Rochelle, Virginia (April 25, 2018) – NDA Partners Chairman Carl Peck, MD, announced today that Alberto Gutierrez, PhD, former Director, Office of In Vitro Diagnostics and Radiological Health, FDA Center for Devices and Radiological Health (CDRH), has been appointed a Partner in the firm. Dr. Gutierrez began working with NDA Partners as an Expert Consultant in 2017 and quickly became an integral part of the firm’s medical device practice as an expert in preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices.
Dr. Gutierrez brings a wealth of knowledge to the firm following his successful 25-year career at FDA, where he served in multiple executive roles at the 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. In addition to his experience at CDRH, Dr. Gutierrez served as Staff Scientist in the FDA’s Center for Biologics Evaluation and Research (CBER), Office of Vaccines Research and Review, where he researched the biochemical properties of vaccine adjuvants and polysaccharides. While at the FDA, he oversaw the Personalized Medicine Staff, developed and managed the policies surrounding companion diagnostic devices, and was a member of the CDRH committee that oversaw policies on Digital Health.
According to Dr. Feigal, Manager of NDA Partner’s Medical Device Practice, “Dr. Gutierrez’s expertise in preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices has been highly valued by our clients, and his leadership as a Partner in the firm will play a crucial role as we further expand our services in support of diagnostic products. We are very pleased to welcome him as Partner in the firm.”
Dr. Gutierrez earned both a PhD and MA in Chemistry from Princeton University and a BS in Chemistry from Haverford College, Pennsylvania.
About NDA Partners
NDA Partners is a life sciences management consulting firm focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and management of client product development programs.
Earle Martin, Chief Executive Officer