Tag

capacity

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

May 30, 2024

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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Building Responsiveness for Growth
MANUFACTURING, VIDEO, MANUFACTURING

Building Responsiveness for Growth

April 22, 2024

Anup Dutt is the VP Technical Director Consumer & Professional Product Divisions at L’Oreal. Anup is an accomplished Industrial Operations Director with extensive experience in leading development and launch of greenfield manufacturing sites, managing consolidation, and transforming existing operations. He has a proven track record of driving business continuity in response to major external and internal events.

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Towards Industrialization of Cell Therapy
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Towards Industrialization of Cell Therapy

November 22, 2023

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

November 22, 2023

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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Expanding Scalability Potential of T-Cell Therapies with Allogeneic Approaches
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Expanding Scalability Potential of T-Cell Therapies with Allogeneic Approaches

November 22, 2023

Amy has been at Atara Biotherapeutics for 5 years. She is currently the Vice President of Manufacturing, which includes External Manufacturing, Material Sciences, and Manufacturing Science and Technology functions. Prior to her current role, she led the joint team that transitioned the commercialization of the first approved allogeneic T-cell therapy to Atara’s strategic partner, Pierre Fabre.

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Empowering Innovation: Enhancing CDMO Capabilities for Collaborative Success
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Empowering Innovation: Enhancing CDMO Capabilities for Collaborative Success

November 22, 2023

Kevin Sharp is the Senior Vice President and Head of Samsung Biologics America Sales. He joined the company in 2017 and has served as the Head of Global Sales and Head of Alliance Management at Samsung Biologics. Kevin has held various commercial and business development positions in pharmaceutical companies in the U.S. throughout his career. Kevin was the Director of Business Development at Contract Pharmacal Corp and served over 9 years at GSK in multiple business development and procurement roles supporting their vaccines, pharmaceutical and consumer healthcare businesses. Kevin has completed the Executive Development Program at the Northwestern University Kellogg School of Management to enhance his business and leadership capabilities.

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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

November 22, 2023

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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Enabling Acceleration & Risk Mitigation in ATMP Development & Beyond
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Enabling Acceleration & Risk Mitigation in ATMP Development & Beyond

November 22, 2023

In her role as President, Azzur Labs & Azzur Cleanrooms on Demand™ (COD), Sarah Stevens is responsible for operations and strategy across all Azzur Labs and Azzur COD locations throughout the United States. Prior to joining Azzur, Sarah held senior leadership roles within the CDMO and pharmaceutical service provider space. Sarah holds a Doctorate of Pharmaceutics from the University of Manchester (Manchester, UK), as well as a Master of Business Administration and a Master of Pharmacy from the University of Strathclyde (Glasgow, UK).

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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

November 22, 2023

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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Unleashing the Potential: Leading the Future of Biologics Market Supply
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Unleashing the Potential: Leading the Future of Biologics Market Supply

November 22, 2023

Dave Stewart, Senior Vice President Operational and Process Technology, Large-Scale Business Unit, is a proven leader in the biologics manufacturing industry, with a focus on building diverse, multi-disciplinary teams that drive customer deliverables. He brings a servant-leadership mindset and more than two decades of biotech leadership experience to cultivate accountability, collaboration and agility – assembling engaged, high-performing teams and partnerships built on trust. Dave is responsible for ensuring a consistent operations and equipment model, performance and incorporating emerging capabilities across the large-scale network at FUJIFILM Diosynth Biotechnologies (FDB) and is a key driver in building the world’s largest and most tightly connected CDMO network.

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The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined
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The Future of Medicine Will Cost Less and Move Faster Than We Ever Imagined

November 27, 2023

Brian Taylor is the Head of Biopharma Solutions at SmartLabs. SmartLabs provides teams of all sizes enterprise-grade labs customized within weeks for any stage of research or modality and can be reconfigured within days as your research evolves. Outsource your infrastructure and avoid the extensive costs of traditional lab builds while your own teams accelerate your research in a private lab.

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