AAiPS is proud to acknowledge Cadmach and Shaffer Products, Inc as our sponsors for this event
Social Hour: 5:30 pm
Seminar: 6:30 pm
Dinner: 7:45 pm
Dr. Satyam Upadrashta, Dr. Srikumaran Melethil
Satyam Upadrashta is a Senior Director of Global Regulatory Affairs - CMC at Millennium: The Takeda Oncology Company in Cambridge, MA. His previous affiliations include Pfizer Central Research, Johnson & Johnson, Bristol-Myers Squibb, Chiron (now Novartis), Aradigm Corporation, and Forest Research Laboratories. Satyam also served as an Assistant Professor of Pharmaceutics at the University of Missouri-Kansas City where he taught industrial pharmacy, and advised five PhD students and a Post-Doctoral Fellow. He received his BSc and MSc degrees in Chemistry from Osmania University in Hyderabad and his PhD degree in Pharmaceutics from the University of Iowa. His research interests are intrinsically tied to the manufacturing process sciences, product quality, and performance which are of paramount importance in regulatory science. He is well recognized for his contributions and dedication to science/regulations interface.
Satyam is an active member of the AAPS. His AAPS involvement spanned the organization, where he chaired the Pharmaceutical Technologies Section, the Arden House Conference, and the AAPS Fellows Committees - both at sectional and national level. He is an AAPS Fellow and also received the 2005 and 2008 Recognition Awards from the AAPS Regulatory Sciences Section, the 2005 Distinguished Scientist Award from the AAiPs, the 2007 Excellence in Science Award from the Telugu Association of North America, the 2008 AAPS Distinguished Service Award, the 2010 AAPS Regulatory Sciences Achievement Award, and most recently the 2012 President’s Award (a Plenary Award) from the Indian Pharmaceutical Association (IPA). Dr. Upadrashta will be presenting on the following topic: Quality Systems & Strategic Regulatory Compliance Management.
Srikumaran Melethil, Ph.D., J.D., is Of Counsel with the intellectual property and technology law firm of Fraser Clemens Martin & Miller, LLC, Perrysburg, Ohio. Dr. Melethil is both a pharmaceutical scientist and a registered patent attorney. He is admitted to practice in the State of Missouri, before the United States Courts for the Western District of Missouri and before the United States Patent and Trademark Office.
Dr. Melethil is a Professor Emeritus, University of Missouri-Kansas City, Schools of Pharmacy and Medicine. His scientific expertise covers the areas of pharmacokinetics, drug delivery, clinical pharmacology and drug analysis; he has published extensively in these areas. In the legal arena, he has published on the regulation of dietary supplements, World Anti-Doping Agency inclusion criteria for prohibited substances, and drug patent litigation arising under the Hatch-Waxman Act. He has also offered short courses in drug and patent law to life scientists. He is a Fellow of the American Association of Pharmaceutical Scientists, the premier association of his peers, and the American College of Clinical Pharmacology. He serves on the Editorial Board of Clinical Research and Regulatory Affairs, and Advisory Committee of Update, published by the Food and Drug Law Institute. He has served or serves as a consultant to the pharmaceutical industry, academia, and federal agencies (FDA, National Institute of Environmental Health Sciences, and National Institute of Drug Abuse), and as an expert witness in drug toxicity and blood alcohol cases.
Dr. Melethil received his B. Pharmacy (First Class, First Rank, Gold Medalist), and M. Pharmacy (Manufacturing Pharmacy, First Class) from Andhra University, Waltair, India; his Ph.D. degree in pharmaceutical sciences from the Department of Pharmaceutics (now Pharmaceutical Sciences), State University of New York at Buffalo in New York; and his Juris Doctor degree from the University of Missouri-Kansas City School of Law. His web site atwww.lawandscience.com provides complete details. Dr. Melethil will be presenting on the following topic: Methods to Adjust Drug Dosages Based on Blood Concentrations: Should such methods be patentable?