Translational Medicine

From bench to bedside and back again.

Translational medicine leverages pre-clinical data and clinical research findings, including pharmacokinetic, pharmacodynamic, biomarker and genomic data, to predict and optimize outcomes for patients. When strategically applied throughout drug discovery and development, translational medicine aids in understanding disease characteristics as well as therapeutic response, including efficacy and safety signals across populations. It has been linked to accelerating approval and commercial success for new diagnostics and therapies. By translating early data into insights that can inform your clinical development strategy, you can de-risk your investment, identify a better patient population, and optimize study design.

Your Medicines Benefit from Our Experience

Parexel’s Translational Medicine team brings together years of first-hand experience in novel biomarker development, bioanalysis, genomics, analytics, pharmacokinetics/pharmacodynamics and modeling and simulation. Together, we will help you find the right dose and determine the right patients for your drug development program. 

Our core services include:

Bioanalysis

Parexel has a global network of qualified lab partners through which the latest analytical techniques and methodologies are validated and performed.  These techniques and methodologies span therapeutic areas, modalities, delivery methods and enables a customized approach for each client. Our internal experts provide strategic and operational guidance to ensure all bioanalytical data generated is optimally translated and generated to ensure the regulatory agencies are satisfied with your submission. 

Novel Biomarkers

There is strong evidence that drugs developed with a biomarker for selection, stratification or enrichment of clinical trial populations can help expedite regulatory and payer approvals. For these reasons, companies need a biomarker strategy for each program and the expertise to make smart decisions about clinical trial design, assays, technology platforms and collaborative partners.

Parexel specializes in biomarker strategy development and execution, for example, determining what biomarkers should be evaluated and what technologies or methods are most appropriate. While the ideal time to develop a biomarker strategy is prior to your first human studies, biomarkers can also be discovered retrospectively and may inform the drug label or need for a companion diagnostic.  Often these discoveries use banked biological samples and data analysis to correlate patient-specific information with clinical outcome including for trials which have demonstrated some drug efficacy but failed met the desired end points.

Genomic Medicine

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. Parexel comprises a deep bench of specialists in genomic medicine with success in leveraging genomic information to support drug discovery and development. We can help you answer critical questions such as:

• 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?

Clinical Pharmacology, Modeling and Simulation

Parexel’s team of experienced clinical pharmacologists can help you optimize your development program to rapidly identify promising new drug candidates. Our quantitative clinical pharmacology services help you plan and design your clinical studies, including first-in-human trials. We provide support for sampling times selection, dose rationale, synopsis and protocol writing, and regulatory reporting and submission.

The strategic implementation of modeling and simulation services helps you drive drug development decisions for a smoother journey to market. Parexel’s team of pharmacometricians, data managers and programmers implement both pharmacokinetic/pharmacodynamic and modeling strategies across numerous indications, from first-in-human studies throughout all phases of development, including marketed products. Through these services, our experts can help you reduce the time and cost of bringing drugs to market, thereby enhancing your return on investment.

Strategic implementation of model-informed drug development (MIDD) 

• Optimize your Phase I and II development program including study design, PK and PD sampling time selection, dose rationale etc. based on pre-clinical and emerging clinical data
• Develop fit-for-purpose models to characterize the PK/PD relationship. This is critical to identify the target therapeutic concentration range and potential therapeutic index to drive future dosing options and determine cost of goods estimates. Our scientists can support all aspects of the clinical trial process, from protocol synopsis, real time PK analysis, and regulatory reporting. Our analyses include, but are not limited to, modelling & simulation, compartmental and non-compartmental analysis, and population PK analysis.
• Continuously utilize emerging clinical data to refine the PK/PD model and inform model-based decision making, including Phase III trial design and dose selection
• Support NDA/BLA/MAA submissions, labelling and regulatory questions including F2F meeting with regulatory agencies
• Develop physiologically-based pharmacokinetic (PBPK) models for your drug development process to support FIH dose selection, identify potential drug-drug interactions, select doses for pediatric indications, support waivers for clinical studies as well as deepen the mechanistic understanding of your drug’s behavior. 

Analytics and programming service

Non-compartmental analysis enables your studies to interpret preclinical and clinical data to inform future clinical trials. Our team of experienced scientist and analysts help you interpret pharmacokinetic evidence to determine whether dose adjustments are warranted for special populations (e.g., renal and hepatic impairment), to select inclusion/exclusion criteria, and to support labeling.

With our analysts and programming experts, we can provide quality data integration and formatting for further data analysis (e.g. NONMEM-ready datasets).