ADVISORY BOARD MEMBERS
Robert McKean, Ph.D.
President, REM Rx Consulting, LLC
CMC Pharmaceutical Development
Robert McKean has over 29 years’ experience in branded drug pharmaceutical development. He gained extensive understanding in new drug characterization and drug product quality improvement. Rob also has worked over two decades in sterile and non-sterile drug product development and manufacturing. He worked in large pharmaceutical companies his entire career including Searle, Rhone-Poulenc Rorer, Cephalon and Teva. Dr. McKean contributed to more than nine NDA approvals and numerous IND submissions in the US and EU. Rob is considered an expert in the areas of drug discovery support and solid-state characterization to help assess and rapidly bring new drugs into clinical trials. This expertise resulted in faster development time and higher quality drug candidates for clinical studies. Most recently Rob was Vice President, Chemistry, Manufacturing and Controls for Teva Branded Products where he was responsible for a large team of scientists and site director. He is now assisting start-up companies to bring new medicines to clinical trials throughout North America and Europe. Dr. McKean received a Ph.D. from the University of Massachusetts at Amherst and has several patents and publications in the areas of drug crystallization, new drug physical and chemical characterization and new drug formulations.
Alpa Parikh, M.S.
Director, Drug Product Development
NewLink Genetics, Inc.
Alpa Parikh has over 25 years’ of experience in branded pharmaceutical drug product development. Her expertise in product development and its characterization led to several product launch and IND submissions in US and EU. Alpa supported preclinical, clinical, commercial and life cycle management of solids, liquids, parenteral, intranasal, topical and biological products. Ms. Parikh held positions of increasing levels of responsibility at Cephalon and Teva Pharmaceuticals. Alpa successfully led the team of scientists to focus on pre-formulation, formulation, solid state characterization, efficient process development and its transfer. Her strength in CMC development including Intellectual Property enabled commercial success to several products. Currently, she is a Director of Drug Product Development at NewLink Genetics, Inc. Ms. Parikh received her Master’s in Pharmacy degree with specialization in drug product development from University of Mumbai, India and has several patents and publications.
Marazban Sarkari, PhD
Senior Director, Global Quality Operations
Marazban Sarkari, PhD is currently a Senior Director, Global Quality Operations with Iovance Biotherapeutics. Previously he was at Teva Pharmaceuticals for more than ten years holding roles of increasing responsibility in the Third Party Operations, R&D and Process Development groups. He is a Chemical Engineer by training and has more than 18 years’ experience in outsourced pharmaceutical drug product manufacturing, and formulation and analytical development covering both large and small molecules. His teams have been involved in vendor selection, contract negotiation, project management and process scale-up and optimization.
He has also held positions in technical operations, process and formulation development and engineering at Cephalon, Endo Pharmaceuticals and RxKinetix gaining a broad experience in the outsourcing of formulation and analytical development as well as the manufacture of clinical and commercial API and drug products. He has presented and published in the areas of new process development, vaccine formulation, novel drug delivery technologies, process optimization and monitoring.
Partha Mudipalli, Ph.D.
Director, Drug Substance Development
Esperion Therapeutics, Inc
Partha Mudipalli has over 25 years of experience in the pharmaceutical industry. His experience includes drug development, technology transfer, manufacturing, plant operations, due diligence, CMO alliance management, and CMC team operations. He has a special interest in polymorphism and crystallization process development. He was involved in commercialization and/or life cycle management of drugs such as Celebrex®, Inspra®, Nasonex®, Claritin®, Provigil®, Nuvigil®, Synriob® and Qbrexza™. Over this long career, he worked in leading companies G.D. Searle (later Pharmacia/Pfizer), Schering Plough, Cephalon (later Teva Pharmaceuticals) and is currently at Esperion Therapeutics as Director of Drug Substance Development. He obtained a Ph.D. in Chemical Engineering from the University of Illinois at Chicago.