For years, Sara worked in a hospital, making care possible for others. Now, after being diagnosed with breast cancer, she was the one in need of care.
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.
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.
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.
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:
Data analytics and informatics:
Pharmacogenetics (PGx) testing:
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.