Interactions between drug regulatory authorities and academia: motivations, barriers, and suggestions

Abstract

In recent decades, there’s been a growing trend in universities to interact with non-academic partners. The term ‘academic engagement’ describes the interactions and activities between academia and these partners, including industries and governmental organizations. Commercialization activities that involve patenting, licensing, and establishing spin-out companies are common for the interactions between university and industry, or so-called University-Industry (U-I) interactions. Examples of University-Government (U-G) interactions previously identified in the literature include advising, school projects, and public exhibitions. Among different U-G interactions, University-Regulator (U-R) interactions refer to those relevant to policymaking and granting legal approval. This study focused on the ones between universities and drug regulatory authorities. U-R interactions in drug development appealed to us for a couple of reasons. Compared to other fields of expertise, U-R interactions in drug development are more common and the bond between academia and regulatory authorities is fairly tight. Moreover, further insights on U-R interactions in drug development were expected to optimize the drug development procedure. We conducted an interview study to understand the context of U-R interactions in drug development and regulations, motivations for academics and regulators to interact with each other, potential barriers in these interactions, and suggestions perceived by both parties to improve the situation. In total, 21 experts from Dutch academia and Dutch and European regulatory authorities participated in the interviews. The online interviews were recorded and transcribed. The transcripts were later analyzed qualitatively to answer our research questions. This study revealed some U-R interactions in drug development that overlapped with U-I and general U-G interactions. People-based activities such as giving lectures and advising were examples of these mutual interactions. On the other hand, interactions on the approval of products were exclusive to U-R interactions, given the regulators’ distinct roles as policy and decision makers. Furthermore, this study concluded that academics and regulators were motivated to interact with each other. We also discovered specific motivations that matched certain contexts of U-R interactions. Optimizing drug development procedures that bring patients timely access to drugs as their mutual goal, academics and regulators identified current barriers to overcome and provided potential suggestions to strengthen U-R relationships in drug development. On top of the barriers respectively experienced by academics and regulators such as lacking time and having to maintain independence, lacking funding was found to be a joint barrier that both sides shared. The suggestions given by the respondents in the study surrounded the concepts of improving either the quality or quantity of U-R interactions in drug development. While educating academics on regulatory affairs could improve U-R interaction’s quality, engaging regulators early in development plans could increase its quantity. To sum up, the results of this study offered valuable insights that would assist drug regulators in making future policies that bring substantial benefits to public health.