Response to comments on Jaki et al., A proposal for a new PhD level curriculum on quantitative methods for drug development. Pharm Stat 17 (5): 593 606, Sep/Oct 2018

We thank Krause and colleagues [[1]] and Burger [[2]] for the extremely supportive comments to our proposal for a PhD curriculum in drug development [[3]]. Their comments clearly highlight the high need for fit for purpose training in drug development at PhD level and support the multi-faceted approach taken in our proposal. Moreover, the increasing demand for these highly qualified researchers in the light of the evolving landscape of drug development has been well articulated by Burger [2].How to best train young researchers in evolving statistical methodology such as adaptive designs [[4],[5]], dose finding [6, 7, 8] and analysis methods [9, 10, 11]? Traditionally, universities play a central role in the conception and implementation of students training. Academic institutions are the most experienced to propose and run well-designed teaching programmes. However, as pointed out by both comments–and how our proposal for a new PhD programme on quantitative methods for drug development is conceptualized–strong involvement of other stakeholders in the construction and execution of such a new PhD programme is key for a successful and sustainable implementation. Public-private partnership is essential to tailor to the needs of all stakeholders, to enlarge the possible experiences and to facilitate application of the newly developed approaches. For this, the pharmaceutical industry and regulatory agencies will play a key role. The growing demand in industry has been highlighted in [2] while the latter also has an accumulated demand for highlytrained statisticians [12, 13, 14]. The European Medicines Agency (EMA) established its …