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Cellares

Welcome Day Panel: The Evolution of Innovative Modalities —Defining the Future of Manufacturing & Development
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Welcome Day Panel: The Evolution of Innovative Modalities —Defining the Future of Manufacturing & Development

Science outpacing Industrialization of Technology: Reviewing next generation cell and gene therapy platforms/technologies, gene editing technologies to unlock new possibilities.
Manufacturing to Scale: Scaling up to meet demand, comparability challenges, production capacity, AI tools and AAV production will drive speed to market/approval
Regulatory Evolution: evolving regulatory frameworks and innovative products necessitate industry and local and global regulatory collaboration to define efficient pathways to approval
Economic/Global Expansion: expanding access to ATMP’s in new regions, reducing cost of goods via production efficiency, expanding global infrastructure to facilitate access to new patients

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Panel: Agile Manufacturing: Technical Strategies for Operational Flexibility
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Panel: Agile Manufacturing: Technical Strategies for Operational Flexibility

Project Farma is an industry leader in providing project management, validation, engineering and consulting services with a proven track record in gene and cell therapy. We partner with gene and cell therapy organizations in addition to healthcare, pharmaceutical, bio-pharmaceutical companies to support finding ground-breaking treatments and solutions. Our gene and cell therapy clients include early stage startups, establish cell and gene therapy companies and CMOs / CROs. We are committed to helping advance cutting-edge medicines by leveraging our deep knowledge and broad experience in cell and gene therapy to meet any new challenges.

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The Coming Patient Treatment Crisis
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The Coming Patient Treatment Crisis

Fabian Gerlinghaus is Co-Founder and Chief Executive Officer of Cellares. He is driven by a strong sense of purpose and is passionate about meeting total patient demand for cell therapies globally. With 10+ years of experience as an innovator and a leader, Fabian has established a track record of assembling top-performing teams to successfully drive novel bioprocessing technologies from ideation to commercial readiness. Prior to co-founding Cellares, Fabian served as Chief Innovation Officer at Synthego, where he co-invented the company’s proprietary RNA synthesizer technology and helped grow the company from five to more than 230 employees. He successfully led the interdisciplinary team that took synthesizer technology from whiteboard sketch to production-ready instruments within two years, enabling the company to be the first to market with its CRISPR/Cas9 product portfolio. He earned a master’s degree in aerospace engineering from the Technical University of Munich, and an honors degree in technology management from the Center for Digital Technology and Management, Munich.

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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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