BlueRidge Life Sciences Expands Regulatory Leadership Team
KATY, Texas — Clintrex Research LLC (Clintrex), a division of BlueRidge Life Sciences, today announced that Paul Lee, M.D., Ph.D., M.A., has joined its regulatory leadership team as Vice President for Pediatric and Rare Diseases.
Dr. Lee comes to Clintrex following an accomplished career at the U.S. Food and Drug Administration (FDA) where he served in positions of increasing responsibility, most recently as Deputy Director of the Office of Neuroscience and Director of the Division of Neurology 2 in the Office of New Drugs. During his tenure at the FDA, Dr. Lee led the division responsible for the regulation of all Investigational New Drug (IND) applications, New Drug Applications (NDAs), and Biological Licensing Applications (BLAs) for drugs being developed and/or approved for the treatment of neuroimmunologic conditions of the central nervous system (such as multiple sclerosis and autoimmune encephalitis), epilepsies, migraine, stroke, traumatic brain injury, and inner ear disorders. As Deputy Director of the Office of Neuroscience, Dr. Lee supervised both Divisions of Neurology and the Division of Psychiatry, represented the Office at international meetings on stroke, epilepsy, and Alzheimer’s disease, and participated in two consequential advisory committee meetings.
Jordan Dubow, M.D., Managing Principal at Clintrex, commented, "It is a great honor to welcome Dr. Lee to the Clintrex team. Dr. Lee is an outstanding clinician and regulator who has an exemplary record of reviewing new drugs and interacting with pharmaceutical companies in the Office of Neuroscience.”
Prior to joining the FDA, Dr. Lee was a staff clinician at the National Human Genome Research Institute where he was a principal investigator in clinical trials of rare diseases and was a reviewer in the renowned Undiagnosed Diseases Program. Dr. Lee completed his residency training in pediatrics at Sinai Hospital of Baltimore, his child neurology residency training at Johns Hopkins, and his fellowship training in neuroimmunology at the National Institute of Neurological Disorders and Stroke. As part of a combined M.D./Ph.D. program, he received his M.D. from the University of Maryland School of Medicine and his Ph.D. in Neuroscience from the University of Maryland, Baltimore.
Karl Kieburtz, M.D. Managing Principal at Clintrex said, “Dr. Lee’s knowledge and expertise in the regulatory process, as well as his deep experience in pediatric and rare diseases, strengthens Clintrex’s regulatory expertise in neurological and psychiatric diseases. Dr Lee is now the third former division director of neurology at the FDA to join the Clintrex team to help companies navigate complex regulatory issues."
About Clintrex
Clintrex Research (Clintrex), a division of BlueRidge Life Sciences, provides scientific, clinical trial, operational, and regulatory assistance to pharmaceutical and biotech companies engaged in the development of new therapies for central nervous system disorders. Clintrex principals have led clinical trials and provided regulatory assistance for companies in the US, Europe and Japan supporting the development of small molecules, devices and biologics that have resulted in the approval of multiple therapies for various neurological disorders. Its team includes leaders in the global scientific, neurological and regulatory communities. For more information, please visit clintrex.com.
About BlueRidge Life Sciences
BlueRidge Life Sciences offers integrated solutions to address complex technical, clinical, and regulatory challenges. With a team of highly experienced scientific, medical, regulatory, and engineering professionals, BlueRidge experts collaborate to deliver science-driven solutions to help clients navigate regulatory requirements, assess safety and efficacy, assess and manage human health and environmental risks, and optimize pharmaceutical commercialization strategies. For more information, visit blueridgelifesciences.com.
Contacts
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