Turning Wine into Medication: 

Moving Natural Dietary Ingredients into the Drug Route - A Clash of Cultures

Session Chair:   Freddie Ann Hoffman, MD - HeteroGeneity, LLC, Washington, DC

Natural products have always been an excellent source of drugs, both in the US and around the world.  Indeed, more than 40% of US drugs are from or derived from natural products.  Many natural products are being marketed as "foods", including dietary or nutritional supplements.  Although there may be sound business reasons to move a food to the drug route, there are distinct differences in these two market channels, which are often results in a clash of divergent "cultures."   This Session will focus on the differences in the marketing and development of natural products as "foods" versus "new" drugs in the US.  What changes would be needed in the types of indications and marketing claims, nonclinical and clinical studies will be explored. Also, what fundamental changes may be needed in the manufacturing process when making the change from a food to a drug, will also be examined by experts, along with the price tag in doing so.

·         Managing Expectations:  How Can Natural Dietary Ingredients be Drugs?  

         Freddie Ann Hoffman, MD - HeteroGeneity, LLC, Washington, DC

         ·          Design & Implementation of Clinical Trials with Dietary Supplements for the Drug Route.

                     Jay Udani, MD - Medicus Research, LLC, Northridge, CA