Lianli Li, PhD
President and Founder, Product Development
Lianli has 19 years of pharmaceutical industry experience, served in technical and leadership roles at Bristol-Myers Squibb, Barr Labs, KV Pharmaceutical and Covidien, and developed multiple products successfully launched at the US market. Her experience covers a broad scope of pharmaceutical development, including pre-formulation study, formulation and process development, scale-up manufacturing, process validation, and regulatory submission. Her research area is mainly on controlled release formulations and trans-mucosal drug delivery systems. Another area of her training is on in-vitro drug permeation and in-vivo pharmacokinetic studies in animal models and human clinical studies. She also authored and co-authored 10 US and international patents and applications.
Krishna Devarakonda, PhD
Advisor, Pharmacokinetics and Clinical Study
Dr. Devarakonda possesses over 20 years academic and industrial experience in clinical pharmacology, pharmacokinetic/ pharmacodynamic modeling, and clinical study design in therapeutic areas of oncology, central nervous system, pain, psychiatry, autoimmune diseases, diabetes & metabolic diseases, and Infectious diseases. He previously served as the Head and Senior Director of Clinical Pharmacology at Mallinckrodt Pharmaceuticals. Dr. Devarakonda has worked with the FDA on multiple New Drug Application (NDA) and Abbreviated NDA (ANDA) products in clinical design and submissions.
Medical Advisor, Washington University in St. Louis, School of Medicine
Erik Dubberke, MD
Dr. Dubberke is an area expert in the in epidemiology, diagnosis, treatment, and prevention of Clostridium difficile infection (CDI). He is on the panel of 2018 CDI clinical guidelines by the Society for Healthcare Epidemiology of America (SHEA) and the Infectious Diseases Society of America (IDSA).
Harry Arader, MBA
Senior Business Advisor, BioGenerator
Harry is the Director of Entrepreneur Development programs at BioGenerator, where he oversees the “Fundamentals Program,” a coaching and resources program for inexperienced executives of local life-science companies. BioGenerator is a St. Louis investment firm with a mission to support and advance local early-stage bioscience companies. Harry received an MBA in Marketing and Strategic Planning from the University of Pennsylvania’s Wharton School of Business. Harry advises Gateway Pharma on business strategy, fundraising, and licensing.
Analytical Scientists and Process Engineers
This support team has an average of 15 years of experience in the pharmaceutical industry in Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) environments. They are competent in analytical method development, method validation, and process validation.