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The notion that political influence has no place in biology appears poised for a test it hasn’t studied for. Trump administration nominations, from RFK, Jr. to HHS and Vivek Ramaswamy to the newly-proposed DOGE, are driving a storm of speculation over the implications for biotech and other life sciences industries. Throw in the increased probability of the Biosecure Act seeing the light of legislation day under a republican congress, and there’s no shortage of biopolitical pontificating to be done. How might this all play out, and how should biotech builders be obviating? On this episode of the Business of Biotech, we’re joined for some reflection by none other than Allan Shaw.
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In August of this year, the first TCR cell therapy to be approved for use in the U.S. was greenlighted by the FDA for patients with unresectable or metastatic synovial sarcoma who have previously received chemotherapy. It marked the first new treatment for those patients in more than a decade; a win for those patients, and a win for Adrian Rawcliffe, who’s had a hand on the wheel at Adaptimmune, the therapy’s developer and manufacturer, since he joined the company as CFO in 2015. Today, Rawcliffe is CEO there, and on this episode of the Business of Biotech, we’re going to get to know him, why he’s all-in on cell therapies, and how he’s applying a solid track record in finance and business development to make good on the promise they offer.
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On this episode of the Business of Biotech, Bill and Melinda Gates Medical Research Institute's (Gates MRI) Dr. Claire Wagner joins us to share insights into her work as head of Corporate Strategy and Market Access there. She shares the development of her North Star while working with the incomparable Dr. Paul Farmer in Rwanda, and how that experience translates to the growth of a biopharmaceutical company taking big swings for grossly underserved populations. We discuss the nuances assoiated with setting strategy and enabling product access in a unique not-for-profit setting, and how, perhaps counterintutively, the Institute's work fits synergistically into an ultra-competitive for-profit biopharma landscape.
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Becoming a biotech CEO wasn't on Paul Romness' bingo card. He'd forged his place in the biopharma industry as a foremost public and policy affairs expert. Thirteen years at J&J, more than 5 at Amgen, and half a dozen at Boehringer Ingelheim had earned him the right to coast into a consulting gig that would enable him to finish out his career on his terms.
Then his daughter's best friend Olivia, a teenage girl and neighbor he'd watched grow up, was diagnosed with osteosarcoma.
The ensuing journey, now in its seventh year, put Romness in the position of CEO and Chair of OS Therapies. It's a company formed through a combination of circumstance, determination, and ingenuity that's now shepherding its HER2 and tunable ADC therapeutics through mid-late-stage clinical trials. On this episode of the Business of Biotech, we dig into the building blocks of an unanticipated biotech startup. We'll learn how Romness leaned into his personal and professional communities to build a company that's now addressing unmet patient need in osteosarcoma and cancers of the breast, esophagus, lung, and pancreas. And we'll get an update on Olivia, who's now in med school at Columbia University and serving on the OS Therapies Board of Directors.Access this and hundreds of episodes of the Business of Biotech videocast under the Listen & Watch tab at bioprocessonline.com.
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It might just be coincidence, but it sure seems like Bill Enright has a knack for making big moves at inopportune times, then turning the expected outcome on its ear. For example, he signed on as CEO at Altimmune when the company was struggling mightily. Enright had a turnaround plan in hand, but as he was in the thick of a non-deal road show to execute said plan, Lehmen Brothers collapsed. On this episode of the Business of Biotech, we'll learn in great detail how Altimmune escaped that death knell. Later, he joined his current company, Barinthus Biotherapeutics, mere months before the Covid pandemic. That was shaky for a hot minute, but it turned out fortuitous when, against his better judgment, he enabled a pivot that became foundational to the company's go-forward plan. We'll learn how he flipped the script on that crisis, too. Tune in for these, and other harrowing tales from the trenches.
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While the trend toward CB1 inhibition for obesity took a small hit with the release of Novo Nordisk's small molecule oral cannabinoid receptor (CB1) inverse agonist monlunabant last month, Skye Bioscience Chairman and CEO Punit Dhillon is shaking it off. He's confident that his company's antibody-based approach to CB1 inhibition will make a moot point of the neuropsychiatric side effects that put a damper on Novo's data. On this episode of the Business of Biotech, we're digging into the uber-hot business of weight loss therapeutics and going deep with Dhillon on why Skye's blood/brain barrier-obeying antibody might turn the GLP-1 and small molecule approaches to obesity on their ears. Over the course of the conversation, we explore the ins-and-outs of the business of metabolic health, a space that's churning out one blockbuster after another.
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Allan Shaw is back with us this week to dig into the complexities of strategic hiring in biotech. We cover strategies for the step-wise assembly of effective executive teams, the importance of aligning key hires with clinical and regulatory milestones, managing salaries in line with cash runways, the pros and cons of fractional/consultative leadership, when it's time to turn fractional into full-time, and a whole-lot more. If you're growing a biotech in these volatile times, this episode of the Business of Biotech offers veteran insight you won't want to miss.
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Mike Kelly faced a self-reckoning before he took the job as CEO at NervGen, a company developing peptide therapeutics targeted specifically at central nervous system repair. The veteran of life sciences business development knew the ropes of the biotech C-suite. He’d been a CEO twice before. He knew how to launch drugs, having seen commercial success several times before. He even knew how to sell them—he’d started his career carrying the bag for TAP Pharmaceuticals. But all he knew about peptides was that they were challenging to manufacture consistently and purify. And he knew that manufacturing is where a lot of biopharma companies fall down. On this episode of the Business of Biotech, we learn how Kelly reconciled that truth, and how NervGen is now leading the way for peptide therapeutics in spinal cord injury and beyond.
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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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