Need analysis

For a few exhilarating decades, in the middle of the twentieth century, it seemed the world might have a reprieve from some major -infectious and non-infectious- diseases (despite medical progress in antibiotherapy, vaccinology, oncology, etc.). The rapid growth and urbanisation of populations, now estimated at 7 billion people living mainly in Asia, in combination with globalisation of the economy (industry and agriculture), increasing mobility and life expectancy, and global warming, mainly in western societies, has given rise to increased incidence of chronic diseases and public concern about both improvement and cost-effectiveness of health care. Environmental factors are estimated to be responsible for 25-40% of the burden of human ill health around the world, and often most seriously affected are the most vulnerable members of society, such as young children, pregnant women, and the poor people.  Recent spikes of pandemics such as SARS or Avian flu have highlighted the close relationship and linkages between people, animals and ecosystems together with the easiness and rapidity by which the diseases travel across borders. Tackling epidemics and pandemics in today’s globalised world clearly requires international cooperation between Europe and Asia. We must take into account: (a) the major threats on public health, such as cancers, respiratory diseases, neurological disorders, chronic metabolic and inflammatory diseases, asthma, allergies, diabetes and obesity; (b) the search for comfort of aging citizens, asking to the society to fight against pain, anxiety, stress and nuisances; (c) the new emerging infectious diseases, dominated by zoonoses (60.3% of Emerging Infectious Diseases), mainly originate in wildlife (71.8%), and increasing significantly over time, such as AIDS, Avian flu, Arboviroses. The propensity of pathogens which develop drug resistance, that results in suboptimal treatment outcomes owing to poor therapy compliance by patients.

The new biotechnological paradigm. Although traditional drug-discovery approaches have yielded notable successes in recent years, current estimates indicate that only 5% to 8% of Phase I projects developing new molecules produce a marketable output, by which time anything up to $1bn will have been spent. The decline in output of new molecular entities and medicines recorded over the last 10 years, despite the steadily growing R&D expenditure, bears testimony to the fact that advances with new targets are more difficult and that R&D projects have become much more prone to failure. Despite significant increase in sales (including generic pharmaceutical), some fear that the pharmaceutical industry may not be able to continue to function in this way if it is to remain profitable. The increasing adoption of high-throughput technologies has been accompanied by an increase in the average total development time for drugs from just over 8 years in the 1960s to just over 14 years in the 1980s and 1990s. Heath Sciences industry is faced with the challenge of identifying new targets that will result in the delivery of effective new therapies. This has important consequences for the structure and functioning of the biopharmaceutical innovation system. A new biotechnological paradigm is replacing the traditional chemical paradigm of drug discovery and development. Biotechnology firms (start-up, spin-off), and public medical research organizations are becoming key actors generating new knowledge, tools and substances for the pharmaceutical and medical industry. Information from “omics” experiments has begun to populate databases on a large scale, and our ability to stitch together such vast amounts of data and thereby investigate model for understanding biological processes on a systems level will be crucial to the pursuit of new therapeutic targets. Systemic modeling and use of simulation tools and IT are a must to overcome technological obstacles described above and to develop a Product Lifecycle Management (PLM) approach in Clinical and Life Sciences

Traditionally, the clinical practice of medicine has been separated from basic research by a series of hurdles or fences. The patients were diagnosed and treated as if they belong to homogenous groups, within disease categories, without any relationships with the quality of the environment (air, water, soil, ecosystems, wildlife, etc.), which play a major role in the epidemiology of many diseases. Case Studies, without any basic knowledge, have been designed to increase the primary care provider’s knowledge of hazardous substances (or emergent pathogens), and to help in the evaluation of potentially exposed patients.  And new drugs were developed independently of the clinic, and often « thrown over the fence » for safety testing and clinical trials. New incentive approaches to diagnostics, prevention, therapy and delivery systems are useful to improve treatment of illness as a part of a drive of more responsive, more personalized, more predictive, and more preventative medicine. In this context, the goal of predictive medicine, which is the first step towards a preventive medicine, is to identify biological/environmental markers in order to enroll individuals at high risk for developing a disease in special early detection trials. The state of clinical knowledge regarding the treatment of patients potentially exposed to hazardous substances (or emergent pathogens) in the environment is constantly evolving, but is often uncertain. In the context of environmental health, healthcare delivery is shifting from a retrospective approach, concerned with analysis of the root cause of failure (“what is your chief complaint?”), to a prospective posture based on risk assessment before the development of symptoms. To develop predictive medicine, it is necessary to integrate clinics and basic disciplinary approaches, such as genomics, proteomics, cytomics and bioengineering such as modeling and computing.