Claremont, CA (PRWEB) May 05, 2015
Synedgen Inc. is pleased to announce the appointment of Lonnissa Nguyen, PhD as Regulatory Affairs Manager.
Dr. Nguyen brings to Synedgen critical regulatory expertise and experience at an important juncture for the company as it moves forward in the FDA regulatory processes for two new drug products over the next two years. Dr. Nguyen will lead the management of nonclinical studies and submission of all the regulatory key documents that must be completed in order to initiate human clinical trials for Synedgen’s pharmaceutical products. She will also be responsible for the filing, submission and ongoing compliance of Synedgen’s future and front running medical device products, one currently under review by the FDA and one pending FDA submission.
“We are looking forward to having experienced regulatory leadership in house,” said Synedgen President, Dr. Shenda Baker. “Dr. Nguyen has the combined experience of tissue science and regulatory affairs, which makes her uniquely qualified to understand our development process and to direct the regulatory process for our pharmaceutical and device products. With her skills and history of high productivity, we are confident that she is well suited to lead our regulatory team and accelerate the regulatory process.”
In addition to her regulatory expertise, Dr. Nguyen is also an accomplished scientist, with post-doctoral expertise directly relevant to the technical development of Synedgen’s products. At Harvard-MIT Health Science & Technology, she micro-engineered vascularized bone using directed stem and progenitor cell differentiation in hydrogel scaffolds, studying wound healing and bone regeneration. She then led the Spinal Biologics Program in the Division of Neurosurgery at the City of Hope Cancer Center, developing biological bone substitutes by directed stem cell differentiation, and worked on a team to develop a 3-dimensional tissue-engineered breast cancer model to predict responses to chemotherapy at the University of California Irvine.
Her previous appointments include serving as a Regulatory Affairs Consultant at Astex Pharmaceuticals, Inc., where she developed and maintained a regulatory document inventory, developed resource plans, participated in clinical site initiation review and provided regulatory support. She has also served as a US Regulatory Professional at Amgen Inc. for two investigational products, preparing and coordinating regulatory submissions to the FDA, and three marketed products, supporting US regulatory strategy for ongoing compliance, development and commercialization.
Dr. Nguyen earned her PhD and MS in Biomedical Engineering from the University of Texas at Austin, a BS in Cybernetics and Applied Mathematics from the University of California at Los Angeles, and a Certificate in Bioscience Management from the Keck Graduate Institute.
She is Regulatory Affairs Certified and a member of the Regulatory Affairs Professional Society (RAPS).
Synedgen Inc. is an innovative biopharmaceutical company focused on developing novel therapies and products through its proprietary biomaterials technology platform. Product development is targeted to specifically address unmet needs for therapies to treat inflammation, damage or infection at dermal, pulmonary and gastrointestinal surfaces. Synedgen’s Corporate Headquarters, Research Laboratories and Manufacturing Facility are in Claremont CA. Additional information can be found at Synedgen’s web site at http://www.synedgen.com.