycle of late. While perhaps not as flashy as a perilous multibillion dollar acquisition deal or potential blockbuster readout, its formal establishment of a research team – comparatively pragmatic as that may be – could have long-term consequences that are just impactful. On this week's episode of the Business of Biotech, we dig into why the company chose to establish a research function, learn why it chose Dr. Robert Stoffel, Ph.D. to run it, and get a step-by-step explainer on how Stoffel went about establishing the department, setting its goals and strategy, staffing it, and integrating it across teams at the fast-rising biopharmaceutical company. 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. The microbiome therapeutics market has been taking a beating, with several clinical-stage companies failing or flailing at the hands of tough financial markets and regulatory scrutiny. MaaT Pharma Founder & CEO Hervé Affagard knows these perils well. Affagard recently navigated his company through a protracted FDA clinical hold, emerging on the other side with a promising Phase 3 candidate in Graft versus Host Disease. On this episode of the Business of Biotech, Affagard offers a transparent look at how MaaT is beating the odds with a redundant clinical strategy and scrupulous cash management.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. Chief Operating Officer is arguably the toughest job in the emerging biopharma C-suite. HR, CMC, regulatory affairs, legal, PR, you name it, the COO touches it, and practically everything rolls up to her. This week's episode of the Business of Biotech brings us to a president and COO who's also a mom, a volunteer, and an advocate for diversity and equality in biopharma. That advocacy isn't just lip service, by the way. Here, Rocket Pharmaceuticals' Kinnari Patel, PharmD, shares on the real, practical, replicable steps Rocket takes to build a diverse and equitable work environment, how the fruits of that effort have proven important to the company's success, and where Rocket is taking its high-flying gene therapy act next.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. Will machine learning revolutionize biopharma drug discovery? Has it already? This week on the Business of Biotech, we explore the intersection of tech and bio with Dr. James Field, founder and CEO of LabGenius. We'll get an insider's look at the formation of a company bridging the divide between computational and biological sciences, we'll learn why this ML-intensive leader applies a scientist's skepticism to the tech he's building, and we'll address fundamental data considerations along the way.  We'll also learn about the challenges and opportunities that come with balancing a company that's building both a high-tech drug discovery platform and drugs themselves. If you're concerned with what ML will do to —  or for —  your biopharma business, don't miss this episode. 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. Ahmed Hamdy, MD didn’t ask to be the subject of Nathan Vardi's new book For Blood and Money: Billionaires, Biotech, and the Quest for a Blockbuster Drug. In fact, that particular chapter of Dr. Hamdy’s career is one he’d rather not relive. But, in display of the resilience required of biotech leadership, Hamdy made a raging comeback. On this week’s episode of the Business of Biotech, we dive into Hamdy’s resurrection; how he shepherded Acerta Pharma all the way to a multibillion dollar blockbuster exit with Astra Zeneca and his plans to recreate that success in his new post as CEO and Founder at cancer therapeutics-focused Vincerx Pharma.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. Last October, we dropped an episode dissecting the relationship between Ray Therapeutics and one of its lead funders, 4BIO, and it quickly rocketed to an all-time Business of Biotech fan favorite. This week, we’re doing it again with a candid, behind-the-scenes breakdown of how Vedanta Biosciences secured the support of K2 Health Ventures in its recent $100 million+ financing to fund a pivotal Phase 3 study. Join us as we dissect a story that started when Vedanta CEO Bernat Olle, Ph.D. met K2HV’s Founding Managing Director & CEO Parag Shah on a mountain during the Timmerman Traverse. Their story serves as a guide to ensuring the cultural and strategic alignment of science and finance.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. Vaxxinity’s John Krayacich likes taking big swings at big indications. He’s played key roles on the teams that launched Lipitor, Lyrica, and Neurontin, which have had measurable impacts on global populations of people suffering from cardiovascular disease, CNS disorders, and pain. He found those opportunities at companies like LEO, Novartis, Parke Davis, and Pfizer. Now, Krayacich is taking big swings at a new set of incredibly challenging candidates—immunotherapeutic vaccines for neurodegenerative and chronic diseases like Alzheimer’s, Dementia with Lewy Bodies, Multiple System Atrophy, Parkinson’s, Migraine, and Hypercholesterolemia. On this episode of the Business of Biotech, the Chief Business Officer shares his inspiration and strategy for seeing therapeutics for big, global patient populations through the commercial finish line. 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. Dr. Adrienne Leussa is one of my favorite follows. If the booming biotech scene on an incredibly diverse continent of 1.2 billion people interests you, she should be one of your faves, too. Dr. Leussa's intellect, energy, and glowing spirit contribute to her ambassadorship of the African biotech scene. She's an entrepreneur, a visionary, a communicator, and a tireless advocate for African biotech opportunity. On today's epsiode of the Business of Biotech, we share a lot of laughs as we learn how Adrienne's entrepreneurial beginnings selling nuts and lollies on the streets of Yaounde, Cameroon set the foundation for an accelerated academic career and a passion for bio business development. We also dive into Africa's growing biotech scene, discussing the support infrastructure available for budding entrepreneurs and the importance of technology transfer and commercial research innovations from local universities. 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. Allan Shaw isn't the only insider who's preemptively critical of the impact the IRA (Inflation Reduction Act) will have on the biopharma industry.  Allan's back this week with analysis of what he and others are tongue-in-cheek calling the "innovation reduction act." He posits that the act's removal of certain protections  will stifle momentum by disincentivizing the pursuit of novel discoveries in molecules small and large. He also suggests that the impact of the IRA will ultimately cost patients and payers more. Tune in to learn why.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. The Business of Biotech took a road trip to Pittsburgh to visit with Peptilogics CEO and founder Dr. Jonathan Steckbeck, whose Ph.D. work was inspired by the loss of his father-in-law to a hospital-borne infection. That work subsequently led to the formation of a company committed to leveraging peptide therapeutics to address PJI (prosthetic joint infection), cystic fibrosis infection, as well as rare genetic disease and oncological indications. Dr. Steckbeck walks us through the transition of his academic work into a clinical-stage company, how he's sustaining the company in a lean capital market, and the virtues of doing biotech business in Pittsburgh. 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. Since Dan O'Connor stepped in as CEO at Ambrx late last year, the company's stock has rallied on the revival of a previously-shelved anti-HER2 ADC. It also raised $78 million and completed its ATM (at-the-market) offering. O'Connor is no stranger to overcoming adversity. A former marine captain, he was among the first deployed to the Persian Gulf to fight in Operation Desert Shield. While his leadership at Ambrx is anything but militaristic, he ascribes much of his style, and certainly his approach to adverse conditions,  to his military time. On this episode of the Business of Biotech, we welcome back Dan O'Connor to discuss the resuregence of Ambrx and leadership resilience in an industry that demands 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. Like many of us, Howard Berman, Ph.D. has personal experience with the tragedy of cognitive decline. Neurodegenerative disorders are on the rise, and when one afflicted his father — a triple board-certified physician — he saw firsthand that they don't discriminate. Berman has dedicated his career to addressing neuro, autoimmune, and metabolic diseases, having founded Nicoya Health in 2020 and overseeing its merger with Coya Therapeutics the following year. The company came out of the gates this year fueled by an 11th-hour 2022 IPO, one of just a dozen on the year. Berman joined the Business of Biotech to share his strategy during a stingy stretch in biotech capital markets. 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. What are biopharma's greatest skilled manufacturing labor needs, and what's the industry doing to fill them? John Balchunas is on the front lines in his position as Workforce Director at NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals, and he says advanced degrees and pedigrees aren't the answer. The breadth and depth of NIIMBL's efforts to influence the next generation of the biopharma workforce — from  high school vocational programs to community colleges and on-the-job development—might surprise you. Listen in as Balchunas brings the Business of Biotech up to speed on a training and development agenda that plants seeds early and often. 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 is fertile ground for a bevy of blossoming biotechs, and one of its most prolific sowers is General Partner Avak Kahvejian, Ph.D. Dr. Kahvejian counts Seres Therapeutics, Rubius Therapeutics, Codiak BioSciences, Cygnal Therapeutics, Ring Therapeutics, Cellarity, Laronde, and Generate Biomedicines among the companies he's played a leading hand in launching. On this episode of the Business of Biotech, Kahvejian takes us under the hood of one of the most burgeoning businesses in biotech,  sharing details on the people, processes, and technologies  fueling its rapid growth.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. We kick this conversation off with the writer Elizabeth Gilbert's take on moss, which she so eloquenlty dubs a "resurrection engine." Gilbert almost certianly didn't realize the potential of moss to play a resurrectional role in human health, but Eleva Biotech's Andreas Schaaf and Bjorn Cochlovius do. On this episode of the Business of Biotech, we learn about a company that's developing proteins to fuel its own pipeline — and its partners' — from a most ubiquitous plant that grows virtually everywhere. It grows particularly well in bioreactors outfitted with custom grow lights, and presents some significant advantages over CHO cell line development. 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. We often talk about biotechs taking "big swings." This week's guest is swinging for the fences with a lineup of gene therapies designed to address multiple forms of hearing loss, which affect multiple millions (if not, billions) of people worldwide. Adding to the challenge she's accepted, Sensorion CEO Nawal Ouzren is architecting an approach that seeks to restore hearing that's been lost due to genetic factors, treat sudden hearing disorders, and proactively prevent hearing loss due to common causes such as cisplatin induced ototoxicity or cochlear implantation. Listen in as Ouzren shares her holistic and aggressive plans with the Business of Biotech. 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. LyGenesis is  developing a pipeline of allogeneic cell therapies using the lymph node as an in vivo bioreactor to grow functioning ectopic organs. What sounds like science fiction to some is starting to look like a life changing therapy for millions of liver, kidney, pancreas, and thymus disease sufferers. The science behind it is being developed not in Boston, not in Philadelphia, nor in San Franciso, but right in the heart of the rust belt in Pittsburgh, PA. This week's episode of the Business of Biotech takes us there for a conversation with LyGenesis CEO Dr. Michael Hufford, Ph.D.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. Today's episode of the Business of Biotech covers a lot of ground with Enzyvant CEO Bill Symonds, Pharm.D. Among other things, we discuss the career moves Dr. Symonds has made within the "vant" environment since his involvement in the launch of the original Roivant,  the approval of Rethymic, the merger of Altavant and Enzyvant, and the company's intentions for a brand new regenerative medicine manufacturing facility in Research Triangle Park. From drug approvals to mergers, from internal manufacturing capacity to founders-turned-presidential candidates, this one's got it all. 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. The more we learn about inflammation and the complex cause/contributor/symptom roles it plays in various disease states, the more business activity we see in the inflammation therapeutics space. But to date, commercial pharmaceutical and biologic efforts have fallen short for patients, says Moonlake Immunotherapeutics CEO Jorge Santos Da Silva, Ph.D. What's the problem, and why does he think his camelid-derived nanobody candidates are poised to outperform big-pharma standards from the likes of UCB and Novartis? Find out on this week's episode of the Business of Biotech. 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. On the surface, the merger of Medsenic (a developer of arsenic salt formulations for therapeutic application in inflammatory conditions) and Bone Therapeutics (which develops allogeneic cell therapies for complicated bone fractures) doesn't look obviously synergistic. But  Francois Rieger,  Ph.D. says that on the scientific level, it's a perfect union, and the veteran biotech founder says the business should always follow the science. The union of the two companies formed BioSenic, which Dr. Regier now serves as CEO. On this week's episode of the Business of Biotech, Dr. Regier shows us the good, the bad, and the ugly of the merger process and shares his philosophy on letting science lead the way, regardless of the analysts' takes. 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. Among a growing cluster of Pittsburgh biotechs, you'll find BlueSphere Bio, an early-stage company discovering T-cell receptors to leverage against tumor-specific antigens in individual cancer patients. Its leader, CEO Keir Loiacono, Esq., works with a sense of urgency inspired by his own cancer journey. Business of Biotech host Matt Pillar and guest co-host Jon O'Connell, executive editor at Bioprocess Online, toured Bluesphere's state-of-the-art facility perched on the bank of the Monongahela River. Then, we sat down with Loiacono to learn his story and discuss the company's vision for the future of personalized, adoptive cell therapy.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. SPECIAL EDITION: BoB@JPMElixirgen Therapeutics CEO Akihiro Ko joins the Business of Biotech for the final  episode in our special series recorded at JPM Week in San Francico. Life Science Leader Chief Editor Ben Comer joined us for the conversation. We dive deep into Elixirgen's unique, temperature-controlled in-vivo gene expression technology designed to address common cell therapy administration challenges and unwanted, off-target immunogenicity effects. Ko also shares progress on the company's ex-vivo candidate EXG-34217,  an autologous cell therapy for telomere biology disorders, offers his take on the ever-crowded RNA therapeutics space and how the company is separating itself from the crowd, and much more!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. SPECIAL EDITION: BOB@JPMFlagship Pioneering plucked Michael Severino, M.D. away from AbbVie to run point at Tessera, a startup it's backed to pioneer a new category of genetic medicine it calls gene writing. The Business of Biotech caught up with Severino at the JP Morgan Healthcare Conference in San Francisco last month. We learned what lured him away from leadership positions at Merck, Amgen, and AbbVie, how gene writing differs from gene therapy and gene editing, why the team at Tessera believes its technologies can write and rewrite DNA at the scales necessary to cure most genetic diseases, and where he plans to take the company from here. 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. SPECIAL EDITION: BOB@JPMBolt Biotherapeutics CEO Randall Schatzman, Ph.D. and CMO Edith Perez, M.D. are no strangers to the Business of Biotech, having previously joined us on episodes 14 and 18, respectively. The last time we spoke with Dr. Schatzman, he was preparing the company for its initial public offering. We caught up with him and Dr. Perez at the JP Morgan Healthcare Conference in San Francisco last month for a conversation on the IPO process, the impacts it's had on the go-forward plan at Bolt Bio, the company's clinical progress, and its collaboration strategy moving forward. 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. SPECIAL EDITION: BoB@JPMThe JP Morgan Healthcare Conference is a target-rich environment for conversations with the leaders of up-and-coming biopharma companies, so we took the Business of Biotech on the road. On today's episode, we sat down with Matt Coffey, Ph.D., who earned his Ph.D. in 1998 and turned his doctoral thesis into a biopharma company called Oncolytics in 1999. Dr. Coffey shares on his abrupt transition from academia to industry,  tells tales of the company's backstory, and updates us on its aggressive clinical activity spanning 7 wide-ranging oncology programs.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. SPECIAL EDITION: BoB@JPMThe Business of Biotech podcast took to the streets of San Francisco during the 41st Annual J.P. Morgan Healthcare Conference. This week's episode features a conversation with Sangamo Therapeutics CEO Sandy Macrae, Ph.D., who rationalizes the company's aggressive pipeline development and its decision to invest in multinational AAV and cell therapy manufacturing facilities in France and California. Dr. Macrae zeroes in on the relationship between people and processes that's enabled the company to grow to more than 500 associates working on nearly 20 cell therapy, gene therapy, and genome engineering programs. 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. Is it past time for a new approach to the COVID vaccine? Ocugen Chairman of the Board, Founder & CEO Shankar Musunuri, Ph.D. says yes, and his ideals would mark significant improvements: fewer shots, better durability, less post-vaccination transmission, and safety proven by time-tested technology. How would such a vaccine be produced? Dr. Musunuri lays out the manufacturing science— and why the improved COVID vaccine his company is currently putting through Phase 2/3 trials makes good business sense—on this week's episode of the Business of Biotech. 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. Call it fortuitous, good planning, instinct, or a combination of all three, but Nadim Ahmed's educational foundation— earned before the IT/Biology combination was cool— is serving him well as CEO at Cullinan Oncology. On this episode of the Business of Biotech, Ahmed shares his story and that of Cullinan Oncology's drug discovery efforts, which have yielded a wide range of multi-modal candidates spanning a range of cancer indications. Our discussion digs into the company's transition from R&D to the clinic, how its built an uncommonly comfortable cash position through partnership, and its ambition to become a fully-integrated commercial-stage biotech. 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. After more than 21 years leading process, product, and technical development efforts at Merck and Takeda, Piper Trelstad, Ph.D. joined the Bill & Melinda Gates Medical Research Institute (MRI) in January, 2022. On this episode of the Business of Biotech, we'll dive into how the MRI, a full-fledged clinical-stage biopharmaceutical company, is tackling health problems that challenge some of the world's most vulnerable populations. Dr. Trelstad also shares her minority perspective as a woman working in a highly technical capacity in biopharma, and how the industry can proactively support and advance women in technical roles. 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/