Alan McEmber, RAC, senior director, immunology, global pharmaceutical regulatory affairs, Abbott.
McEmber has more than 25 years of experience in regulatory affairs pharmaceutical development. His responsibilities have provided broad international and domestic regulatory and product development experience from discovery to market approval and lifecycle management. McEmber’s experience encompasses drugs, biologics and devices in several therapeutic areas including immunology, cardiovascular, metabolism/ endocrinology, ophthalmology, respiratory and urology. Prior to Abbott, McEmber was a regulatory affairs director in worldwide regulatory strategy with Pfizer. He also held regulatory positions at Alexion Pharmaceuticals, Boehringer-Ingelheim, Parke-Davis, and 3M Pharmaceuticals. McEmber holds a BS in microbiology from the University of Michigan and an MS from the University of Minnesota. He is a lecturer at Columbia University where he teaches a course on biopharmaceutical development and regulatory.
Sarah Powell, RAC, executive director, regulatory strategies, Liquent
Powell has more than 20 years of experience in the pharmaceutical and related regulated industries. For the last seven years, Powell has worked on a variety of projects related to implementation of regulatory solutions and has contributed to defining product strategies for industry leading software solutions. While in industry, Powell performed a variety of roles within the clinical, quality, regulatory affairs and regulatory operations groups. She has extensive experience with FDA’s guidance for electronic submissions, including recently established requirements for electronic submission of labeling information (SPL and PIM).
Katharine Reinisch, DVM, director, worldwide regulatory strategy & quality assurance, Pfizer Inc.
Reinisch moved to Pfizer in November 2007 from Bayer Healthcare Pharmaceuticals where she was head of global regulatory affairs in the therapeutic area of hematology/cardiology & specialized therapeutics. She and her team successfully developed and implemented global regulatory strategies for development projects and marketed products in Multiple Sclerosis, Parkinson’s disease, gastrointestinal diseases and ophthalmology. Prior to Bayer, Reinisch held positions in global regulatory affairs at Schering AG. She has more than seven years global regulatory experience (US, Europe and Japan) in all phases of drug development in varied therapeutic areas and more than 10 years experience of pharmaceutical drug development, with three years in global preclinical development leading the reproduction toxicology department at Schering AG as well as preclinical development teams for several projects. In addition to her vast industry drug development experience, Reinisch has more than seven years experience in research of pharmacology and toxicology in international working groups. She earned a DVM from the Free University Berlin with a concentration on embryopharmacology and toxicology and has successfully completed the Building Global Leadership Program of the Duke Corporate Education in December 2004.