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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.

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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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