PPD Laboratory Services, Comprehensive Biomarker Solutions

A holistic approach to streamline biomarker development, enhancing your drug’s potential for commercial success

The drug development field faces numerous challenges, with low success rates being a major concern. Biomarker analysis plays a crucial role achieving success by determining the efficiency, effectiveness, and safety of a drug, enabling you to make informed decisions throughout the development process and ultimately accelerating it to the market.

A biomarker-driven approach enables risk mitigation throughout the drug development process, meaning:

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 solutions engage biotech and pharmaceutical companies early in the drug development process, using our comprehensive analysis of biomarkers of interest and custom assay development to enhance efficiency and synergy.

Move your drug development forward. Connect with us.

Overview

Biomarker Capabilities Overview

Our biomarker lab works closely with customers to shape biomarker strategy and drive projects to completion, even where regulatory uncertainty exists.

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Delivering the right expertise and capabilities

By leveraging a diverse set of technologies, robust project management and dedicated expertise, your assay is supported throughout the drug development process globally.

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Studies completed in the past five years

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Different compounds supported

Our expertise

Backed by more than 20 years of experience and expertise, we enable you to shape your biomarker strategy at each phase to ensure actionable results that drive informed decisions about the future of your compound.

Our biomarker services are customized for the unique needs of each study
Project-specific, de novo assays to help you identify and measure your biomarkers throughout the trial
Experienced transfer and cross-validation of assays to global locations or under multiple regulatory requirements
Effective integration of safety and efficacy biomarkers into clinical development
Support for high complexity biomarkers requiring specialized scientific oversight, assay development and life cycle management
A tiered regulatory strategy developed for each stage of drug development, from exploratory, fit-for-purpose, to GLP/GCLP and CAP/CLIA
Partnerships to expand expertise and facilitate LDT and companion diagnostic projects

A seamless biomarker service experience

Our innovative approach aligns global lab capabilities and bioanalytical offerings to deliver cohesive and efficient biomarker services spanning the drug development timeline across several platforms.

Our biomarker services offering will make your experience seamless from method development to technology transfer. Whether you have a kit or a custom assay, exploratory or clinical sample analysis, our scientists optimize development and move your program through to global sample testing.

Method development

Verification and exploratory study support

Full method validation

Technology transfer globally

Our extensive biomarker service offering include assay development, validation and sample analysis with more than 1,500 validated methods:

Flow cytometry and cell-based assays
Ligand-binding assays
Immunoassays
LC-MS/MS, Hybrid-LBA-LC-MS/MS, and LC-HRMS

Molecular genomics
Immunohistochemistry
Companion diagnostics
O-Link platform for high throughput biomarker discovery

Our biomarker project manager works closely with you to shape the strategy and drive your project to completion, even where uncertainty exists.

We are experienced in working solid and liquid matrices in various indications including oncology, neurology, endocrinology/metabolic, hematology, infectious disease, and cardiovascular indications.

Explore our expertise and capabilities

Integrated approach to meet your study needs

The integration of our biomarker capabilities into both our PPD™ Laboratory services Central and PPD™ Laboratory services Bioanalytical labs enables us to fully customize your biomarker development strategy and provide global coverage for studies of all sizes.

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 the PPD Bioanalytical and PPD Central labs

Provides access to lab data in real time through our Preclarus™ LIMS
Enables the biomarker lab to apply a tiered regulatory approach from fit-for-purpose characterization to GLP/GCLP to CAP/CLIA
Provides a 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

Explore our Central Lab

Explore our Bioanalytical lab

Learn more about our biomarker capabilities

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