Mr. Clark brings significant experience to our firm in the development and commercialization of diagnostics devices.
WASHINGTON (PRWEB)
October 18, 2022
NDA Partners’ General Manager, Eric Fish, announced today that Kevin Clark, a diagnostic device executive, has joined the firm as an Expert Consultant. Mr. Clark has extensive experience in business development and commercialization of diagnostic devices including ELISA and IFA laboratory testing systems.
Mr. Clark is founder of ImmunoVision, Inc. (subsidiary of IVAX Diagnostics, Inc.), where he served as COO and CEO. In 2011, IVAX merged with ERBA Diagnostics, Inc. and he served as CEO and President of the new company. Following his role at ERBA, Mr. Clark joined NOWDiagnostics as CEO where he led product development and commercialization efforts for the company’s point-of-care (POC) testing platform.
Throughout his career, Mr. Clark built a diagnostic company which went public, served in COO and CEO roles, managed multinational business operations, sourced investors, and brokered mergers and acquisitions, all while developing, manufacturing, and selling products that required FDA approval. He has successfully achieved marketing approval for 126 products through the regulatory approval process and scaled diagnostic companies from inception to lucrative exit on a global scale.
According to Dr. Alberto Gutierrez, Manager of NDA Partners’ diagnostics device practice, “Mr. Clark brings significant experience to our firm in the development and commercialization of diagnostics devices. His expertise will be valuable to companies navigating the regulatory approval process and scaling up their manufacturing operations.”
Mr. Clark received his master’s degree in immunology and a bachelor’s degree in pre-veterinary studies from the University of Arkansas. He has served as Chairman, Executive VP and Founding Member of the Arkansas Biotechnology Association, and on the Boards for the University of Arkansas Technology Development Foundation and Arkansas BioVentures. He currently serves on the Board for Biomedical Engineering College and the Entrepreneurial Board for the University of Arkansas, Sam Walton College of Business.
About NDA Partners
NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); 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, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.
Contact
Eric Fish, General Manager
Office: 540-738-2550
FishEric@ndapartners.com
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