CDMO Collab with Scorpius BioManufacturing's Steve Lavezoli + Fina Biosolutions' Dr. Andrew Lees

We love to hear from our listeners. Send us a message. 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. Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!

We love to hear from our listeners. Send us a message. 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. Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!

We love to hear from our listeners. Send us a message. 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. Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!

We love to hear from our listeners. Send us a message. 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.Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!

We love to hear from our listeners. Send us a message. 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.Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!

We love to hear from our listeners. Send us a message. 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.Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!

We love to hear from our listeners. Send us a message. 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!Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!

We love to hear from our listeners. Send us a message. 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. Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!

We love to hear from our listeners. Send us a message. 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.Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!

We love to hear from our listeners. Send us a message. 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. Register for Bioprocess Online’s Bio Expo Live, being held July 30th through August 1st . This inaugural expo is a fantastic opportunity for biopharma companies and contract manufacturers to evaluate the latest and greatest from the comfort of your desktop or mobile device. Conveniently, we’ve broken down the lineup into Upstream Solutions July 30th, Downstream Solutions July 31st, and Quality, Analytical, and Data Solutions August 1st. It’s absolutely free to register for this series of short, digestible, and interactive sessions -- just hit the links above to register for Bio Expo Live today!