Biopharmaceuticals (includes Biologics)
Strategic
Jim Kaput, PhD
Co-founder and Chief Scientific Officer
Vydiant
Jessica O'Connell, JD, MPH
JD, MPH
Participants will learn about regulatory hurdles (examples), and how to envisage creative solutions applicable to their job and career. Innovative approaches in nutrition hold great promise for developing targeted consumer care and medical food products, based on specific nutritional requirements for managing health and disease. The development of novel experimental designs and better tools (e.g. ‘omics’ technologies; computational models) promise to assess key variables among nutrient intake and nutritional status, genetic variants, and other environmental factors useful for predicting health outcomes.
The interpretation of the current regulatory and policy framework needs to adapt rapidly, e.g. addressing legal limitations on the use of disease prevention claims for nutrition and dietary disease management, as well as to create favorable development conditions (e.g. gut microbiome) to provide innovative solutions in citizen (i.e. consumer and patient) care.
In a fast changing external environment, driven by science, technology, as well as social streams and behavior (e.g. millennials), applying the newly gained knowledge and developing the proper mindset will be pivotal to regulatory professionals for converging ideas and help shaping their own bright future.