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IMI on the Move to Improve Drug Development in Europe

By Nuala Moran
Staff Writer

DUBLIN, Ireland – It has not been long since the first research programs got under way, but there is evidence already that projects undertaken by the €2 billion (US$2.4 billion) Innovative Medicines Initiative (IMI) are having an impact on the environment for drug development in Europe.

The signs of improvement include the scrapping of some poorly predictive preclinical models, improvements in patient enrollment and trial design and getting regulators to engage with IMI's overarching objective of remodeling the drug discovery and development process, Michel Goldman, executive director of IMI, told delegates at the Euroscience Open Forum in Dublin last week.

"It is critical to measure the added value of working in such a public-private partnership," Goldman said. "[Pharma] companies are experiencing very difficult times for a number of reasons – this is true worldwide, and particularly in Europe, [and the] motive for establishing the IMI is to invigorate pharma across Europe."

To date, 37 IMI projects are up and running, with €600 million committed by industry. Those involve 350 researchers from 19 companies and 500 researchers from academia. In addition, four regulatory bodies and seven learned societies are involved. "The main mission is to address bottlenecks in pharma R&D: for example, knowledge fragmentation, insufficient understanding of diseases, lack of biomarkers," Goldman said.

In addition, IMI aims to remove a structural and cultural barrier that hampers the efficient operation of public-private partnerships, which is that pharma does not understand basic research and academics don't know about clinical development. "That's why an important part of the program is to better train and educate scientists," Goldman said. "We need to train a new generation of researchers in industry and academe to make public-private partnerships as efficient as possible."

Of the total budget of €2billion, €1 billion is coming from the industry as in-kind contributions of staff time and other resources, while the European Commission is putting in €1 billion in grants to biotechs and academics taking part in projects.

Goldman said it is important to stress that all the research is pre-competitive. "This is noncompetitive research on activities in which pharma companies that are normally strongly competitive agree to mutualize efforts and share risks," he said.

A further key principle of IMI is that more than one pharma company is involved in each project and that external partners are selected through competitive, peer reviewed calls. "The pharma companies and their partners work together in an environment of open collaboration and open innovation, so there is a flow of knowledge between companies and partners," Goldman said.

As a result, the boundaries of pre-competitive research are moving and extending. An example is in collaborations to run late-stage clinical trials, as in New Drugs for Bad Bugs, which is developing new treatments for antibiotic-resistant infections. GlaxoSmithKline plc and AstraZeneca plc both are putting in Phase II compounds to be advanced through further trials by the collaboration.

Since each project has several companies involved, Goldman noted that "the critical aspect is the need for an honest broker to stand between large pharma and academics and biotechs. The IMI executive office provides a safe harbor when necessary – if difficult decisions need to be taken, for example negotiations on IP [intellectual property]," Goldman said.

Another important element is the involvement of regulators, to ensure they will accept changes to traditional R&D pathways, such as allowing the introduction of biomarkers. "It is critical the regulators will endorse the results of IMI projects," Goldman said.

Following approval and registration of a drug, there is no longer any guarantee that it will be reimbursed, and that is prompting IMI to engage with Health Technology Assessment Agencies, and also encouraging a move to demonstrate cost-effectiveness of drugs by running Phase III studies in comparison to standard of care, rather than demonstrating efficacy against placebo.

The overall mission of IMI is to ensure the sustainability of the European pharma industry. "What we've got to create in Europe is the correct environment where academics and biotechs have a very important role. That's what the big pharma companies in Europe are asking for," Goldman told delegates.