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Investigating Interactivity

In a recent FDA report, the Agency recognised that not enough scientific work has been done to create new tools to get fundamentally better answers about how the safety of new products can be demonstrated faster, with more certainty and at lower cost (1). The FDA has planned the ‘Critical Path Initiative’ in which the early assessment of safety is crucial for successful drug development. More recently, the European Commission and the European Federation of Pharmaceutical Industries and Associations joined forces to create and operate a new not-forprofit international organisation that has the objective of implementing the ‘Innovative Medicines Initiative’. Similarly to its US counterpart, the European initiative proposes a number of paths that will accelerate discovery and development programmes by earlier safety assessments.

Clinically relevant drug-drug interactions (DDIs) occur when the therapeutic or toxic effects of a drug, administered as therapeutically recommended, are changed to such an extent that dosage adjustment or medical intervention may be required. DDIs are recognised by regulatory authorities and pharmaceutical companies as one of the major causes for early termination of clinical development, refusal of approval, severe prescribing restrictions and withdrawal from the market. DDIs are thus important determinants of the safety of a new product. In addition, a meta-analysis of adverse drug reactions (ADRs) indicates that these are the fourth leading cause of death after heart disease, cancer and stroke.


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Dr Stefano Persiani is Director of Translational Sciences and Pharmacokinetics at Rottapharm-Madaus, Italy. His experience within pharma and CROs ranges from drug discovery and lead optimisation to early preclinical and full clinical development in different therapeutic areas such as oncology, cardiovascular, gastrointestinal and rheumatology. He is an expert evaluator for the EU’s Seventh Framework Programme and Innovative Medicine Initiative.
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Stefano Persiani
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