.png){kind=small}
Dr. Lianli Li graduated from Shanghai Medical University (now Fudan University) with a BS in Pharmaceutics, from Shanghai Huashan Hospital with a MS in Clinical Pharmacy, and from St. John's University in New York with a Ph.D. in Pharmaceutical Sciences. An entrepreneur and executive leader with 23 years of experience in the U.S. pharmaceutical industry, she specializes in formulation and drug product development. Dr. Li has held positions ranging from scientist to Director of Research and Development at Bristol-Myers Squibb, Teva Pharmaceuticals US, KV Pharmaceutical, Covidien, and DanSol Pharma Group. He has extensive experience in drug development, including research on the physicochemical properties of drugs, formulation and process development, scale-up and process validation, pharmacokinetics and clinical research, CMC, and regulatory submissions.
​
Dr. Li founded a consulting company that provides services to several large pharmaceutical companies domestically and internationally. She has developed and consulted on over 50 products (including solids, semi-solids, nasal sprays, oral, and ophthalmic solutions), with more than 40 successfully launched in the U.S. or China markets. She is the inventor of 10 U.S. and international patents. Dr. Li holds a Six Sigma Black Belt certification, specializing in Quality by Design (QbD), Design of Experiments (DOE), and optimization.
​
In 2016, she founded Gateway Pharmaceutical, focusing on the development of 505(b)(2) new dosage form products. Her research areas include sustained and controlled-release formulations and transmucosal drug delivery systems. The project for metronidazole enteric-coated microcapsules for colon-targeted delivery, aimed at treating Clostridium difficile, received Small Business Innovation Research (SBIR) grants from the National Institutes of Health (NIH). Dr. Li joined Humanwell Pharmaceutical US in 2023.