US Food and Drug Administration
Dr. Johnny Lam is a lead CMC/product reviewer and research scientist in the Division of Cellular and Gene Therapies (DCGT) in CBER at FDA. His regulatory work experience in DCGT involves the lead CMC/Product review of myriad regulatory submissions for early/late-stage biologic products, innovative/new cell-based therapies including Regenerative Medicine Advanced Therapies (RMAT), and medical devices. His research in DCGT focuses on developing strategies that leverage bioengineering tools for evaluating potency/bioactivity-related quality attributes of human mesenchymal stromal cells (MSC) and MSC-derived products to address significant regulatory science problems that hinder successful clinical development. One such research area involves studying how MSC quality attributes relate to MSC functional potential using physiologically relevant, higher-throughput platforms. Dr. Lam received his Ph.D. in Bioengineering in 2015 at Rice University, where he developed and evaluated injectable multi-layered hydrogel composites for cell and controlled growth factor delivery for in vivo cartilage tissue repair. Following his graduate studies, Dr. Lam first joined CBER at FDA as a post-doctoral fellow and then as a Staff Fellow. During his previous research, Dr. Lam developed and adapted wide-ranging microscale and microfluidic-based platforms to evaluate various functional outcomes of MSCs toward improving the quality and potency of manufactured cell-based products.