Innovative Medicines Initiative says its early goals being met

The Innovative Medicines Initiative (IMI) has helped change attitudes, with academics gaining much needed insights into the drug development process and pharma companies getting access to new tools that are influencing how they conduct their research, according to an independent review of the programme published yesterday.

For many of the academics taking part in an IMI project was their first exposure to the commercial drug development process. “The greater understanding that has been gained about the complexities of the process will influence how academics think about problems and so will influence the future direction of research,” the review said.

The IMI model gives pharma companies the freedom to try new research approaches and has encouraged greater inter- company collaboration. The sharing of knowledge and the development of new animal models, tools, methods, biobanks and databases, has avoided duplication of effort, whilst increasing the utility of these outputs.

The new report released on Wednesday looks in detail at the first nine projects to be completed. In total they received €82.3 million from IMI, or eight per cent of the IMI budget between 2008-2013. This money attracted an additional investment of €104.8 million from pharmaceutical companies and €30.5 million from other sources. The funding generated 546 journal papers.

“The findings of the report are all the more impressive when one considers that the projects featured account for less than 10 per cent of the total IMI budget,” said Pierre Meulien, IMI director.

IMI was set up to address the flight of pharmaceutical R&D from Europe and to remove major bottlenecks in drug discovery and development. It is the biggest public private research programme in Europe and the largest such life sciences programme in the world.

While half of the value of the programme is in hard cash from Horizon 2020 to fund academics and small biotechs, the remainder is in the form of in-kind contributions from pharma companies.

Although it has led to improvements in the innovation system, the true socio-economic dividends of IMI, in terms of new products, are still off in the future. IMI projects carrying out research in areas including diabetes, chronic pain and drug safety have had a limited commercial impact so far, with only a handful of new spin-off companies and patent filings.

“These projects are, by definition, pre-competitive and so one would not expect competitive activities and near-market innovations to follow soon. Given that the average project size of the IMI projects reviewed was less than €25 million, it would not have been reasonable to expect the impacts to include new medicines available on the market, even if the projects had been focused on developing new products,” the review says.

With a typical drug development cycle lasting 13 years, the review says, “Even a marginal improvement to the medicines development process, whether it was related to cost, time or attrition rates could be very valuable.”

New partnerships, approaches and attitudes

IMI has promoted partnerships, both within the industry and between industry and academics. “Collaborations… are unlikely to have happened without IMI-generated initiatives and investments, certainly not on the scale and scope that they did. Many of the leading scientists from companies that got together had never even met before,” according to the report.

There have been a number of repeat collaborations, including academics receiving further funding from pharma to do more research.

The IMI budget of €2 billion over the period 2008 to 2013 represented around one per cent of European pharmaceutical R&D investment and just over a quarter of one per cent of global pharma R&D investment over the same period.

Pharma companies spent €30.5 billion on R&D in Europe in 2014 so their contribution to IMI that year was around one third of one percent of annual investment.

Project outputs

There was praise in the report for a project led by King’s College London project called Newmeds, which did research on psychiatric disorders, including schizophrenia and depression. It has been one of the most highly cited IMI projects. Before Newmeds, “There had been little or no history of collaboration between companies working in central nervous system research,” the evaluators note. Touch screen technology developed by the project is now commercially available.

The Safe-t project, led by Novartis Institutes for BioMedical Research, generated a “vast amount of data on 105 initial biomarker candidates, of which more than 20 showed promising performance”. A spin-off company is planned for later this year.

A study on chronic pain led by Denmark’s Valby resulted in the formation of a new company.

The only project the report finds fault with is U-biopred, run by the Academic Medical Centre in Amsterdam and Novartis, which looked at severe asthma. Many of the expected outputs had not been achieved at the formal close of the project.

There is a difference in views on the success of the project from academic and industry perspectives. For academics, it did what it set out to do: recruited patients, gathered samples, undertook analysis and found new pathways for further research.

However, U-biopred did not succeed in identifying any biomarkers or targets for drug development. “There is a question of whether the outputs of commercial interest are sufficient to justify their level of investment.”  

The analysis was carried out by four experts, Charles Edquist, professor of innovation at the Centre for Innovation Research and Competence in the Learning Economy in Lund; Bengt Jönsson, professor emeritus in the Department of Economics at Stockholm School of Economics; Katherine Payne, professor of health economics at Manchester University; and Robert Tijssen, professor of science and innovation studies at Leiden University.