Healthcare Industry News: valproic acid
News Release - April 16, 2019
Cerebral Therapeutics Strengthens Clinical Development Leadership with Strategic AppointmentsLisa Shafer, Ph.D., Chief Scientific Officer, and Eric Distad, Vice President of Clinical Development, add Extensive CNS Drug-Device Development Experience
AURORA, Colo., April 16, 2019 -- (Healthcare Sales & Marketing Network) -- Cerebral Therapeutics, a clinical-stage pharmaceutical company developing specialty medications for uncontrolled neurological diseases, announced today the appointments of Lisa Shafer, Ph.D., as Chief Scientific Officer, and Eric Distad as Vice President of Clinical Development.
"Lisa and Eric bring decades of leadership experience in successfully developing specialized drug-device combination therapies to Cerebral Therapeutics," said Dan Abrams, M.D., President and CEO. "Drug-device combination therapies play a vital role in the healthcare landscape; but adds complexity to the regulatory process. Both Lisa and Eric are uniquely experienced in successfully navigating this development and approval pathway. They join Cerebral Therapeutics at a critical juncture as we advance our therapy for severe refractory epilepsy patients, prepare for regulatory filings with the U.S. Food and Drug Administration (FDA) and enroll more patients in our clinical studies."
Dr. Shafer's technical and leadership experience in R&D, strategy, product and business development spans the medical device, biotechnology and pharmaceutical industries. Prior to her experience in the pharmaceutical industry, Dr. Shafer spent more than 10 years in the medical device industry. While at Medtronic Inc., Dr. Shafer held various roles in neuromodulation research, drug-device combination product development, and management. Dr. Shafer's foundational research and leadership resulted in seminal publications regarding mechanistic, proof-of-concept and clinical evidence for a portfolio of translational and clinical research programs to advance targeted drug-delivery to the central nervous system (CNS). Dr. Shafer began her career at 3M in the Pharmaceutical and Drug Delivery Division, and she holds a B.S. in Genetics and Cell Biology and a Ph.D. in Neuroimmunology.
"I am thrilled to be joining the company at this time in its development," said Dr. Shafer. "Cerebral Therapeutics' therapy has the potential to change patients' lives and offer a new modality to a disease in desperate need of new treatments."
Mr. Distad, Vice President of Clinical Development, has more than 24 years' experience in medical device and combination product clinical development. Mr. Distad has been responsible for the development and management of more than 40 investigational device exemption (IDE) studies from protocol development through final submission resulting in numerous global product approvals. Mr. Distad has focused his efforts on Class III devices and drug-device combination products in the therapeutic areas of movement disorders and epilepsy. Prior to joining Cerebral Therapeutics, Mr. Distad's experience included Global Program Management at Medtronic in the Cardiac Rhythm Management and Neuromodulation Divisions, start-up and early commercial orthopedic companies, as well as leadership roles at two large Clinical Research Organizations within their Global Medical Device and Combination Product Divisions. In addition, Mr. Distad has served in advisory positions for Medical Technology Angel Funding groups, International Medical Device and Combination Product Regulatory Panels and Therapeutic Advisory Panels.
"Since joining Cerebral Therapeutics, I have seen firsthand the tremendous impact this therapy has demonstrated in patients' lives during our early-phase study," said Mr. Distad. "I am very excited to contribute to this potentially life-changing therapy through clinical development and on to the U.S. and global markets."
Epilepsy is the fourth most common neurological problem in the world. Approximately three million people in the United States are living with epilepsy, with one million people experiencing uncontrolled seizures; medications and surgery have not been an option for the majority of these patients. Cerebral Therapeutics' therapy uses a specialized implanted, refillable catheter – pump infusion system to deliver a continuous micro dose of its proprietary formulation of valproic acid called CT001 for which Cerebral Therapeutics has an exclusive license agreement from the University of Colorado.
About Cerebral Therapeutics
Cerebral Therapeutics is a clinical-stage company dedicated to improving the lives of patients living with severe refractory epilepsy. Founded by experts in the fields of neurology, neurosurgery and drug delivery, the Company is pioneering the development of drug-device combination therapies that enable precise targeted delivery to the central nervous system. The goal of this novel approach is to maximize efficacy while greatly reducing systemic drug exposure and enhancing drug regimen compliance. Cerebral Therapeutics' infusion therapy may offer a more efficacious and reliable approach to treating neurological diseases for which oral and I.V. infused medicines are not able to achieve adequate control and/or are limited by systemic toxicities. For more information please visit www.cerebraltherapeutics.com.
Source: Cerebral Therapeutics
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