Life Sciences Consulting
- Medical Affairs
- Scientific Staffing
- Product Development
- Correlates of Protection analysis
- Laboratory Concordance Studies
- Clinical Trial Support and Logistics
- Product Strategy Development and Planning
- Sample Repository and Stability Management
- Lifecycle Support (Drug Substance/Drug Product)
- Regulatory Affairs Support including Health Authority Filings
- Pre-clinical and Clinical Immunoassay Development and Validation
- Small Molecules/API Support (Pharmaceutics/Formulation/CMC, Scalability and Process Chemistry)
- Biologics Support (Process Development, CMC, GMP manufacturing, and QA) for product development and clinical evaluation of vaccines and biological therapeutics
Case Study
Our Experience Providing Product Development and R&D Support
In May 2020, the US government (USG) launched Operation Warp Speed in response to the COVID-19 pandemic to accelerate COVID-19 Vaccine and Therapeutic Development. As part of that effort, the USG established an initiative to determine the correlates of protection (CoP), an easily-measured biomarker that correlates with vaccine efficacy, for COVID-19 vaccines. Shabas was engaged as a subcontractor and its SMEs provide technical and operational support for the initiative to coordinate with vaccine developers, CROs and statisticians to obtain samples from efficacy studies, run assays, and conduct statistical analyses.
Problems and Solutions
- CoPs were established for Phase 3 COVID-19 vaccine clinical trials against the original Wuhan Strain at peak immunogenicity; however, acceptance of these data within regulatory agencies has been slow. At the July 2022, White House summit on the future of COVID-19 Vaccines, several speakers pointed to the absence of an immune correlate of protection as a barrier to vaccine progress. Due to the complex and expanding scope of work with the COVID-19 vaccines CoP, the USG requested technical and program management support to continue building the case for the establishment of a COVID-19 vaccine CoP.
- Shabas SMEs have supported the USG with the coordination of academic and government laboratories to develop, qualify and validate new antibody-based assays; develop statistical plans for conducting CoP analysis; coordinate sample selection with vaccine manufacturers, transfer of samples to testing laboratories, laboratory testing of study samples and sharing immunogenicity data; and sharing the CoP results with internal and external stakeholders and the broader scientific community through briefings and scientific publications.
- The emergence of new SARS CoV-2 variants has complicated the establishment of a CoP, impacting the ability of regulators to monitor the durability of vaccine and therapeutics efficacy. Shabas SMEs assisted USG with development of prioritization list and criteria for assay development aimed at addressing those challenges.
Impact
- Our broad experience in clinical testing, working with government agencies, CROs, assay development, and data analysis has accelerated sample testing, statistical analyses, and publishing of COVID-19 vaccines CoPs research. These data are being used to establish a prespecified biomarker that can be measured in a limited-sample size immunological bridging study and compared to an established benchmark to inform regulatory agency decisions for future vaccine strain selection and booster doses.
