Site-Specific Drug Delivery
Priority AxisTechnological and Social Innovation
Lead partnerUniversité de Lille
Project budget4 885 143 €
ERDF amount2 931 086 €
The large majority of drug products available on the market deliver the drug in a non-targeted manner into the human body: The drug is circulated via the blood throughout the entire organism. Parts of it reach the target site (e.g., a specific organ). However, the large majority of the administered drug dose is distributed within the rest of the body. Importantly, this drug is not only “lost” for the treatment, it is often harmful for the patient, causing potentially severe side effects. The latter have 3 major consequences, they: (1) constitute a major health burden for the patient (e.g. causing nausea, headache, cardiovascular complications), (2) can limit the drug dose that can be given to the patient, leading to nonoptimal therapeutic effects (the drug amount reaching the target site cannot be further increased), and (3) cause considerable costs for the health care systems (e.g., due to the treatment of side effects, prolonged hospitalisation times
and sub-optimal treatments).
The aim of this project is to develop innovative drug products, which are able to control the resulting drug distribution in the patient’s body: The drug amount at the site of action is to be optimized, and the amount that is “lost” into the rest of the human body is to be minimized. This is to be achieved by “site-specific delivery systems”, which release the drug at a controlled rate at the site of action. Thus, the therapeutic efficacy will be improved & undesired side effects reduced. This will help reducing the current cost burden on our healthcare systems due to adverse drug effects. The latter are estimated at 79 billion Eur/year in Europe (https://doi.org/10.1111/eci.12875), eq. to 3.1 billion Eur/year in our 2 Seas region. Also, 200k deaths are caused by adverse drug effects in Europe/year (eq. to 8,000 in our region). The diseases/disorders we are targeting affect more than 60 million citizens in Europe (> 2.3 million in our region), whose quality of life is to be improved.
(1) Innovative drug products (TRL 5) for a safer and more efficient treatment of patients suffering from Crohn’s disease, ulcerative colitis, ovarian cancer, breast resection due to cancer, and hearing loss/deafness.
(2) A novel in vitro characterization method (TRL 5) facilitating the development of this type of innovative drug delivery systems and assuring adequate quality control during production.
(3) A feasibility study (TRL 5) demonstrating the validity of the newly developed prototypes. The main target groups are private pharmaceutical companies and medical doctors (e.g. working in hospitals) treating patients suffering from the respective diseases.
Patients are not “directly targeted”, since only innovative “prescription drugs” are to be developed.
Another “target group” are animals, because their number and suffering for drug product testing can be reduced by the newly developed in vitro test.
Cross border approach
None of the consortium partners would be able to conduct the project on its own (or in collaboration with national partners). The critical mass needed to unite the required spectrum of knowhow, facilities, theoretical and experimental techniques as well as long term experience is only reached by the proposed cross-border collaboration of world-wide leading specialists providing very different and complementary knowledge and competences. This includes cutting edge skills in the fields of pharmaceutical and medical sciences, (micro)biology, physics, chemistry, (bio)engineering, and patient care (hospitals). Importantly, the consortium partners provide the required knowhow, equipment and facilities to manufacture innovative implants for site-specific drug delivery to the inner ear, colon, peritoneal cavity and breast, test new prototypes, scale-up the production, translate the obtained new knowledge into practical applications, and treat patients suffering from the addressed diseases.