Why You Should Care About the Innovative Medicines Initiative: An Interview with Jackie Hunter

Interviewed by Edward D Blair MICR

Keywords

Innovative Medicines Initiative (IMI) , Interview, Partnership, Pre-competition

The EU Innovative Medicines Initiative (IMI) was established in 2007 and issued its first call for proposals in 2008. Funding for the successful proposal has been allocated and the work kicks off in June this year. So, the IMI is for real and is beginning to deliver, but how well known is it and why will it change the pharmaceuticals industry in ways that will benefit ICR members? This short article explains why…

The Innovative Medicines Initiative (see http://imi.europa.eu/index_en.html and/or www.efpia.org/Content/Default.asp?PageID=515) is a unique partnership between the European Commission and the European Forum of Pharmaceutical Industry Associations (EFPIA). It also mirrors some of the key activities undertaken by the US Critical Path Initiative (see www.fda.gov/oc/initiatives/criticalpath).

To get a first-hand insight into the aspirations of the IMI, CRfocus talked to Dr Jackie Hunter of GlaxoSmithKline, who has seen the IMI develop from a twinkle in the eye of EFPIA into the operating entity that it is now.

What is your role at GSK and why are you involved with IMI?

Well, I’m Senior VP covering the science environment, and part of my role involves sitting on the EFPIA Research Directors Group. EFPIA and the EU Commission first discussed setting up the IMI in 2004 in response to the major issues that were affecting drug development in Europe. I am one of the elected EFPIA members on the IMI board, a body which is involved in final approval of the successful project proposals, proposed call topics and the oversight of IMI. I do also represent GSK on the EFPIA Research Directors Group (RDG), which does have a wider remit than just partnership in IMI.

In a nutshell, why was the IMI created and what is its purpose?

The IMI was initiated in 2007 as the European Commission saw a drain on pharmaceutical research from EU and wanted to encourage investment in pharmaceutical R&D in the EU, including FP7-derived technologies. The research agenda highlighted areas for pre-competitive work in certain disease areas and to bring R&D into the EU and to accelerate medicines development.

The IMI aims to provide information on biomarkers, disease models, patient management, and training. The process within IMI is different in that the EFPIA partnership companies must match EU cash, given to academia and SMEs, with ‘in-kind’ contributions (eg, people-time and -skills, reagents, study materials etc.). Interestingly, the process of setting up the IMI has begun a dialogue amongst partners, so some intangible benefits have also been realised already.

The first formal call for proposals was launched in 2008 and successful applicants were informed earlier this year. The activities funded by this first call will start in mid- to late-2009. Each year a new call is issued, and we are already reviewing potential topics for the next call.

Which strands of the initiative are of particular interest to you as an individual and GSK more broadly?

My individual interests are of minimal influence, and secondary to ensuring that the interests of GSK and the overall pharmaceutical industry are met.

However, it is industry, not just GSK, that sets the questions around which the calls are issued and these questions are inevitably of interest not only to GSK but also all EFPIA members. Consortia of small/medium enterprises (SMEs), academics and other interests, are expected to respond to the calls. Expressions of Interest (EOIs), which are short five-page documents, are reviewed by the relevant scientific committees and the successful applicants then submit detailed workplans. Examples of questions that industry might ask are: “How can better biomarkers be found?” and “What are good [surrogate] outcomes in COPD?”

The educational aspects are also important. The IMI training programmes are designed to up-skill EU personnel and can cover a broad range of skills in pre-clinical and developmental areas. As there are challenges in drug development for CROs and pharmaceutical companies, the potential links to ICR clinical training programmes are clear.

How do the EU and particularly the pharma partners benefit?

The European Commission benefits through research networks that ensure better integration of SMEs and academics with industry. Having pharmaceutical companies access these skills in a pre-competitive way is a win-win. As I said, predictive toxicology or biomarkers for specific disease are obvious examples of big questions that can be answered in a pre-competitive way. In addition to the well-known concerns for the industry (eg, high attrition rates and high expenditure) another key driver is the regulators’ demands on safety signals. Thus patient stratification is clearly pre-competitive in understanding how to generate better predictions of safety.

Now that it is up and running, what impact is the IMI actually having on innovative medicines?

The first responses to new programme were amazing and many broad-consortium responses came in. The first programmes will certainly support industry and the organising fora themselves were of great interest. The IMI trying to ensure that this effort does not duplicate activities ongoing in other initiatives, unless it is deemed appropriate and valuable to all parties. Within clinical development, the IMI will also drive consolidation, integration, knowledge management and standardisation. This may include harmonisation of clinical trial activities, eg, pharmacovigilance, novel endpoints, efficacy surrogates, that type of thing…

How closely linked is the IMI project to the Critical Path Initiative in the USA?

A good relationship with the The Critical Path Initiative (CPI) is key The CPI started quickly but I think that the IMI will draw ahead of CPI activities. This is partly because in the US of ‘in-kind’ contributions are frequently not valued and so this kind of large matched funding consortium is not easily organised. Another reason is that CPI is really a framework; the operational part is the Critical Path Institute (see www.c-path.org). The President and CEO of this institute, Raymond Woosley, is a key partner for IMI. We’re also linking to The Biomarkers Consortium (see www.biomarkersconsortium.org, led by David Wholley, ex-SNP Consortium) through presentations and relationships.
What should ICR members be doing to support and promote the ethos of innovative medicines?

ICR members should understand role of IMI and seek national representatives to understand how to integrate with the training and education activities, perhaps as part of a pan-EU consortium of clinical research [representative] organisations. Key is for ICR to seek ways to operate on a pan-EU basis, but the opportunity is there as the clinical research piece of IMI is very important.

What other pre-competitive consortia would GSK and industry seek to participate in, particularly in respect of clinical research?

The IMI will ensure that maximum value is obtained from these studies for all involved. GSK has always played an active role where appropriate in precompetitive consortia; we are involved in safety consortia such as the serious adverse events consortium (SEAC), OMOP and other clinical consortia. GSK has also partnered in the preclinical arena eg the structural genomics consortia and the Dundee kinase consortium. I believe that we will see many more precompetitive initiatives of this kind along the whole spectrum of drug discovery and development.

And your final thoughts…

The gateway to IMI is currently through the EPFIA and EU websites but a new IMI website is pending. The appointment of a Chief Executive is also pending.

The key message is that industry can benefit from sharing knowledge and learning on a pre-competitive basis. The IMI is an example of this and there are other non-EU initiatives planned or in place. In addition, there is a real opportunity to address the perceptions of the industry, in particular regaining trust and support of industry by patients and the wider lay public. Knowledge management, education, training ought to be of interest to ICR members and ICR is encouraged to contact the UK member states advisor via the IMI web portal. There will be annual stakeholder meetings too.

Conclusion

The interview illustrates several key points on IMI:

• It is seeking to answer the big questions affecting the pharmaceutical industry
• It is operating at several levels with different stakeholders
• Modernisation and harmonisation of clinical research is a big component and so ICR should become a stakeholder
• Training, education and standardisation around clinical research are key activities
• Successful delivery of the IMI aspirations will have a significant impact on clinical research

It is hoped therefore that the Innovative Medicines SIG will be able to act as a bridge to the IMI on behalf of the ICR and its members. Watch this space in CRfocus for more information over the coming months.