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Action Details

CA 21147- European Network on Optimising Treatment with Therapeutic Antibodies in chronic inflammatory diseases (ENOTTA)

Description

Although treatment of chronic inflammatory diseases has been revolutionised with the introduction of targeted therapies with therapeutic antibodies, a large portion of patients do not respond to treatment or they lose response over time. This is mainly attributed to suboptimal dosing, immunogenicity and interpatient variability in pharmacokinetics.

To overcome the problems of suboptimal treatment, researchers have started to focus on individualised treatment optimisation strategies based on development of patient stratification tools and therapeutic drug monitoring (TDM)-guided dose adaptations based on serum drug concentrations.

A substantial improvement in patient care will be realised by implementing individualised (TDM-guided) dosing schemes of therapeutic antibodies in daily clinical practice for treatment of chronic inflammatory diseases, which will ultimately result in a more cost-effective use of these expensive drugs (“the right drug at the right dose for the right patient”).

However, expertise on individualised (TDM-guided) treatment optimisation is highly fragmented in Europe, and largely limited to a few pioneering centres. Transferring knowledge and techniques to other (peripheral) centres is challenging, especially due to the need for inhouse expertise and a lack of standardisation in TDM assays. Therefore, this Action will create an interdisciplinary, pan-European Network in order to defragment and structure the scientific research in this field and to facilitate the implementation of individualised (TDM-guided) cost-effective dose optimisation of therapeutic antibodies in daily clinical practice for treatment of chronic inflammatory diseases.

Objectives

To achieve the main objective described in this MoU, the following specific objectives shall be accomplished: Research Coordination

  • Create an interdisciplinary society of researchers, clinicians, experts and stakeholders in order to defragment the European research community working on dose optimisation of therapeutic antibodies.
  • Investigate and develop patient stratification tools to predict and optimise treatment with therapeutic antibodies, before and upon the start of treatment, with the contribution of predictive analytic companies or academic groups.
  • Develop guidelines for clinical management and best practices for individualised (TDM-guided) dose optimisation.
  • Improve the reproducibility, standardisation and harmonisation of TDM assays and protocols.
  • Set up a comprehensive and structured overview on the availability of patient data/samples, and the availability of TDM assays across all participating hospital/research centres.
  • Evaluate the cost-effectiveness of individualised (TDM-guided) dose optimisation of therapeutic antibodies as an instrument to reduce healthcare expenditures, thus ensuring access and affordability.
  • Investigate how TDM may be implemented and secured in the community with the support of e-Health SMEs.
  • Disseminate knowledge and findings within the scientific and clinical community and to policymakers

Capacity Building

  • Facilitate scientific collaboration and knowledge exchange by organising and coordinating an open, sustainable, and multidisciplinary network using an electronic platform.
  • Stimulate the development of a joint research agenda to facilitate the development of new research projects, post-marketing studies and prospective multicentre clinical trials.
  • Offer a balanced vision and expertise to European and national decision-makers by their participation in the network as external advisors and by targeted communication measures.
  • Identify and interact with stakeholders. Stakeholders will be actively identified among Action members and their networks but also beyond.
  • Form an educational programme to offer training in different multidisciplinary areas embedded in this Action, allow for dissemination of knowledge and research outputs, and open opportunities to interact with and learn from more experienced research groups.
  • Help Young Researchers and researchers from inclusiveness target countries (ITCs) develop and expand their professional networks, meet experts and stakeholders, and create opportunities for collaborations.
  • Support researcher mobility by encouraging Young Researchers and ITC researchers to participate in training schools and STSMs. The Action will strive for a fair and diverse membership and will promote gender equality.
  • Give the opportunity to SMEs and pharmaceutical companies to join the Action (pharmacometricians, biostatisticians, assay developers, software producers, data managers and clinical trial designers).

Are you Interested in joining us?

Are you a research-active scientist working in the field, then the
COST Action ENOTTA welcomes you.