With its emphasis on involving a range of key stakeholders in discussions at a very early stage in the drug development process, the adaptive pathways approach to drug evaluation and market access being spearheaded by the European Medicines Agency is "unique worldwide at the moment". However, "this particular pilot has been under-resourced at all levels" and it will take "three to five years" to see whether it does in fact meet its objective of cutting drug development times and getting products to patients faster.
The first quote, from Susan Forda, vice president of international regulatory affairs at Eli Lilly, illustrates the excitement in some...
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