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.
The cross-border collaboration of 10 highly complementary partners in France, Belgium, The Netherlands and the United Kingdom in the field "Drug Product Development" has fostered the European competitiveness in this crucial domain: As evidenced by the COVID crisis, the capacity to develop and produce life-saving medicines is of utmost importance for our community. The knowhow and facilities to do so must be provided in Europe. Otherwise, the supply with essential drug products is "out of our control".
Leading specialists in the fields of pharmaceutics, medicine, microbiology, engineering & physics have joined their forces and started to develop novel drug products for improved medical treatments, allowing to reduce undesired site effects. The fruitful collaboration of leading researchers at the Universities of Cambridge, Delft, Ghent, Leiden, Lille & London and in pharmaceutical companies allows to combine the required know-how and experience of theoretical & experimental scientists, medical doctors and engineers to develop innovative drug products for patients suffering from hearing loss, different types of cancer and Crohn's disease.
This collaboration could start despite the spreading of the corona virus and related lockdowns: Appropriate mitigation measures were taken so that first prototypes of the novel medicines could be prepared and characterized. This highly interdisciplinary work became only possible due to the cross-border action supported by the Interreg 2 Seas programme: The required knowledge & facilities are not provided in a single member state.
In the first phase of the project, the most promising manufacturing techniques and product compositions are being identified, for example injection molding and 3D printing of personalized breast implants. The drug is released in a time-controlled manner to optimize the therapeutic efficacy and minimize toxic side effects.
Awareness on this project has been risen in the scientific & medical community, for instance via online conferences with oral presentations & scientific discussions and emailings, reaching more than 8000 scientists in the field. Also, a network of industrial observer partners is being built up, with major pharmaceutical companies like Pierre Fabre, Pfizer, Johnson & Johnson. Jointly with such industrial partners the novel drug products, which are to be developed in this project at the laboratory scale, are to be up-scaled and introduced to the market in follow-up projects.