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Cell and Gene Therapy

Addressing Cell Therapy Challenges for Rare Diseases
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Addressing Cell Therapy Challenges for Rare Diseases

Robert W. Beall -Vice President, ProPharma Group has 35+ years of industry experience. Robert has supported the development and commercialization of multiple cell therapy products and processes including decentralization of CD19+ CAR T therapies, development of hospital cellular therapy labs, including expansion of the NIH Center for Cellular Engineering, as well as the expansion of the first commercialized CAR-T therapy process capabilities. Other Cell therapy programs included remediation support for cellular and media manufacturing programs, and guidance for multiple CAR-T manufacturing automation advancements. Robert supported the COVID-19 response by establishing global safety systems for three major vaccines. He has led hundreds of international product transfers utilizing both internal transfers and CMO’s at multiple top 10 Pharmaceutical companies. He is a graduate of the Rochester Institute of Technology (RIT) with a BS in Engineering and has completed advanced degree studies as well as completing his PMP certification. He is an international speaker and author.

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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 Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing
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The Integrated Development and Manufacturing Organization: The Future of Cell Therapy Manufacturing

John Tomtishen is Vice President of Operations at Cellares Corporation. At Cellares, John is responsible for Cellares’ IDMO business, supporting partnership activities, and facilitating accelerated market adoption of Cellares’ Cell Shuttle technology to transform the cell therapy manufacturing paradigm and address industry bottlenecks to accelerate access to life saving cell therapies. John has extensive experience in cell and gene therapies, biologics, and vaccines with diverse roles in Business Operations, CMC/Technical Operations, R&D, Supply Chain, Engineering/Facilities, and Operational Excellence. While at Novartis Pharmaceuticals, John had an integral role in the filing and approval of the first CAR T-cell BLA, Kymriah™ (tisagenlecleucel) for pALL (pediatric acute lymphoblastic leukemia) and DLBCL (diffuse large B-cell lymphoma).

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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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Technical Operations Strategies in an Uncertain Market

 State of the current market and impact on manufacturing cell and gene therapies Key factors to consider when scaling up a facility for advanced medicines Make vs. Buy and the advantages and challenges of both solutions given the current market Moderator: Adam Pfeiffer VP of Strategy Project Farma Adam Pfeiffer is the Vice President of Strategy at Project Farma. In his role, Adam drives overall business strategy, aligning with operations, marketing, and business development groups in growing the firm’s global life sciences partnerships.With 16+ years of life sciences consulting experience, Adam has supported countless drug manufacturers in bringing life-saving therapies…

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How to Make the Bio-Revolution a Reality: Building Bayer’s Cell & Gene Therapy Platform
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How to Make the Bio-Revolution a Reality: Building Bayer’s Cell & Gene Therapy Platform

How Bayer AG built its Cell & Gene Therapy unit New business model joining best of Biotech and best of Pharma How to build a sustainable pipeline? How to manage complexity and keep focus? What are the “must haves”? what are the learnings on common threats of significant transformations? New ways of working accelerated by COVID-19 pandemic Wolfram Carius EVP, Cell and Gene Therapy Bayer AG Prof. Wolfram Carius is the EVP, Cell and Gene Therapy at Bayer AG and is a member of the Executive Committee for Bayer Pharmaceuticals. He is based in Berlin, Germany. Prior to joining Bayer,…

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