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It wouldn't be accurate to say that surgeon-turned-healthcare investment banker and consultant Dr. Ali Pashazadeh traded his scalpels for spreadsheets. In fact, he still wields a scalpel quite frequently, and on this episode of the Business of Biotech podcast, he offers a fantastic reason why. Yes, it's a bit of a departure from our normal routine of biotech founders occupying the guest chair. But, Pashazadeh's no-holds-barred reflections on and analysis of biotech breaking points, drawn from more than 2 decades of troubleshooting broken bipharmaceutical businesses and correcting courses, makes for some great programming. Whether you're a biotech builder in the throes of disruption, or feeling lucky that you've been threading scientific, clinical, capital, and regulatory needles all along, this episode offers a ton of insight from the unwritten textbooks on the business of biotech.
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Hilary Eaton, Ph.D. was a self-described AI skeptic, particularly as it relates to using the tool in drug discovery. Then, a series of professional and deeply personal life events and medical discoveries put her in a position to confront that skepticism head-on. Today, she's Chief Business Officer at ProFluent Bio, a company that's committed to democratizing access to open-source AI gene editing tools that are custom-built for pharmaceutical development. On this episode of the Business of Biotech, Dr. Eaton shares her story and makes a pragmatic case for the transformative value of AI to biotech builders. Whether your bullish or bearish about the intersction of advanced therapeutic development and artificial intelligence, this one's a must-listen.
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SR One Capital Management CEO Simeon George, M.D. has a seemingly innate ability to pick winning biotech builders. Early on, he and his firm got behind CRISPR's Samarth Kulkarni, Ph.D., Arcellx' Rami Elghandour, and Nkarta's Paul Hastings, for example. With nearly 50 biotech leaders in SR One's portfolio, there are plenty more where those three came from. On this episode of the Business of Biotech, Dr. George, admits that despite his gifted brain he more readily follows his heart. Still, over the course of our conversation, he shares insight into the decision making processes that have contributed to his success at picking winners as an investment banker and biotech venture capitalist.
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Erik van den Berg is CEO and board member at Memo Therapeutics, and he's a student of biotech chaos. In fact, he's been embracing it with intention for the past 30 years. On this episode of the Business of Biotech, he walks us through the management of that chaos in specific detail. Navigating gluttonous Covid-fueled financial markets. Achieving clinical outcomes during the pandemic. Keeping development on the rails in a protracted financial drought. Creating differentiation in crowded and noisy renal and oncology antibody therapeutic spaces. We cover it all, with van den Berg offering detailed insight into the guiding principles of navigating constant change in biotech.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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When we last caught up with Brian Culley, CEO at Lineage Cell Therapeutics, it was January, 2021. A pandemic was raging. His company was moving mountains to keep its OpRegen dry AMD clinical trial together, and did so despite lockdowns that kept a largely aged patient population from setting foot anywhere near a healthcare clinic. Lineage emerged stronger, signing a collaboration and license agreement with Roche and Genentech later that year. In May of this year, it doubled down on the commitment with a new services agreement with Genentech to support the OpRegen program. All this, while simultaneously progressing its OPC1 spinal cord injury program into Phase 2 and laying the clinical groundwork for programs in hearing loss, vision loss, and neurologic indications. On his long-overdue return to the Business of Biotech, Culley opens up on how the company addressed struggling programs, wrestled manufacturing control issues and delivery inefficiencies in its spinal cord program to the ground, and maintained control of its regulatory progress along the way.
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The cell therapy company Arcellx has, by any and every measure, been outperforming its peers. Its stock has rallied on the back of the strong performance of its multiple myeloma candidate, and the promise of its AML, MDS, and solid tumor pipelines is attracting the kind of interest it takes to be in it for the long run. Asked about his company’s rapid rise since taking the helm in 2021, CEO Rami Elghandour cites a few critical and risky decisions, the execution of some specific people on his all-star team, and a relentless commitment to diversity, equity, and inclusion. Before you skepticize, let me assure you: the man brings receipts.
As we head into Juneteenth celebrations, and as pride month comes to a crescendo, we’re all seeing plenty of companies putting a DEI foot forward. Much of this is hollow noise. It’s diversity-washing, the DEI equivalent to greenwashing, whereby organizations misrepresent their environmental practices to create the perception of a commitment to sustainability. Arcellx, and Rami Elghandour, are not that. On this episode of the Business of Biotech, Rami shares vivid lessons from the rise of Arcellx and gets specific on how his steadfast commitment to diversity has fueled its takeoff.
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If there's anyone qualified to analyze an early-stage therapeutic technology and place bets with other people's money, it's scientist-turned-venture capitalist Jonathan Behr, Ph.D. He built a distinguished venture capital career on the back of an MIT Ph.D. in biological engineering, having co-founded no fewer than 7 life sciences companies, served on or observed the boards of at least 17, and led investments at Pure Tech Ventures, the JDRF T1D Fund, SV Health investors, and now, the Dementia Discovery Fund, where he's a partner. Drawing from all that experience, this episode of the Business of Biotech delivers a trove of knowledge on biotech corporate finance and entrepreneurship, as well as the interplay between business strategy and influences like regulatory and scientific trends. We focus on the spirited neurodegenerative space, where case studies in investment and regulatory success and missteps abound. Tune in here and subscribe wherever you listen to podcasts!
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Just a few years ago, Daiichi Sankyo wasn't considered a player in the oncology therapeutics space, and it certainly wasn't a player in ADCs. But then, just a few years ago, who was? Fast forward to 2023, and we see an ADC arena that drove nearly $100 billion in M&A, licensing, and partnership deals, and a Daiichi Sankyo that can rightfully lay claim to lighting that fire. In fact, it was our guest on this episode of the Business of Biotech, Ken Keller, Chairman of the Board, President, and CEO at Daiichi Sankyo, Inc. who made the bold move to jump headlong into oncology armed with ADCs that, at the time, weren't exactly the darling of biotech. On this episode, Ken shares the story of his climb from "carrying the bag" all the way to the Big Biotech C-Suite, how and why Daiichi Sankyo pivoted from its roots in cardiovascular therapeutics into Oncology and ADCs, his reflections on the antibody-drug conjugate market, and a whole lot more.
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Mythic Therapeutics Chief Scientific Officer and co-founder Brian Fiske, Ph.D. broke some unwritten protocol with his rapid and multifaceted transition from academia to industry. He calls his many, and sometimes concurrent, early experiences as an MIT Ph.D. student, a Flagship Ventures Fellow, a Bain consultant, a hospital researcher, and a biopharma consultant indiciative of a young man who didn't want to make decisions. In retrospect, it looks more like the perfect preparatory mix for a guy who's leading a company with a unique approach to a white-hot ADC (antibody-drug conjugate) therapeutics market. On this epsiode of the Business of Biotech, get to know Brian as we peel back the layers to expose what's fueling the rapid rise of Mythic's ADC candidate in non-small cell lung cancer.
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This isn't your typical drug sponsor + CDMO story. In fact, CTMC's Jason Bock, Ph.D. says you shouldn't even classify his company a CDMO. He's not wrong. While some of the company's services aren't dissimilar from those offered by a contract developer, CTMC began with a more fundamental mission in mind -- to help early clinical-stage companies like KSQ Therapeutics prepare for and enter their clinical stage on the best possible footing, and with the best possible clinical partner in the MD Anderson Cancer Center. On this episode of the Business of Biotech, KSQ's Thomas Leitch and Dr. Bock join us to share the story of CTMC's evolution, KSQ's partnership need as it advanced its lead phase 1 TIL therapy for solid tumors, how the partnership unfolded and who's on the hook for what as KSQ begins its clinical journey.
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Find Matt Pillar on LinkedIn: https://www.linkedin.com/in/matthewpillar/ - Visa fler
