As safety risks and lack of clinical efficacy are the leading causes of drug attrition, well designed and executed preclinical pharmacology and toxicology packages are of utmost importance. Nevertheless, due to the complexity of the process and the ever-changing environment, many unexpected hurdles can appear, requiring continuous revisions and updates of the plans. Our vast nonclinical experience in drug development allows for the flexibility needed to bring your product forward. The Drug Development Team delivers a high quality, cost-effective preclinical package to optimize clinical development of your assets.
A robust pharmacology package is key to successful drug optimization and development. We will help you to design and execute your IND enabling studies, which includes the selection of the appropriate CRO, design of the key experiments, coordination of the study conduct and evaluation of the final data. For regulatory submissions, we can author the nonclinical sections of all necessary documentations. The Drug Development Team can help to create the Target Product Profile (TPP) and the Translational Science Plans (TSP) to provide a clear path towards future clinical goals and to provide an early strategy towards biomarkers and patient stratification. In addition, we can assist you in the setup of a network of Key Opinion Leaders that can bring valuable knowledge and experience to your projects.
Crucial in the discovery phase is the early understanding of the potential safety risks associated with a drug target and its associated pathways. The Drug Development Team can provide Target Safety Assessments based on publicly-available literature sources that identify potential safety liabilities related to the drug target and possible risk mitigation plans. We can design and coordinate an in vitro and/or in vivo experimental strategy to address the potential safety concerns and to enhance understanding of the potential consequences for the clinic.
In the early development Phase, we can build a tailored nonclinical safety program that will enable you to rapidly reach your clinical objectives. In addition, for the GLP toxicology studies, we can select the most appropriate CRO, provide advice and input for the study design, manage study conduct, interpret the data and review the reports. We can provide the nonclinical documentations and support for regulatory agency meetings globally given our experience with regulatory agencies Asia, Europe and the Americas.