project . 2021 - 2025 . On going

RealHOPE

Real World Handling of Protein Drugs - Exploration, Evaluation and Education
Open Access mandate for Publications and Research data
European Commission
Funder: European CommissionProject code: 101007939 Call for proposal: H2020-JTI-IMI2-2020-20-two-stage
Funded under: H2020 | IMI2-RIA Overall Budget: 7,105,980 EURFunder Contribution: 3,139,980 EUR
Status: On going
01 Jul 2021 (Started) 30 Jun 2025 (Ending)
Description

RealHOPE will create an understanding of the real-life handling of protein drugs in hospital pharmacy, clinics and in the hands of patients by applying smart tag technologies. Different parameters will be logged and combined with protein characterisation at different stages, as well as with information from EFPIA partners on their drugs in use. Statistical evaluation of the data will be used to identify patterns in handling that are linked to protein destabilisation occurrence and type of protein degradation. Focus interviews with personnel in hospital pharmacies, clinics and with patients/care givers will be used to understand current handling practice and what the desired handling instructions and limitations are. These insights will be used to design in-use mimicking stability protocols for the protein drugs in the project. Ultra-scaled-down devices for stability assessment will be designed to be used in early phase for efficient development cost effective and safe future protein therapies. Protocols and devices will be validated towards the collected handling data base. Interventions in hospital pharmacies using e.g. compounding robots will be investigated. Techniques to assess e.g. aggregate formation in the final drug preparation situation will be evaluated together with SMEs producing analytical tools and hospital pharmacists. The collected data and interviews will form the base of development of teaching materials directed towards different target groups: hospital pharmacists, nurses and patients/care givers. App developers will be active in this part to design attractive and efficient apps for teaching and collecting therapy performance data.

Data Management Plans