The FDA Perspective: CDx, Combination Products & Targeted Therapies

Special Industry Keynote
Alberto Gutierrez, PhD, NDA Partners

The rise of personalized medicine has led to the development of therapies tied to specific biomarkers for increased clinical efficacy. Companion Diagnostics (CDx), tests to identify individuals for whom a drug or device would be appropriate, are becoming increasingly important as more targeted therapies are developed. This multi-billion dollar industry is growing, and the FDA has implemented policies for CDx that vary from combination product regulation, and will drive how these products are developed and marketed for years to come.

Combination products and therapies requiring a CDx are important across our local industry sector and product areas beyond medical devices. Alberto Gutierrez, PhD, served in several executive roles at the Center for Devices and Radiological Health (CDRH) within the FDA. In that capacity, he oversaw the Personalized Medicine Staff at the FDA and developed and managed the policies surrounding companion diagnostic devices. Dr. Gutierrez, now a Partner at the local regulatory consulting firm NDA Partners, will share deep insights about how the policies emerged and how they are changing the regulatory game.