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IMI can help advance regulatory science for advanced therapies and digital tech, stakeholders say

Unblocking the regulatory challenges surrounding advanced therapies and digital technologies could be game-changing for all players, said attendees at IMI’s recent regulatory science summit.


Every few years, IMI teams up with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) to organise a regulatory science summit. The overall aim of these summits is to identify scientific gaps that could be addressed collaboratively within a public-private partnership such as IMI, and to ensure that potential IMI projects would deliver tangible results that are relevant from a regulatory perspective to maximise their impact on drug development and on the delivery of innovative products to patients.

The last summit, held in Brussels in December 2019, brought together over 50 people from regulatory agencies, health technology assessment (HTA) bodies, industry (including the pharmaceutical, vaccines, and medical technology industries), the European Commission, the IMI Scientific Committee, and notified bodies (i.e. organisations charged with assessing the conformity of certain products before release to the market).

Over two days, they discussed regulatory science challenges that, if unblocked, could be game-changers for the use of advanced therapy medicinal products (ATMPs), and digital technologies for research and development, as well as digital health products. Both areas are characterised by rapid developments, as well as changes in the boundaries of what is considered competitive vs non-competitive.

‘Regulators’ input is key to the success of IMI, as it helps ensure our project results can have a real impact on drug and technology development and ultimately, patients’ lives,’ says IMI Executive Director Dr Pierre Meulien. ‘The convergence of different technologies in the health space will only increase our need to work closely with regulators from different sectors in the future.’

The summit participants’ conclusions and recommendations are summarised in a report.

They conclude: ‘There are numerous regulatory science challenges and opportunities related to new types of therapeutic interventions such as ATMPs as well as to integration of digital technologies in product development or combinations of medicines and digital products, that – when unblocked – would be game changers for all players. None of these challenges can be addressed by one party in isolation and collaboration is key.’

The report sets out six key recommendations:

  • Continued scientific and regulatory dialogue and collaborative research mechanisms, such as IMI, are needed to create a common understanding of problems, a body of knowledge and proof of concepts that would inform the evolution of regulatory practice. Some questions, such as technology integration, call for a broader multisector collaboration with a neutral broker, as set out for instance in the innovative health partnership concept discussed in the framework of Horizon Europe.
  • The very competitive field of advanced therapies would benefit from platforms for rapid knowledge and experience sharing and optimisation of preclinical tools. Rare diseases may be a good theme to explore the right time to treat, the right biomarker, and the long-term effects of treatment.
  • Many uncertainties related to the interplay between medical devices and medicines regulations require some time to gain experience, but also setting up a platform to engage continued regulatory dialogue, and rapid good practice sharing, as well as to identify scientific and technical challenges that need to be addressed.
  • As far as the digitisation of development is concerned, IMI may be the right framework for a project that could surface uncertainties for various stakeholders (regulators, payers, industry, patients, etc.) and try and address them. Some areas, like paediatric development, may particularly benefit from such an approach.
  • It would be important to have a mapping of all IMI projects developing tools, and an assessment of their deliverables and impact to support innovation in public health.
  • Finally a dialogue with regulators (e.g. the EMA innovation network) would be a good approach to define research questions around various types of novel trial designs and their practical implementation. The result could become a future research project in IMI or in future partnership(s) of a multisector nature.


Read more

Report from the IMI-EMA-FDA Regulatory Science Summit of December 2019

How regulators can get involved in IMI
(this page also includes the report from the previous summit, in 2017)

Advice for IMI projects on engaging with regulators

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