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NOV 17, 2016 9:00 AM PST

From bench to BLA - a review of common regulatory questions

Speakers
  • Regulatory Consultant, Frey-Vasconcells Consulting, LLC
    Biography
      Joyce Frey-Vasconcells is considered one of the foremost regulatory experts regarding cell therapies, combination products, gene therapies, tumor vaccines, and tissues and brings extensive regulatory expertise and experience for this unique group of products. Prior to starting FreyVasconcells Consulting, Dr. Frey-Vasconcells served 6 years as a regulatory consultant for Pharmanet working with industry whose mission is to foster product development in the areas of cell therapy, tissues, gene therapy, and tissue engineered products. Prior to joining Pharmanet, she served more than 12 years at the FDA. At FDA, Dr. Frey-Vasconcells was the Deputy Director, Office of Cellular, Tissue, and Gene Therapies (OCTGT) with the Center for Biologics Evaluation and Research (CBER). She was instrumental in developing many of CBER's science and public health policies regarding the regulation of cells, tissues, gene therapies, tumor vaccines, and combination products (tissue engineered products). In 2001, Dr. Frey-Vasconcells was named the Regulatory Expert for Cell Therapies at FDA. She also served on various committees related to combination products, tissue reference group, and HHS committee on tissue engineering to name a few.

      Since starting Frey-Vasconcells Consulting, Dr. Frey-Vasconcells has continued working with industry on an individual basis and with organizations whose mission is to foster product development in the areas of cell therapy, tissues, gene therapy, and tissue engineered products. She is clearly considered one of the foremost regulatory experts regarding tissues, cell therapies, combination products, gene therapies, and tumor vaccines and is recognized by various state and country stem cell networks as an expert in the regulation of stem cell therapies. She brings extensive regulatory expertise and experience for this unique group of products.
    • Owner, Chief Consultant & Advisor, Hybrid Concepts International
      Biography
        Michael Mendicino established Hybrid Concepts International (HCI) as a consultancy and advisory firm in the niche and emerging fields of cell therapy, gene and gene-modified cell therapies, other regenerative medicines, tissue engineering, and cell-based drug discovery. Michael also previously worked at four biotech companies, and/or consulted, all within the aforementioned fields, covering areas such as CMC and strategic regulatory affairs, R & D, commercial, and product & technology due diligence activities. During his FDA appointment, Michael worked in the Office of the Commissioner with the regulatory science & innovation team. He also worked in the Office of Cellular, Tissue & Gene Therapies (OCTGT), where he performed regulatory submission review and provided guidance to sponsors for cell therapy products, devices and combination products. Major accomplishments include world's first IND trend projects (published in Cell Stem Cell and Nature Biotechnology), and a semi-finalist ranking for the Kauffman Fellowship (venture/investment). Michael is a representative on multiple Alliance for Regenerative Medicine (ARM) and International Society for Cellular Therapy (ISCT) committees (including Co-Chair of ARM's Science & Technology Committee, both ARM and ISCT Regulatory committees, and the ISCT Commercialization committee and Process & Product Development subcommittee). Michael is currently a member of the Board of Directors, first President and a key leader for the nonprofit Standards Coordinating Body (SCB), which is now a public-private partnership.
      • Sr. Director Global Regulatory Affairs, Clinical, & Compliance for Life Sciences Solution Group (LSG), Thermo Fisher Scientific
        Biography
          Kelli L. Tanzella, Ph.D. Sr. Director Global Regulatory Affairs, Clinical, & Compliance for Life Sciences Solution Group (LSG) at Thermo Fisher Scientific, Inc., has over 20 years' experience in quality and regulatory requirements in both the pharmaceutical and medical device industries. She has been with Life Technologies/Thermo Fisher Scientific for 14 years in Regulatory Affairs with increasing levels of responsibility. Her expertise includes quality systems management, clinical trial monitoring, and the filing of U.S. and foreign regulatory submissions. She leads the global regulatory team within the Life Sciences Group at Thermo Fisher and provides functional leadership to regional regulatory teams outside of this Group to enable regulatory pathways in the applied markets. Kelli received a Bachelors of Science in Biology from Niagara University and went on to receive a Masters of Science and Doctorate degree in Health Services Administration with a focus on government health policy.

        Abstract

        This panel will discuss quality requirements of ancillary materials used in cell therapy manufacturing, relevant standards and how requirements vary by phase.  Participants will learn what to look for in RUO and translational materials to ease the transition to the clinic including GMP and USP guidelines, what to consider when preparing for a clinical trial or a marketing application and common regulatory findings in cell therapy submissions that have the potential to delay approval. The panel will also discuss recent initiatives that have been put in place by regulators in different regions to accelerate cell therapy commercialization.
         


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