PPD® Laboratory Services, Biomarker Lab
Drug dose. Therapeutic effects. Adverse events. Individualized responses.
Biomarkers reveal critical insights about your drug and its potential for commercial success.
In fact, biomarkers are so important that clinical trials are twice as likely to succeed if they use them, and the use of biomarkers triples the chance of a drug moving from Phase I trials to the market.
At PPD, we harness the full power of biomarker-driven data to rapidly move your drug toward market success.
Integration of laboratory expertise enables:
- Customized development strategy per project
- Greater flexibility
- Tiered regulatory strategy from fit-for-purpose and GCLP to GLP and CLIA
OUR INTEGRATED APPROACH TO BIOMARKER DEVELOPMENT IS AS FLEXIBLE AS YOUR PROJECT IS UNIQUE
We have a dedicated biomarker lab and additional capacity integrated into our bioanalytical lab and our central lab to achieve the following results:
- Access to clean lab data in real time
- Provides flexibility needed to meet customer’s unique program needs
- Leverages the operational experience of PPD Laboratories’ bioanalytical and central labs
- Allows the biomarker team to provide a customized development strategy for each project
- Enables the biomarker lab to apply a tiered regulatory approach from fit-for-purpose (FFP) characterization to GLP/GCLP to CAP/CLIA
- Allows PPD Laboratories to provide global coverage for studies of all sizes
PPD® PPD Laboratory services met or exceeded expectations for oncology and precision medicine for 100% of surveyed PPD customers1.
Our Experience Ensures Your Success
Scientists dedicated to biomarker programs
Studies completed in the past five years
Different companies supported from startups to large pharma
We Customize our Solutions to Achieve Actionable Results
We help shape your biomarker strategy to ensure actionable results that drive informed decisions about the future of your compound by:
- Selecting the right development approach
- Choosing the best technology platform
- Developing and validating methods under the appropriate regulatory guidelines at each stage of drug development
- Transferring and cross-validating assays to different/multiple locations or under multiple regulatory requirements
- Effectively integrating safety and efficacy biomarkers into clinical development
- Navigating and overcoming regulatory uncertainties
Our Biomarker Lab is Equipped with Depth and Breadth of Industry Experience
Explore our capabilities:
A case study in partnership and innovation
Our biomarker lab tackles scientific challenges both large and small. As an example, our customer needed a sophisticated new method to precisely monitor the persistence of CAR T-cells in a Phase I study. In collaboration with the customer, we adapted a flow cytometry assay with a novel internal control to accurately quantify the engineered cells. Well-controlled studies validated that the new flow cytometry assay was both suitable and repeatable.
Related Resources
Explore additional biomarker labs resources to learn more about our capabilities.
