Manufacturing
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Acepodia's Approach To ACC & CAR Manufacturing Scalability
1/19/2021
Acepodia CEO, President, & Co-founder Dr. Sony Hsiao and Dr. Mark Gilbert, SVP of R&D, join Erin Harris and Matt Pillar for a discussion on the company's approach to dramatically reducing the cost of cell therapy development, manufacturing, and administration via its oNK, CAR, and ACC candidates.
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Commercial Readiness with ImmunityBio's Bobby Reddy, M.D.
4/14/2024
This episode of the Business of Biotech begins with a personal story about my dad and the standard of care in bladder cancer, before shifting to the work that Dr. Bobby Reddy and his team at ImmunityBio are doing to change that standard of care. They're painfully close. Dr. Reddy, Chief Medical Officer at ImmunityBio, gives us a long look behind the curtain at the commercial preparations the company is making as its lead Phase 3 candidate, Anktiva, nears the goal line in non-muscle invasive bladder cancer (NMIBC).
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Commercial Readiness with Orca Bio's Dan Kirby
9/14/2023
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.
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Inflammation & Antibodies With Ampio Pharmaceutical's Mike Martino, CEO
6/1/2022
Ampio Pharmaceuticals is currently weaving the gauntlet of a clinical hold triggered by COVID's disruption to clinical studies of its lead candidate Ampion, and recently launched an independent investigation into that trial and others. On this episode. Ampio Pharmaceuticals chairman and CEO Mike Martino joins the Business of Biotech for a candid discussion on the company, the candidate, the disruption, and the go-forward plan.
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Propagating Peptides With Peptilogics' Jonathan Steckbeck, Ph.D.
5/24/2023
Peptilogics CEO and founder Dr. Jonathan Steckbeck walks us through his transition from academic work into a clinical-stage company, how he's sustaining the company in a lean capital market, and more.
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Product Vs. Platform With Surface's Vito Palombella, Ph.D. And Robert Ross, M.D.
11/6/2022
Earlier this month, Surface Oncology shared that it will open a second stage of its monotherapy trial of SRF388, an antibody targeting IL-27, on the heels of a promising phase 2 data readout. Shortly before that release, the Business of Biotech caught up with Surface's CSO Vito Palombella, Ph.D. and CEO Rob Ross, M.D. in the company's Cambridge, MA HQ. We discussed the first-of-its-kind target, the company's "product versus platform" strategy and how it fits in the industry's current "platform" vibe, the finer points of building and maintaining a startup bio culture, the difference between that Bob Ross and the Rob Ross, M.D., and whole lot more.
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Gene Therapy Manufacturing Advances With Aruvant CTO Dr. Palani Palaniappan
9/7/2021
Aruvant Chief Technology Officer Palani Palaniappan, Ph.D. joins the Business of Biotech with special guest Tony Khoury, EVP at Project Farma to discuss recent advances in gene therapy manufacturing. We cover the role of artificial intelligence in the discovery of AAV capsids that can avoid the immune system, the growth of non-viral vectors, the scale up advantages of suspension technologies versus adherence, the evolution of the regulatory environment, manufacturing capacity and talent constraints, and much, much more.
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A Hybrid mAb Manufacturing Model With John Glasspool
1/30/2022
Post-operative venous thromboembolism (VTE) is a serious and prevalent post-operative risk that has several contributing factors. John Glasspool, CEO at Anthos therapeutics, is on a mission to address the issue—and a host of other cardiovascular and metabolic conditions—with monoclonal antibodies that inhibit coagulation Factor XI and its activated form XIa. On this episode of the Business of Biotech, Glasspool discusses the advantages and challenges of the hybrid manufacturing approach at Anthos, and how its strategy has enabled phase 1 and 2 clinical studies that have demonstrated an 80% reduction of the rate of VTE in post-operative total knee arthroplasty patients compared to the standard of care (enoxaparin).
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Peptides & Proteins: Resetting The Immune System With Revolo CEO Jonathan Rigby
8/9/2021
Revolo Biotherapeutics has entered phase 2 clinical studies of two molecules for autoimmune or allergic diseases that act to reset the immune system “upstream,” or ahead of the inflammatory cascade. On this episode of the Business of Biotech, Revolo CEO Jonathan Rigby shares the outsourced manufacturing strategy behind the endeavor, why it's so important to avoid immune suppression and how the therapies work to avoid it, and how the company managed to raise a $53 million Series B to fund development in the midst of a raging global pandemic.
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Inhalable mRNA With Ethris' Carsten Rudolph, Ph.D.
2/1/2024
Without doubt, the grand and collaborative experiment that was the mRNA COVID vaccine contributed mightily to the pandemic response and continues to save lives untold. It also demonstrated the collective power of public/private partnership in biopharma.