With experience in all aspects of non-clinical studies, from designing proof-of-concept (POC) and efficacy studies, through to FIH supporting pivotal safety good laboratory practice (GLP) programmes, our team employ expert knowledge of the contract research organisation (CRO) landscape specialising in ATMPs and a comprehensive understanding of the ATMP development process to rapidly progress your therapy to the clinic and beyond.
Our non-clinical team can help you address the in silico, in vitro and in vivo scientific and regulatory evidence to help streamline your therapy’s development in an ethical and regulatory compliant manner.
Benefit from our expertise in:
Non-clinical strategy design
- Creating customised “route to clinic” and “route to market” plans for your ATMP
- Structuring of in vitro approaches including advice on vector design
- Design of POC, mode-of-action (MOA), and efficacy studies
- Safety study design, management and support with implementation and monitoring of the studies
- Due diligence of non-clinical programmes for out/in-licencing
Laboratory study design
- Pivotal GLP study design along with CRO engagement to ensure that your strategy is expertly translated to support future Clinical Trial Authorisation (CTA) filing
Clinical trial preparation
- Provide recommendations for a path to CTA and Investigational New Drug (IND) application, as well as Marketing Authorisation and Biologic License Application (MAA/BLA)
Risk assessment and gap analysis
- Risk assessment of your candidate ATMP in the selected clinical indication
- Gap analysis of your POC and safety data
Regulatory support and compliance
- Expert support in the preparation of the non-clinical sections of regulatory documents, such as Briefing Document, Investigator’s Brochure, and Investigational Medicinal Product Dossier
- Reporting of non-clinical studies to worldwide regulatory standards
- Combined ATMP strategies (all safety aspects including International Organisation for Standardisation (ISO) compliant medical device strategies)
Facilitating interactions with regulators
- Supporting our collaborators in their interactions with Regulatory Authorities (MHRA/EMA/FDA), Scientific Advice, Innovation Office and INTERACT meetings
Working on a cell or gene therapy innovation challenge?
Contact us today to find out how we can support you.