Michael J. Dalton, Pharm.D.

Michael is 22nd Century’s liaison to the FDA. He is a founding partner of the Gnomon Group, LLC, a consulting company which provides regulatory and drug safety services to the pharmaceutical industry. Mike has more than 25 years of experience in the pharmaceutical industry working with large companies, small start-ups, and contract research organizations. Mike started his career at Burroughs Wellcome Co. in the clinical research department in 1982. He later moved to regulatory affairs (1986) and has worked in this area throughout his career. Following the merger of Glaxo and Burroughs Wellcome in 1995, Mike joined PharmaResearch, a new CRO based in Wilmington, NC. As Vice President of Regulatory Affairs, he was responsible for helping develop regulatory affairs functions including regulatory submissions and compliance, the corporate training group, and the drug safety section. Mike next moved to Triangle Pharmaceuticals in Durham NC, where he again headed regulatory affairs and was named acting Director of Drug Safety. Mike left Triangle following its buyout by Gilead Pharmaceuticals and over the past several years has worked with small pharmaceutical companies as a consultant or director of regulatory affairs and drug safety.

During his career in the pharmaceutical industry, Mike has been involved with at least 15 NDA approvals for NCEs and many other important supplemental NDAs. Mike has also helped file more than 50 INDs and has been the FDA contact person for many of these applications.

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.

James C. Morrison

James has been 22nd Century’s regulatory affairs consultant since 2007. He was employed by the FDA for 37 years in senior management positions related to new drugs, generic drugs, drug regulations, prescription drug advertising and in general management of the drug regulatory process, including CDER Ombudsman. Since 2003 he has been an independent consultant, trainer and expert witness in drug regulation and in establishing and maintaining effective relations with the FDA. Among many publications, Jim authored the chapter “From FDA’s Perspective” in How to Work With the FDA, published by the Food and Drug Law Institute.

James L. Myracle

James has been a technical advisor for 22nd Century since 2004. He is co-founder and Partner at TMT Associates, Inc., a consulting practice where he is focused on leading and managing business strategy, operations and innovation. Prior to co-founding TMT Associates, Inc., Jim spent 22 years at Philip Morris USA, holding executive leadership positions in research and development, manufacturing, and operations management. Specifically, Jim was Vice President of Product Development; Manufacturing Quality; Research and Development Planning and Business Systems; and New Technology R&D. Jim is also on the adjunct faculty at the Management Institute within the University of Richmond, Robins School of Business.

Jim earned a Bachelor’s Degree in Mechanical Engineering from The Catholic University of America in 1976. He attended The Executive Program at The University of Virginia’s Darden School in 1994. During his career at Philip Morris, Jim was awarded seven United States Patents.