Preclinical and nonclinical studies designed with regulatory compliance in mind
Preclinical (nonclinical) development refers to the process through which investigational drugs are subjected to extensive laboratory testing to determine their safety for humans trials.
Typically, preclinical testing can take between one to five years, and provides information about the effects of the biopharmaceutical composition on mammalian cells — particularly whether the proposed product and formulation will result unpredictable toxicological effects. The results of such studies and assessments provide valuable information for subsequent clinical trials.
Here at Woodley BioReg, our expert team of consultants can guide you through the preclinical / nonclinical stages, and begin to develop a commercially astute clinical strategy at this early stage in product development.
A major challenge for the biopharmaceutical industry is the extended and risky process for the development of new drugs — this is a costly activity and can take up to 10 years from lab to clinical assessment.
Specifically for biopharmaceuticals, we ensure all aspects from setting up cell banks — including Master Cell Banks and Working Cell Banks — and characterisation the cells and genetics to ensure stability is robustly performed and documented to future-proof the product development activities.
Our biopharmaceutical experts have practical industry and regulatory experience to mitigate many of the empirical risks and help our clients navigate through the regulatory hurdles.
Requiring specialist bioanalytical and product knowledge, method scouting is a highly technical activity requiring practical experience of the advantages, limitations and potential pitfalls of bioanalytical tests, such as bioassays, protein structure / conformation, and post-translational modifications.
Our team of consultants guide our clients to ensure robust, knowledge-based and well-documented method scouting that withstands regulatory rigour. Woodley BioReg provides expert guidance and consultation gained through practical and successful industry experience, and has published its approach to enable others in the industry to adopt best practice.
We’ll help you to design study protocols that provide the data needed to evidence safety and efficacy in humans and help to establish the manufacturing and formulation strategies. This early stage of development also sets the scene for bioanalytical development, product testing and characterisation, as well as starting to define the Product Quality Specification (PQS).
Our experienced consultants will guide you and help you to review the data from preclinical / nonclinical studies to determine if it is suitable to move on to the next stage, or if further studies are needed to address any remaining regulatory requirements.
Recognising and, where possible, mitigating potential risks underpins the way we work at Woodley BioReg, and forms a key pivot when deciding whether further development is merited.
Preclinical and nonclinical study summary reports are crucial in providing regulators with an overview of the findings. Woodley BioReg consultants will guide you through the process and if needed will write the report on your behalf; we always ensure you are in control.
If the review of data shows that further (bridging) studies are required, we will assist you in the planning and designing of further study protocols to ensure that you have everything you need to move on to the clinical trial stage.
AAs products develop and grow into new markets and indications, there is often the need to scale-up or replicate manufacturing processes. Our consultants will guide you through the most efficient and effective processes including the strategic use of comparability protocols in the EU and US.
Having successfully delivered many such projects, our ultimate aim is always to reduce or eliminating the need for bridging clinical studies.
As we demonstrated during the Covid-19 pandemic through our support for governments and manufacturers, a strong regulatory strategy can enable the robust development and rapid licence approval of innovative products, including mAbs and vaccines.
At Woodley BioReg, we ensure the implementation of well-defined strategies drive the preclinical, clinical, and pharmaceutical development stages. If appropriate, we’ll seek scientific advice to ensure regulatory alignment throughout the process. Our team of regulatory affairs professionals are expert at this, and will support and guide you from start to finish.
