Wednesday April 17, 2019 0 comments
AURORA -- Cerebral Therapeutics, a clinical-stage pharmaceutical company developing specialty medications for uncontrolled neurological diseases, announced the appointments of Lisa Shafer as chief scientific officer, and Eric Distad as VP 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, Cerebral’s 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 and enroll more patients in our clinical studies."
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, Shafer spent more than 10 years in the medical device industry.
While at Medtronic Inc., Shafer held various roles in neuromodulation research, drug-device combination product development, and management. Her 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.
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 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."
Distad has more than 24 years' experience in medical device and combination product clinical development. He has been responsible for the development and management of more than 40 investigational device exemption studies from protocol development through final submission resulting in numerous global product approvals.
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, his experience included Global Program Management at Medtronic in the Cardiac Rhythm Management and Neuromodulation Divisions, startup 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, he 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 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 U.S. are living with epilepsy.