Preclinical and toxicology

Preclinical Life Science Expertise

We draw upon expertise in pharmaceutical formulations and have played a major role in the development of 15 commercial assets. These comprise oral, topical, transdermal and parenteral products containing novel chemical entities, fermentation products, semi-synthetics and a biopharmaceutical. Of these 15 products, at least two saw blockbuster success.

We have over 20 years’ experience in industrial statistics, providing input into all areas of drug development, including assay systems, shelf life estimation, preclinical studies and Phase I/II/III clinical trials. We have represented clients at regulatory agency meetings in the US, Europe and Japan, and provided support for regulatory submissions for new drugs.

Our toxicology team have acted for UK, US, Japanese and European companies on diverse aspects of conventional pharmaceuticals, recombinant DNA products and medical devices, as well as pesticides and industrial and consumer chemicals. Some examples include:

  • having responsibility for all toxicological aspects of the development of new human and veterinary medicines and pesticides, including product licensing negotiations and patent briefs
  • playing an active role in UK and German advisory committees concerned with chemicals and medicines
  • acting as temporary advisers to the WHO and the IPCS
  • organizing training courses for preclinical assessors in various national medicines evaluation agencies in Europe

Case study: Managing preclinical programs into Phase I/II clinical trials

Challenge

A leading cancer research charity needed project management and drug development expertise to shepherd two preclinical programs into Phase I/II clinical trials.

Solution

Our duties included overseeing the formal preclinical development program, submission of IND and execution of a Phase I/II clinical trial for two of the charity’s targeted therapy compounds. We were responsible for:

  • identifying and negotiating contracts with appropriate CROs
  • managing the CRO relationships
  • identifying and overcoming issues as they arose
  • ensuring regulatory compliance
  • liaising with ethics committees
  • monitoring and ensuring GMP compliance
  • providing regular progress reports

Further case studies regarding Preclinical and toxicology are available here.

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