Vaccine Development Experience Across the Continuum of Drug Development
“Once everyone has a moment to pause and reflect, we’ll learn many lessons from this pandemic—whether it was learning to have clinical monitors in closer geographic proximity or developing the ability to do remote monitoring. There are multiple changes across the industry, and we’re not going to go backward. We’ll continue to move forward.”
Pandemic Preparedness and Rapid Response
During the pandemic, PPD developed leading approaches to help accelerate COVID-19 vaccines and other therapeutics for emerging and high-risk diseases.
PPD supported many COVID-19 vaccine studies and vaccine development efforts with its dedicated vaccines unit: an established global network of sites, principal investigators, clinical research associates (CRAs) and site staff with specific vaccine experience. We worked at warp speed to make sense of an evolving regulatory environment to accelerate vaccine development, while also solving customer challenges, such as recruiting diverse populations, boosting vaccine infrastructure to tackle future pandemics, and supporting the next generation of mRNA vaccines and therapeutics.
PPD emerged as an early leader in the COVID-19 pandemic space, conducting some of the very first clinical trials, which ultimately led to multiple vaccines receiving emergency use authorizations (EUAs) and rapid global marketing authorizations. We continue to innovate, refine and evolve the delivery of vaccine clinical trials to stay on the leading edge.
In 2021, PPD leveraged lessons learned to establish a blueprint for a pandemic preparedness rapid response workstream. At the foundation of our robust, expedited, end-to-end delivery model for pandemic response are proven strategies for vaccine development that help clients navigate and respond to future public health emergencies.
Vaccine Clinical Trials Expertise and End-to-End Clinical Consulting
Our global team of therapeutic specialists is fully immersed in the latest advances in vaccine development with expertise in trial design, data analytics, manufacturing, project management, logistics, laboratory testing, pharmacovigilance and regulatory requirements. We combine our extensive therapeutic and laboratory expertise with our global resources to offer a distinctive caliber of vaccine development services.
Joining Thermo Fisher Scientific has allowed for the expansion of PPD’s end-to-end vaccine capabilities with the addition of manufacturing. Thermo Fisher Scientific, a global leader in vaccine clinical development and vaccine clinical trial services, partnered with global vaccine manufacturers during the COVID-19 pandemic to provide a wealth of end-to-end clinical consulting and clinical development services expertise. Our vast combined knowledge of the vaccine regulatory landscape, and global regulatory expertise, makes us the best CRO for vaccine development, especially in the emerging mRNA vaccines and therapeutics space.
PPD has vaccine experience across all populations and phases. Our vaccine development team comprises medical, operational and laboratory experts who are dedicated to vaccine clinical trials and supported by the resources of a leading global CRO. Our skilled, global clinical development team of more than 2,000 vaccine experts boast a historically low turnover rate. PPD’s dedicated business unit for vaccines offers consistency across assigned study teams and works fast to stay ahead of future public health challenges.
PPD services can be tailored across trial phases, for localized or global studies, for biotech and large pharmaceutical companies, and not-for-profit and governmental programs. Our footprint extends across six continents — with local expertise in all regions — to apply needed insights for trial approvals, site identification and close oversight during study conduct. Our technologies enable rapid and transparent risk assessments and data access for subject safety on a real-time basis. Our proven solutions cover the entire life cycle of vaccine development — from early development to Phase II/III, to pharmacovigilance, to peri- and post-approval services — to ensure your product’s success.
Paving the way in mRNA vaccine and therapeutics development
The COVID-19 pandemic elevated the need for a rapidly testable and deployable vaccine, which could be produced amid supply chain disruptions and in line with regulatory considerations. The pandemic also shed light on the need for greater pandemic preparedness for vaccines in novel disease targets.
mRNA vaccines entered the limelight because they could be designed quickly and tested immediately. Companies continue to make advances in the mRNA space following the successful clinical development of the first mRNA vaccine to prevent hospitalization for severe disease and death in those infected with COVID-19. Thermo Fisher Scientific, the parent company of PPD, had the opportunity to partner with mRNA vaccine manufacturers to rise to the pandemic’s challenges.
Studies are in progress to validate mRNA vaccines for more viruses including CMV, RSV and influenza. Many of the vaccines currently in clinical development may also be used together as combination vaccines.
The mRNA vaccine landscape is nascent, with promising advances in store in the coming months and years. The market for COVID-19 vaccine boosters will continue to grow, and advances in mRNA vaccine technology have paved the way for new therapeutics. mRNA vaccine technology in development includes preventative vaccines, cancer vaccines, regenerative therapeutics (including cell and gene therapies), and vaccines to inject into solid tumors and to help combat heart disease.
As a global leader in vaccine clinical trial services, PPD is at the forefront of digital and decentralized clinical trials solutions, vaccine clinical research, and global regulatory expertise, and understands the challenges of mRNA vaccine and therapeutics development.
End-to-end solutions to support pandemic preparedness
PPD’s experience across many COVID-19 vaccine studies and end-to-end services allow us to provide customized and integrated solutions that accelerate vaccine development timelines. Our agile and flexible model can include risk-based monitoring, near real-time access to safety assessments via interactive dashboards, and digitally enabled technologies to conduct low- or no-contact trials. Our commitment to urgency includes:
- Global operational teams with pandemic vaccine expertise, enabling us to deploy knowledgeable resources in expedited timeframes
- Statistical and epidemiological modeling to aid trial planning, site selection processes and alignment of demography of study populations
- Global network of Accelerated Enrollment Solutions (AES) sites for vaccine clinical trials with surge capability of up to 3,000 patients per week and experience in emerging disease vaccines
- Digital solutions to speed recruitment and support remote/virtual patient follow-up post-vaccination
- Deep experience navigating government contract requirements, and close collaboration with health authorities to avoid unnecessary delays
- Global clinical supplies capabilities with direct-to-patient options
- Digital and decentralized solutions to increase clinical trial access for patients, improve their overall experience, produce efficiencies and enhance data quality
- Integrated PPD Laboratory services, including serology, neutralizing antibody and functional assays designed specifically for COVID-19 trials, as well as peripheral blood mononuclear cells (PBMCs) capabilities
High-Quality Results through our Vaccine Sciences Labs
Our vaccine sciences lab offers custom assay development, clinical testing and submission support services for new, modified and existing vaccines. Our capabilities and more than 25 years of specialized vaccine laboratory experience ensure development of innovative analytical methods and accurate, high-quality test results. We work with clients of all sizes across a wide spectrum of vaccine programs — from legacy vaccines to emerging pathogens. Our vast global footprint enables rapid deployment of teams to support the staffing needs of vaccine studies, including separate unblinded teams. We offer:
- PPD priority vaccine sites and networks to support rapid startup and timely enrollment with performance guarantees
- Expertise with seasonal studies and Northern/Southern Hemisphere execution strategies
- Innovative, real-time data technology to support safety trends analysis and decision-making during trial conduct
- Operational expertise to deliver pivotal, field-efficacy studies globally and across a range of targeted populations
- Rapid site identification and capacity to support large vaccine efficacy trials
- Broad experience with cold-chain management and sample logistics
- Distinct quality control for serology specimens, including storage facilities with centralized alarm systems to protect serum integrity
- Expertise in immune assay development and laboratory testing
Integrated Biostatistics Experts
We have an experienced biostatistics group that is fully integrated into our PPD Laboratory services operations from scheduling through data archiving. Our proprietary, fully electronic system supports the development, qualification, validation and routine maintenance of vaccine assays with tools specifically created to support complex bio functional assays and molecular genomics studies.
- Streamlined the documentation process
- Complete electronic audit trail
- Improved data integrity and quality
- Reduced full-time equivalent (FTE) time and cost