Working together for a PARADIGM shift for patient engagement in medicines development

Better health outcomes are linked to expanding the therapeutic arsenal with innovative but most importantly efficient medicines, that are truly relevant to the needs of the patient communities. Over the next decade, clearly, the patient engagement in medicines development will be a paramount topic.

Our vision at EPF is that patient engagement is systematic, efficient, ethical and sustainable when it lies on three main pillars:

  • investing in education of the patient representatives,
  • fostering increase capabilities of all stakeholders to operate this engagement,
  • sustainability of the process.

When it comes to patient education, EPF has been leading what was the first of this kind public private partnership in patient training, EUPATI (or European Patient Academy on Therapeutic Innovation). EUPATI is a flagship project for EPF and 96 patients from all over Europe have successfully graduated the programme. But training alone is only a part of what is needed to truly engage patients in the development of medicines.

Over the last two years, EPF was active along side with some of our members to put on the agenda of the IMI the topic of patient engagement. This is how PARADIGM, standing for “Patients Active in Dialogue and Research for Improved Medicines” was born.

The PARADIGM consortium is co-led by EPF and EFPIA (the European Federation of Pharmaceutical Industries Association). It brings together 34 partners including three EPF members (EURORDIS, EATG and Alzheimer Europe), academic institutions, NGOs, SMEs, pharmaceutical and biotech companies, and the EMA as ex-officio member of the Steering Committee.

What is PARADIGM about?

Firstly, it focuses on timing in the medicine development value chain. The consortium will focus on three decision points in the medicine development: priority settings, early dialogue between regulators and HTA bodies, and design of clinical trials. Furthermore, it will focus not only the general patient community but focus on more vulnerable groups such as the children and young patients, and older people with dementia.

Overall, the PARADIGM consortium brings together a critical mass of expertise and commitment to contribute in creating a common framework allowing a structured, meaningful, sustainable and ethical patient engagement. (All words are important here!)

PARADIGM is not operating in a vacuum and we are committed to not contribute to more fragmentation and competition in the field. Many other initiatives exist in this space, and PARADIGM doesn’t want to reinvent the wheel. The project is conceived from the start as a complement to EUPATI of course, but also to our involvement in PFMD (Patient Focused Medicines Development), in ADAPT SMART, and EUnetHTA.

We are passionate and will work hard to represent the patient community while building in the operations of the project consulting mechanisms to get as much relevant perspective as needed.

EPF is leading a collective effort! You can follow the project on Twitter @imi_paradigm and on the project website www.imi-paradigm.eu!

For more information about PARADIGM, contact Mathieu Boudes, Project Coordinator.