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

18 June 2020
webpage
Webinar: Tackling the Challenges in Development and Clinical Adoption of Advanced Therapies
Panos Kefalas
25 November 2019
pdf
Safety of Cell Therapy Products In vitro Methods to Assess the Tumorigenicity of Human Cell-Based Therapeutic Products
Beata Surmacz-Cordle
08 October 2019
pdf
Safety of Cell Therapy Products: In vitro Methods to Assess the Tumorigenicity of Human Cell Based Therapeutic Products
Beata Surmacz-Cordel

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