Manufacturing
-
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.
-
Observations On Outsourcing With Molecule To Market's Raman Sehgal
8/15/2022
Raman Sehgal has made a career out of putting his energy— and he's got a lot of it— into building biotech outsourcing companies and the people who make them run. After years spent supporting several from within, he launched ramarketing, a firm dedicated to helping CROs, CDMOs, CPOs, and other providers to the biotech ecosystem build their businesses, in 2009. He's also an international best-selling author (The Floundering Founder), co-founder of life sciences recruitment firm Lead Candidate, and founder & host of the Molecule to Market podcast.
-
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).
-
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.
-
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.
-
Orchard Tx's Bobby Gaspar On Manufacturing Hematopoietic Stem Cells
1/25/2021
In this third installment of our cell & gene therapy manufacturing miniseries, Erin Harris and Matt Pillar sit down with Orchard Therapeutics CEO Dr. Bobby Gaspar. An update on the company's pipeline progress gives way to an in-depth discussion on the process challenges his company faces in the production of hematopoietic stem cells to treat neurometabolic disorders, primary immune deficiencies, and blood disorders.
-
CAR T Process Automation With Kite Pharma's Charles Calderaro III
7/12/2021
Kite Pharma Global Head of Technical Operations Chuck Calderaro joins the Business of Biotech for a conversation on a dichotomy in the CAR T-cell supply chain: the inherent source material advantages and subsequent logistical challenges associated with the distribution of cell therapies. Calderaro discusses the implementation of manufacturing automation at Kite, the manufacturing hurdles that remain, and reflects on the company's autologous and allogeneic roadmaps.
-
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.
-
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.
-
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.