B. Melina Cimler, PhD, Former Senior Vice President of Regulatory & Quality at Adaptive Biotechnologies, Joins NDA Partners

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NDA Partners Chairman Carl Peck, MD, announced today that Dr. B. Melina Cimler, a senior quality, regulatory, and in vitro diagnostic device expert with more than 28 years of experience in the life science and FDA-regulated global diagnostic industry with a focus on precision medicine, has joined the firm as an Expert Consultant.

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Dr. Cimler’s expertise in regulatory strategies, quality management, clinical affairs, and product development, focus on precision medicine, and experience in the global in vitro diagnostic industry makes her a welcome addition to our team of Expert Consultants.

NDA Partners Chairman Carl Peck, MD, announced today that Dr. B. Melina Cimler, a senior quality, regulatory, and in vitro diagnostic device expert with more than 28 years of experience in the life science and FDA-regulated global diagnostic industry has joined the firm as an Expert Consultant. Her experience includes leadership roles in regulatory strategy, quality systems, clinical affairs, research, and product development organizations with a focus on precision medicine.

Prior to joining NDA Partners, Dr. Cimler served as Senior Vice President of Regulatory and Quality at Adaptive Biotechnologies. She was formerly Head of Global Quality and Vice President of Quality, Regulatory, Clinical, and Government Affairs at Illumina Inc., where she defined and executed the regulatory strategy for the first next generation sequencing platform (MiSeqDx) to receive FDA marketing authorization.

Dr. Cimler has also previously held executive leadership positions in quality management, regulatory affairs, clinical development, and government affairs at Abbott Molecular, Beckman Coulter Inc., Gen-Probe Inc., and CR Bard, Inc., and she was formerly head of Product Development at Epitope, Inc. (now OraSure Technologies, Inc.).

According to Dr. David Feigal, NDA Partners’ Medical Device Practice Manager, “Dr. Cimler’s expertise in regulatory strategies, quality management, clinical affairs, and product development, focus on precision medicine, and experience in the global in vitro diagnostic industry makes her a welcome addition to our team of Expert Consultants. We are very pleased that she has joined NDA Partners.”

Dr. Cimler earned her doctoral degree in pharmacology and her bachelor’s degrees in biology and chemistry from the University of Washington. She currently serves on the Board of Directors of Nanostics, Inc. and is a Scientific Board member of M3 Biotechnology.

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.

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

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