The aim was to establish in the 2 Seas area a centre of excellence in the field of pharmaceutical solids based on a high level technological platform, transdisciplinary research activities and training.

Objectives:
i) To implement a trans-disciplinary (physics, chemistry and pharmacy) technological platform at the state-of-the-art dedicated to: i) material synthesis, ii) advanced characterisation and iii) formulation of pharmaceutical materials. It would help establish the EU region as an attractive choice for leading the technological development of new drug products. It will also support the training program of the project. It will provide active drug ingredients and excipients under new physical forms and innovative drugs with fully characterized and certified dissolution, stability and biodisponibility properties.
ii) To develop an integrated research programme based on the unique diversity and complementarities of know-how which are present in the 2 Seas. This research will provide new strategies to overcome poor drug solubility which is a major bottleneck of the pharmaceutical development. It will thus be specifically adapted to the needs of the local pharmaceutical industry. This will lead to an increased interaction with local industry facilitated through regular contact at the different industrial and academic locations.
iii) To provide a multidisciplinary training programme to meet the needs of pharmaceutical firms all co-organized in the cross border area. In particular the programme will train specialists at the interface between the physics, chemistry and pharmacy of materials used by these industries whilst at the same time reinforcing bilingual competency. Specialist schools and workshops will be organized to promote contacts with business at the level of research, communication and vocational training in academic and related industries centres in the 2 Seas area.

The IDEA project is organized in three interacting activities:

• Activity 1 aims at gathering technical and methodological means for synthesis, characterization and formulation of pharmaceutical solid materials. It offers a mutualised technological platform providing all practical means for the design of optimized forms of active pharmaceutical ingredients.

• Research strategies are defined in Activity 2. They guide the works to be done by the technological platform (activity 1) and use the obtained results in order to propose solutions to overcome major bottlenecks of the pharmaceutical development.

• Training activities are performed in Activity 3 for which the technological platform (Activity 1) is employed as hosting place for practical trainings. They concern co-supervised Phds, common master and doctoral courses and common trainings for personnel undertaking continuing professional development.



Activity 1:The main aim of this activity is to run, harmonize and use a transdisciplinary technological platform for which synthesis and characterization equipments located at the different partner’s institutions in the 2 Seas area are mutualized. Pharmaceutical technologies, chemical engineering, mechanical engineering and material sciences are mainly concerned.

The experimental means allow to: i) produce active substances and excipients under new physical forms with higher solubility and bioavailability properties of poorly soluble therapeutic molecules in traditional physical states and formulations.

ii) Undertake all the analyses needed to characterize the physical states, to evaluate the functionality and to control the stability of the pure and formulated compounds.

iii) Support the research (Activity 2) and training (Activity 3) strategies



Activity 2 aims at developing an original research strategy to define optimized formulation protocols which will improve the therapeutic properties of potentially active, but insoluble, drugs. We use the opportunity to gather scientists of different disciplines present in the EU region to implement a new rational approach. It incorporates the understanding of the solid state chemistry of drugs and dosage forms to overcome the present empirical approach. It improves the bioavailability, the efficacy and the safety of pharmaceutical products. Single drug compounds and formulations are considered.



Activity 3 concerns training activities aiming to educate highly qualified specialists for pharmaceutical companies and academic research institutions in the 2 Seas area:

Training at the PhD/Doctoral level. 6 PhD students have performed transdisciplinary research projects co-supervised by the IDEA partners having full access to the facilities offered by activity 1.

Training at Master level. The principal aim of this sub-action is to establish Master courses jointly run at the different partner institutions focusing on the IDEA transdisciplinary activities related to pharmaceutics with the aim of tailoring specific training needs to fill gaps in an individual's skills.

Transdisciplinary Training schools. The complementary expertise of the different project members offers a very special opportunity for this creation of trained individuals able to move between the different disciplines in a smooth and effective way thereby creating very special advantage unique to the region.

• New mechanosynthesis protocols to manipulate the solid state of active ingredients and excipients and to modify their physical properties so that their pharmaceutical functionality are improved.

• Development of new experimental and numerical tools to characterize, predict and modify the physical stability of amorphous pharmaceutical solids.

• Availability for SMEs within the 2 Seas region of a large knowledge base as well as the analytical facilities to allow them to develop new drug products and formulations.

• Development of a strategy for drug formulation to enable generic methods of drug formulation to be developed for the general use of the pharmaceutical industry.

• Identification of appropriate excipients in order to optimize drug release.

• Production of novel drug products by hot-melt extrusion, freeze-drying and spray drying with appropriate excipients to allow for optimized drug release and long term stable products.

• Production of prototypes of new drug products.

• Development of a Dynamic Gastric Model (DGM) as a novel means of mimicking the biological environment of the human stomach to be used by companies working in the 2 Seas region.

• Test of industrial scale-up of the new developed drug products produced by IDEA partners.

• Publication of 35 articles in international reviews. 30 oral communications were given at national and international conferences.

• 15 PhD students (6 directly paid by IDEA) and 12 Master students obtained a high quality transdisciplinary training given by IDEA partners.

• IDEA Partners organized: 6 specialized trainings schools at different partners sites and 3 opened meetings.

The pharmaceutical industry: SMEs as well as major pharmaceutical companies, in particular those located in the 2 Seas area. Most of the current drug candidates in the pipelines of the pharmaceutical industry are difficult to deliver to the patient, because they are poorly water-soluble. The presented project aimed at overcoming this restriction and to allow for efficient drug formulation and administration, assuring that the active agent is able to reach its target site.

• Companies providing instruments for advanced characterization of drug products

• Personnel working in the health care domain undertaking continued professional development

• Undergraduate students, PhD students, post-doctoral fellows and researchers in pharmacy, physics, medicine and chemistry.

The final “beneficiaries” are the patients.

More than 40 % of newly discovered drugs have little or no water solubility and 90 % of drugs approved by the regulatory authorities since 1995 have poor solubility, poor permeability, or both. The IDEA project aims at overcoming this major bottleneck. All types of diseases will be addressed, although, anticancer drugs exhibit particular challenges during formulation. Cancer is currently the second leading cause of death in Europe and the disease takes a very high human toll. This is particularly true for the 2 Seas region. The improvement of drugs efficacy and availability resulting from the project is expected to have a direct positive impact on the therapeutic efficacy of these treatments.

The close vicinity of the partners helped a lot:

to setup the trans-disciplinary technological platform (physics, chemistry, pharmacy)
dedicated to: Material synthesis, Advanced characterisation and Formulation of pharmaceutical materials. The technological platform is easily accessible by all partners in order to perform experiments and analysis. It thus allows to undertake a joint research activity programme very efficiently with technical applications to the design of new solid state pharmaceuticals including fast and efficient validation provided by the SME localized in Ghent.

to create a training centre for a new trade dedicated to the optimization of the solid-state drug manufacturing processes. The training was provided by the members of the partnership and meets the need of pharmaceutical industries.
Targets: local students and personnel from industries undertaking continuing professional development.

Synergies with the MULTIDES project. Both IDEA & MULTIDES merged in the AMPTEC cluster.

We should learn from one's mistakes and not repeat them in future. During te preparation of the project, we had under estimated the preparation work for all partners, we had not shared costs of the closing conference that have been taking account by the partner leader, the timesheets should be prepared monthly and not to wait the last minute to fulfill them. What is important: the coordination of the project between partners and to follow the recommendations of the JTS. It is very clear that for academicians it is the best way to share our research results and it is still the best way we know of in developing powerful researchers in our university.

In summary, it is the best investment for us to become a successful researcher sharing practice and theory and also to be near the needs of industrials.

All academic partners receive core funding from their national government and some benefited from private money ensuring sustainability of the project when the Programme has come to an end.

The partners continue to cooperate in the framework of the AMPTEC cluster that has officially started on January 1st 2014. Application for an INTERREG V is also highly probable.

The IDEA project promotes strengthening of the links with industries that reinforce the partnership in their future fundraising capacity. It will also offer opportunities for others national and international European funding projects (IFMAS, ANR, Marie Curie network, COST).