BURLINGAME, CA, August 15, 2022 – Accumulus Synergy, a non-profit organization
working to develop an information and data exchange platform aimed at transforming
how drug innovators and health authorities worldwide interact, today announced the
appointment of Khushboo Sharma as its Chief Regulatory Innovation Officer and a
member of the company’s Executive Leadership Team (ELT).
“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
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. For more
information, please visit www.accumulus.org.