Dr. Ho-Young (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 fields, with a focus on analytical development and quality control for Cell and Gene Therapies, and Biologics. Her extensive scientific background in academia from Stanford Univ and UC Berkeley 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. Dr. Lee is adept at navigating complex CMC technical challenges and guiding strategic decisions in program management.

Her consulting services span advanced GxP Analytical services and training for cell and gene therapies and biologics, including but not limited to laboratory, equipment, method validation and qualification, release and stability testing, and the comprehensive lifecycle management of assays, reference standards, and QC SOPs. Dr. Lee is also skilled in technology transfer and developing phase-appropriate specifications. Additionally, she offers expert guidance in analytical development, conducts thorough quality audits, and advises on CDMO/CRO partnerships, focusing on due diligence for capabilities and compliance, as well as strategic technical in-licensing.

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.

Professional Experiences

Founder, Independent Consultant, Elevalue Consulting

Biopharmaceutical Advisory Board member, PDA Advisory Board

Committee Member, US Technical Advisory Group (US TAG) to ISO/TC276

Senior Director of Analytical Development, Kyverna Therapeutics

Cell Therapy Analytical lead and Head of Analytical Development Group, Principal Scientist, Genentech  

Group leader and Analytical lead, Analytical Development & Quality Control, Senior Scientist, Genentech 

Postdoctoral scholar, Molecular and Cell Biology, UC Berkeley 

Ph.D. Chemistry, Stanford University