Four main objectives in line with the purpose and aims of the CONFIRM Initiative have been identified by the Steering Committee. A 4-year timeline has been agreed; suggestions and opinions from registered members are welcome to update and expand this short list of objectives, whenever considered appropriate and timely.
1. Posters, workshops and scientific publications
In order to ensure visibility of the CONFIRM Initiative, and spread current knowledge and new findings on immunological safety evaluation in Göttingen Minipigs to the scientific and regulatory toxicology community, the following actions have been approved:
(i) submission of poster and workshop proposals to scientific meetings of international or national societies, e.g. Eurotox and the Society of Toxicology. A poster will be displayed at Eurotox 2017 annual congress. An exhibitor-hosted session will be held at SOT 2018 annual congress and a scientific workshop proposal submitted for SOT 2019 annual congress. Registered members are encouraged to forward draft proposals to the Steering Committee so that they can be submitted with the CONFIRM Initiative 'banner' after adequate interactions.
(ii) publication of a white paper, the objectives of which are to describe the CONFIRM Initiative regarding: knowledge and gaps about the immune system and pathophysiological processes in minipigs; available immunotoxicity data in minipigs; anticipated contribution of minipigs to the practice of immunological safety evaluation; introduction of the CONFIRM initiative to the scientific and regulatory toxicology community. Submission to the Journal of Immunotoxicology is scheduled in Q3 2017.
(iii) contribution to annual Minipig Research Forums (MRF). The CONFIRM Initiative held an introductory workshop during the 11th MRF in Cambridge (UK) in May 2017. A session (provisional title: 'Translation of immunotoxicity findings from minipigs to humans') is in preparation for inclusion in the 12th MRF scientific program to be held in 2018.
2. Web-hosted media
It is considered essential that the CONFIRM initiative should be recognizable by the scientific and regulatory toxicology community. In addition to item #1 (see above), this can be achieved through the creation and administration of both dedicated web-pages and LinkedIn blog.
(i) CONFIRM dedicated web-pages are hosted within the Ellegaard Göttingen Minipigs web-site. They consist of two sections. One free-access section includes downloadable information on the CONFIRM Initiative, such as the Project Description, Members' Charter, and Member Application Form, together with public news relevant to immunological safety evaluation, particularly in Göttingen Minipigs. Access to the second section is restricted only to those registered members who have received an individual password upon membership approval. One conclusion of the 10th MRF held in Copenhagen (2016) was the need to compile the available experience about those immune reagents and in vitro assays that can (or should not) be applied to immunotoxicology research and immunological safety evaluation in minipigs. Accordingly, the CONFIRM Initiative will start compiling such a database. The Executive Committee is expected to serve as an administrator of the database with active assistance of a dedicated working group to validate any data scientifically before inclusion. Only fully registered members of the network are allowed to access and contribute to the password-protected area of the web pages.
(ii) A LinkedIn Group “The CONFIRM Initiative” allows for open communication of the with non-registered individuals about immunological safety evaluation in minipigs. Adequate filtering will be used to avoid useless interferences. The primary aim of this blog is to attract new CONFIRM members.
3. Active contribution to a better understanding of immunopathological processes in minipigs
Another conclusion of the 10th MRF is the need to improve current understanding of immunopathological processes in minipigs, and whether they can be considered relevant to extrapolate immunotoxicity risk assessment to human subjects.
The Steering Committee highlighted the importance of this topic with respect to the purpose and aims of the CONFIRM Initiative. Initially approved decisions include: the session in preparation for the 12th MRF and the planned proposal for a scientific workshop to be held during the SOT annual congress 2019, as mentioned above. Convening an independent minipig immune safety workshop before the end of 2021 to present and discuss data and results generated by the CONFIRM Initiative is another attractive possibility.
4. Coordination of interlaboratory immunological safety evaluation studies in minipigs
The last conclusion of the 10th MRF was the need to standardize and validate in vitro and/or in vivo immunotoxicity studies in minipigs. It is essential to remind that interlaboratory validation studies as cited above, indeed played a critical role to improve the quality and relevance of toxicity studies.
One major aim of the CONFIRM Initiative is to contribute to the standardization of study plans and the validation of study results using relevant panels of positive and negative reference compounds in order to recommend study designs and strategies documented to be applicable to (regulatory) immunological safety evaluation in minipigs. Interlaboratory studies can target one in vitro assay, one in vivo test, or any original evaluation strategy.
Contributions from registered members of the CONFIRM Initiative are obviously considered to be essential. The Executive Committee will monitor and follow up any agreed action/study. Generated data will be included in the CONFIRM Initiative, but only password-restricted web page area.