Dr. Susan Alpert, MD, PhD, Joins Cognos Therapeutics as Lead Regulatory Consultant
Dr. Susan Alpert, MD, PhD, has been named Lead Regulatory Consultant for Cognos Therapeutics, Inc. Dr. Alpert is considered one of the top U.S. regulatory experts. Dr. Alpert leads the Cognos Therapeutics regulatory team’s FDA strategy and interaction for the approval of the Sinnais technology platform.
Among her many important positions spanning a 30 career, she was Senior Vice President and Chief Regulatory Officer of Medtronic, and Director for the Office of Device Evaluation/CDRH at the U.S. Food and Drug Administration.
Dr. Alpert is an Executive in Residence at the Medical Industry Leadership Institute at the Carlson School of Management. She holds a PhD in microbiology from the NYC School of Medicine and an MD from the University of Miami. She currently serves as a regulatory advisor for many medical device companies.
“We are delighted to have Dr. Alpert lead our regulatory affairs program,” CEO Frank Adell said. “With her expertise and intimate knowledge of the regulatory landscape for implantable devices and biologics, she will be important as we submit for FDA approval of our Sinnais Smart Implantable Pump technology.”
Cognos Therapeutics, headquartered in Los Angeles, is an implantable device manufacturer that is developing the Sinnais platform, a metronomic infusion pump system with an initial focus on neuropathic delivery.