July 6, 2018

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Recent Posts

FDA Comments on Recently Released Rare Disease Guidance for Industry

September 16, 2015

Jonathan Goldsmith, M.D., F.A.C.P., FDA’s Associate Director, Rare Diseases Program, Center for Drug Evaluation and Research, comments on the recently...

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Toxicologist Gary Wolfe, PhD, DABT joins Patagonia's Advisory Board

April 24, 2015

We are pleased to welcome Dr. Gary Wolfe to our Advisory Board.  Dr. Wolfe is a board-certified toxicologist with over 35 years of experience in the conduct of nonclinical toxicology studies, director of nonclinical laboratories, and preparation of regulatory submissions and documents.  He received his M.S. and Ph.D. in pharmacology and toxicology from Purdue University in 1976 and 1978, respectively.  He is a member of the Society of Toxicology, American College of Toxicology, and Teratology Society.  He has made over 40 presentations at the annual meetings of the Society of Toxicology and American College of Toxicology and has authored numerous manuscripts.

Dr. Wolfe served as study director on many nonclinical studies intended for FDA or EPA submissions as well as holding positions of increasing responsibility in both technical and management roles at Hazleton Laboratories (now Covance) and TherImmune Research Corporation (also known as R.O.W. Labs and GeneLogic Labs).  At TherImmune he served as Chief Scientific Officer and Senior Vice President.  He also served as the Principal Investigator for the National Toxicology Program’s  General Toxicology and Reproductive Assessment by Continuous Breeding Programs for over 15 years. 

Dr. Wolfe has designed drug development programs for small molecules and biologics and identified and placed nonclinical studies at various domestic and international contract research laboratories.  He has also authored the nonclinical sections of numerous regulatory documents, e.g., IND, NDA, position papers, for submission to the FDA.

 

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