Big Data Strategies for Cell Therapy Manufacturing


17th September 2019 | 10.00 am EST | Scott R. Burger, MD, Principal, Advanced Cell & Gene Therapy, LLC And Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti Inc |WATCH FOR FREE

The quest to retrieve, analyze, and leverage that data has become the new gold rush in life sciences. This presentation will discuss the role of big data in cell therapy process development, real time analytics and commercial scale manufacturing.

Presented by Scott R. Burger, MD, Principal of Advanced Cell & Gene Therapy, LLC

Scott R. Burger, MD, is the Principal of Advanced Cell and Gene Therapy, a consulting firm specializing in cell and gene therapy product development, manufacturing, and regulatory affairs. Dr. Burger has over 25 years of experience developing cell and gene therapy products and has consulted for over 100 industry and academic clients in North America, Europe, Asia, and Australia. He has directed or consulted on process development, manufacturing, and regulatory aspects of a wide range of cell therapy and gene therapy products, including CAR T-cells, gene-edited cells, dendritic cell vaccines, natural killer (NK) cells, and other immunotherapies, hematopoietic stem cells (HSCs) from bone marrow, blood, umbilical cord blood, and regenerative medicine products such as mesenchymal stem cells (MSCs), chondrocytes, pancreatic islet cells, and other somatic cell therapies.

Dr. Burger’s regulatory background includes numerous IND and IDE submissions and productive interactions with FDA-CBER Office of Tissues and Advanced Therapies (OTAT, formerly the Office of Cellular, Tissue and Gene Therapies, OCTGT). Dr. Burger is a member of several scientific advisory boards, and has served on the USP Cell, Gene and Tissue Therapies Expert Committee, the ISCT advisory board and ISCT committees on gene therapy, regulatory affairs, commercialization, and product/process development. A graduate of the University of Pennsylvania School of Medicine, Dr. Burger completed training in clinical pathology and transfusion medicine at Washington University in St. Louis. Prior to founding Advanced Cell & Gene Therapy in 2002, Dr. Burger was Vice-President for R&D at Merix Bioscience, and director of the University of Minnesota Cell Therapy Clinical Laboratory. Dr. Burger is author of over 200 scientific publications and presentations, and recipient of numerous honors and awards.

Sponsored by Vineti Inc

Vineti creates the essential software solution to drive and scale personalized therapies.. Our leading Personalized Therapy Management (PTM) Platform™ delivers simplicity, compliance, and patient safety to medicine’s most complex supply chain, providing the next-generation technology that advanced therapies need.
Today’s personalized therapies require new technology strategies. Vineti combines leading software expertise with deep, first-hand personalized therapeutics experience to develop a cloud-based “platform of record” that ensures quality, scale, security, efficiency, traceability, and patient safety for personalized therapies. The Vineti platform also provides actionable insights to continually optimize the cell and gene therapy process, accelerating time to revenue and decreasing costs.
Vineti partners with a range of small and large pharmaceutical developers, and offers the only independent platform to have been part of a successful, expedited cell therapy approval. The company is expanding rapidly, and now supports hundreds of leading medical centers worldwide.
Vineti was co-founded by GE and the Mayo Clinic to address the unique challenges in the personalized therapeutics paradigm. From the beginning, Vineti’s founders have understood the challenges that pharmaceutical innovators face in developing personalized therapies. Now a fully independent company, Vineti is headquartered in San Francisco, California, with offices in Bethesda, Maryland and Yerevan, Armenia.

And Heidi Hagen, Co-founder and Chief Strategy Officer for Vineti Inc

When it comes to personalized therapeutics, few experts have more hands-on experience than Heidi Hagen. Heidi has overseen the delivery of more than 100,000 doses of personalized cell therapy, and has guided numerous therapies through clinical phases on to commercialization. Heidi is a Co-founder and Chief Strategy Officer for Vineti Inc., a company that is scaling and digitizing cell and gene therapies through an advanced software platform and data analytics. Heidi is also a consultant and advisor for a variety of cell therapy companies, and currently sits on the Board of Directors for Vericel Corporation, a cell therapy company that markets and produces Carticel and Epicel for orthopedic and wound healing indications. She is also the former Global COO for SOTIO a.s. in Prague, CZ Republic. Before joining SOTIO, she worked at Dendreon for ten years as Senior Vice President of Operations, where she was responsible for all technical operations. She built the commercial U.S. Provenge facilities and operations for Dendreon and led all operations for the US and the EU. Heidi has a B.S. in Cell and Molecular Biology, an M.S. in Bioengineering, and an MBA from the University of Washington.


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