Title: Genetic Technology Policies that Stimulate Innovation While Protecting the Public Interest

Speaker: Dr. Shannon Barker

Recent exciting advances in genetic technologies are driving the emergence of modern medical approaches, specifically diagnostics and gene transfer, for improved human health. Our increasing understanding of the role of DNA in health and disease, through human genome sequencing and breakthroughs in gene manipulation, delivery, and analysis technologies, is leading to improved diagnostics and more effective and personalized treatments for patients. While highly promising and potentially cost-saving, these technologies present many technical and policy challenges, and come with a multitude of complicated issues regarding translation into actual health care.

For example, the regulatory mechanisms of genetic tests in the U.S. have significant gaps in comprehensive oversight that exists within a wide range of regulatory agencies. Little evidence-based research has been performed for determining the affects of these gaps on test development, implementation, and ultimately, patient care. The development of appropriate oversight and regulation to address technological, societal, and ethical concerns is crucial for both the innovation of the genetic testing field and the protection of patient safety.

Another genetic technology rapidly approaching reality is human germline genetic modification (HGGM). HGGM refers to permanently altering one