child receiving vaccination shot

Vaccine Development

EXPERTISE AND FLEXIBILITY TO ACCELERATE YOUR VACCINE PROGRAM

Vaccines are among the greatest advancements in public health, and developing new vaccines remains one of the most difficult challenges we face. As vaccine development researchers achieve important success to control one devastating disease, another pathogen emerges. Your vaccine strategy represents an important blueprint for tackling some of the world’s most deadly and disabling diseases and ensuring science and society work together to protect public health.

At PPD, we apply the expansive global footprint, development capabilities and expertise we’ve built in vaccine development to help customers attend to the unique needs of vaccine trials and accelerate development with proven solutions and dedicated resources.

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Staff with vaccines experience

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Studies in the past five years

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Priority network sites

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Mega trials successfully completed

Up to 30,000

Patients in each mega trial

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COVID-19 vaccine and therapy awards*

*as of August 4, 2020

“We understand the urgency surrounding the development of vaccines, now more than ever. We provide innovative solutions to expedite clinical trials to accelerate vaccines. In these challenging times, our mission has never been more clear — helping deliver life-changing therapies to people in need.”

25+ YEARS OF VACCINE DEVELOPMENT EXPERIENCE

As a global team of therapeutic specialists, we are fully immersed in the latest advances in the field of 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.

Our 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. This expertise, coupled with advanced technologies, enable us to provide an unparalleled partnership for your vaccine development needs.

PPD has conducted vaccine studies in more than 90 countries

END-TO-END SOLUTIONS TO EXPEDITE COVID-19 VACCINE DEVELOPMENT

PPD’s early and evolving experience and end-to-end services allow us to provide customized and integrated solutions that accelerate COVID-19 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
  • Dedicated tools to identify prevalent regions for COVID-19 and 100+ infectious disease and vaccine specialists in Latin America
  • Use of the Weekly Assessment of COVID Epidemiology (WAVE) prediction model to aid trial planning, site selection processes and alignment of demography of study population with epidemiology
  • Global network of 60+ AES/Optimal vaccine sites with surge capability of up to 3,000 patients per week, experienced 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 laboratory services including serology, neutralizing antibody and functional assays designed specifically for COVID-19 trials, as well as PBMC capabilities

BROAD EXPERTISE IN VACCINES CLINICAL TRIALS

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

Vector/Zoonotic
Dengue, malaria, West Nile,
Zika, Chikungunya, Japanese
Encephalitis, rabies, yellow fever

Respiratory
RSV, SARS/MERS, pandemic SARS-CoV-2, pandemic flu, seasonal flu, meningococcal, pneumococcal, tuberculosis, pertussis, strep A/B, diphtheria

Enteric
Rotavirus, norovirus,
E. coli, Shigella, typhoid,
cholera, C. difficile

Sexually transmitted
HIV, HPV, CMV, herpes,
chlamydia, hepatitis B

Other
Hepatitis, rubella, measles,
mumps, MMR, varicella, tetanus,
polio, HIB, Staph. aureus

Real-Time Access to Clinical Trial Data

Preclarus®, our comprehensive data solution, provides real-time access to the tremendous quantity of clinical trial operations and subject data produced in vaccine studies. Our Preclarus solution enables:

Collection of subject-level data, which facilitates real-time feedback on safety and immunogenicity measures and direct communication of key study assessments
An integrated technology platform that links data across sites and laboratories

Less frequent on-site monitoring visits and a remote monitoring approach with a customizable plan drive by continuous site-level risk assessment
Development of eSource solutions for sites, allowing for more immediate access to source documentation and facilitating remote source verification

Targeted High-Quality Monitoring Strategies Tailored to Vaccine Studies

We leverage the Preclarus platform as part of our approach to risk-based monitoring to create a customized profile of subjects across a wide range of clinical laboratory findings and to review safety trends for vaccine reactogenicity, labs and toxicity gradings. We share this data with you to inform early phase research and dose escalation meetings.

We create study-specific, risk-based monitoring plans based on key site performance indicators. This proprietary method allows CRAs to maximize their time on-site and focus holistically on site performance. This approach provides cost savings in conjunction with quality data.

Laboratory Services for Vaccine Studies

PPD Laboratories’ 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 have an experienced biostatistics group that is fully integrated into our lab 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 biofunctional 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
PPD Laboratories has supported 15 vaccine programs approved by the U.S. Food and Drug Administration and has experience with more than 25 therapeutic agents that are currently being assessed for use against COVID-19.

Access to Special Subject Populations

Our priority vaccine site network includes 450 high-quality vaccine-experienced sites across all geographic regions that have with vast experience with diverse patient populations, including:

  • Pediatric
  • Adolescent
  • Elderly
  • Maternal