Non-clinical safety

We will create a ‘route to clinic’ plan specific to your therapy using our unique approach to development of non-clinical safety programmes for cell and gene therapies.

Non-clinical safety programmes and the corresponding regulations for cell and gene therapies are different from other pharma products. It’s easy to do too much work that takes up time and budget that is irrelevant. Using our knowledge of the specifics of cell and gene therapies we can ensure you do the right studies to meet the requirements. We can also help you prepare documentation for your submission. 

We will create a ‘route to clinic’ plan specific to your therapy using our unique approach to development of non-clinical safety programmes for cell and gene therapies:

  • Get you to the clinic as fast as possible by designing the most efficient programme.
  • Make sure you have the right programme and don’t do unnecessary work.
  • Ensure you address all the regulatory requirements for cell and gene therapies.

Our in-house approach was developed using our extensive expertise in the individual needs of cell and gene therapies to risk assessment, due diligence and gap analysis. We can provide oversight and implementation of your whole non-clinical safety programme, using our knowledge of the industry. We can also prepare the non-clinical section of your regulatory documentation including investigational medicinal product dossier and Investigator’s Brochure. We will use our knowledge and network of key stakeholders to ensure your programme addresses all regulatory requirements.

Our services

  • Report providing a full review and gap analysis of the non-clinical programme and a recommendation for a path to clinical trial application.
  • Non-clinical study management support including protocol generation, study monitoring and report preparation for pivotal non-clinical safety studies.
  • Outsourcing and oversight of pivotal GLP safety studies.
  • Preparation of non-clinical section of IMPD and support in regulatory agency interactions.

 

We have designed and implemented non-clinical safety programmes for pluripotent stem cell therapies, somatic cell therapies, immune therapies, genetically modified cell therapies, tissue engineered products and medical devices.

Case studies

  • Design and oversight for a non-clinical programme for an SME resulting in successful and rapid CTA approval. 
  • Gap analysis and innovation office meeting support for an academic group resulting in an MHRA approved non-clinical plan. The non-clinical programme subsequently successfully supported CTA approval.
  • Due diligence on a non-clinical programme for a pharmaceutical company facilitated study rationalisation and reduction in the non-clinical development phase.   

Contact us to find out more about our non-clinical safety capabilities.

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