Recently I was reminded about one of the most ambitious open innovation projects around- the Innovation Medicines Initiative- set up here in Europe. I think you will find this interesting to pick up upon.
Without doubt, this is one of the most highly ambitious and bold initiatives I’ve come across.
I think anyone seriously interested in the combination of open innovation, the use of a collaborative technology platform built around a novel new business model within such a highly competitive industry of Pharmaceuticals should watch this initiative with growing interest.
It can point to significant changes in the impact and contribution of innovation management.
From its initial concept inception in 2004 and 2005, with the IMI established in 2007 as a Joint Undertaking, it has operated as an autonomous body for approximately a little over two years as I understand it.
Here I provide a fairly concise outline of its evolution and what challenges it is currently facing. It still is too long but it provides the essentials (I hope) on an amazing and bold initiative here in Europe and is worth reading until the end-really!
Background to the Innovation Medicines Initiative (IMI)
The Innovative Medicines Initiative is the largest public-private partnership aiming to boost pharmaceutical innovation in Europe and to speed up the development of better and safer medicines for patients. IMI is a joint undertaking between the European Union and the pharmaceutical industry association EFPIA. www.imi.europa.eu
With a €2 billion euro budget, IMI supports collaborative research projects and builds networks of industrial and academic experts in Europe that will boost innovation in healthcare.
Acting as a neutral third party in creating innovative partnerships, IMI aims to build a more collaborative ecosystem for pharmaceutical research and development (R&D).
IMI will provide socio-economic benefits to European citizens, increase Europe’s competitiveness globally, and establish Europe as the most attractive place for pharmaceutical R&D.
The European Commission’s Seventh Framework Programme contributes €1 billion to the IMI research programme. That amount will be matched by mainly in kind contributions (consisting mostly of research activities) worth at least another €1 billion euro from member companies of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
IMI supports research projects in the areas of safety and efficacy, knowledge management and education and training. Projects are selected through open call proposals; the favoured way in EU funded projects
The research consortia participating in IMI projects consist of:
- large biopharmaceutical companies that are members of EFPIA, and a variety of other partners, such as:
- small- and medium-sized enterprises,
- patients’ organisations,
- universities and other research organisations,
- hospitals,
- Regulatory agencies, and finally any other industrial partners.
IMI’s overarching objectives
IMI’s overall goal is to build a more collaborative ecosystem for pharmaceutical R&D in Europe and to speed up the development of more effective and safer medicines for patients.
To reach this objective, IMI is creating unique, large-scale networks of innovation in pharmaceutical research. Joining forces in the IMI research and training projects, competing pharmaceutical companies collaborate with each other and with academia, regulatory agencies and patients’ organisations in order to tackle the major challenges in drug development.
The IMI Research Agenda
This builds on the recommendations in the earlier Strategic Research Agenda to overcome the principle causes of delay in pharmaceutical R&D by focusing on four areas:
- Predicting safety: more accurately evaluating the safety of a compound during the pre-clinical phase of the development process and the later phases in clinical development.
- Predicting efficacy: improving the ability to predict how a drug will interact in humans and how it may produce a change in function.
- Knowledge management: more effective utilisation of information and data for predicting safety and efficacy.
- Education and training: closing existing training gaps in the drug development process.
To address the main challenges identified, IMI will harness the know-how and expertise available across Europe’s biopharmaceutical sector, by pooling competencies and resources from the public and the private domain.
Expected effects
IMI will make Europe more attractive for pharmaceutical R&D investments and boost the competitiveness of European life science R&D. By directly addressing the challenges facing the pharmaceutical sector in Europe, IMI has the potential to:
- Modernise the development of medicines.
- Expand European expertise and know-how in new technologies to attract bio-medical R&D investment to Europe.
- Anchor R&D jobs in Europe and reverse the ‘brain drain’.
- Enhance Europe’s economy by strengthening the competitive position of smaller companies, enabling them to collaborate with a multitude of stakeholders.
The strategic imperative for this scale and scope of collaboration was the driving force.
A platform for better coordination, co-operation and collaboration among all the stakeholders involved in developing innovative medicines in Europe was seen as sorely needed.
To change the present situation, there was a real need to form stronger links between the stakeholders, more efficient use of modern predictive methodologies and techniques, improved management and sharing of existing knowledge – not yet fully utilised – better exploitation of promising strengths and assets, and upgraded education and training.
Equally the pharmaceutical industry is undergoing sharply worsening working conditions and many challenges. Escalating development costs, patent expiry on major products, increased competition including R&D activities on the global market, the perception of greater risk-aversion among regulators and worsening public image are conspiring to cripple the European pharmaceutical industry.
This has been seen as a negative spiral that would become highly detrimental to the European economy as well as to patients seeking relief from disease and illness.
The initial analysis relating to the benefits of a platform approach were expressed as:
- Exploiting existing strengths and assets in Europe and building on existing structures
- Ensuring the active involvement of member states of a community of 27 countries across the EU
- The platform can become as a brilliant vehicle for assembling the stakeholders
- Improve the necessity of communication for better understanding and collaboration
- Proper networking as a key to success can break down existing barriers
- Exploiting the platform to develop common standards and an ongoing innovative culture
- Ensuring the transparency of all steps and procedures in the platform had real value
- Better training and education of scientists to do the job in more open, collaborative ways
- Ensuring balance in selecting disease targets would have a potential greater impact
- Establish common standards for bench marking would give all equal opportunity to improve.
Recently in 2011 a first interim evaluation report was made by a panel.
At the time of the first interim evaluation, the IMI had operated as an autonomous body for approximately one year, had launched its first two calls and was about to launch the third call.
Fifteen projects from the first call had kicked-off and were ongoing, and a further 8 projects from the second call were under negotiation. These projects have been launched in the first few months of 2011.
The in-kind contribution from the EFPIA companies to projects in the first two calls is € 198 million and the financial contribution from the EU budget, disbursed by the IMI JU is € 190 million. This is slightly lower than what was foreseen at the launch of IMI (€ 199.5 million).
The IMI interim reports objective was to is to address the bottlenecks currently limiting the efficiency, effectiveness and quality of the drug development activities needed to bring innovative medicines to the market and provide a clarification of the positive progress made.
My extra note here
-Just take a look at what they are attempting to address.
- Through the IMI JU, Europe has succeeded in establishing a new business model between public and private sectors, which unites research strengths across European pharmaceutical industry, academia and small to medium enterprises (SMEs).
- The consortia formed carry out focussed research addressing problems of immediate relevance to industry and future public health. To have formed and embedded this new, applied, research environment is a significant achievement for Europe.
- The IMI development has been meaningfully enhanced by its engagement with the regulatory authorities and patients organisations. To have succeeded here is rare, and taken together with the scale of interest of research organisations, is a tremendous illustration of Europe’s strengths in creating consensus and collaboration.
- By facilitating enhanced cooperation between academic, SMEs, patients organisations, regulatory authorities and the pharmaceutical industry, the IMI enables mutual learning and the opportunity to build understanding of respective rationales and approaches, with benefits to all parties. This is powerful. Although at a relatively early stage, the dialogue now underway across the participating groups aligns well with the IMI intent.
- The scientific scope of the initiative is well targeted, embodied in the IMIResearch Agenda, and the IMI JU has had the foresight to ensure that the Research Agenda is updated regularly. The first such review and update was on-going at the time of the Panel’s review.
- The financial resources available to the IMI JU, totalling €2Bn, make this the largest public private partnership in health research in the world. Yet the research challenges to be addressed with this sum are significant.
- The Panel was satisfied that the funding is being distributed adequately to help reach the objectives set and also saw appropriate consideration being given to the scope and scale of future projects to best achieve impact from the finite research funding.
- IMI constitutes a novel model for implementing the concept of “open innovation”. No other European programme has enabled cross-company collaboration within the pharmaceutical sector on the scale that has been achieved with IMI. This step is very important in developing open innovation in the health sector as it has enabled an unprecedented pooling of industrial research assets allowing scientific challenges to be tackled in a manner that could not be done otherwise.
- In many respects the IMI is an incubator for changing minds on how parties can work together across traditional boundaries and is therefore likely to have an important structuring effect in Europe, fully in line with the Innovation Union objectives
The panel also identified certain weaknesses for the Joint Undertaking bodies to address
- Internal governance structures are not yet working optimally: e.g. pace of decision making, clarity on responsibilities for key actions, crispness in assignment of accountability for tasks;
- Proactive communication activities have been lacking, as exemplified by the diffuse and varied understanding various stakeholders have of the purpose of IMI;
- The advisory potential of several stakeholders, such the European Medicines Agency (EMA), is not exploited fully by the IMI.
- The lack of identified and used key performance indicators by the IMI JU risks making the output of the whole initiative diffuse.
The Panel therefore came up with seven recommendations summarised below. Each is associated with a precise set of actions detailed in the report but not provided here.
- Continuously improve stakeholder involvement in IMI-supported research projects
- Continuously ensure EFPIA and Commission commitment to IMI’s success and sustainability
- Ensure excellence and exploit new ways to support IMI scientific objectives.
- Improve IMI communication
- Reinforce and streamline decision making and well functioning processes
- Ensure best use of IMI results and IMI sustainability
- Develop monitoring and evaluation processes
The EU Commission has issued its response to this report- in summary:
The Commission welcomes the interim evaluation report about IMI. It takes note of the recommendation of the evaluation panel. The Commission is committed to working with EFPIA to implement the recommendations addressed to the IMI Governing Board, where the two founding members work together to give strategic direction and oversight to the IMI.
The Commission is committed to implementing the recommendations addressed to it and is open to collaborating with EFPIA and the IMI Executive Director implementing the recommendations addressed to them. Most of the recommendations can be implemented in the short to medium term and indeed many are already being addressed through actions from the Governing Board and the Executive Office.
Both the Commission and EFPIA are recommended to dedicate enough staff to IMI. The Commission considers that both founding members have shown extraordinary commitment towards the successful setting up of IMI, including the launch of the IMI JU as an autonomous entity.
Considering the number of processes that had to be established, the Commission considers that overall this has succeeded well, while recognising that some delays have occurred. It is inherent in a partnership between partners as different as EFPIA and the European Commission that it takes some time to agree on certain points, especially at the beginning.
With the IMI JU Executive Office now almost fully staffed, all operational responsibility has moved to it. Indeed, the Commission is committed to giving the Executive Director full autonomy for this responsibility
My conclusions
Without doubt this Innovation Medicines Initiative is something to be watched. There is enormous learning to be gained as it evolves. It is tackling some incredible and well-discussed barriers to innovation on a grand scale. Will it be successful, time will tell but recently the CEO of Glaxo Smith Kline, Mr Andrew Witty was very upbeat.
The industry is reeling from much in disruptive winds blowing and battering at its door. Taking this one imaginative approach on its own will not solve all the ‘ills’ but can provide a catalyst of real change. It can also provide us all with some significant rethinking of what is possible, when something is in crisis, as the Pharmaceutical industry certainly is.
This is a seismic undertaking that could have a profound impact on how we view collaborative innovation and what it attempts to tackle on the scale needed for many challenges we face. We can learn an awful lot from studying this initiative.