ECNP, IMI and the paradigm shift in drug research
It was less than 15 years ago when I approached two drug companies to request support for an RCT that I had designed. I wanted them to contribute by providing the drugs for each of the two active arms in the RCT. I received the same response from both companies: we are willing to fund your study, but only if we are the sole company doing it.
In his 1962 seminal work The Structure of Scientific Revolutions, Thomas Kuhn describes how science advances in cycles ending with a crisis that results in a paradigm change. He himself changed the previous paradigm that held that science advances due to the steady accumulation of new facts and theories (normal science) with his ground-breaking theory that sciences advances through revolutionary explosions of new knowledge, each revolution triggered by the introduction of new ways of thinking so momentous they must be called new paradigms (revolutionary science). In his description of the cycle that ultimately results in a paradigm change, there are a number of phases. The one preceding the model revolution and the paradigm shift is the ‘model crisis’. When there are many unsolved problems, the model enters a crisis. An economic crisis can foster such a model crisis. I believe that a change in the way the pharmaceutical industry approaches new drug development could be an example of a Kuhnian paradigm shift.
Where there used to be extreme suspicion, isolation, protectionism, and the impossibility of sharing data, there is now unity in addressing common problems. And there is strength in unity. There are many unmet needs that different companies share regardless of the specific molecules they may have in their individual pipelines. In fact, such knowledge gaps are shared by many other stakeholders, including academia, patients and families, regulators, and society in general. So why not take a united approach in which everyone wins? For instance, why waste resources by doing the same research study many independent times, or why not combine the contributions of many different stakeholders each with knowledge that is difficult or impossible for others to gather? Perhaps the best example of this paradigm shift in drug development is Europe’s Innovative Medicines Initiative (IMI), initiated in 2008, which aims to speed up the development of better and safer medicines for patients. The IMI is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
As of this writing, the IMI (http://www.imi.europa.eu) is the world's largest public-private partnership in the life sciences. The budget for the IMI 2 programme is €3.3 billion for the period 2014-2024. Half of the budget is provided by Horizon 2020, the EU Framework Programme for Research and Innovation. The IMI supports collaborative research projects and builds networks of industrial and academic experts, along with other stakeholders (e.g. small and medium-sized enterprises (SMEs), patient organisations, and drug regulators), in order to advance pharmaceutical innovation in Europe.
ECNP is in an ideal position to contribute to all IMI consortia that address brain disorders. The ECNP Networks programme launched in 2007 shares the vision of the IMI. The 13 current ECNP Networks, along with the new ones to come (https://www.ecnp.eu/research-innovation/ECNP-networks.aspx), are themselves a good IMI laboratory for the co-operation of academia, SMEs, industry, and regulators working to address widely recognised, critical shortcomings in translational neuroscience. ECNP – which reaches an audience of more than 30,000 in the field of translational neuroscience worldwide and whose meetings are attended by some 5,000 participants – is likewise in a uniquely powerful position to contribute to dissemination of the IMI consortia in this respect.
The IMI is at the core of the ECNP vision, and we not only applaud the efforts of this public-private partnership in its search for common solutions, but want to be a part of it.