Manufacturing
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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.
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GSK's Michael Mehler On The Cell & Gene Talent Crunch
6/22/2021
Michael Mehler honed his cell therapy chops at Adaptimmune before joining GSK as Senior Clinical Development Manager, Cell Therapy Oncology in 2017. He and Cell & Gene chief editor Erin Harris joined the Business of Biotech podcast for a candid and detailed discussion on finding, hiring, and retaining cell and gene therapy professionals, facilitating their on-going training, bridging the gap between academia and industry, why clinical feedback is an underappreciated source of intelligence, and the resources available to cell and gene developers to further their "pipelines" of bench-level talent.
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In-Vivo CAR T Update With Umoja Biopharma's David Fontana, Ph.D.
11/28/2022
2023 is just around the corner, and it's shaping up to be a big year for Umoja Biopharma. The company is on the leading edge of the effort to break the solid tumor barrier with in vivo CAR T-cell therapies, with one such effort currently enrolling patients for a phase 1 trial. It's planning two more INDs in the coming year. This episode of the Business of Biotech finds us getting the inside story from Umoja Chief Operating Officer David Fontana, Ph.D., whose storied career includes leadership positions at heavyweights including Sanofi, SeaGen, Pfizer, Juno, and BMS. Fontana shares on how he applies his experience playing a lead role in the success of Breyanzi, Adcetris, Bavencio, and Relatlimab in his new role at Umoja, the outsourcing battle scars that motivated the company to build its own 146,000 square foot development and manufacturing facility, and much more.
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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.
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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.
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Cell Therapy Platform Dev With Precigen CEO Dr. Helen Sabzevari
3/29/2021
Learn how Precigen is advancing a deep pipeline of immuno-oncology, infectious disease, and autoimmune disorder candidates through the clinic on the back of its UltraCAR-T platform. CEO Dr. Helen Sabzevari describes the promise of the platform to change the CAR T complexity paradigm with an overnight manufacturing process to affect patients in urgent need of timely therapy.
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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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Managing Momentum With Rezolute Bio's Nevan Charles Elam, JD
8/16/2023
Since we last spoke in the Spring of 2021, Nevan Charles Elam, JD has managed to advance both of small-but-mighty Rezolute Bio's candidates onto the next phases of their journey. This year, on the back of a $130 million investment, Rezolute Bio is prepping its RZ358 candidate, a monoclonal antibody for congenital hyperinsulinism, for a pivotal phase 3 trial. On this week's episode of the Business of Biotech, we're settling in for an interrogation of Elam on the management principles of maintaining multi-candidate clinical momentum among highly disparate candidates and raising big dollars as a small biotech.
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Gene Therapy Manufacturing At-Scale With Geoff MacKay
12/8/2020
AVROBIO President & CEO Geoff MacKay tells the Business Of Biotech about the technology his company is using to drive at-scale gene therapy production for lysosomal disorders, replete with the story of how the company overcame a major manufacturing investment that didn't quite work as planned.
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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.