Bios
In addition to the founding partners below, The Gnomon Group maintains a network of highly experienced associates in related fields, such as statistics/data management, medical writing, clinical pharmacology, and toxicology. A description of capabilities document for our associates is available for your review.Mike Dalton, Pharm.D.
Mike Dalton has over 25 years of experience in Clincal Development and Regulatory Affairs in the pharmaceutical and biotech industries. He assists clients in all phases of regulatory strategy development. Through his work at Burroughs Wellcome, GlaxoWellcome, PharmaResearch, Triangle/Gilead and now at The Gnomon Group, he has had a leadership role in at least 15 NDA approvals for NCEs and many other important supplemental NDAs. He has also helped file more than 50 INDs and served as the FDA contact and liaison. He has also served as Head of Pharmacovigilienc at several companies and advises on Drug Safety for clients. In addition, he has acted as project manager for several Phase I/II programs including management and operations for clinical trial support. Mike obtained his undergraduate education at the University of Nebraska at Omaha School of Pharmacy. After serving as an officer in the U.S. Army, Mike worked as a staff pharmacist at Veterans' Administration hospitals in Detroit and Ann Arbor, Michigan. In 1982, he earned his Pharm.D. degree from the University of Michigan. Soon after, Mike accepted a clinical fellowship with the University of North Carolina at Chapel Hill School of Pharmacy and Burroughs Wellcome Company in Research Triangle Park, NC. Following the fellowship, Mike joined the BW Regulatory Affairs Division in 1986, where he provided regulatory support for AZT, Valtrex, and many other BW drugs. Mike left GlaxoWellcome in 1995 to join PharmaResearch Corp., a contract research organization, as vice president of regulatory affairs. In 2000, he joined fellow Burroughs Wellcome colleagues at Triangle Pharmaceuticals, Inc. in regulatory affairs where he also headed the drug safety unit. Before becoming a full-time consultant in 2007, Mike headed regulatory affairs for two smaller drug companies, XTL Biopharmaceuticals Ltd, and Trimeris, Inc. Contact Mike >
Tom Shumaker, M.S.
Tom Shumaker has over 30 years of experience in Pharmaceutical Research and Regulatory Affairs in the pharmaceutical and biotech industries. He assists clients in all phases of regulatory strategy development. Through his work at Burroughs Wellcome, GlaxoWellcome, GlaxoSmithKline, Triangle/Gilead, BioDelivery Sciences International and now at The Gnomon Group, he had a pivotal role in at least 10 NDA approvals for NCEs and many other supplemental NDAs. He has also helped file more than 40 INDs and served as the FDA contact and liaison. He advises clients on drug labeling and promotion and advertising issues. He has extensive experience in regulatory operations and electronic submissions. In addition, he acts as project manager of the virtual development teams for clients. Tom obtained his undergraduate degree in chemistry from the Allegheny College and an M.S. from the State University of New York, Fredonia. He started his career as a chemist at Sterling Drug, before moving to Burroughs Wellcome & Company in the Organic Chemistry Department in 1977. In 1992, he joined the regulatory operations group and became assistant director of regulatory affairs following Burroughs Wellcome's merger with Glaxo, Inc. in 1995. At GlaxoWellcome and subsequently GlaxoSmithKline, Tom was responsible for regulatory strategy and submissions in the antiviral and anti-infective areas. In 2001, Tom joined Triangle Pharmaceuticals, Inc. in Durham, NC. Following the acquisition of Triangle by Gilead Sciences, Inc. in 2004 Tom became director of regulatory affairs for BioDelivery Sciences International, a small start-up company focused on pain management. He started The Gnomon Group with Mike Dalton in 2007. Contact Tom >