Robert J Timko

Background

About Robert J Timko

Dr. Timko has over 35 years of experience in the Pharmaceutical Industry. He is also an Adjunct Facility Member (Lecturer) in the Pharmaceutical Development Program at West Chester University of Pennsylvania. Dr. Timko has 20+ years of Pharmaceutical Development experience from compound identification through formulation and process development, clinical supply manufacture, product and process scale-up and technical transfer, and production troubleshooting of commercial manufacture for a variety of traditional and novel dosage forms. Dr. Timko also spent 15+ years in Regulatory Affairs dealing with the US FDA, EU EMA, Health Canada, and the ROW Heath Authorities for INDs/CTAs. NDAs/ANDAs/MAAs, and sNDAs/Variations. He has been involved in preparing or reviewing 30+ Marketing Applications either in a Pharmaceutical Development or Regulatory capacity for innovator or generic small or large molecule compounds in various non-sterile and sterile dosage forms. Dr. Timko is considered a subject matter expert in Quality-by Design, Process Analytical Technology, and Real Time Release and has served as an expert witness in patent litigation cases. He holds several formulation patents, has extensively published in both peer review and technical journals, and presented at numerous scientific meetings. Dr. Timko is a member of number of professional organizations including AAPS, ISPE, and IACP. He is a Registered Pharmacist in New Jersey and Pennsylvania.