Right treatment to the right patient at the right time – the EU unveils €3.4B drug discovery collaboration

The programme, one of five Joint Technology Initiatives launched under the €70 billion Horizon 2020 R&D programme for 2014-2020, will build on the €2 billion IMI programme which was set up with the backing of the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Commission in 2008 to speed up drug discovery. 

To date, 4,000 researchers have participated in forty different IMI projects, including deriving the first-ever human pancreatic beta-cell line, developing new in vitro models to better predict drug toxicity and building the world’s largest database of clinical trials in schizophrenia. This has given Europe international recognition, “as a pioneer in open collaboration for health research,” said Michel Goldman, Executive Director at IMI, outlining the plans for IMI 2. 

The EU will contribute up to €1.725 billion from the Horizon 2020 budget, which will be matched with a commitment from EPFIA members of up to €1.5 billion. 

The challenge for IMI2

“Until now we have worked in compartments”, said Ruxandra Draghia-Akli, Director of the Health Directorate at DG Research, “and each compartment has incurred high costs.” It is hoped that collaboration in IMI2 will reduce the expense and risk of drug discovery, ending the “innovation blockage” Europe is suffering from, said Draghia-Akli. “We need to bring all the innovation we have to patients.” 

Unlocking innovation in healthcare is particularly important in the context of an ageing population and the corresponding prevalence of chronic diseases. This challenge will shape the agenda for IMI2, said Draghia-Akli, “IMI has been a big success, but we are moving to a different strategic research agenda - to address public health needs.” 

The aims for the updated initiative include:

• A thirty per cent  better success rate in clinical trials of priority medicines identified by the World Health Organisation, including diabetes, cancer, autoimmune disease and respiratory diseases
•  Clinical proof of concept in immunological, respiratory, neurological and neurodegenerative diseases in just five years
• New and improved diagnostic markers for four of these diseases and at least two new drugs, which could either be new antibiotics, or treatments for Alzheimer’s disease

Personalised medicine will be a key theme, said Draghia-Akli. This will be driven by a shift from diagnosing disease by symptoms, to molecular-based medicine, in which the underlying molecular and genetic characteristics of diseases are identified by objective diagnostics, rather than relying on subjective and erratic reporting of symptoms. 

Peter Anderson, Senior Vice President of Lundbeck and Chair of EFPIA Research Director Group, said Parkinson’s disease is a prime example where such an approach could improve diagnosis and treatment. Multiple genes have now been implicated in the initiation and progression of this disease. “It is not Parkinson’s disease, it is a genetic disease and we need to treat each patient differently based on their genetic make-up,” he said. 

IMI 2 aims to stratify at least four diseases based on genetic analysis.  Anderson said this would be revolutionary, noting schizophrenia alone has been linked to one hundred genes. If Parkinson’s disease and schizophrenia were broken down and reclassified based on the genes that have been implicated in their aetiology the market would be split many ways. “Each new treatment will need a new business model and regulatory approach,” said Anderson. “This is why IMI2 has a much broader perspective.”

On the other hand, the use of genetic profiling to select likely responders to a new drug, based on understanding of the precise mechanism of action, will result in a better success rate for clinical trials, reducing costs and improving treatments, said Draghia-Akli. 

The focus will not just be on drug discovery, but on successful marketing and business models. This will be particularly challenging for antibiotics, where to avoid the development of antibiotic resistance it is necessary to limit their use, said Richard Bergstrom, EFPIA Director General. “Unlike most products, you want there to be as many variations as possible of the drug with as many tweaks as possible. We are currently working on a business model,” he said. 

Learning from IMI 1

IMI2 will bring together the members of EFPIA, but will also be open to other industries and sectors. “One criticism of IMI was the idea that it was a closed club,” said Draghia-Alki. The impression was that it was an exclusive project for big pharmaceutical companies only, and small biotechs or companies from other industrial sectors could not participate, she said. “We are now creating a very flexible framework for others joining.”