r. Edward D. Purich

Dr. Edward D. Purich

Founder
r. Edward D. Purich

Our founder, Dr. Edward D. Purich, was born in Western Pennsylvania in the small city of Farrell. He attended the University of Pittsburgh where he received a BS in Pharmacy, MS in Synthetic Medicinal Chemistry, and Ph.D.in Biopharmaceutics. While attending the University of Pittsburgh, hereceived support of Scholarships and Fellowships that included the Wright Foundation Scholarship, NIH, American Federation of Pharmaceutical Education, and the AFPE E. Meade Johnson Memorial Fellowship. He received numerous academic awards including the Galen Award, George Wurdack Award, and Locke Award. He taught courses in industrial pharmacy, synthetic organic chemistry, pharmaceutical quantitative and qualitative chemistry, applications of computers in medical sciences, biopharmaceutics, pharmacodynamics, pharmacokinetics, statistical analysis, and dosage form formulation and analysis.

Dr. Purich began his career in industry at the Upjohn Company as head of the Drug Disposition Group in the Cancer Research Group. He helped pioneer the development of flow limited pharmacokinetic (PK), computer modeling of animal PK and pharmacodynamics (PD) data to expedite the transition from animal to human studies. While in industry, he was involved in the successful preparation and approval of greater than 40 NDAs and 225 ANDAs. In addition he organized and wrote significant portions of two orphan drug NDAs: 1) for aerosol pentamidine for HIV; and 2) Gallium Nitrate for reducing bone loss in cancer patients. He has been a consultant to over 122 Pharmaceutical Companies in the U.S., Europe, and Japan.

At the FDA, Dr. Purich helped in formulating the Code of Federal Regulations (CFR 320 “Bioavailability/Bioequivalence Regulations”), NDA Rewrite of 1982, Control Release Regulations, Transdermal Policy, Alternate Site of Manufacture Policy, Format and Content of Biopharmaceutics and Statistics Guidelines, Analytical Validation of Method Policy, Electronic NDAs, and many other guidelines and policies. At the FDA, he was involved in formulating Section Six of the New Drug Application. He provided the initial computer database of FDA Approved Drugs that when printed became known as the Orange Book. He was involved in the supervision and review of over 3,900 NDAs and sNDAs submissions. For his efforts, he received the FDA’s Award of Merit. He is an author of five monographs and over 86 publications and presentations. Dr. Purich has spent the last 23 years in gastroenterology research concentrating on the pancreas. During this period, he founded ChiRhoClin which developed three approved NDA’s including ChiRhoStim® (Human Secretin for Injection). ChiRhoClin utilized its resources to promote research of pancreas diseases and pancreatic cancer through development of starter grants, travel grants, and other programs for young physicians interested in pancreas research. He is a member of APhA, AAPS, DIA, AGA, ACG, APA and is a founding member of The Collaborative Alliance for Pancreatic Education and Research (CAPER). He is on the Board of Directors for CAPER and the APA Foundation. Dr. Purich was awarded 3 patents pertaining to diagnosis and treatments of pancreatic disease. In 2012, he received the first American Pancreas Association Distinguished Service Award.