Dr. Grace Lee is a founder and consultant of Elevalue Consulting LLC. She brings over 20 years of experience in research, technical development, quality, and regulatory, with a focus on analytical development and quality control for Cell and Gene Therapies, and Biologics.
Her extensive scientific background in academia is complemented by her industry expertise in CMC and GxP disciplines in big pharma and start up, enriching her unique strategic, business-oriented approach to drug development. Previously, Dr. Lee was a senior director of analytical development at Kyverna Therapeutics and served in various roles at Genentech supporting >10 biologics and cell therapy products from pre-clinical, clinical, to commercialization for potency assay development and other QC release and characterization assays. Dr. Lee holds a Ph.D. in Chemistry from Stanford University and finished her postdoctoral fellowship under Professor Jennifer Doudna at UC Berkeley.
She has a prolific record of peer-reviewed publications in leading scientific journals and active participation in prominent industry conferences and consortiums such as PDA, US-TAG ISO/TC276, ASGCT, BioPhorum, and ARM. Dr. Lee has contributed to several white papers and guidance documents, sharing her expertise and insights.
Dr. Lee serves as PDA Biopharmaceutical Advisory Board Member since 2021. Her dedication to addressing high-impact, challenging issues continues to advance the fields of pharmaceutical science and biotechnology.

Presentation Title: Navigating the Complexity of Cell and Gene Therapy Development and Outsourcing

Abstract: The cell and Gene Therapies (CGT) landscape is rapidly changing and is characterized by a significant upsurge in clinical trials and outsourcing endeavors.
External partnerships play a pivotal role within this framework, particularly for small—to mid-sized biotech companies with limited experience in Good Manufacturing Practice (GMP) compliance for new modalities. In this presentation, Dr. Lee will provide insight into the complexity of CGT development and the critical components to consider in outsourcing partnerships with case studies.

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