ROADMAP Stakeholder Partnerships: The Importance of regulatory engagement 21 Sep 2017

Today’s post is by Michael Happich (Director HTA BioMeds, Canada & Europe) at Eli Lilly & Robin Thompson (Director, EU+ Value and Market Access) at Biogen International

One of the key strengths of the Innovative Medicines Initiative (IMI) is the focus on broad stakeholder engagement that facilitates open discussion. Alzheimer’s disease progresses over many years, there are limited validated biomarkers available and there are differing perspectives on the endpoints. Differing data requirements between industry, regulatory and HTA bodies can hinder progress towards diagnostic and treatment development. In recent years industry, regulators and HTA bodies have become increasingly aware of the need to consider differing perspectives and subsequently the need for broader engagement.

In this spirit of engagement, representatives from the ROADMAP project met with the EMA Innovative Task Force (ITF) at a meeting in London on 29th June 2017. The objective of the meeting focused on how ROADMAP could best engage with EMA, focusing on three topics.

Topic 1 discussion highlighted potential opportunities for interaction via the ITF, Scientific Advice and/or Qualification of New Methodologies procedure, as well as a number of other ad hoc opportunities (e.g. shared workshops and participation in surveys). There was consensus that EMA engagement should be guided by the specific ROADMAP project aims and associated timelines.

On the EMA Big Data Task Force and Registries Initiative (Topic 2) there are also opportunities for engagement. The EMA is holding a series of workshops and there would be scope for collaborating with the ROADMAP Consortium on these workshops.

A further avenue for engagement is the Patient Registries initiative, launched in September 2015, which aims to improve the use of patient registries in the benefit-risk evaluation of medicines within the European Economic Area. The EMA Registries Initiative coordinator has offered to engage with ROADMAP and suggested a call to discuss further.

The final Topic focused on Disease Models. EMA suggested that engagement via the Qualification of New Methodologies procedure could be used to assess and validate a disease progression model. Early engagement is important and the process should be seen as being iterative, meaning that the procedure can start before a model is finalised such that advice can be taken into account.

In summary, the initial ROADMAP experience with regulators highlights a number of avenues that can be explored to ensure that the appropriate input is tailored to specific ROADMAP goals. The experience to date highlights a collaborative desire by stakeholders to engage on shared issues of interest that will facilitate a greater understanding of the disease and measurement of outcomes.

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