PPD Laboratory Services, Biomarker Capabilities
Ensure biomarker usefulness for your drug and its potential for commercial success
The drug development field encounters numerous challenges – a significant one being low rates of success. Even after completing the preclinical process, many drugs may not make it to the market.
To expedite the availability of treatments, drug developers are increasingly seeking a biomarker-driven approach. This approach enhances success rates and reduces costs in the drug development process, ultimately moving the drug to market.
Biomarkers are critical to a trial’s success.
- Clinical trials are twice as likely to succeed if drug development companies use them.
- The use of biomarkers triples the chance of a drug moving from Phase I trials to market.
Our biomarker capabilities have provided biotech and pharmaceutical companies with a comprehensive analysis of biomarkers of interest and custom assay development by leveraging a diverse set of technologies, robust project management and dedicated expertise. Our specialized teams, platforms and instrumentation enable clients to make informed decisions and accelerate drug development.
Delivering the right expertise and capabilities
Scientists dedicated to biomarker programs
Studies completed in the past five years
Different compounds supported
Our expertise
Backed by over 20 years of experience and expertise, we will shape your biomarker strategy to ensure actionable results that drive informed decisions about the future of your compound. Our customers benefit from:
- Our biomarker development and validation services customized for each project
- Project-specific, de novo assays to help you measure your biomarkers throughout the trial
- Use of the best technology platform and the right development approaches, including flow cytometry, molecular genomics, LC-MS, next generation sequencing, ELISpot, ligand binding and anatomic pathology
- Development and validation methods under the appropriate regulatory guidelines at each stage of drug development
- Transference and cross-validation of assays to different/multiple locations or under multiple regulatory requirements
- Effective integration of safety and efficacy biomarkers into clinical development
- A tiered regulatory strategy developed for your project, from fit-for-purpose and GLP to GCLP and CAP/CLIA
Our capabilities
Our biomarker capabilities offer traditional ELISA, electrochemiluminescence and microfluidics-based ELISA, and we will work with you to develop a tiered approach to validation. Explore our capabilities:
Explore our flagship laboratory in Richmond, Virginia
PPD™ Laboratory services met or exceeded expectations for oncology and precision medicine for 100% of surveyed PPD customers1.
Integrated approach to meet your unique needs
Leveraging an integrated and flexible approach to biomarker development enables you to meet your project’s unique requirements
Our biomarker capabilities are integrated into both our central and bioanalytical labs, enabling us to fully customize your biomarker development strategy.
Our customers benefit from a cross-laboratory model that:
- Offers global coverage for studies of all sizes
- Allows the biomarker team to provide a customized development strategy for each project
- Leverages the operational experience of bioanalytical and central labs
- Provides access to clean lab data in real time
- Enables the biomarker lab to apply a tiered regulatory approach from fit-for-purpose (FFP) characterization to GLP/GCLP to CAP/CLIA
- Provides a lab concierge (dedicated project manager) to streamline communication between your team and our scientists, as well as sites, couriers and any third-party labs, and serves as your single point of contact
Learn more about our biomarker capabilities
To request a proposal or contact your local business development representative, please complete the form below.