Interview: Michel Goldman, Innovative Medicines Initiative

Launched in 2008, the Innovative Medicines Initiative (IMI) is a public/private partnership between the European Commission and the European Federation of Pharmaceutical Industries and Associations (EFPIA), which funds eligible projects developed by collaborations of stakeholders. Both the EU and EFPIA are represented on its governing board.

The two hot topics under consideration for the first half of 2012 are: one to address resistance to antibiotics through the discovery and development of novel antibiotic drugs, which is a current EU priority, and the other to build a joint European compound library and screening centre for drug discovery.

As the IMI's executive director, Michel Goldman manages a team of around 30 people, launching calls for proposals, evaluating the subsequent expressions of interest (submissions) and preparing the grant agreements. He is responsible for monitoring the projects from both the scientific and administrative, financial and legal sides.

"The projects we handle are mostly research and development proposals conducted by consortia comprising several large pharma companies, members of EFPIA," explains Goldman. "These partners do not receive funding and, in fact, commit resources to the projects. Their partners in the consortia include academy teams, biotechs, other small businesses, patient organisations and sometimes regulatory institutions, all of which are eligible to receive EU funding."

After each call for proposals, IMI appoints independent experts to rank the submissions received. These proposals come from the groups that compete with one another for the finance available and that hope to partner big pharma. Then the best ranked applicant is invited to work with the pharma companies connected to the topic to prepare the full project proposal. This then undergoes a final peer review by a panel of experts appointed by the agency. 

The funding granted varies from project to project, with education and training projects less costly, for example. "Typically, we have a total of around €20m to allocate over a five-year period, which includes the matched contribution from the large pharma companies," says Goldman. "In the future, we aim to fund larger-scale projects. For instance, we have two projects that will receive a total budget of €50m for five years. Increasingly, will will go for even more ambitious, really game-changing projects and obviously we will allocate more funding to them.

"Really, the goal of IMI is to develop new tools, new technologies, new standards which are needed for the drug development process. And we do this by implementing proposals in different areas. For example, we have several projects on brain disorders, diabetes, cancer, inflammatory disorders and several projects on pulmonary diseases, to give you an idea of the key areas."

The idea behind IMI is, he continues, to create across Europe a new ecosystem for pharmaceutical research and development by building partnerships between large pharma companies and teams from research institutions, all collaborating together to develop these new tools.

"Examples of our success include the NEWMEDS consortia, which assembled the largest database ever on studies of schizophrenia. We have data on in excess of 20,000 patients from more than 60 studies in over 25 countries. Those studies were conducted by pharma companies separately, and through the IMI initiative they pooled the information together. The analysis of this pooled data is very important to identify the parameters which are most relevant to assess the efficiency, the efficacy of new drugs for this disorder. Plus, the same consortium units assembled a database on more than 2,000 patients with major depression, which has helped to identify the genetic factors that might predict a response to antidepressants.

"Another project, by the IMIDIA consortium on diabetes, has generated cell lines which reproduce the response of insulin-secreting cells in the pancreas, the beta cells, and these beta cell lines are useful tools for drug development in this disease," he enthuses. 

"We also have a diabetes SUMMIT consortium that is developing new biomarkers for the complications of the disease, as well as the important eTOX consortium, which has developed preclinical models: computer models that can predict the side effects of drugs. The eTOX system can predict the action of new drugs on the heart. This is an important development because it could reduce the number of animals and possibly patients that need to be exposed to experimental drugs, which is imperative in terms of drug safety."

Meanwhile, the SAFE-T consortium is working in close collaboration with the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) in the US to develop new biomarkers for drug-induced injury to the liver and the vascular system. Several projects use data recorded by patients themselves, Goldman points out, which provide valuable patient-reported outcomes to help assess drug efficiency or potential side effects. One such investigation is underway in pulmonary diseases, using patient information. 

Talking of the challenges IMI has faced, Goldman says: "I'm quite proud that we have been able to overcome a number of potential barriers and have managed to get all of these people working together from different worlds, from different cultures. Such effective partnerships deliver, and deliver in a very short period of time. In the case just mentioned, the first results were obtained in less than two years, as it was initiated only in 2009. It could have been difficult to get the consortia, with scientists from different cultures, working efficiently, but the IMI has demonstrated that it is possible to manage them and get them working together productively." 

Another potential problem for IMI has been the management of intellectual property (IP) rights in the consortia. However, Goldman explains that, through discussion at the outset, in project after project, solutions acceptable to all parties have been found.

"A major goal for IMI is to fill the gap which remains in translating results of research and innovation into new projects and in meeting the expectations of the large pharma companies, which are currently revising their business models. They see the benefit of sharing more R&D information in certain steps of the R&D path. The pharma companies define these steps as 'pre-competitive' or 'non-competitive', so the challenge for IMI is to offer them the best partner to make this research as efficient as possible." 

Goldman believes that the IMI is fully integrated in the pharma companies' new business models, contributing to the new ecosystem. 

The IMI's funding has not been affected by the wider budget cuts happening across the EU, to date, as the money was committed at the launch of the IMI initiative. However, each Euro spent by the EU must be matched in kind by the large companies. "The challenge is to at least maintain this balance and to maintain the commitment of the large companies, which has been the case so far," Goldman states. "However, this is a constant challenge because to mobilise EU funding, we must first mobilise the contribution of the large pharma companies."

In terms of volume of applications, Goldman explains that they received fewer in the third call for proposals "probably because people now understand that only the first-ranked applications go through and receive funding and also the fact that the topics were more narrow. We received 32 requests for seven research topics. Also, probably only those who can meet the challenges of working in consortia now apply." 

Goldman is pleased that IMI is uniting so many parties to bring about positive change: "I think that the success of IMI lies in the fact that it fills the need for a system that can bring a range of stakeholders together. Academia was looking for project consortia in which it could see the translation of its efforts facilitated. Plus, the large pharma companies were looking for models in which they could implement their new vision of research and development, based on more collaboration between the companies themselves, as well as between companies and academia and small biotech." 

The regulatory agencies also wanted to be more actively involved in studies investigating new biomarkers for drug efficacy and drug safety, to help their decision making later in the process. Plus, patients also needed a mechanism through which their voices could be heard.

Goldman adds: "IMI really came at the right time, with all of these stakeholders wanting to find new opportunities to collaborate. I believe that a change in mindset has created a collaborative culture across Europe for drug development which didn't really exist before and which has, through IMI, put Europe at the forefront in collaborative approaches to drug development and mobilised resources from the private sector."

The effects of IMI are also reaching beyond Europe, with great interest from the US, which does not have a similar model itself. IMI has been visited by a Chinese delegation to see how it operates, too. 

Looking to the future for IMI, Goldman says that while most senior managers in big pharma share a common vision on precompetitive research and open collaboration, the challenge is to work to engender a collaborative spirit at every level of each company, not only among the scientists, but also among the lawyers and everyone else involved further along the drug development process. "In academia, too, people are sometimes reluctant to collaborate with industry, so there is a need to communicate and explain the benefit for everyone. Our major aim is to demonstrate the real added value of IMI and to show that we are producing game-changing results in key areas, resulting in such things as new standards, new tools for the regulatory institutions. Through implementing transformational projects we facilitate drug development and in the end benefit patients.

"I am a doctor by training, so for me, patients remain central. My aim is to continue to promote the work of IMI and help patients and patient organisations have more input with industry and the process of drug development. I want IMI recognised as a unique vehicle to build bridges between stakeholders. It is also important to remember the European dimension and to show the added value of IMI at the society level, which again brings us back to benefits to patients."

The Interviewer
Linda Banks is editor of PME