Venable LLP and KGK Synergize, a clinical trial research and development company, will join forces as cosponsors at SupplySide West Expo and Conference in Las Vegas. Venable's Todd Harrison, Claudia Lewis, Angel Garganta, Andrew Pratt and John Moore will lead a number of educational workshops and briefing sessions covering a variety of pertinent topics including: clinical trials for today's headlining health issues; ITC and supply chain integrity; FSMA implications for dietary supplements; and class action lawsuits.
Clinical Trials for Today's Headlining Health Issues
Wednesday, Oct. 8
Noon to 12:50 p.m.
- Malkanthi Evans, D.V.M., M.Sc., Ph.D., scientific director/CRS division, KGK Synergize Inc.
- Todd A. Harrison, Esq., partner and chair – food and drug practice group, Venable LLP
- Claudia A. Lewis, Esq., partner, Venable LLP
Clinical trial design is a critical issue to consider when making the decision to substantiate health claims for labeling on your product or ingredients. As it stands today, the regulatory landscape is complex and inconsistent across the globe. Understanding the various regulatory obligations is pivotal when marketing products and claims around the world. With the dietary supplement market becoming more competitive, clinical trials are essential for product development, claims substantiation and marketing efforts intended to gain consumer confidence and avoid regulatory potholes. Before embarking on the journey to provide scientific evidence for health claims, it is important to identify what type of claim you want to make in relation to where the product will be marketed. A poor trial design can lead to claims not being approved by a regulatory board. This session will take a critical look at designing clinical studies for claims substantiation. By addressing issues such as "How you are more likely to hear from the FDA," "How to choose the right population and the importance of the population to your study" and "The best biomarkers and how many are necessary for your study," these expert speakers will reveal how to navigate the regulatory landscape and the key steps to conducting clinical research to provide scientific evidence for your health claims.