Designing your proof of concept, and predicted safety and efficacy profile alongside characterisation of your product.
GRA has expertise in multiple modalities ranging from vaccines, antibody drug conjugates (ADCs), mono-clonal antibodies (mAbs), advanced therapy medicinal products (ATMPs) to stem cell based therapies. We therefore have extensive experience to support pre-clinical, non-clinical and toxicology studies to drive drug development effectively and efficiently.
The regulatory strategy is considered throughout design and performance of Non-clinical, preclinical and tox studies. Our team are able to advise on regulatory requirements and preparing documentation for Investigational New Drug (IND) applications or Clinical Trial Applications or Notifications (CTAs/CTNs), etc.
We follow the guidelines relating to the 3Rs (eg. EMA guidance), which are required to be considered when choosing tests to be used. This initiative intends to Replace with in vitro testing where possible, Reduce the requirement for lives where no replacement is available, and Refine approaches to minimise pain, suffering, distress or lasting harm that may be experienced in vivo.
Preclinical studies involve laboratory in vitro and/or in vivo testing/3D-organoid models to evaluate the proof of concept (efficacy, safety and biological activity) of a drug candidate before it progresses to human trials and to determine the starting dose for humans.
Non-clinical studies encompass not only the preclinical studies but a broader range of tests, including in vitro (cell-based) and in vivo (animal-based) experiments, performed after clinical trials have started, eg. long-term toxicity studies, reproductive toxicity studies, and environmental impact assessments. These tests may be performed throughout the product lifecycle to support the drug development process and post marketing surveillance.
Toxicology studies are critical for assessing the potential adverse effects of a drug candidate. We understand that these studies may be complex and require multiple testing platforms to help determine safe dosage levels and identify any toxicological risks. Support is available as follows:
- Study Design: developing/designing robust study protocols.
- Pharmacokinetics (PK) and pharmacodynamics (PD): designing studies to understand how the drug is absorbed, distributed, metabolized and excreted in the body (PK) and the biological effects of the drug and its mechanism of action.
- Vendor Selection: identifying and managing contract research organizations (CROs), including GLP compliance through auditing.
- Gap Analysis: reviewing existing data to identify gaps and recommend additional studies, including a deeper understanding of the product.
- Development Plans & Reports: creating comprehensive non-clinical development plans to guide the drug development process.
- Scientific Advice: providing expert guidance on study design, data interpretation, and regulatory interactions.
By leveraging GRA’s expertise, we help clients navigate the complexities of preclinical, non-clinical, and toxicology studies, ultimately enhancing and accelerating the likelihood of successful drug development and regulatory approval.