Scientific Roundtable Series 2: Defining “Bioactive”

Professor Sharon Donovan is the Melissa M. Noel Endowed Chair in Nutrition and Health at the University of Illinois Urbana-Champaign. She received her Ph.D. in Nutrition at the University of California at Davis and completed a post-doctoral fellowship in Pediatric Endocrinology at the Stanford University School of Medicine.

Research in her laboratory focuses on the coordinated development of the gut microbiome, immune system, and cognitive development in early life. A key focus is on how human milk bioactives (human milk oligosaccharides, milk fat globule membrane, lactoferrin, and osteopontin) influence microbiome composition and immune function in neonates.

She has served as president of the American Society for Nutrition (2011–2012) and the International Society for Research on Human Milk and Lactation (2018–2020). She served on the 2020–2025 Dietary Guidelines for Americans Advisory Committee. Dr. Donovan was elected to the National Academy of Medicine in 2017 and was recently named Chair of the Food and Nutrition Board of the National Academy of Medicine.

Paul Hanlon earned his doctorate in molecular toxicology from the University of Wisconsin–Madison and is a Diplomate of the American Board of Toxicology. He is currently a Director of Regulatory Affairs at Abbott Nutrition where his duties include the evaluation of new food ingredients.

Paul is active in the food toxicology community and over the past years has authored multiple papers covering different aspects of food risk assessment, and given presentations on these topics to audiences around the world.

Manki has been working in the food and nutraceutical industry since 2011. She began her career at a consulting firm, where she gained extensive expertise in the safety assessment of novel foods and food ingredients, along with the regulatory processes required to bring these products to market.

Currently, Manki works at Novonesis, a global ingredient supplier, where she is responsible for regulatory submissions to secure premarket clearance for a diverse range of ingredients, particularly those within the early life nutrition portfolio.

Manki earned her Ph.D. from the Department of Pharmacology and Toxicology at the University of Toronto, and she is a diplomate of the American Board of Toxicology (DABT).

Dr. Keefe has 30+ years working in FDA on food additive regulatory issues and 15+ years working on the development of international standards for food additives in the Codex Alimentarius. From 2011–2022 he was the Director of the FDA’s Office of Food Additive Safety (OFAS).

OFAS is responsible for the premarket review of food additives, color additives, and food contact substances, and manages FDA’s voluntary GRAS programs, biotechnology notifications, recycled plastics in food packaging, and foods derived from cultured animal cells.

During his tenure, major achievements included folic acid fortification of corn masa flour, removal of partially hydrogenated oils (PHOs) from foods, sodium reduction guidance, PFAS removal agreements, approval of soy leghemoglobin, and delisting lead acetate in hair coloring.

From the mid-1990s until 2011, Dr. Keefe led the Codex effort to develop the Codex General Standard for Food Additives. He is now a Senior Managing Scientist with Exponent.

Dr. Vanessa Feher Castagna is the Director of Food Safety and Claims at SciPinion where she is developing an expert peer-review program for food ingredient safety evaluations.

Vanessa is a PhD scientist from UC Davis, trained in microbiology and nutritional immunology with expertise in milk bioactive proteins for infant health. She has served in higher education and early-stage food biotech roles across scientific communication, regulatory affairs, clinical and preclinical research, and program management.