Manufacturing
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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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Building LEO Pharma's U.S. Presence with Brian Hilberdink
8/23/2023
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. 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.
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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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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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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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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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CDMO Collab with Scorpius BioManufacturing's Steve Lavezoli + Fina Biosolutions' Dr. Andrew Lees
12/27/2023
A new year marks a fresh start for biotech partnerships, and to kick off 2024, we're highlighting a good one. Fina Biosolutions' Dr. Andrew Lees recently signed on with Scorpius BioManufacturing to support his company's growth plan. On the Business of Biotech, Lees sits down with Scorpius VP of commercial operations Steve Lavezoli for a frank conversation on the ups, downs, and expectations of a biotech + CDMO relationship. If you're considering signing on with an outsourced manufacturing partner, or thinking about making a switch, you won't want to miss this episode.
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Regenerative Wound Care With BioStem Technologies' Jason Matuszewski & Andrew VanVurst
9/29/2022
Here's the story of BioStem, its young founders, and how they reached commercial status in short order with a portfolio of proprietary regenerative wound care products developed from perinatal tissue. Fueled by a personal story of resilience and inspiration, Jason Matuszewski (CEO) and Andrew VanVurst (COO) built a company that's developed a local microenvironment activation platform drawing on a combination of small molecules, cytokines, and growth factors to promote tissue repair and regrowth. The company's internal development and cGMP manufacturing facilities have already yielded three approved products poised to change the paradigm for diabetic, traumatic, and other wound care.
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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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CMC Developability Assessments For Rapid Ph.1 Entry With AltruBio's Gene Lee, Ph.D.
10/12/2021
Fresh on the heels of an outstanding talk with AltruBio President & CEO Judy Chou, Ph.D., the company's VP of Technical Development, Gene Lee, Ph.D., joins the Business of Biotech for a deep dive into the importance of CMC developability assessments. On this episode we cover the key points CMC developability assessments must address, when to begin them, how to go about them efficiently, and why they're integral to early milestones and rapid entry into Phase 1 clinical trials.