Michael Dalton, PharmD
Michael J. Dalton, Pharm.D., Regulatory Affairs Consultant has 35+ years of regulatory and drug development experience in the pharmaceutical industry working with large and midsize companies, small start-ups, and contract research organizations. Mike has an undergraduate degree in pharmacy from the University of Nebraska, a Doctor of Pharmacy degree from the University of Michigan, and completed a two-year fellowship in Clinical Drug Research/Drug Development at the University of North Carolina at Chapel Hill and Burroughs Wellcome Co. Mike started his career at Burroughs Wellcome Co. in the clinical research department, later moved to regulatory affairs, and has worked in regulatory affairs in large and small pharma companies throughout his career.
Mike started a regulatory affairs consulting company, The Gnomon Group, LLC., in 2006 and has provided regulatory and drug development services to 75+ pharmaceutical companies. During his career in the pharmaceutical industry, Mike has been involved with several NDA approvals for NCEs and many other important supplemental NDAs. Mike has also helped file more than 150 INDs and has been the FDA contact person for many of these applications.
Mike joined Ridgeback Therapeutics as a regulatory affairs consultant in 2020 following their acquisition of EIDD-2801, an investigational antiviral treatment for Covid-19 infections, from Emory University. Mike and his consulting company colleagues have provided drug development support services to Ridgeback Therapeutics including regulatory strategy, FDA and other regulatory authority contact, medical writing, virology, statistics, nonclinical support, and regulatory operations including electronic submissions.