Sandy serves as Vice President of Regulatory Affairs and Quality Assurance. He is responsible for the company’s strategies, activities and interactions associated with all regulated activities and compliance with the U.S. Food and Drug Administration (FDA) and international regulatory agencies. He will also serve as a member of the company’s senior management and Pharmaceutical Leadership Team (PLT).

Prior to joining Tikvah Therapeutics, Sandy served as Senior Director of Fast Trak BioDefense at GE Healthcare and Senior Regulatory Adviser to GE Healthcare Life Sciences. He was responsible for the Fast Trak BioDefense Program, providing grant funding, regulatory, scientific and technical support to the biodefense research programs and biomedical companies.

Sandy’s career spans 30 years, including academic responsibilities in biomedical entrepreneurship; consultant to the industry and the FDA; founder of a successful family of international regulatory and bioinformatics companies; and regulatory advisor to the EMEA, South Korea Food and Drug Administration, Food and Drug Administration of China, and Canadian Bureau of Biologics.

Sandy’s academic responsibilities included roles in biomedical entrepreneurship as Vice President and Director of the Institute of Entrepreneurship, Muhlenberg College where he directed research tracking emerging regulations from FDA, EPA, NIST, CDC, ISO and European and Japanese agencies. He also taught academic and industrial courses on venture capital, regulatory affairs and compliance; Professor, Institute of Biomedical Sciences & Engineering, Drexel University where he was responsible for researching system validation regulations, international regulatory harmonization with the FDA, European Commission and ISO; Professor and Chair, Department of Information Systems and Management, St. Joseph’s University where he had management responsibility and research in regulatory compliance.

Sandy founded managed and grew four prominent international regulatory and bioinformatics companies including Weinberg Associates, Weinberg Spelton and Sax, International Validation Forum and Validation Data Systems including raising venture capital, developing intellectual property and strategic management. These companies provided regulatory related consulting for pharmaceutical, biotechnology, medical device and diagnostic companies worldwide. After running the companies for 10 years, he successfully sold off all of these companies and retired for a very brief period of time.

He is the author of 14 regulatory books and more than 100 related articles.

Sandy earned his bachelor’s degree from Dickinson College and his master’s degree from the University of North Carolina. He earned his doctorate degree from University of Michigan biomedical informatics studying adrenal reactions in high stress environments. He completed post-doctoral studies in Computer Engineering at the University of Florida where he developed computer models of complex biomedical problem solving.

Sandy serves as an international ambassador for the Boy Scouts of America (BSA) and as health and safety advisor to the Atlanta Area Council of the BSA. He also serves on the advisory boards of three emerging companies.