Around the Globe

COVID-19: Maybe You’ve Heard Of It?
A European Perspective

Thomas Kühler
Sanofi R&D


colleague of mine recently told me she was maybe more overwhelmed by the COVID-19 news flow than by the actual virus itself. This resonated with me. Of course, it is good to learn that her health was not affected by the virus, but the time and effort required to keep abreast of the COVID-19 news flow was well reflected in one word: overwhelming.

Health Authorities around the globe continue to issue numerous guidelines related to managing the COVID-19 pandemic, and there are no signs that the news stream will dry up anytime soon. In the EU alone, many documents have already been issued addressing diverse and wide-ranging topics such as procurement of medicines, how to best conduct clinical trials to generate evidence on COVID-19 treatments, and free scientific advice to stimulate the development of new pharmaceutical principles.

It is evident that EMA is activating all regulatory tools that are available to them to speed up the development of new treatments to curb this pandemic. As an initial response, they triggered their plan for managing emerging health threats in early February 2020.

Key provisions from a regulatory affairs perspective include the activation of three principal tools. First, EMA offers full fee waivers for scientific advice for developers of therapeutic drugs or prophylactic vaccines. Second, a set of support measures that facilitates the development of new therapeutic agents involves fast track assessment procedures comprised of the PRIME scheme, and the accelerated assessment and the conditional marketing authorisation procedures. Third, the expedited handling of Orphan Drug designations to further stimulate drug development, which has already been offered during previous emergency situations.

In addition, EMA has established enhanced measures to capture emerging post-approval data on the safety (and efficacy) of already centrally approved products that may be used to combat the COVID-19 virus.

In addition, although overshadowed by the focus on the current pandemic, EMA released its Regulatory Science to 2025 strategy. The draft strategy was opened for public consultation one year ago and 150 stakeholders, including industry representatives, have provided feedback and insights for consideration. Unsurprisingly (from an industry perspective}, fostering innovation in clinical trials and advancing the use of high-quality real world data to support regulatory decision-making were ranked as the top two priorities for developing pharmaceuticals for human use.

When it comes to regulatory decision-making, EMA has expressed an ambition to exploit digital technologies and artificial intelligence (AI). This is being discussed under the promising heading “Driving collaborative evidence generation – improving the scientific quality of evaluations.” But the EMA also acknowledges that, in the pharmaceutical domain, the field is still in its infancy, and therefore discussions have been limited to application of advanced analytics to processing large structured or unstructured datasets.

As proposed by the pharmaceutical industry, the dossier in the cloud concept, which enables the application of both AI and machine learning to support regulatory decision-making, is only implicitly referred to in EMA’s strategy, which includes the need to “Establish a digital innovation lab to explore, pilot and develop solutions and processes, across the drug regulation spectrum, that leverage novel digital technology and artificial intelligence to support increase in efficiency and regulatory decision making.” This is a bit vague and unspecific and does not provide any tangible insights into what direction the Agency may take – but the upside is that there may be room for industry to help shape the agenda.

Another recommendation to deliver significant benefits when developing pharmaceuticals for human use brought forward by industry during the consultation process was diversification and expansion of regulatory advice along the entire development continuum. In this instance, EMA’s response was explicit: it committed to invest the resources required to strengthen and improve the current scientific advice platforms and open up opportunities for earlier and more frequent dialogues.

As I commented in last year’s editorial when the public consultation was launched, this is a very comprehensive strategy, and this column has touched upon only a few select topics. One lingering question that remains is whether the EMA has the resources and capacity to see it through (especially considering the loss of skilled and experienced staff and momentum precipitated by the move to Amsterdam) and—to close the circle—the resources required to cope with the COVID-19 pandemic. There is a risk that some initiatives may not be carried out within the set timeframe and may indeed be delayed. Let’s hope not.