Drug Delivery Systems and Biomedical Imaging Materials

Drug delivery systems aim at administering a pharmaceutical compound to achieve a therapeutic effect in humans or animals through a combination of properties such as drug release profile, distribution and elimination. Such techniques improve product efficacy and safety, as well as patient convenience and compliance. Administration methods include peroral, topical (through skin), transmucosal, inhalation and injection delivery. While certain delivery formats, e.g. transdermal, have successfully found its market, mostly for niche applications, the great market opportunities and technical challenges in this field are still awaiting the development of designed delivery vehicles that allow for efficient transportation in the body to the target tissue/organ with minimum adverse side effects, and controlled spatio-temporal drug release profile at the target site. This is in strong contrast to the current practice of continuous and systemic release.

Smart packaging and drug-(bio)polymer conjugation are particularly important aspects in oral administration of “difficult” drugs, such as water-insoluble molecules and highly cell-toxic anti-cancer drugs, for difficult-to-target diseases such as metastatic and brain tumours, and generally for delivery of modern pharmaceutical proteins, peptides and antibodies. Another promising field is modern immunotherapy strategies, for example exploiting efficient targeting of lymphatics and draining nodes/dendritic cells by ultra-small, antigen-bearing, intradermally injected nanoparticles (the latter concept successfully developed with CCMX support in the period 2006-09). From an industrial perspective, novel delivery formats have the capability of improving drugs already on the market, preventing candidates from falling out of the product pipeline, or making use of developed drugs of high efficacy but also high toxicity. It is furthermore widely believed in our community that such difficult-to-administer bio(macro)molecular drugs, and biologics in general, are going to comprise an increasing proportion of the new-drug market. Finally, novel and proprietary dosage forms may constitute a way for continued protection of drugs coming off patent, as well as an opportunity for the future development of a generic industry in analogy to the one that evolved from the development of small molecule drugs.
For quite some time, the focus in both academia and industry has been on applying existing materials for use in drug delivery applications, i.e.: materials that have already cleared regulatory hurdles in the US FDA and the European EMEA.  This approach, which focuses on materials processing rather than new materials chemistry, has led to very limited progress and limited translation to clinical impact.

Therefore, this thematic area  will focus on the development of novel materials for drug delivery designed at the molecular level and with the envisaged therapeutic pathways in mind, i.e.: materials that can display a novel function and yet are designed to exhibit biocompatibility and favourable toxicology.  The novel functionality of these materials could be in efficiency of processing, fidelity of nanomaterial fabrication, improved drug loading capacity, extra-long circulation time, targeting of particular tissue sites such as inflammation of tumour vasculature or lymph nodes, targeting of particular cellular domains, or delivery of difficult-to-handle drugs. Materials designed for any class of drug that meets a clear clinical need are appropriate. Novel chemical structures, designed at the nano and molecular scale, for example intelligent materials that efficiently and specifically release a drug in a controlled fashion in response to stimuli, externally or biochemically triggered, are a plus, especially with support of the proposed design from the literature or from preliminary data.  As such, this portion of the call focuses on chemical creativity and novelty of design, yet with a clear prospect for propensity for translation to animal research and ultimately human medicine.Biomedical imaging: With regard to imaging, material-sensitized contrast enhancement in any imaging modality is desired, e.g., novel magnetic materials (composition, shape) with improved magnetic properties/contrast, sufficient circulation time and favourable toxicity data for application in magnetic resonance imaging (MRI), or optically active constructs with improved stability, penetration depth and/or level of contrast. A further important criterion refers to the degree of resolution and the envisaged ability to detect very small malign structures by imaging, for example the diagnosis of developing metastasis or the initiation of tumour growth.  We particularly encourage submission of proposals where structured nanomaterials are to be developed that will be capable of fulfilling more than one function for in vitro and/or in vivo applications, e.g.: (a) Creative designs of multi-functional and smart materials that, for example, enhance contrast in more than one imaging modality; (b) Nanoparticles with well-defined size and shape that present biochemical cues for targeting specific cells/tissue, e.g., in the context of diagnosis of cancer or cardiovascular diseases such as early stages of atherosclerosis; and (c) Constructs combining targeted imaging with triggered release and therapeutics are in particular demand (“theragnostics”).

• Structural evolution and rheological properties in gel carrier - Project approved, to start in 2010