The Gnomon Group, LLC
Regulatory Affairs Consulting
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., received 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, where he conducted clinical research at the University of Michigan Hospital. Soon after, Mike accepted a clinical fellowship with Burroughs Wellcome & Company in Research Triangle Park, NC, in partnership with the University of North Carolina at Chapel Hill. Following the fellowship, Mike joined the BW Regulatory Affairs Division in 1986, where he had responsibility for approvals of AZT, Valtrex, and many others. During his 13 years at Burroughs Wellcome, Mike 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. Mike left BW in 1995 to join PharmaResearch Corp. as vice president of regulatory affairs, a contract research organization located in Wilmington, NC. He then 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.
Tom Shumaker, M.S. 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 BW's merger with Glaxo, Inc. 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, where he continued his regulatory work. Following that company's takeover by Gilead Sciences, Inc., in 2004, Tom became director of regulatory affairs of BioDelivery Sciences International, a small start-up company focused on pain management. During his career, Tom has been involved in at least 10 NDA approvals for NCEs and many other important supplemental NDAs. He has also helped manage and file more than 40 INDs and has served as FDA contact person and liaison. Tom has an undergraduate degree in chemistry from the Allegheny College and a M.S. from the State University of New York, Fredonia.
Mike Dalton, Pharm.D., received 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, where he conducted clinical research at the University of Michigan Hospital. Soon after, Mike accepted a clinical fellowship with Burroughs Wellcome & Company in Research Triangle Park, NC, in partnership with the University of North Carolina at Chapel Hill. Following the fellowship, Mike joined the BW Regulatory Affairs Division in 1986, where he had responsibility for approvals of AZT, Valtrex, and many others. During his 13 years at Burroughs Wellcome, Mike 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. Mike left BW in 1995 to join PharmaResearch Corp. as vice president of regulatory affairs, a contract research organization located in Wilmington, NC. He then 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.
Tom Shumaker, M.S. 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 BW's merger with Glaxo, Inc. 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, where he continued his regulatory work. Following that company's takeover by Gilead Sciences, Inc., in 2004, Tom became director of regulatory affairs of BioDelivery Sciences International, a small start-up company focused on pain management. During his career, Tom has been involved in at least 10 NDA approvals for NCEs and many other important supplemental NDAs. He has also helped manage and file more than 40 INDs and has served as FDA contact person and liaison. Tom has an undergraduate degree in chemistry from the Allegheny College and a M.S. from the State University of New York, Fredonia.
