Tag

Commercialization

Where Cell and Gene Therapies are Going — A Conversation with Diluks De Silva of Compliance Architects
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Where Cell and Gene Therapies are Going — A Conversation with Diluks De Silva of Compliance Architects

At the 2024 edition of the Biomanufacturing World Summit series we sat down with Diluks de Silva to talk about Cell and Gene Therapies. For many years we have been hearing these and other Advanced Therapy Medicinal Products (ATMPs) are moving towards commercialization, and each individual therapy that has been approved is heralded as a pioneer to be celebrated and studied for lessons learned and best practices. This year something like 40 cell and gene therapies came to market, and by every indication this is just the start of a whole new generation of medicine about to help patients around the world. What does that look like on the ground? What is the industry doing to prepare itself for what comes next? How do you control things like cost and scalability while you are still inventing how to manufacture the new therapies in the first place? How are these innovations pairing with medical devices, and what does that mean for the future of medicine? There is so much good work being done, and so much still to do. As always, the experts at Compliance Architects have a comprehensive understanding of where the industry is, where it is going, and what needs to happen to ensure everyone’s success. For everyone looking for the updates that matter most on this exciting frontier of medicine, give this episode a listen!

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The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services
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The Role CDMOs Play in the Future of Medicine — A Conversation with JR Humbert of INCOG BioPharma Services

JR Humbert is currently the VP, Quality at INCOG BioPharma Services, and created and implemented the quality system at INCOG, which in three years went from company creation through successful FDA inspection in 3 years.

JR has over 20 years of pharmaceutical and biotechnology industry experience in validation, quality, technology transfer, process engineering, and program management. Some of JR’s previous companies include Piramal Pharma Solutions, Roche/Genentech, Hospira, and Cook Pharmica.

JR has participated in multiple global health authority inspections and developed inspection responses. JR has an MBA from Indiana University, and a BA in Chemistry and Biochemistry from the University of Colorado-Boulder.

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Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity
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Industrialization Challenges for ATMPs: Achilles’ Heel AND Opportunity

Ralf Altenburger joined the Technical Operations Leadership Team at Roche/Genentech in July 2015 as Head of Pharma Technical Regulatory. Additionally, in Oct. 2021 he assumed the role of Global Head Cell and Gene Therapy. Ralf has more than 20 years of experience in the pharmaceutical industry and joined Roche in 2009 leading global functions in Technical Development.

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Towards Industrialization of Cell Therapy
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Towards Industrialization of Cell Therapy

Dr. Jens Vogel is SVP & Global Head of Biotech, Bayer Pharmaceuticals Product Supply, leading biologics operations, development and strategy across five sites, including cell & gene therapy industrialization. Jens has more than 20 years of professional and leadership experience in biologics development, operations, program management and regulatory affairs.

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Unlocking the Power of Gene Therapy to Accelerate Healthcare Transformation
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Unlocking the Power of Gene Therapy to Accelerate Healthcare Transformation

As Spark Therapeutics’ Chief Patient Supply Officer, Chris Stevens leads a team of dedicated professionals working together in manufacturing and technical operations, supply chain, quality and compliance to deliver transformational therapies for patients globally. Chris is also responsible for capital investments, engineering, EHS, real estate and facilities management across the enterprise.

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Small But Mighty: How Digital Technology Can Support Small Batch Manufacturing of mRNA Therapeutics
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Small But Mighty: How Digital Technology Can Support Small Batch Manufacturing of mRNA Therapeutics

Katarina works for Cytiva in the Manufacturing capacity solutions business unit. She has worked over 20 years in the industry and has extensive expertise in developing end-to-end manufacturing solutions that includes process workflows, process equipment, automation, consumables, and facilities. Her focus over the last few years has been developing and designing solutions for the manufacture of new product modalities such as viral vectors, plasmids, and mRNA therapies.

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Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics
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Fireside Chat: The Emerging Role of the CDMO in Commercialization of Advanced Therapeutics

Spencer has more than 30 years of experience in Manufacturing and CMC product development. While at Rubius, Spencer built the technical functions to design and deliver the RED™M manufacturing platform, including clearance of 4 IND’s over 4 years.

He also led the acquisition and re-fit of their Red Cell Therapeutics manufacturing site in Smithfield Rhode Island, where the team transferred and delivered clinical supplies for their 3 oncology programs. Prior to joining Rubius, Spencer served as VP & Global Head of Cell & Gene Technical Development and Manufacturing at Novartis where he led the CMC development and manufacturing organization to deliver the CAR-T portfolio. Under his leadership, the team successfully registered and launched the first CAR-T cellular therapy product, Kymriah, which has demonstrated transformative efficacy in patients with acute lymphoblastic leukemia. While at Novartis, Spencer also led technical development teams across the Novartis Biologics portfolio in support of the commercialization of Cosentyx® and the registration and approval of Erelzi™M? and Rixathon®.

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Cell and Gene Therapy Issues and Trends — A Conversation with Judith Koliwer, PhD, of Körber Pharma Software
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Cell and Gene Therapy Issues and Trends — A Conversation with Judith Koliwer, PhD, of Körber Pharma Software

At the most recent edition of the Pharma Manufacturing World Summit held May 15-16, 2023, in Boston, we spoke with Judith Koliwer, PhD, the Principal Consultant Cell & Gene Therapy Software, Körber Business Area Pharma at Körber Pharma Software. Judith is one of the industry’s leading experts on Cell and Gene Therapies, as she led an academic research group on CGT processes years before these new therapies were approaching commercial manufacturing. At PMWS23 she gave a presentation entitled, “The Iterative Approach to a Digital Cell and Gene Therapy Process – an Overview & Best Practice.” In this interview we discuss what she shared with the audience, as well as her thoughts on current issues and trends pharmaceutical manufacturers need to be aware of as they forge a path into the new frontier of medicine. Give this one a listen!

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