Chief Regulatory Innovation Officer
Khushboo Sharma joins Accumulus Synergy as Chief Regulatory Innovation Officer. Most recently, she served as Chief of Staff and Senior Vice President at BIO. She oversaw the Science and Regulatory team that largely focused on major regulatory policy initiatives spanning from preclinical through post-market activities. Through her work at BIO, Khushboo was at the forefront of identifying challenges and offering concrete solutions and suggestions to help build the appropriate regulatory framework.
Khushboo joined BIO in 2021 after spending 11 years in various roles at the FDA, including Deputy Director of Operations in the Office of New Drugs (OND). She oversaw business, regulatory, and programmatic operations, supported regulatory review for the New Drugs Regulatory Program through the New Drugs Modernization effort, and served as an FDA negotiator during the latest Prescription Drugs User Fee Act (PDUFA) negotiations. Khushboo was named as one of InVivo’s Rising 30 Leaders in 2021 in Healthcare and Science.
Prior to joining the FDA, Khushboo worked as a scientist for four years at Janssen Pharmaceuticals, where she managed oncology and therapeutic monoclonal antibody drug products, supporting development in Phase I/II and Phase III clinical studies. She earned an undergraduate degree in Biotechnology and Microbiology and her master’s degree in Business Administration in Healthcare and Biotechnology Industry Management, both from Pennsylvania State University.