Regulatory 
Advisor
Dr. King Lee has more than 25 years in the pharmaceutical/medical device industry, mostly in regulatory affairs related to US and worldwide regulatory submission. Dr. Lee previously held senior positions at Cornerstone Pharmaceuticals, Inc., Acorda Therapeutics, Inc., ATON Pharma, Inc. (acquired by Merck), VION Pharmaceuticals, Inc., IBEX Technologies, Inc., and Sterling-Winthrop. He has been involved with multiple projects leading to FDA approval, such as ZOLINZA™ (vorinostat) for leukemia, Primacor (milirinone) for congestive heart failure, Omniscan™ (gadodiamide) as a MRI contrast agent, and several in vitro diagnostic (IVD) medical devices for hematologic testing. He is the founder of the consultant company, King Lee PhD, LLC. Dr. Lee’s consultant company provides services to companies in regulatory submission and clinical development, leading to FDA approval, of pharmaceutical, biologics and medical devices. He is a partner of Axella/Brightech, a unique joint venture investment plus Clinical Research Organization (CRO) company for clinical development, clinical trials, data management, statistical, FDA submission, regulatory affairs, etc. of pharmaceutical products, biologics and medical devices. Dr. King C. Lee is an adjunct professor at Quinnipiac University. He has authored over 40 peer-reviewed manuscripts, over 100 abstracts, and numerous presentations at scientific/professional conferences. Dr. Lee received his Ph.D. in Pharmacology from the University of Kentucky.
