Partnerships that ease pain

The first 23 projects launched by the Innovative Medicines Initiative (IMI) in 2009 and 2010 are already generating impressive achievements.

These steps forward span areas from schizophrenia, asthma, cancer and diabetes through to chronic pain, lung disease and drug safety, for example:

• The IMI for Diabetes (IMIDIA) consortium has developed an innovative tool that will help researchers understand diabetes and test potential new drugs under laboratory conditions. This exciting achievement is recognised by the scientific community as a significant breakthrough in the field of diabetes research.
"As a result of the IMI’s first two calls for proposals, 221 research groups from 23 major pharma companies are collaborating in projects."
• The eTOX consortium has developed an innovative computer model that predicts if a candidate drug is likely to cause serious heart problems in patients. This new system provides better results than the computational systems currently in use and should help researchers pick up drug safety problems earlier on in the development process.
• The Europain consortium has revealed important findings that contribute to a better understanding of the mechanisms of chronic pain - an achievement that has been covered in major international news media. This should result in more effective treatment of such pain.

IMI research achievements

In many IMI projects, patients are helping to move research forward by providing information and updates about their condition. In some, the presence of patient organisations in the project consortium ensures that patients' voices are heard; for example, some patients are directly involved in the PROACTIVE project, helping researchers to better understand the impact of lung disease on their daily lives - the first step towards optimal management of the disease.

Many IMI research projects have already published significant achievements in high-level scientific literature. An overview is available on the IMI website at www.imi.europa.eu. In addition, IMI Education & Training projects have set up targeted training courses and information platforms for students and scientists who wish to develop their career in the areas of drug safety, preclinical testing or any other aspect of drug discovery and development. This will allow industry and other research organisations to recruit better trained scientists.

As a result of the IMI's first two calls for proposals, 221 research groups from 23 major pharmaceutical companies are collaborating in projects, along with 298 academic teams, 45 small and medium-sized enterprises (SMEs), 11 patient organisations and seven regulatory agencies, including the European Medicines Agency. As these projects gain momentum and demonstrate the success of the IMI approach with impressive early achievements, interest in the organisation is growing worldwide, particularly in the US.

Improving pharmaceutical R&D in Europe

These early achievements confirm that the IMI is on track to achieve its goal: creating new insights that help move drug development forward by pooling knowledge and expertise from public and private partners.

The IMI's primary aims are to reinvigorate the European pharmaceutical industry and biopharmaceutical research, and to improve the health of patients by finding solutions to some of the scientific challenges that hold up the search for new medicines. All IMI projects are carefully defined to focus on pre-competitive needs and protect the intellectual property of all participants. Nevertheless, great advances are being made as companies pool their data and their talent. This gives access to data from a potential population of up to half a billion people, which is a great opportunity, and enables areas to be studied that would otherwise be too risky or expensive for a company working alone.

The level of investment and collaboration is unique, both in Europe and in the global pharmaceutical industry. While the challenges of such big projects are immense, the end results should provide a major boost to pharmaceutical science and research in Europe. Manufacturers will be able to bring new medicines to patients faster because they will have additional tools and knowledge to identify potentially efficacious assets, lower the attrition rate for drug development and select the most appropriate patients for trials.

All organisations taking part in IMI projects will gain from access to pre-competitive information and data, sharing knowledge and risk, and learning from and being creatively stimulated by collaborating with key partners in other sectors. Large pharmaceutical companies will also benefit, along with the other participants, from the discoveries made in projects that are worth many times the value of each individual company's contribution. In some cases, this offers tremendous cost savings, as the IMI projects replicate work that individual companies would have had to do anyway.

The NEWMEDS project has demonstrated the power of this collaborative approach. The companies involved have pooled data to create the largest known database of studies on schizophrenia, including information on 23,401 patients from 67 studies in over 25 countries. It offers the industry and the academic community unique opportunities for the development of tools, methods and models that will help find targeted treatments for schizophrenia. Working with regulators such as the European Medicines Agency will help pharmaceutical companies to better understand, and thereby meet, regulators' requirements for the approval of new medicines.

SMEs benefit from partnerships

SMEs in IMI projects gain access to data and industry know-how in industry that would otherwise be unavailable to them. Their participation in IMI projects gives them international visibility, and their collaboration with partners in industry and academia is likely to lead to other interesting partnerships.

By funding the participation of SMEs in game-changing projects, the IMI offers these companies pole position in the reshaped pharmaceutical sector; for example, an SME in the IMIDIA consortium has played a key role in the generation of an innovative tool that will help researchers to understand diabetes and test potential new drugs in laboratory conditions. This achievement is recognised by the scientific community as a breakthrough in diabetes research.

Think big

In early 2012, the IMI will call for proposals on two new topics with a considerable funding budget attached:

• A European lead factory: the joint European compound library and screening centre. The aim is to establish a unique, comprehensive and high-quality compound collection for high throughput screening (HTS); the Joint European Compound Collection, which comprises a Pharma Consortium Library build of compounds from all participating companies (the expected volume is 300,000 compounds); and a Public Collection aggregating multifaceted design approaches from academic and private partners, realised through the assembly of a library by selected chemistry providers (up to 200,000 compounds). In addition, a European screening centre will be responsible for the logistical processes around the compound library, bioassays for HTS, HTS campaigns for publicly sponsored projects, a suite of generic tests for follow-up studies, and initial medicinal chemistry support, such as analytics, resynthesis and limited hit expansion.
"SMEs in IMI projects gain access to data and industry know-how in industries that would otherwise be unavailable to them."
• Antibiotics research to tackle resistant bacteria: this IMI topic is part of a larger EU Action Plan on Antimicrobial Resistance. More details on the content of this IMI call topic will be made available in the first half of 2012. In line with the IMI's revised Scientific Research Agenda, future IMI projects will aim to tackle challenging issues in medical R&D that cannot be taken on by individual organisations alone. These 'think big' projects will be built on broad collaborations and large budgets.

Focus on pre-competitive needs

Meanwhile, a wave of projects resulting from the IMI's third call for proposals is due to start activities shortly and will include projects on autism, tuberculosis and vaccine safety. All IMI projects are carefully defined to focus on pre-competitive needs. A more recent batch of projects is undergoing the last phase of evaluation, focusing on areas such as obesity, Alzheimer's disease, sustainable chemistry, knowledge management and stem cells.

In order to facilitate participation in IMI projects for both industrial and the public partners, the IMI has simplified its procedures and reduced reporting obligations for project participants, considerably lightening the administrative burden of project management. In addition, changes in funding rules have been introduced that make IMI projects more attractive from a financial viewpoint.

With further simplifications planned (in the application process), the improvements make IMI better equipped to mobilise public and private participants, and tackle the major challenges in medical R&D.