Perceptive Preclinical Imaging CRO reduces uncertainty in clinical translation

Partner with Perceptive Discovery, a Preclinical Imaging CRO de-risking oncology, radioligand therapy (RLT), and CNS research through rigorously designed, translationally relevant, preclinical imaging models and global workflows.

Introduction

One of the biggest challenges of pharmaceutical drug development is the gap between preclinical research and clinical trial outcomes. Many drug candidates show promising results in preclinical studies, but then fail to demonstrate success in human clinical trials. Approximately 75% of drug candidates emerging from preclinical studies for further investigation go on to fail due to lack of efficacy or safety during Phase II or Phase III human trials. This high attrition rate highlights the importance of robust, reliable, and translational preclinical research findings. The design, execution, and interpretation of preclinical studies can directly impact future clinical trial success, and the potential to lead to an investigational new drug application (IND). In order to bridge this translational gap, it is extremely important to utilize a Preclinical Imaging CRO that houses the expertise, global reach, and advanced imaging capabilities needed to ensure robust preclinical research. 

Sponsors are increasingly relying on Perceptive Discovery, having over 15 years of experience as a Preclinical Imaging CRO. Supported by our specialized imaging CRO lab, Perceptive Discovery delivers centralized imaging analysis, harmonized workflows, and regulatory-compliant preclinical trial design to promote clinical translation. 

The role of preclinical imaging in the drug development pipeline

Preclinical imaging studies are designed to allow the visualisation of drug-modulated processes in living organisms, utilising various imaging modalities to study biological processes in real-time in order to predict the response of future drug candidates. Preclinical research focuses on understanding disease mechanisms, and developing and testing potential drug candidates across tailored animal models.

Preclinical imaging provides non-invasive, longitudinal insights, allowing researchers to monitor disease progression, visualise pharmacodynamics, biodistribution, and treatment efficacy over time. Findings from preclinical research have a significant role in understanding the safety and potential toxicity or side effects from an investigational drug compound or treatment, which many regulators require before granting approval to proceed with human studies.

Translating preclinical findings is an essential aspect of all pharmaceutical drug development, guiding clinical trial decision-making prior to expensive and time-consuming human trials. Without the findings from preclinical research, clinical trial failure rates would likely increase, not to mention the increased risk to human trial participants without much-needed preclinical insight.

Why translational uncertainty exists

Preclinical to clinical translation refers to the decision to proceed to human clinical trials with a drug candidate, having already been tested in preclinical models. However, the translation of preclinical findings to human studies often does not live up to expectations. Preclinical disease models may only capture a narrow aspect of complex human conditions, which can reduce clinical translation. Research suggests the robustness of preclinical research can affect such outcomes. 

Perceptive Discovery, a Preclinical Imaging CRO, helps to mitigate uncertainty in clinical translation, aligning preclinical models and imaging protocols with clinically relevant endpoints to produce data which sponsors and regulators can trust.

Perceptive Discovery guides effective decision-making with:

• Proven expertise in delivering high-quality clinical trial imaging data at a global scale
• Ensures rigorous scientific analysis and high-quality data generation
• Highly established clinical and imaging centers supporting first-in-human and multicenter studies
• Coordinated imaging protocol development across preclinical and first-in-human clinical studies
• The use of clinically relevant models 
• Advanced imaging capabilities, with modality alignment leading to rapid identification of the most promising compounds
• Risk-reducing strategies and optimized study design for maximum impact

Perceptive Discovery’s translational strengths

Perceptive develops and validates in vitro models which better describe and predict in vivo preclinical outcomes, improving the translation of results. Imaging protocols are designed with clinical trials in mind, with experienced imaging analysts who have a firm understanding of preclinical trial regulation and the realities of preclinical research.

Perceptive’s medical imaging analysis team specializes in developing advanced algorithms to tackle even the most complex imaging science challenges, extracting precise quantitative data for studies ranging from preclinical discovery research to late-phase clinical trials.

By combining the latest advancements in imaging science with engineering expertise, we innovate and refine new algorithms and automated and semi-automated image analysis processes
to ensure efficient, reliable analysis.

We support a range of preclinical image analysis tasks, tailoring our approach based on the species, imaging modalities, and therapeutic focus. Using our in-house software, including VivoQuant and iPACS, we apply existing tools or develop new ones to meet the specific needs of each study while offering sponsors convenient access to all imaging data and results.

Conclusion

As a well-established Preclinical Imaging CRO, we have extensive experience in the design, execution, and interpretation of preclinical research. Our integrated approach across early-phase research and development enables you to generate high-quality data earlier, improving decision-making and streamlining your drug development timeline to produce translational findings. 

We have supported over 3,000 studies across Neuroscience, Oncology, Radiopharmaceutical Therapy & Theranostics, with key expertise across all therapeutic areas. Perceptive Discovery enables smarter clinical planning by delivering translational imaging data with purpose. Perceptive Discovery’s preclinical imaging data is not just exploratory, it is designed to inform your clinical strategy.

To accelerate your research with Perceptive Discovery’s best-in-class preclinical imaging and in vivo imaging services, go to: Perceptive Discovery Services today, or Contact a Discovery solutions specialist.

Resources

Advanced Drug Delivery Reviews. Engineered tissues and strategies to overcome in drug development. https://www.sciencedirect.com/science/article/pii/S0169409X20301368 

Current Gene Therapy. Uncertainty in the Translation of Preclinical Experiments to Clinical Trials. Why do Most Phase III Clinical Trials Fail? https://pmc.ncbi.nlm.nih.gov/articles/PMC2864134/