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

12 March 2021
The UK ATMP Landscape (video)
Matthew Durdy
20 July 2020
Annual Review 2020
Cell and Gene Therapy Catapult
18 June 2020
Webinar: Tackling the Challenges in Development and Clinical Adoption of Advanced Therapies
Panos Kefalas
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