BTCs4ATMP EU COST Action - European Network of SoHO Establishments for Rapid and Sustainable Access to ATMPs

Objectives

Research Coordination

• Define a benchmarking approach to evaluate current QC strategies and propose a unified QC methodology across BTCs.
• Design and implement a high-quality training program through the creation of the BTCs4ATMP training school.
• Establish effective communication channels with all actors involved.

Capacity Building

• Create a web-based platform for discussion, validated reagents, protocols and QC panels
• Foster international cooperation for the development of new QC strategies, standards and protocols.
• Facilitate applications for future coordinated funding schemes to further develop new technologies and to enhance SoHO research and ATMP development in Europe
• Initiate collaborative innovative state of the art technological developments using SoHO in BTCs and RDI labs
• Act as a stakeholder platform for effective clinical translation of ATMPs
• Provision of training, educational and exchange programme

Leadership

Action Chair: Joaquim Vives

Action Vice-chair: Erja Kerkela

Scientific Officer: Joana Sousa

Science Communication Coordinator: Mr Orion Jucja

Grant Awarding Coordinator: Ms Marta Costa

Working Group 1: Allison Waters, & Adomas Bukauskas

Working Group 2: Emile van den Akker & Ioannis Papantoniu

Working Group 3: Riana Gjeta & Petr Lesny

Working Group 4: Agata Mikolowska & Ander Izeta Permisan

Working Group 5: Margarida Serra & Zoltan Vereb

Working Group 6: John De Vos & Mari Tsoumakidou

Working Groups

WG1: Challenging the frontiers of soho management to realise a new model of applicability in personalised medicine

• Review of initiatives and literature on uses of SoHO and methodologies for their processing.
• Propose criteria that define optimal eligibility of SoHO donors for ATMP manufacturing as well as a source of reagents to be used in QC testing.
• Establishing good practice for donor screening, source material collection and tracing.
• BTCs expert meeting to establish minimal criteria for characterising SoHO quality
• Establishing a European wide framework for distribution of SoHO and SoHO-derived reagents of interest in ATMP production and/or QC testing.
• Establishment of control cell lines and/or SoHO-derived products suitable in manufacturing and QC testing of ATMPs with defined attributes and specifications.
• Realisation of potential allogeneic applications of SoHO-derived products by analysing their immunobiological characteristics (i.e. rejection and tolerance mechanisms, safety aspects).

WG2: Consolidated and emerging cell processing technologies

• List established standard operating procedures (SOP) of methodologies for ATMP production
• Promoting, integrating and refining experimental techniques, design adequate instrumentation coordinating efforts between partners to adopt techniques in a synergistic approach.
• Establishing teams for validating methods for use in SoHO/ATMP processing and/or QC testing.
• Continuous identification of new emerging technologies, including the potential impact of AI.

WG3: Quality control standardisation and strategy for harmonisation 

• Literature review and consultation with expert networks on ATMP characterisation criteria
• Annually define the set of procedures to be benchmarked and QC tests in partner facilities.
• Analyse and define for each procedure, optimised methodology, resources, reagents and instruments required and quality control tests to be performed for product quality assurance.
• Foster exchange of expertise in specific technologies and promote harmonisation.
• Establishing focus groups for and to validate QC assays.
• Identification of the optimal framework to promote standardisation of methods and harmonisation at European level and beyond, involving developers, clinical researchers and regulators.
• Development of a data resource, access platform and registry for available control cell lines suitable for use in QC testing.
• Standardisation of ATMP QC panels for CQA (identity, purity and potency) for use by basic and clinical researchers and regulators.

WG4: Regulation & Ethics

• Bring together expertise in pharmaceutical quality management and regulatory issues related to SoHo and ATMP in particular and regenerative medicine and immunotherapy in general.
• Promote highest standards in ethics in biomedicine, from donor to patient, including possibility of commercialisation of SoHO and derived products for ATMP manufacture and QC testing.
• Establishment of a consensus approach to identification and testing for the wider range of acute and emerging infectious diseases beyond the viral infections tested prior to clinical use.
• Establishment of the regulatory landscape for donation and clinical use of SoHO-derived ATMP.
• Proposal for BTCs4ATMP Consent Form and Information sheet to be signed by donors.

WG5: Training and professional development

• Define the needs and priorities in training for career development of both consolidated and, more specifically, early career stage members of the network.
• Launch a mentoring programme by setting up a network of mentors and YRI mentees focusing on ATMP manufacture and characterisation, immunology and data handling, as well as coaching on soft skills and complemented with lab exchanges.
• Horizon scan, plan and implement the training plan for the network.
• Define the focus for the annual training after annual survey launch and analysis.
• Organise the network annual training workshop(s).
• Organise virtual lectures from experts in quality management, bioprocessing and ethics and regulatory aspects of ATMP development and manufacturing.
• Organise training schools for IP management and ethical regulations/ awareness building.
• Organise, monitor and evaluate STSM, prioritising mobility of YRI from/to ITC.

WG6: Network building and strengthening

• Plan and execute the annual network symposium according to the network working groups.
• Invite external speakers from leading labs in the field, industry and stakeholders to interact and further collaborate with the network.
• Identify and promote shared grant applications between members of the consortium.
• Endorse, promote and facilitate open-access publication for research conducted within the network.
• Facilitate access to infrastructure by sharing costly and precision instrumentation and equipment.