CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cognito Therapeutics, a pioneer in non-invasive optogenetics to treat neurodegenerative diseases, announced today the appointment of Jennifer Newberger as Vice President, Head of Regulatory Affairs and Compliance. In this role, Jennifer will lead key regulatory, compliance and operations activities at Cognito in conjunction with the leadership team.
Jennifer brings nearly 15 years of experience across medical device, software, and digital health regulatory matters. After ten years as a regulatory attorney in the life sciences and digital health space, Jennifer joined Apple to help drive its global regulatory strategy. She played an instrumental role in obtaining Apple’s first de novo authorizations for its ECG app and irregular rhythm notification. After four years at Apple, Jennifer worked at Abbott Laboratories, providing support to the diagnostics and diabetes care business units in the US, Canada, and Latin America. Jennifer has also served as a policy advisor at the U.S. Food and Drug Administration and a public health analyst at the Centers for Disease Control and Prevention.
“As Cognito prepares to launch our pivotal study of our lead treatment for mild-to-moderate Alzheimer’s next year, we are excited to have Jennifer join us to further strengthen our leadership team and regulatory expertise,” said Brent Vaughan, Chief Executive Officer of Cognito Therapeutics. “Her experience navigating the intersection of technology and medical devices to gain FDA approvals for innovative medical products that can change the standard of care for millions of people, will be invaluable as Cognito prepares to launch its Phase 3 pivotal study in Alzheimer’s disease next year.”
“Cognito’s breakthrough designated platform has the potential to transform the landscape across a number of indications by addressing the etiology of neurodegenerative diseases, beginning with Alzheimer’s,” said Jennifer Newberger, Vice President, Head of Regulatory and Compliance, Cognito Therapeutics. “I look forward to working with Brent and the rest of the executive leadership team to bring Cognito’s next-generation platform to patients suffering from neurodegenerative disorders.”
Jennifer has a B.A. in anthropology from Washington University in St. Louis, an M.P.H in international health from Emory University and a J.D. from the University of Miami School of Law.
About Cognito Therapeutics
Cognito Therapeutics is a pioneer in optogenetics to treat neurodegenerative diseases and improve human cognitive performance. The company has completed multiple clinical studies demonstrating its investigational therapeutic has the potential to safely slow or stop cognitive decline and loss of brain volume in Alzheimer’s disease. Cognito has received FDA Breakthrough Device Designation for the treatment of Alzheimer’s disease and expects to start pivotal studies in 2022. The company’s technology was based on pioneering optogenetics research by scientific co-founders Professors Li-Huei Tsai and Ed Boyden at MIT. Cognito Therapeutics is based in Cambridge, MA. For more information, please visit www.cognitotx.com. Follow us on Twitter at @cognitotx.