Aim A FACTT
The objective of this Action is to build a network of European Centres involved in Cell-based Tolerance-inducing Therapies (CTT) that will synergise CTT efforts to maximise gain of knowledge and to fast-forward directed CTT development for treatment of AID, allergy and prevention of graft rejection.
This will create a forum for the exchange and integration of knowledge and expertise and in doing so, will advance the systematic and standardised development and application of CTT in a more efficient and cost-effective way.
The Action aims to achieve this goal by
- setting up common protocols between different centres,
- defining and validating comparative functional parameters for safe CTT product application and
- integrating and standardising immune monitoring of CTT.
Secondary Objectives A FACTT
The secondary objectives of this Action are to:
- Define, test, evaluate and standardise quality control (QC) parameters and protocols (safety and functionality) for CTT products, and publish consensus QC guidelines and protocols in scientific journals and on the A FACTT Website.
- Develop, implement and evaluate standardised panels of biomarkers for monitoring the immune status of patients before, during and after treatment with CTT and publish consensus biomarker guidelines and protocols in scientific journals and on the A FACTT website.
- Develop and standardise ex vivo assays, based on the proposed mechanism(s)-of-action (MoA) of specific CTT and analyse their potential to identify Correlates of Protection (COP) in upcoming CTT trials.
- Evaluate pre-clinical and clinical data in relation to different pathological conditions to determine the optimal type of CTT, including antigen-specificity of CTT.
- Promote European coordination through direct exchange of ideas and findings and organisation of meetings between members of this Action (A FACTT) and other parties involved in CTT, like pharmaceutical companies, regulatory authorities (national and European), other research programs and EU consortia and the US-based and NIH-sponsored Immune Tolerance Network (ITN).
- Train Early-Stage preclinical and clinical Researchers (ESR) in the field of CTT (taking into account gender balance) by organising Workshops, Training Schools and by facilitating Short-Time Scientific Missions (STSM) (all WGs).
- Submit applications for joint research programs and multicentre trials in the context of Horizon 2020 or other large-scale funding opportunities.
A FACTT – Seeking Collaborations
A FACTT seeks to establish collaborations with various stakeholders in the field. Essential interactions will be established with:
• COST Action BM09/07 “European Network for Translational Immunology Research and Education: From Immunomonitoring to personalised immunotherapy”
• The ONE Study (FP7): A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
- International Organisations: an important interaction will be initiated with the US-based and NIH-sponsored Immune Tolerance Network (ITN). This Action will actively involve ITN leaders to participate as external experts in the scientific Workshops and the educational activities. This Action will try to establish synergies with groups of the ITN for applying for joint research funding.
- Regulatory agencies, such as EMA. A FACTT aims to define recommendations for CTT translation into the clinics. Regulatory authorities will be invited for specific meetings to discuss consensus statements and guidelines defined in this project.
- The pharmaceutical/biotechnology companies. A FACTT will actively approach them for both, scientific and collaborative purposes.
Why networking is the way to go
Networking within the Action will yield the objectives by:
- Facilitating exchange of expertise and knowledge between the participants in the Action by means of business meetings, Web-based fora, interactive Workshops, Training Schools and STSM.
- Defining consensus criteria, standardising techniques, developing and validating Standard Operating Procedures (SOPs) for quality control and immunomonitoring of CTT and exchange of biological samples.
- Improving European/international visibility of the network by establishment of a dedicated Website and organisation of meetings and Workshops, in order to attract researchers, investors and industry.
- Disseminating results and informing the scientific community, regulatory authorities, pharmaceutical industry and general public on the current status of important topics in the field of CTT.
- Increasing the interaction with the local regulatory boards and European Medicines Agency (EMA) in order to streamline the regulatory process. This will speed up the early clinical development of CTT approaches and by enabling reciprocal education and maximising mutual understanding of specific expertise needed to develop safe CTT applications.
Should you be interested in receiving the full A FACTT’s project memorandum, please send us your request using our Contact Form.