IMI chief: ‘We need to learn how to share data in a safe and ethical manner’

Meulien: "For complex diseases, like Alzheimer’s, all the big companies have not managed until now to develop new treatments." [Sarantis Michalopoulos]

This article is part of our special report Biotechnology in Europe.

Ethicists, humanists, lawyers and patients should come together to understand the risk of data in healthcare and whether patients are willing to take that risk, Pierre Meulien told euractiv.com.

Pierre Meulien is executive director of the Innovative Medicines Initiative (IMI), a public-private partnership between the EU and the pharmaceutical industry.

Meulien spoke to EURACTIV’s Sarantis Michalopoulos on the sidelines of the  Biovision 2017- The World Life Sciences Forum in Lyon.

Tell us what exactly the Innovative Medicines Initiative (IMI) is all about?

The Innovative Medicines Initiative is a public-private partnership between the European Commission and the European pharmaceutical industry association (EFPIA). We are talking about a long-term engagement, over 12 years, with a budget of 5 billion euro.

So, we run projects, usually quite complex in their construction, in which pharma companies agree to share knowledge among themselves and the public sector and we fund public sector players, who can have an added value in a particular field.

Such as universities for instance?

Yes, universities, SMEs, regulatory bodies and patient groups. We are trying to bring together all the stakeholders who are required for a particular project in a single platform.

What’s the objective?

The final goal is to accelerate and streamline the drug development process so that we can get new medicines and innovations in healthcare to patients quicker, faster and cheaper than normal.

Do you focus on particular diseases?

Our priorities are those of the World Health Organisation’s priority medicines report. That means there is a guarantee that there is a public health interest and there is no secret what this list contains.

For instance, Alzheimer’s disease, cancer, infectious diseases, antimicrobial resistance, are some of the fields we are dealing with. We try and focus our efforts on those diseases, where there is a market failure. Antimicrobial resistance is one because there is hardly any incentive for pharma companies to invest. Alzheimer’s disease is another very tricky, complex and difficult disease.

By bringing all these actors together, both from the public and private sector, we can share risk, we can accelerate developments and we have the best minds working on a project.

For complex diseases, like Alzheimer’s, all the big companies have not managed until now to develop new treatments. We, therefore, have to work on another way to achieve results.

This means we need to involve the patients, the regulatory authorities, very much upfront.

Because it’s clear that trying to treat dementia once it is already settled in is too late. So we need to find a way of collectively finding people who are at the very early stages of the disease and intervene with pharmacological or other types of prevention that would delay dramatically the onset of the disease.

It’s a whole new thinking and partnership model that needs to be built. And we are investing over €200 million in Alzheimer’s disease only.

We have considerable resources at our disposal. The challenging part is not finding the money but getting the right partnership together from the public and the private sector and making sure it is as productive as it can be.

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Have you made tangible progress in a particular field so far?

Let me clarify that our objective is to speed up the access patients could get in new innovations. We believe that with the focus that we have and the consortia that we build, it can happen.

The patient is the centre of our attention. We have a long way for some diseases because they are too complex, but we have others that have already impacted patients, like asthma, chronic obstructive pulmonary disease (COPD). That model seems to have worked in other diseases too. So now, we are tackling more serious diseases like cancer, or Alzheimer’s. We believe that this model can work.

How could cooperation with the biotech sector speed up access to innovative medicines?

We already have 200 biotech SMEs working on our projects. So, they are already quite involved in what we do. We can always enhance that for sure because they have a lot of new ideas that they could bring to our projects.

We want to find ways of reaching out to them, bringing them in as partners. Making sure that they are aware of a particular disease area, there might be an opportunity coming up for them.

The biotech industry claims that it faces funding difficulties in Europe compared to the US. What are your suggestions to help biotech companies better position themselves on the EU market?

It’s a pretty complex question as it’s very difficult to compare the financial ecosystem in Europe with the US one. In the US, there is a culture of risk, which is not cultivated in Europe as much as it should be.

How do we change that? We need to change the culture of Europeans in that way. What we are trying to do, is to bring people together who would like to share risk and rewards. If a biotech company wants to develop only its product then it goes to another instrument, for instance, Horizon 2020, IMI might not be for them.

But if it is an SME, which is building a technology platform, and their potential client is going to be the pharma or the diagnostic sector, then they should be interested in coming together and joining IMI in order to get closer to their client.

They have advantages in developing their technology, we can fund them directly and they get their networking access to bigger companies who will become their clients.

Europe’s biotechnology potential hindered by investment fears

In terms of pure biotechnology, Europe has embraced innovation. However, it cannot compete with the US yet because it cannot drive private investment in the field, as well as open up the market to new products, a pharmaceutical executive told EURACTIV.com in Lyon.

 

Do you believe that “share the risk but also the reward” should be the norm?

I don’t think that one-size-fits-all. It depends very much on the strategy of the company, of the kind of technology they are developing. I think all depends on that. There is not a norm in this direction.

The EU is building the partnership and collaborative model. We have agreed on the need to find ways to incentivise the private sector to invest. Once this is done, I think we can make huge progress.

Big data and privacy remain a hot topic in the healthcare sector. How do you deal with that?

I think there are many different layers of complexity regarding big data and three main things that we have to get right.

The first is how to integrate data from different research and clinical platforms, to make the best use of all the data that has been collected. So, integration is the first thing.

The second thing – and this is where privacy and other concerns come in – is that we need to learn how to share data in a safe and ethical manner not only across jurisdictions but also across hospitals, institutions.

The third thing is how we scale that integration and sharing model up so that Europe and EU citizens benefit from this. We have the capacity to do something in Europe but it’s very complex and we need to bring the ethicists, humanists, lawyers and patients together to understand who will take the risk.

If the patients are willing to take the risk, why not ask them and put them at the center of that debate.

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