Former FDA Director, Alberto Gutierrez, PhD, Joins NDA Partners as Expert Consultant

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NDA Partners Chairman Carl Peck, MD, announced today that Alberto Gutierrez, PhD, former Director of the FDA Office of In Vitro Diagnostics and Radiological Heath, has joined the firm as an Expert Consultant. Dr. Gutierrez is an expert in preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices, applications for approval, and post-marketing surveillance and compliance.

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Dr. Gutierrez’s knowledge of FDA regulations, in addition to his extensive experience with preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices, makes him an outstanding addition to our team and a highly valued resource for our clients.

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 joined the firm as an Expert Consultant. While at the FDA, Dr. Gutierrez oversaw the Personalized Medicine Staff, developed and managed the policies surrounding companion diagnostic devices, and was a member of the Center for Device and Radiological Health committee that oversaw policies on Digital Health. 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.

During his 25-year career at FDA, Dr. Gutierrez 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 Biologic Evaluation and Research (CBER), Office of Vaccines Research and Review, where he researched the biochemical properties of vaccine adjuvants and polysaccharides.

Dr. David Feigal, Leader of NDA Partners’ Medical Device Practice, noted that Dr. Gutierrez has quickly become an integral part of the firm’s device practice area, working closely with a number of clients that are developing diagnostics. “Dr. Gutierrez’s knowledge of FDA regulations, in addition to his extensive experience with preclinical and clinical testing of in vitro diagnostic devices and radiological imaging devices, makes him an outstanding addition to our team and a highly valued resource for our clients.”

Dr. Alberto 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 strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. 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 virtual product development teams.

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Earle Martin, Chief Executive Officer
Office: 540-738-2550
MartinEarle(at)ndapartners(dot)com

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Earle Martin
NDA Partners LLC
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