NDA Partners LLC: A Development Partner to Biopharmaceutical Investors and Companies

Alberto Gutierrez, PhD

Practice Area Focus

  • Combination Products
  • Devices
  • Diagnostics
  • OTC
  • Radiological Health
  • Regulatory Compliance
  • Development Strategy
  • Manufacturing
  • Post-Marketing
  • CLIA Regulations

Biography

Alberto Gutierrez, PhD is a Partner with NDA Partners and has worked with the company as an Expert Consultant since 2017. He is an expert in preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices, premarket notifications of devices, applications for approval, and post-marketing surveillance and compliance. Dr. Gutierrez oversaw the Personalized Medicine Staff at the FDA and developed and managed the policies surrounding companion diagnostic devices. Dr. Gutierrez was also a member of the Center for Devices and Radiological Health committee that oversaw policies on Digital Health.

During his 25-year career at FDA, Dr. Gutierrez served in several executive roles at the Center for Devices and Radiological Health (CDRH) including, Director, Office of In Vitro Diagnostics and Radiological Health; Director, Office of In Vitro Diagnostic Device Evaluation and Safety; Deputy Director, New Product Evaluation, Office of In Vitro Diagnostic Device Evaluation and Safety; and Director, Division of Chemistry and Toxicology Devices. He served as Toxicology Team Leader in the Division of Chemistry and Toxicology Devices and as Scientific Reviewer in the Chemistry and Toxicology branch (CDRH). In addition to his experience at the Center for Devices and Radiological Health, Dr. Gutierrez served as Staff Scientist in the FDA’s Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review researching the biochemical properties of vaccine adjuvants and polysaccharides.