Manufacturing
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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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Cold Chain Integrity & Sustainability With Celyad Oncology's Thomas Lequertier
8/18/2021
Maintaining therapeutic integrity through cryopreservation and super cold supply chains have challenged, and continue to vex, biologics producers. On this episode of the Business of Biotech, Celyad Oncology Head of Cell Therapy Manufacturing Thomas Lequertier shares best practices for the cryopreservation of cell therapies while minimizing cell degradation, maintaining their integrity on the journey from the lab to the patient, and what the future holds for cold chain biologic therapy logistics.
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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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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.
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The CDMO Capacity Crunch ft. Discovery Labs' Audrey Greenberg And Iovance Biotherapeutics' Sumit Verma
10/27/2021
While nary a day goes by without a shovel breaking ground on a new CDMO buildout, biopharmas remain hard-pressed to secure the outsourced manufacturing space and expertise needed to meet timelines, satisfy investors, and drive competitive advantage. On this episode of the Business of Biotech, we're tackling the CDMO capacity crunch from every angle in a spirited discussion with Discovery Labs & Center for Breakthrough Medicines Co-Founder Audrey Greenberg, Iovance SVP of Commercial Manufacturing Sumit Verma, and Project Farma CEO Anshul Mangal.
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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.
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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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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.
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A More NIIMBL Biotech Workforce With John Balchunas
5/4/2023
What are biopharma's greatest skilled manufacturing labor needs, and what's the industry doing to fill them? John Balchunas is on the front lines in his position as Workforce Director at NIIMBL, the National Institute for Innovation in Manufacturing Biopharmaceuticals, and he says advanced degrees and pedigrees aren't the answer. The breadth and depth of NIIMBL's efforts to influence the next generation of the biopharma workforce — from high school vocational programs to community colleges and on-the-job development—might surprise you. Listen in as Balchunas brings the Business of Biotech up to speed on a training and development agenda that plants seeds early and often.
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CDMO With A Pipeline Featuring Forge Biologics President & CEO Dr. Timothy J. Miller
10/6/2021
Inspired to develop a treatment for Infantile Krabbe Disease, the founders of Forge Biologics picked a unique but strategic approach to funding the initiative. They built a CDMO that aims to become one of the largest on the planet in the cell and gene therapy space. On this week's episode of the Business of Biotech podcast, co-founder, President, & CEO Timothy J. Miller, Ph.D. joins us to discuss the strategy, why it was a no-brainer given the white-hot market for contract development and manufacturing space, the state of the biologics manufacturing capacity crunch, and what companies like Forge are doing about it.