Digital summits are a new experience in online education, optimized for professionals who need deeper-dive information to help them make key business decisions. These immersive education programs are presented by thought leaders in the probiotics industry, addressing the industry's top challenges.
As a registered user, you can attend the live event on December 10th to view video content in real time with live Q and A interaction with the presenters, or you can watch the content on-demand after the live event.
Inside the Digital Summit platform, users have access to a resource library featuring premium content from INSIDER, along with whitepapers, briefs, and webinar content from the event underwriters. You'll have the ability to create your own profile, pose questions, start a dialogue, download resource material, and much more.
Probiotics for use in functional foods and dietary supplements have several regulatory hurdles to overcome. The intended use for probiotics needs to have demonstrated safety for the actual article of commerce and to have proper regulatory status that is convincing to FDA. Label claims should have competent and reliable scientific evidence for the specific strain and need to meet the "truthful and not misleading" requirement of the FTC. While in the United States, structure-function claims do not require FDA approval, it is important to design and describe studies in a manner that doesn't cause regulators to classify the probiotic as a drug.
Probiotics are finished products comprised of live micro-organisms with purported beneficial effects on the body. In the United States, "probiotic" is a term of art—not a regulatory category. This session will describe regulatory and marketing options for probiotics in the United States, discussing differences between the market categories in requirements for manufacturing, controls and claims substantiation, as well as proprietary insulation and potential return on investment.
Dr. Endres is the chief scientific officer for AIBMR Life Sciences Inc. with corporate headquarters located in Puyallup, Washington. He earned a doctorate degree in Naturopathic Medicine at Bastyr University in Seattle. Dr. Endres is a full member of the Society of Toxicology. He has been a member of numerous expert panels assembled for the evaluation of Generally Recognized as Safe (GRAS) Self-determinations, and has been intimately involved in the preparation of GRAS and New Dietary Ingredient notifications sent to FDA. Dr. Endres is an author on a number of safety assessments published in top-tier academic journals specializing in toxicology and has functioned as a peer-reviewer for several of these journals. At AIBMR, he manages a team of research scientists specializing in research and regulatory affairs consulting related to the natural products and functional foods industries.
Freddie Ann Hoffman, M.D., is the CEO of HeteroGeneity LLC, a consulting firm that focuses on development strategies for complex products, including botanicals and probiotics. She is an internationally recognized expert on natural health product development, regulation and policy. She spent nearly a decade at the National Cancer Institute (NCI), holding positions as section chief for Nutrition and Supportive Care for the Clinical Investigations Branch, and then director of Extramural Clinical Trials of the Biologic Response Modifiers Program for the Division of Cancer Treatment. In 1986, she joined FDA as chief of the Cytokines, Growth Factors, and Oncologic Products Branch in the Center for Biologics Evaluation and Research (CBER) and deputy director of the Medicine Staff in the FDA Commissioner's Office. After retiring from FDA she was senior medical director for new product development at Warner-Lambert (Pfizer) Consumer Healthcare, and in 2003 founded HeteroGeneity.
Sonia Michail, M.D., is a pediatric gastroenterologist in Los Angeles, California and is affiliated with multiple hospitals in the area, including Children's Hospital Los Angeles and Long Beach Memorial Medical Center. She serves as attending physician and associate professor of pediatrics at the Keck School of Medicine, University of Southern California. Dr. Michail's research interests include probiotics and studying the gut microbiome; her ongoing research studies include investigating the role of the gut microbiome in a number of pediatric disorders and studying the effect of probiotics and how they modify the gut microbiota. She is a fellow of the American Academy of Pediatrics and American Gastroenterology Association, and received her medical education at Ain Shams University, Cairo, Egypt.