The summit addresses a paradox summed up by Rodney Butt, M.Sc., MBA, Sr. VP of Strategic Solutions at Nutrasource: “Many of the current prescription drugs are derived from natural products. So why aren’t there more natural products developed as prescriptions?” He invites all interested parties—from researchers to brands to government regulators—to join Nutrasource in addressing this gap: “Join us on June 17thas we discuss development options for naturally based products, making them available to the widest possible audience.”
To this end, sessions will cover topics including medical foods, nutra-to-pharma strategies, and pharmaceutical regulations. Those sessions include:
- 9 am EST—Blurred Lines: Natural vs Pharma (Joshua Baisley, H.B.Sc., Vice President of Clinical Design and Delivery)
- 10am EST—Bridging the Gap Between Nutra & Pharma Regulatory Pathways for Successful Market Access (Tania John, M.Sc., Director of Regulatory Affairs; Anna Metcalfe, B.Sc., Vice President of Pharmaceutical Sciences)
- 11am EST—Regulatory Guidance for Marketing—Drug and Dietary Supplement Claims (Dr Douglas Kalman, R.D., Ph.D., Vice President of Scientific Affairs; Dr Susan Hewlings, R.D., Ph.D., Director of Scientific Affairs)
- 12pm EST—Medical Foods: Disease Claims Without The Drug Pathway (Amy Mozingo, M.Sc., Director of US Operations—GRAS Associates; Dr Derek Tobin, Ph.D., Director of Business Development—EU)
- 1pm EST—Quantum Mechanics of Developing Naturally Based Products as a Prescription Drug (Rodney Butt, M.Sc., MBA, Senior Vice President of Strategic Solutions)
- 2pm EST Closing Panel—Demystifying Drug Development for Natural-Based Products: From Pre-Clinical Development to Manufacturing. Confirmed panelists include Michael Stellar, Unit Head / Health Products and Food Branch, Health Canada / Government of Canada (Regulator perspective); Len Monheit, CEO, Trust Transparency Center (Market insight and Bioanalytical perspective); Sam Ricchezza, President North America Operations, Bora Pharmaceuticals (Manufacturing perspective); Brian J. Malkin, Counsel, Arin Fox (Legal perspective); and Dave MacDonald, President, MSI Methylation Science Inc. (Sponsor perspective).