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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.

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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. 

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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. 

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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. 

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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. 

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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. 

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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.

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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.

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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. 

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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.

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