Non-clinical safety

We will create a custom-made ‘route to clinic’ plan for your cell or gene therapies - all designed to get you to the clinic as fast as possible. 

Our team of specialists have a deep understanding of the specifics of cell and gene therapies and a unique approach to the development of non-clinical safety programmes, which means you can spend more time on the things that matter.

Our approach

Our in-house approach has been developed to help take the headache out of risk assessment, due diligence and gap analysis.

How we can help

  • Oversight and implementation of your non-clinical safety programme, helping you get it right, first time.
  • Preparation of the non-clinical section of your regulatory documentation including investigational medicinal product dossier and Investigator’s Brochure.
  • Access to our network of industry specialists, who can help ensure your programme ticks all regulatory requirements.

We have supported the design and implementation of non-clinical safety programmes for pluripotent stem cell therapies, somatic cell therapies, immune therapies, genetically modified cell therapies, tissue engineered products and medical devices.

Our support

  • 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.

Case studies

  • Design and oversight of non-clinical programme for an SME resulting in successful and quick 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 successfully supported CTA approval.
  • Due diligence on a non-clinical programme for a pharmaceutical company facilitated study rationalisation and a reduction in the non-development phase. 

The process

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

Related Publications

16 July 2019
webpage
Annual Review 2019
Cell and Gene Therapy Catapult
07 January 2019
pdf
Preclinical database 2018
Cell and Gene Therapy Catapult
25 June 2018
webpage
Preclinical Development of Cell-Based Products: a European Regulatory Science Perspective
Michaela Sharpe
  • RT : Atelerix Consortium Awarded £267,000 Innovate UK Grant for collaboration with the Cell and Gene Therapy Catapult an… https://t.co/78puK3LzW6 1 hour 59 min ago

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