Dr. Li has over 30 years of hands-on experience in research, regulatory affairs, and management within Rx, OTC, and generic CMC product development, covering both sterile and non-sterile products for the US, EU, and China markets. He also has GMP auditing experience with both small and large molecules. Before joining Eliquent, Dr. Li worked at Allergan, Schering-Plough (now Merck), Wyeth (now Pfizer), Eisai, Frontage, GSK, and the FDA.

From 2014 to 2019, Dr. Li served as a Biopharmaceutics Reviewer in the Division of Biopharmaceutics/Office of New Drug Products, a CMC Drug Product Reviewer in the Office of Lifecycle Products and completed a 4-month assignment in the Office of Surveillance. In the Division of Biopharmaceutics, he reviewed biopharmaceutics data in IND, NDA, and ANDA submissions, including bridging study data. In the Office of Surveillance, he drafted site dossiers for inspectors to help them focus on residual cGMP gaps and recurring quality issues identified in recent inspections. In the Office of Lifecycle Products, Dr. Li reviewed ophthalmic and injectable generic product submissions and collaborated with the OGD Science team to develop guidance for complex ophthalmic generic products. He was also a member of the Ophthalmic Product Working Group, where he discussed challenging review issues.

Dr. Li’s industry experiences spans CMC product development from candidate selection to commercial launch, marketing communications that translate science into accessible language, evaluating a broad range of drug delivery systems to address developability challenges, and lifecycle management of marketed products. Additionally, he has experience managing CROs and CMOs. His combined industry and FDA experience provide him with a unique perspective on regulatory and development issues.