For many years we’ve taken an active interest in the time required by regulatory authorities globally to approve orphan drugs. Clearly this kind of activity is required for forecasting and planning, but it also helps in communications to give our broader audience a realistic idea of the timelines ahead and some of the hurdles we may face.
Predicting timelines in drug development is an imprecise business fraught – each case or drug needs to be indivudally assessed, there are no comparables – but it is nonetheless one method by which we can anticipate the period of time required before any decision from the European Medicines Agency (EMA) is published. (more…)
Take ten years, half a billion dollars and countless man hours from some of the most highly trained, intelligent individuals on the globe. You still stand a 90% chance of failure, some of which is totally out of your control. This is the apparent reality of modern drug development.
When Andrew Pollack of the New York Times declared that the “world’s largest drug company is thinking small”, he wasn’t referring to reductions in sales force.
Held biennially, the Porphyrins & Porphyrias conference (P&P) is the world’s largest gathering on the porphyrias – a group of metabolic disorders causing biochemical disruptions in the pathway of the body which synthesizes haem (heme).
