“I am pleased to welcome two of the top names in the industry to the Kymanox team,” said Stephen M. Perry, CEO. “Many organizations are struggling with development and commercialization activities related to Human Factors which often results in wasted time and budget. Our clients will now benefit from the exceptional talent and experience that Evan and QuynhNhu bring to Kymanox. We’ve enhanced our capabilities to become the world-class leader in Human Factors Regulatory and Program Strategy for combination products in the biotechnology and pharmaceutical industries.”
With over 17 years of experience in the pharmaceutical and medical device industries, Evan Edwards joins Kymanox as Principal Executive Advisor working directly with Perry and advising on growth strategies for Kymanox as well as co-leading the HUman factors Regulatory And Strategy (HURAS) practice. He was the cofounder of kaléo Inc. and co-inventor of the AUVI-Q (epinephrine injection, USP) and kaléo’s drug delivery device technologies. He has extensive experience in drug device combination products and is named on over 200 patents, issued and pending, both domestically and abroad. Edwards is a subject matter expert in Usability Engineering, Design Controls, Combination Products, Operations, Industrialization, Quality Systems, Executive Leadership, Pre-Approval Inspection Readiness, Human Factors, Intellectual Property Strategy and Invention and Design. Edwards holds a B.S. in Mechanical Engineering from University of Virginia and an M.S. in Systems Engineering from University of Virginia with a concentration on Human Factors Engineering.
QuynhNhu Nguyen joins Kymanox as Director of Human Factors, working with Edwards and also providing leadership for the HURAS practice. With over 15 years in Human Factors Regulatory and Evaluation at the FDA, Nguyen served as Associate Director of Human Factors within the Division of Medication Error Prevention and Analysis (DMEPA), part of the Center for Drug Evaluation and Research (CDER) where she co-led development of the Human Factors program and provided oversight for review of over 500 submissions. She also led Human Factors Reviews at the FDA Center for Devices and Radiological Health (CDRH) with over 400 reviews of medical products. Nguyen has been recognized with 26 US Public Health Service Awards and Medals, and 17 Formal FDA and Center Recognitions. She will serve as a subject matter expert for Kymanox in Human Factors/Usability Engineering, Program Management, Combination Products, Human Factors Regulatory Strategy, Patient Safety, Risk Management, and Medication Error Prevention. Nguyen holds a B.S. in Biomedical Engineering from George Washington University and a M.S. in Systems Engineering from John Hopkins University.
To learn more about how Kymanox can help you with combination products in general or our capabilities in Human Factors Regulatory and Program Strategy for the medical device, biotechnology and pharmaceutical industries, contact us at [email protected] or visit www.kymanox.com today.
About Kymanox: Your Life Science Solutions Partner
Kymanox is a premier one-stop solutions provider supporting development and commercialization of vital medicines and treatments for people to live better, love longer, and GET MORE DONE. Leveraging a corporate DNA of Ideal Knowledge Transfer™, the Kymanox team partners with global clients to facilitate development and delivery of products with optimized safety, quality, efficacy, accessibility, and efficiency. As a true life science solutions partner, the company operates in the Biotechnology, Pharmaceutical, Medical Device, and Combination Product industries. Kymanox offers a broad range of professional services with turnkey project delivery, serving clients globally from the corporate headquarters in Durham (RTP), North Carolina and branch offices across the US including Boston, Chicago, and New Jersey. Learn more about Kymanox at https://kymanox.com/.