For thousands of years, humans have been inhaling substances to induce effects on the body. Despite this long history, the field of inhaled medicines (or inhalational medicinal products) is only now reaching a level of maturity that can lead to rapid developments. Progress over most of the twentieth century was slow, focusing mostly on the treatment of airway disease. This is now changing because the underlying science and technology has reached a critical point of development. In recent years, the lung has also been studied as a possible administration route for the treatment of systemic diseases, such as diabetes type I and II. Inhaled vaccines are also being actively investigated by several groups worldwide. For example, preventive immunization by inhalation has yielded encouraging results for measles vaccines in large trials in school children. Moreover, eliciting an immune response at the port of-entry of numerous pathogens, among them the "global killer", Mycobacterium tuberculosis, is an intriguing concept, however, as yet burdened with concerns with regard to toxicity and safety.
One of the greatest challenges considering the aging of the world population in combination with the reduction of health budgets is to keep the costs of therapy low. This has the consequence that medication has to be cheap, but yet highly effective, and that patients need to comply and adhere to the therapy in order to prevent periodic or permanent exacerbations of the disease that lead, e.g. to bacterial resistance development (against antibiotics) and frequent hospitalizations. In this respect, the main challenge in relation to inhaled medicines is to overcome technological difficulties while keeping the manufacturing costs low, the drug administration techniques simple and the time needed for the administration short.
The accelerating rate of progress in the field is reflected in the number of scientific articles published. The total number of articles published over most of the nineteenth and twentieth centuries (between 1838 and 1990) is roughly equal to the number of articles being published every two years since 2005.
This activity is driven by the culmination of largely independent developments in five major areas of research, namely Particle Engineering and Formulation Development; Device Engineering and Formulation-Aware Inhaler Design; Integrated Computer Simulations; Advanced Imaging, Patient Monitoring and Delivery Verification; and Toxicity, Risk Assessment and Regulation.
Yet, further progress is currently stymied by a number of important scientific and technological gaps. The way forward is difficult because these gaps and open issues are faced within distinct scientific and engineering disciplines and yet they are strongly interlinked. In order to be able to find effective solutions, these questions must be approached as much as possible through a holistic methodology that will bridge the barriers dividing disciplines. Wide relevance and benefits: The pulmonary delivery of medicines and vaccines is a complex field involving numerous scientific and technological disciplines.
Over the last half-century, developments in the various disciplines that contribute to the field have occurred largely independently of each other. While the overall technology remained in infancy, the compartmentalization of effort was not particularly problematic. However, today we find ourselves in a unique position, because knowledge in most of the contributing subfields has reached a critical point of development. As a result, the field as a whole is on the verge of a technological breakthrough that stands to revolutionize how we treat many chronic and acute illnesses and how we vaccinate populations against infective agents. At this point, to achieve the potential that is within reach, coordination and integration of research and development efforts is of paramount importance because the problems remaining to be solved are highly interlinked.
The prospect of highly customized, patient-tailored inhaled medicines with an expanded scope of action necessitates a much closer coordination of research and development activities. Simlnhale will bring together, for the first time, key experts from all areas concerned with inhaled aerosol deposition. The promotion of synergies and interdisciplinary collaboration is particularly important at the current conjecture because it can become the catalyst for a step change in the overall technology. Possible synergies with ongoing research will be leveraged from the start.
The aim is to accelerate the introduction of a new generation of safer and more effective inhaled medicines, with obvious social and economic benefits. Furthermore, the Action will consolidate and disseminate unbiased scientific knowledge thus contributing not only to accelerated technological progress, but also to the assimilation of developments by society in general.