Accumulus Synergy Announces the Appointment of Khushboo Sharma as Chief Regulatory Innovation Officer
“We are extremely excited that Khushboo is joining Accumulus Synergy as she brings a wealth of experience from her tenure at the US Food and Drug Administration (FDA) and Biotechnology Innovation Organization (BIO), strong engagement with Health Authorities around the world, along with proven leadership in working with sponsor organizations of all sizes,” said Frank Nogueira, CEO of Accumulus Synergy.
Khushboo Sharma joins Accumulus Synergy from BIO where she most recently 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 though 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.
About Accumulus Synergy, Inc.
Accumulus Synergy, Inc. was formed in 2020 to create a cloud-based platform to transform data sharing between the biopharma industry and global health authorities. The common-platform approach aims to improve efficiencies in the regulatory process by leveraging advanced technology, including data science and AI, as well as tools for secure data exchange to improve patient safety, help reduce the cost of innovation, and ultimately bring patients safe and effective medicines faster. It will work with partner companies, key stakeholders, and global health authorities to build and sustain a platform that meets regulatory, cybersecurity, and privacy requirements spanning clinical, safety, chemistry and manufacturing, and regulatory exchanges and submissions. Accumulus Synergy sponsors include Amgen, Astellas, AstraZeneca, Bristol Myers Squibb, GSK, Johnson & Johnson, Lilly, Pfizer, Roche, Sanofi, and Takeda.