Manufacturing

1. The Anti-CDMO with CTMC's Jason Bock, Ph.D. and KSQ's Thomas Leitch 5/19/2024

   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 as a CDMO. He's not wrong.

2. 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.

3. Antibody-Cytokine Combinations With Philogen's Dr. Dario Neri 6/29/2022

   Swiss-Italian biopharma company Philogen was co-founded in 1996 by three brothers, all of them PhDs. This unique family affair has fueled the development of an incredibly deep and advanced pipeline of no fewer than ten therapeutic products, most of them in oncology, contributing to 16 active clinical trials, three of them at Phase 3. On this episode of the Business of Biotech, co-founder, CEO, and CSO Prof. Dario Neri shares the incredible story of the company's progress and explains Philogen's approach to delivering bioactive agents to the site of disease using antibodies or small organic ligands, thus increasing therapeutic activity and helping spare normal tissues.

4. Filling A Vaccine Void With Cue Biopharma's Dan Passeri, J.D. 4/18/2021

   CUE Biopharma CEO Dan Passeri, J.D. joins us for a discussion on the development of the company's Immuno-STAT platform for the selective targeting and alteration of T cells. Passeri shares the rationale behind his belief in the company's immunotherapeutic approach, and how the CUE-100 series of candidates in its pipeline are being developed to address a scourge of HPV-related head, neck, and other cancers.

5. Foundations Of Flexible Manufacturing With Sarepta Therapeutics' Brian Winstead 11/1/2021

   Is "flexible manufacturing" just another empty buzz concept concocted by the biopharma equipment marketing community, or does it demonstrate real benefit to bioprocess pros and their companies? On this episode, we sit down with Sarepta Therapeutics Director of Pharmaceutical Engineering Brian Winstead and Project Farma VP Tony Khoury to discuss what flexible manufacturing means, where it works, and where it doesn't. Listen in as Winstead shares the flexible manufacturing philosophy at Sarepta.

6. AAV & Lentiviral Gene Therapies With Sio Gene Therapies' Dr. Pavan Cheruvu 5/24/2021

   Fresh on the heels of a significant data readout on its AXO-AAV-GM1 candidate at the recent ASGCT meeting, Sio Gene Therapies CEO Pavan Cheruvu, M.D. joins the Business of Biotech podcast. We discuss Dr. Cheruvu's formative years and inspiration, his company's origins, its progress developing AAV and lentiviral gene therapies to treat GM1 gangliosidosis, Tay-Sachs / Sandhoff disease, and Parkinson's disease, and the challenges the company has overcome in a hybrid manufacturing environment that will ultimately transfer entirely in-house.

7. ADCs Ignited with Daiichi Sankyo Inc.'s Ken Keller 6/2/2024

   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.

8. mAb Manufacturing with Rezolute Bio's Nevan Charles Elam, JD 4/5/2021

   Nevan Charles Elam, JD founded Rezolute Bio ten years ago on the heels of a complex career intersecting law, high tech, and life sciences. On this episode of the Business of Biotech, Elam shares the company's rationale for pursuing congenital hyperinsulinism and diabetic macular edema therapeutics by leveraging monoclonal antibodies and discusses the company's approach to process development and manufacturing.

9. 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.

10. Episode 6: Building An All-Star Biotech Team With Vivek Ramaswamy 8/13/2020

    Roivant Sciences, founded by Vivek Ramaswamy, is parent company to some 20 emerging biopharma entities with dozens of candidates in their collective pipelines. On this episode of The Business Of Biotech, Ramaswamy shares practical and applicable advice on the people, positions, and characteristics that constitute a winning biopharma team, and best practices for recruiting and retaining them.