Jan 12, 2023
Reimagining R&D Webinar Series presenting “Re-Imagining Drug Development with a Transformative Approach to Regulatory Submissions.”
Vivpro Corporation has partnered with experts and industry leaders to discuss critical pharma and biotech topics. Our goal is to share valuable information and allow the audience to engage with questions while they receive real-time feedback.
For our January session, we are joined by Khushboo Sharma, Chief Regulatory Innovation Officer, at Accumulus Synergy.
Session Overview
Learn about the impetus behind transforming how the drug innovators and health regulators interact.
Learn about global information exchange platform being developed by Accumulus Synergy to transform these interactions.
Understand the vision and the role played by different stakeholders.
Discuss use cases and the role the proposed platform will play in shaping the future of regulatory submissions.
About Khushboo Sharma
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 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.
