Banyan Biomarkers Inc announces that Lynda Hague has been appointed Vice President of Clinical and Regulatory Affairs, effective June 21, 2010.
“Lynda Hague is a seasoned healthcare executive with direct clinical and regulatory experience. She has extensive knowledge in the design and implementation of clinical trials and we are pleased to welcome her to Banyan Biomarkers.”
Lynda Hague comes to Banyan Biomarkers from Abbott Molecular where she held the position of Director of Clinical Research. She has 20 years of clinical research and regulatory affairs experience. She has directed industry sponsored in vitro diagnostic clinical trials for genetic diseases, oncology, and infectious diseases as well as NIH sponsored treatment trials for pediatric and maternal AIDS.
Her clinical trial management experience also includes assisting clinical development of a Vaccinia (smallpox) vaccine and a Vaccinia immunoglobulin therapeutic for the Joint Vaccine Acquisition Program at Fort Detrick, Maryland. Ms. Hague’s regulatory affairs experience spans managing Bioresearch Monitoring inspections and preparation of Pre-Investigational Device Exemptions, Premarket Approval applications and 510(k)s for submission to the U.S. Food and Drug Administration.
As Banyan’s Vice President of Clinical and Regulatory Affairs, Ms. Hague will be responsible for bringing the company’s proprietary immunoassays for Traumatic Brain Injury through clinical trials and the FDA’s Pre-market Approval process.
Jackson Streeter, MD, Chief Executive Officer and Chief Medical Officer of Banyan Biomarkers added, "Lynda Hague is a seasoned healthcare executive with direct clinical and regulatory experience. She has extensive knowledge in the design and implementation of clinical trials and we are pleased to welcome her to Banyan Biomarkers."
Source: Banyan Biomarkers
