Speakers

Dr. Young K. Jhon is currently a senior chemist working at Division of Product Quality Assessment IV (DPQA IV), Office of Product Quality Assessment I (OPQA I), Office of Pharmaceutical Quality (OPQ), Center of Drug Evaluation and Research (CDER) at the FDA. He has more than 20 years of experience in the field of long-acting injectables, drug-delivery system, polymers, colloids (emulsions and suspensions), nanotechnology, implants, fluid mechanics, thermodynamics, and rheology. In OPQ, he has been involved in assessment of complex dosage forms for oral, ophthalmic, parental, and topical routes, and in working groups for multiple guidances and research for complex drugs, including complex API sameness and the drug products that contain polymeric excipients, including PLGA. Also, he serves as application technical lead (ATL) for regulatory drug application assessments and as USP liaison for General Chapters. Prior to joining FDA, he worked as an NRC fellow in Chemistry division at U.S. Army Research Office, RTP, NC. He received a Ph.D. in Chemical Engineering from North Carolina State University, Raleigh.