First Catch Your Regulatory Science Hare

The instructions of a legendary 19th recipe for jugged hare began: "First catch your hare". By the same token, the first task of drug developers in this new year should be to make their thoughts known on how to drug development should be assessed-and they have the perfect opportunity to do just that with the construction of a new strategy from one of the world's leading authorities.

The European Medicines Agency has drafted a plan (https://www.ema.europa.eu/documents/regulatory-procedural-guideline/ema-regulatory-science-2025-strategic-reflection_en.pdf) for closer engagement with regulatory science over the next decade, and it is actively seeking comments on its approach. To make it even easier for input, the agency has put a questionnaire on line (https://ec.europa.eu/eusurvey/runner/EMARS2025PublicConsultation2019).

The proposed ‘Regulatory Science to 2025’ strategy "aims to build a more adaptive regulatory system that will encourage innovation in human and veterinary medicine,” according to Guido Rasi, EMA’s Executive Director. It is an explicit response by European regulators to the challenges that have emerged in recent years from new technologies. Against the background of the long-established classic medicines testing systems dependent on 'gold-standard' randomized clinical trials, it holds out the prospect of a genuine assessment of the benefits and risks of innovative therapies and diagnostics.

Stakeholders are being asked to give their views on what the priorities should be in this recast. The proposed top themes in the draft strategy range from "catalyzing the integration of science and technology in medicine development" and "driving collaborative evidence generation-improving the scientific quality of evaluations" to "enabling and leveraging research and innovation in regulatory science", with "advancing patient-centred access to medicines" and "addressing emerging health threats" thrown into the mix too.

Should the clever money go into supporting developments in precision medicine, biomarkers, and ‘omics, or into translating cell, genes, and tissue-based products into patient treatments through the EMA's (so far under-used) advanced therapy medicinal products scheme? Do novel manufacturing technologies get enough attention at present? Should regulators create an integrated evaluation pathway for the assessment of medical devices, in vitro diagnostics and borderline products?

Should the accent be on leveraging novel non-clinical models and foster innovation in clinical trials, or catering for more digital clinical data generation? What emphasis should be given to initiatives for special populations, to making more use of modelling and simulation? And how far should artificial intelligence play a role in decision-making? 

The draft ranges across all these questions. But there is also scope for offering additional priorities or approaches too. "Are there any significant elements missing in this strategy. Please elaborate", asks the questionnaire. "We want to hear from our stakeholders whether they consider this strategy is ambitious enough,” confirmed Rasi, launching the consultation at the end of 2018. So, stakeholders, you have until June 30 to influence the future. Over to you.

Peter O'Donnell is a freelance journalist who specializes in European health affairs and is based in Brussels, Belgium