TO THE POINT
- Former Senior Vice President, Global Regulatory Affairs, at Medtronic
- 30 years of experience
- Master’s degree and PhD in Biomedical Sciences from NYU
- Medical Degree from University of Miami
- Former Chair of the Regulatory Affairs Professional Society
- Former Chair of the Society for Women’s Health Research (SWHR)
- Served on Executive Committee Clinical Trials Transformation Initiative (CTTI)
- Senior Advisor and Regulator Consultant to investment & medical firms
- Former Director, Office of Device Evaluation, FDA
Dr. Susan Alpert, MD, PhD
Lead Regulatory Consultant
Dr. Alpert is leading Cognos Therapeutics’ regulatory efforts. Dr. Alpert has had an extensive career of more than 30 years. Dr. Alpert was most recently the Executive Vice President of Regulatory Affairs for Exalenz Bioscience Ltd, and has been the Senior Advisor and Regulatory Consultant for Accelmed and several medical firms.
In her eight year career with Medtronic, she held many positions, including six years as Senior Vice President, Chief Regulatory Officer of Medtronic. In that role, Dr. Alpert was responsible for all Medtronic global regulatory efforts.
Prior to joining Medtronic, Dr. Alpert served as Vice President of Regulatory Sciences for C.R. Bard, Inc.
She also previously worked at the Food and Drug Administration (FDA) where she held a variety of positions in the centers dealing with drugs, devices and radiological health and foods, including six years as the Director of the Office of Device Evaluation.
Dr. Alpert is a Microbiologist and Pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials. Dr. Alpert completed her undergraduate degree at Barnard College, Columbia University and holds a Master’s degree and PhD in Biomedical Sciences from New York University. She received her Medical Degree from the University of Miami, and completed her clinical training at Montefiore Medical Center and at Children’s National Medical Center.
Dr. Alpert is active in several industry leadership organizations, including past Chair of the Regulatory Affairs Professional Society and a Fellow in that society. She also served on the Executive Committee of the Clinical Trials Transformation Initiative (CTTI), one of the public/private partnerships working with the FDA to streamline the development of medical products. Dr. Alpert served as Chair for the Society for Women’s Health Research, an organization promoting research on gender differences in health and disease, and has served on the board of the Food Drug Law Institute (FDLI), a forum for the FDA and the legal, business, academic and consumer communities to exchange perspectives on public policy, law and regulation relating to products subject to FDA jurisdiction. In addition, she served on the Board of Advisors for the Medical Technology Leadership Forum (MTLF), an educational organization focused on policy makers, the general public, and the media regarding critical issues affecting the development and adoption of advanced medical technology, and on the Board of the Women Business Leaders, or organization of women leaders in the health care sector.