Moderna and Thermo Fisher Scientific Win TOPRA Award for Regulatory Excellence for COVID-19 Vaccine Authorization
WILMINGTON, N.C. (February 8, 2023) –The PPD clinical research business of Thermo Fisher Scientific Inc., the world leader in serving science, and Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, have won a 2022 TOPRA Award for Regulatory Excellence, recognizing the important partnership of their regulatory affairs teams in expediting vaccine submission and approval during the COVID-19 global pandemic.
The TOPRA award honors Moderna and the PPD clinical research business for their ongoing collaboration on the regulatory approval process for Moderna’s mRNA COVID-19 vaccine. The PPD clinical research business supported Moderna on a diverse range of regulatory activities, from the provision of technical advice and regulatory support to the preparation and submission of marketing authorization applications. The partnership between the teams enabled the submission of the conditional marketing authorisation in the European Union through the rolling review procedure, as well as the successful submission of an emergency use authorization application and a subsequent biologics license application in the United States. This regulatory support underpinned the process of bringing the Moderna mRNA vaccine to patients in an expedited timeframe under pandemic conditions.
“The PPD team has been a trusted, reliable and engaged partner that was instrumental in helping Moderna’s COVID-19 vaccine reach the finish line and delivering an immense impact on public health,” said Charbel Haber, senior vice president and head of global regulatory science, Moderna.
“Through a professional and trusted approach, these teams worked tirelessly to meet incredible goals during the submission and approval of Moderna’s vaccine,” said Sebastian Pacios, president, clinical development services, clinical research, Thermo Fisher Scientific. “Despite constraints and challenges imposed by pandemic conditions, we worked with Moderna to develop an efficient global regulatory support system, enabling our teams to meet expedited timelines for the submission of a quality product globally. We are thankful for Moderna’s continued confidence in us to assist its team in gaining regulatory authorizations and approvals.”
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.
The PPD clinical research business provides end-to-end, full-service vaccine development capabilities and is recognized as a market leader in the mRNA technology space. As an experienced contract research organization partner, the business enables biotech, pharmaceutical and government leaders to save time and resources when developing mRNA-based vaccines and therapeutics, and, when necessary, to rapidly address unmet or urgent public health needs.
Additionally, the PPD clinical research team has supported Moderna’s research initiatives since 2016 across its expanding portfolio, including vaccines, oncology, rare diseases and autoimmune conditions. Earlier this year, Thermo Fisher announced a 15-year strategic collaboration agreement with Moderna for dedicated large-scale manufacturing in the U.S. of the Moderna COVID-19 vaccine other investigational mRNA medicines in its pipeline. This expanded agreement includes dedicated capacity for a range of aseptic fill-finish services, including lyophilized and liquid filling, and inspection, labeling and final packaging services.
The PPD clinical research business and Moderna were also named “Clinical Research Team of the Year” at the 2021 Citeline Awards competition for the teams’ collaborative approach to vaccine trials, including the pivotal Phase III COVE study.
About Thermo Fisher Scientific
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue of more than $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories, improving patient health through diagnostics or the development and manufacture of life-changing therapies, we are here to support them. Our global team delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.
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