Rogério Gaspar, Vice-Rector at Universidade de Lisboa (ULisboa)

The increased complexity of factors involved in drug discovery, design, development and usage (3DU) makes way for new approaches that can integrate Science & Technology serving the needs of patients. Among those approaches the need to establish more efficient strategies to transform Science in better Healthcare faces challenges from Industrial organization (and business model), from Science gaps (in certain areas evident lack of adequate models for translation to first in man or clinical trials) and from non-harmonized views in certain areas between regulators and scientists.
Systems approaches will become more common through the introduction of complex analytical and predictive tools, by opening new doors for systems toxicology (allowing room for the introduction of modern toxicology methods), systems pharmacology (a whole new paradigm currently addressed by a number of NIH initiatives), systems therapeutics (integrating also pharmacoepidemiology and pharmacogenetics, as well as efficacy and effective evaluation tools, paving the way for health technologies assessment with a better scientific base), systems technologies (Quality by Design or QbD approaches, through the use of PAT), and complex systems, through the development and use of new hybrid and increasingly complex structures that will allow to combine different therapeutic targets with
a combination of diagnostics, therapeutics and monitoring. These five systems approaches are the Science base for modern Regulatory Science.
All advances need to be put in the context of improved healthcare, more efficient, with increased rationale use of complex therapeutic platforms, optimizing diagnostic and therapeutic functions, delivering affordable technologies capable of really improving healthcare in specific groups or populations of patients.
Health technology assessment (HTA) will bring to the table the need to integrate medicines and diagnostics, including better biomarkers for both safety and efficacy, including the use of new imaging techniques together with new purposely engineered materials platforms.
Drug usage based in science approaches making use of Pharmacoepidemiology and/or Pharmacogenetics as well as improved communication skills from health professionals, will be increasingly a key-point in the rationale use of medicines in the context of the overall rational use of healthcare technologies.

26Oct