funding from IMI, EFPIA
partners throughout Europe
About the APPROACH project
Osteoarthritis (OA) is a degenerative disease that leads to pain and joint deformities. The disease has many different manifestations, and treatment targeted more specifically at different disease phenotypes might lead to improved outcomes. The IMI-funded APPROACH* project aims to develop a set of guidelines that allow for the selection of patients to support clinical trials, with medication that is specifically designed for subsets of OA patients. To this end, the consortium will set up a biomedical database of different OA patients, as well as a longitudinal cohort based on innovative stratification methods. For more information about the project, please visit the APPROACH website.
* APPROACH: Applied Public-Private Research enabling OsteoArthritis Clinical Headway
Providing independent program management
APPROACH engages with many different stakeholders throughout Europe. CTMM – now part of Lygature – was instrumental in setting up the consortium. In close collaboration with the UMC Utrecht, CTMM coordinated and supported the complete two-stage application process, followed by the contractual negotiations. From January 2016, a broad range of support is provided under the Lygature brand, including:
- Coordination and stakeholder interactions. Lygature is co-lead of the project management work package in APPROACH. Together with the project’s Executive Project Management Team, we coordinate and manage what is a multi-disciplinary program. Activities include monitoring effective execution of the work plan and its progress, stimulating collaboration, and involving various stakeholders, including a Patient Council, in the project.
- Communication and dissemination. The development of the consortium’s communication strategy, including publication guidelines, newsletters, press releases, website, and visual identity is also part of Lygature’s APPROACH responsibilities. In addition, Lygature provides its specifically developed IT platform, which includes a publication approval system to safeguard scientific confidentiality and enable smooth dissemination of the consortium’s results.
- IT infrastructure for translational research. The IT platform of APPROACH will be based on the tools and expertise built up within the Lygature-coordinated Dutch national translational IT network, TraIT. Lygature’s responsibilities include creating technical upload procedures for the APPROACH database. In addition, Lygature manages the actual upload of data to this database from existing cohorts, and from the APPROACH cohort. Lygature is also accountable for managing services from the hosting partners, including Legal Agreements, ethical framework, and data security arrangements.
APPROACH is a pertinent example of Lygature’s mission to bring together a wide variety of public and private partners, who share clinical datasets to realize medical solutions for patients. Setting up the APPROACH project has required extensive expertise in science, data infrastructure, and program management.
Lygature together with
AbbVie, Arthritis Research UK , Artialis SA, Assistance Publique - Hôpitaux de Paris, Centre National de la Recherche Scientifique, Diakonhjemmet Hospital AS, Dutch Arthritis Foundation, European Technology for Business Ltd, Friedrich Alexander University Erlangen Nuremberg, GSK, Hemics B.V., Immunodiagnostic Systems Limited, Leids Universitair Medisch Centrum, Lund University, Medical University of Vienna, Merck Biopharma, Newcastle University, Nordic Bioscience A/S, Servier, Servizo Galego de Saúde, Universitaetsklinikum Erlangen, University Medical Centre Utrecht, University of Leeds, University of Surrey
Successful Annual Meeting in Germany
On 20 and 21 November 2018 the APPROACH consortium gathered for its Annual Meeting, this year organized by partner Merck KGaA at their headquarters in Darmstadt, Germany. In total about 60 participants of the meeting, including the project’s Patient Council and the Scientific Advisory Board, presented the achievements and project progress of the last 12 months and the plans for the upcoming year.
Why, How and What you Win when you Involve Patients
Harrie Weinans (APPROACH academic Project Leader) and Jane Taylor (Chair Patient Council) were guest speakers during the Lygature Partnerships Meetup in Utrecht on 1 November 2018 where they presented the APPROACH Patient Council as example for patient engagement in clinical studies.
During the session “Why, How and What you Win when you Involve Patients”, representatives from academia, industry, patient associations and government organizations debated together with patients on the do’s and don’ts for patient involvement and identified new ideas for ongoing and future clinical studies in disease areas as Alzheimer’s Disease, breast cancer and major depression.
Available now: second edition of the APPROACH Newsletter in English, Dutch, French, Norwegian and Spanish
The APPROACH newsletter appears in Dutch (APPROACH Nieuwsbrief), English (APPROACH Newsletter), French (APPROACH Bulletin), Norwegian (APPROACH Nyhetsbrev) and Spanish (Hoja Informativa APPROACH). A printed copy will be handed out to APPROACH study participants when they visit their hospital. Interested?