Biomarker and Genomic Medicine Strategy

Expedite and improve drug development with precision bioanalysis and genomic research

You want to get your drug from the lab bench to your patients as quickly as possible. We make that possible by designing strategies from the molecular level on up, analyzing biomarkers and genomic data to help you target your drug to patients more effectively.

Exceed your production goals through biomarker strategy

There’s strong evidence that drugs developed with a biomarker for the selection, stratification, or enrichment of clinical trial populations move more quickly through regulatory and payer approvals. For these reasons, you need a biomarker strategy for each program to make smarter decisions about clinical trial design, assays, technology platforms, and collaborative partners.

At Parexel, we specialize in biomarker strategy development and execution. We can help you determine what biomarkers should be evaluated and what technologies or methods are most appropriate. And while it’s ideal to develop a biomarker strategy prior to your first human studies, biomarkers can also be discovered retrospectively and may inform the drug label or need for a companion diagnostic. 

Extensive access to validated bioanalytical methods

Bioanalysis is the discipline that allows quantitative determination of chemical entities and biomarkers in biological matrices. Parexel® Early Phase offers the highest quality bioanalytical services for qualitative and quantitative drug, metabolite, and biomarker analysis in a variety of matrices.

How genomics can enhance your drug development journey

Our genomic medicine team helps you integrate genomic research into global drug development programs for a smoother journey to market. Often applied in preclinical or early clinical development, genomics expertise can help inform key decisions and carry a company from first-in-human trials through to commercialization and reimbursement.

Recognized by biopharmaceutical companies, peers, and regulatory authorities as thought leaders and influencers in their field, our scientists have a cumulative 300 years of experience incorporating genomics into drug target selection and validation, medicine development, registration, commercialization, and differentiation from competitor medicines.

We can help you answer critical questions, including:

• What genetic variants are relevant for selecting or stratifying patients?
• How does genomic variation impact feasibility and site selection?
• What technology is best to generate the genetic results?
• What is the best way to mitigate risk of variability in global regulations related to genomic testing?

Simplifying the route to product approval and maximizing patient access

• Our genomic medicine scientists apply expertise, innovation and state-of-the-art methodologies in the strategic and operational implementation of genomics services to help clients:
• Better understand the genetic/genomic basis for the disease, drug, target, and pathway
• Differentiate their drugs from competitor medicines in development or on the market
• Stratify drug responders/non-responders and enrich clinical trial design
• Develop companion diagnostics strategies, where appropriate
• Inform the benefit-risk profile of your personalized medicine
• Expedite regulatory and payer approvals

Our core genomic services

Data analytics and informatics:

• DNA variation
• RNA variation
• Microbiome
• Proteome
• Metabolome
• Bacterial/viral phylogeny
• Host-pathogen interactions
• Mechanistic pathway analysis
• Genotype imputation
• Human genome sequencing
• Database mining

Pharmacogenics (PGx) testing:

• Genomic strategy development from first-in-human (FID) through commercialization
• Operationalize genomic strategy
• PGx protocol and informed consent language
• Sampling requirements
• Sample and consent tracking and reconciliation
• Qualify and manage genomics specialty labs
• Genomic data management
• Analysis & reporting of genomic results
• Inclusion of PGx in regulatory submissions and labeling
• Develop and support medicine companion diagnostic strategy
• Improve sample collection rates
• Inform understanding of drug mechanism of action
• Inform drug dose selection with ADME PGx

Target validation and repositioning: This service provides genomic evidence to improve understanding of the disease, identify novel drug targets, inform compound selection, validate drug target/indication relationship, and identify potential alternatives or new indications.