Masterclass - FDA Demystified: A Practical Path to the U.S. Market for Nicotine Products

Chief Regulatory Science Officer McKinney Speciality Labs 

Dr. Roxana Weil leads the Business Development and Scientific Engagement team and serves as Chief Regulatory Science Officer for McKinney Specialty Labs. Roxana holds a PhD in Pharmacology and Physiology from the University of Florida, a MSc and BSc in Biology from University of Waterloo, Canada. She is a Diplomate of the American Board of Toxicology (DABT) with specialized expertise in human health risk assessment and toxicology, and extensive experience spanning across U.S. FDA and Global Regulatory Strategy, Organizational Development, Risk Management and Tobacco Regulatory Science and Policy. Prior to joining McKinney Specialty Labs, Roxana successfully lead and implemented JUUL Lab Inc.'s Product Integrity function and Toxicology programs, and served as a Lead Toxicologist at the U.S. FDA Center for Tobacco Products (CTP) where she was responsible for leading an interdisciplinary team of scientists, providing science-policy recommendations and developing the scientific basis to support regulations, guidance and review of tobacco product applications via all regulatory pathways. 

Chief Executive Officer McKinney Speciality Labs 

Dr. Willie McKinney is an established regulatory and inhalation toxicology expert with over two decades of research, product development, and regulatory strategy experience in the Consumer-Packaged Goods industry. As the founder and CEO of McKinney Regulatory Science Advisors, LLC, he leverages his extensive background, including his previous role on the FDA’s Tobacco Product Scientific Advisory Committee and his past position as Vice President of Regulatory Sciences at Altria, to guide clients through multiple constantly evolving regulatory landscapes.

Dr. McKinney’s knowledge and experience are widely respected. He holds a Ph.D. in Environmental Toxicology from the University of North Carolina School of Public Health and is certified by the American Board of Toxicology. He launched McKinney Specialty Labs, LLC in January 2024 to offer specialized aerosol testing services as well as chemical and GLP toxicology analysis.

Together, McKinney Regulatory Science Advisors, LLC, and the newly established lab provide over 25 years of combined expertise in regulatory strategy, application filing, and product testing. This suite of services is customized to meet the unique needs of each client, guaranteeing integrity and quality at every step. Dr. McKinney’s leadership remains instrumental in driving scientific research and regulatory compliance forward.