April 1, 2022 – The clinical research business of Thermo Fisher Scientific has won a 2021 TOPRA Award for Regulatory Excellence, recognizing the important role of its regulatory affairs team in expediting vaccine approvals during the COVID-19 global pandemic.
The TOPRA Award resulted from a nomination by Novavax, a Maryland-based biotechnology firm that has developed its own protein-based COVID-19 vaccine. Novavax made the nomination in the “support” category based on its ongoing clinical research organization (CRO) partnership with PPD, a leading global CRO that Thermo Fisher acquired in December 2021.
“The support PPD offered to our regulatory operations team has been integral to our success in working with regulatory authorities around the globe,” said Henrietta Ukwu, M.D., chief regulatory officer, Novavax, and winner of the TOPRA 2012 Inspirational Leadership Award. “PPD’s global footprint enabled timely, near simultaneous and successful submissions to many regulatory agencies leading to the major accomplishment of regulatory agencies’ authorizations for the Novavax COVID-19 vaccine around the globe.”
As part of its support for Novavax’s COVID-19 vaccine development program, PPD engaged with the appropriate regulatory authorities to expedite the review and approval of Novavax’ innovative COVID-19 vaccine.
“Our team worked tirelessly and seamlessly to guide Novavax through the procedures to ensure timely COVID-19 vaccine approval,” said Cindy Elko-Simms, M.D., senior vice president, pharmacovigilance, regulatory affairs and medical writing, clinical research, Thermo Fisher Scientific. “I am proud of our team for their expertise and professionalism, and we’re thankful to Novavax for their trust and close collaboration.”
TOPRA, a global organization for regulatory affairs professionals, promotes the profession by providing support, education and accreditation. Each year, the organization holds an awards competition for regulatory excellence, and all submissions are evaluated by an independent judging panel in the regulatory sector.