InDevR Announces New Director of Regulatory Affairs to Advance FluChip-8G
Preparation for Clinical Validation of FluChip-8G In Vitro Diagnostic Underway
BOULDER, CO–(Marketwired – August 04, 2015) – InDevR, Inc., an innovative life science company dedicated to improving biopharmaceutical and vaccine manufacturing, announced today the appointment of Elizabeth Malo as Director of Regulatory Affairs.
Ms. Malo will be managing and executing InDevR’s regulatory submissions and compliance efforts. Her early focus will be on the FluChip-8G™ in vitro diagnostic product currently in advanced development funded (HHSO100201400010C) by the Biomedical Advanced Research and Development Authority (BARDA). With over 10 years of experience in global medical product policy and regulations, she has supported the development and commercialization of a variety of medical devices with positions at Biodesix, Covidien, and Ventana Medical Systems. Her successful engagements with regulatory authorities have fostered open communication, early planning, and streamlined review of global regulatory submissions. Elizabeth holds a M.S. in Regulatory Affairs for Drugs, Biologics, and Medical Devices from Northeastern University in Boston, Massachusetts.
“I am delighted to have Elizabeth join the team to help guide InDevR on regulatory submissions and compliance processes. Her experience and leadership skills will be a true asset as we work towards an FDA 510(k) submission for FluChip-8G,” commented Dr. Kathy Rowlen, CEO of InDevR.
Once cleared by the U.S. Food and Drug Administration, FluChip-8G will enhance clinical diagnosis of influenza in hospitals, urgent care facilities, and clinical laboratories by enabling physicians to rapidly distinguish between seasonal strains and potential pandemic non-seasonal strains of the influenza virus, such as H5N1 or H7N9.
Last month, InDevR met in person with FDA professionals at the Center for Devices and Radiological Health (CDRH) to engage and inform the FDA about the FluChip-8G assay. Malo commented, “We were pleased to have such a productive discussion with colleagues at CDRH. Our visit provided us with additional insight into critical product development activities and points to consider as we move forward with the FluChip-8G product.”
InDevR has a demonstrated commitment to innovative solutions for the clinical and life science industries. With focus on enhancing diagnostics as well as vaccines and other biotherapeutics, InDevR has emerged as a leader in progressive new analytical technologies that enable accelerated development and manufacturing of these life-saving products. For more information about the company and products, please visit www.indevr.com or call 303-402-9100.