GoCART is a multi-stakeholder coalition of patient representatives, health care professionals, pharmaceutical companies, regulators, Health Technology Assessment (HTA) bodies and reimbursement agencies, and medical organisations, collaborating to maximise the potential of cellular therapies manufactured from cells and tissues of hematopoietic origin.
Our mission is to promote patient access to novel cellular therapies and to contribute health and well-being through innovation by multi-stakeholder collaboration on clinical data, standards of care, centre qualification, education and policy.
Our vision is to be a trusted partner and a leading force in the field of cellular therapies at national and international levels.
Our core values underlying the activities of GoCART are:
- Patients-centred – GoCART exists to save and improve patients’ lives. We measure outcomes and take decisions based on how well it serves patients;
- Build relationships and deliver results – we believe in the power of working together to rise to the challenges in the field of cellular therapy;
- Creating value by sharing data – by adopting the principle ‘collect once, use often’ data sharing will support better decision making and drive efficiencies for all stakeholders;
- Transparency breeds trust – we believe in open, honest and respectful communication and decision making;
- Grow and adapt – we cannot predict the future, but we are ready for the challenges that come our way and are committed to ensure sustainability and lasting impact of this Coalition.
The aims of GoCART are to:
- Improve health outcomes for patients;
- Engage stakeholders and establish a sustainable European coalition in the field of cellular therapy;
- Collaborate and share data and knowledge to prevent duplication of effort and resources;
- Promote harmonisation of data collection, education, standards of care, regulatory approval and reimbursement processes in Europe;
- Set-up a pre-and post-marketing registry that supports regulatory and shared research purposes;
- Develop a cellular therapy Education and Information program for patients and health care professionals;
- Harmonise standards of care and centre qualification;
- Advance policies that further the shared mission and vision.
GoCART organises its activities through its work packages that are open for participation to all GoCART members.
Content work packages:
- Data harmonisation
- Standards of Care
- HTA process
- Educational standards
- Policy and advocacy
- Scientific excellence
Transversal work packages:
- Coordination and management
Each of the focus areas will be addressed by Work Packages who are accountable to an Executive Committee with balanced representation of the different stakeholders. Ultimately it will be this Executive Committee that will steer GoCART and mark the strategy.
Upcoming GoCART Meetings
28 October at 4pm CEST
If you are interested in participating in this virtual meeting, please e-mail us at GoCART@ebmt.org so we can provide you with the agenda and details to connect.
The LRAC and CTIWP have launched an open call for feedback and participation in workpackages (WP) - all EBMT Members as well as non members interested in CAR T therapies are invited to answer this open call until the September 1, 2019.
The EBMT registry has been qualified by EMA as a suitable platform for the collection of data for post-authorisation safety surveillance and efficacy studies.
EBMT requested qualification of the cellular therapy module of the EBMT Registry as suitable for performing pharmacoepidemiological studies for regulatory purposes, concerning CAR-T cell therapy for haematological malignancies.
The EBMT responded to the public consultation by the European Commission "Targeted stakeholder consultation on the draft Guidelines on Good Clinical Practice for Advanced Therapy Medicinal Products".
European Medicine Agency (EMA) releases their draft qualification opinion on the cellular therapy module of the EBMT registry for public consultation.
This report summarises observations made by the participants of the workshop organised by the EMA on February 9th 2018 on the use of registry data to support regulatory benefit-risk evaluations of CAR T-cell therapies and, in particular, post-authorisation follow-up.
Representatives from the following stakeholder groups are invited to participate in the GoCART coalition:
- Patient representatives
- Health Care Professionals
- National and European Health Authorities
- Health Technology Assessment (HTA) bodies and reimbursement agencies
- National registries
- European and national medical organisations