LONDON – The EU's next large-scale public-private research partnership in health is taking shape and due for launch at the start of 2021, succeeding the current €3.6 billion (US$4 billion) Innovative Medicines Initiative 2 (IMI2).

The new program, the Innovative Health Initiative (IHI), will see the scope of joint research among the industry, academics and SMEs expand beyond pharmaceuticals, to include medical technology, biotech, digital health and vaccines.

Rather than being solely the fiefdom of the European Federation of Pharmaceutical Industries and Associations (EFPIA), which currently manages big pharma's contributions to IMI2, IHI will involve the members of five pan-European industry bodies, Europabio, Medtech Europe, Vaccines Europe and COCIR, an association representing medical imaging and radiotherapy companies, along with EFPIA.

IHI will be "a really unique" type of collaboration, said Annika Eberstein, senior research manager at COCIR. "It will be the first time these sectors have worked together at this scale, at a European level, and will reinforce the entire health research ecosystem in Europe."

The outline and objectives of IHI have been scoped over the past year between the industry and the European Commission and this week the final public consultation on the proposal was launched. Following that, there will be further negotiations with the commission, as part of the process of agreeing to the EU's overall €100 billion 2021 – 2027 research program, Horizon Europe, of which IHI will be a part.

IHI's predecessor, IMI2, and before that the €2 billion IMI1, which ran from 2008 to 2012, were both slated as the largest R&D collaborations in health in the world. As yet, there is no indication what the budget for IHI will be, though it will be structured in the same way, with cash from Horizon Europe to support academics and SMEs, and industry making in-kind contributions.

Of the €3.6 billion IMI2 is due to invest up to the end of 2020, €1.64 billion comes from the EU in grants for academics and small companies, with pharmaceutical companies making in-kind contributions of staff and resources, for individual projects they choose to take part in.

IMI originally was set up to plug the gaps in Europe's system for translating biomedical science into new drugs. Now, the move to expand the scope of public-private collaboration in IHI will have a significant impact on the research agenda, which currently is decided by the research directors of pharmaceutical companies.

In IHI, "multiple companies are joining forces, combining proprietary knowledge, data and assets, and opening up for collaboration with public [sector] partners," Eberstein said, launching the consultation, through which the industry bodies want to get feedback from prospective partners and stakeholders in patients' groups, regulators, health care professionals and health technology assessment agencies.

A wave of powerful technologies, including digital tools, artificial intelligence, machine learning and new diagnostics, is creating enormous potential to improve health care, said Eberstein. "It's also clear we are not making the most of these, because there are too many barriers between the different sectors, which are addressing different parts of the health care system, and working with differing standards," she said.

"Really excellent research currently being conducted in Europe is not being translated, or not being translated fast enough," Eberstein said.

Defining value

The areas on which IHI will focus reflect both the pressure drug and devices companies are under to demonstrate the value their products bring to Europe's hard-pressed health care systems, and the fact that industry is increasingly reliant on external resources and expertise, from understanding of basic disease biology to accessing and analyzing patient data and securing regulatory approval and reimbursement.

As one example, IHI will set out to identify new ways of assessing products and services, to create "common definitions of value" that are accepted by patients, regulators, payers, companies and health care systems," said Patrick Boisseau, director of research and innovation at Medtech Europe.

Agreed value metrics will both optimize health delivery and optimize products themselves, Boisseau said. Rather than disparate products, the companies in IHI will work to develop integrated "care solutions" that sit across the health care continuum.

Magda Chlebus, executive director of science policy at EFPIA, pointed to prostate cancer self-care, as a possible project. Here, the aim would be to provide individuals with tools for self-management and monitoring, with the aim of reducing overtreatment of indolent disease, whilst ensuring timely diagnosis and treatment of aggressive tumors.

Another example would be to apply big data and advanced analytics to stall the development of antimicrobial resistance. That would include a tool for tracking the geographical spread and prevalence of infections, and the development of models to predict the emergence of drug-resistant pathogens.

While expanding in reach, IHI will be "building on what IMI has achieved, both in terms of scientific outputs and how to work together," Chlebus said. "We will bring outputs from IMI to the next level and integrate them with other industries," she said.

According to Chlebus, one important lesson from IMI is that success does not depend on money, but on what partners are prepared to put on the table, as the starting point of a joint research project.

"Real collaboration works when you bring together people: in-kind contributions create a new level of quality. In [IHI], in-kind contributions are even more valuable, to bring assets together across sectors," said Chlebus.

When IMI first started, there were long-running discussions about who would hold rights to intellectual property, which meant it was some time before any projects got off the ground.

Another stumbling block was that in order not to be viewed as a public subsidy to pharma companies, all research had to be precompetitive. At first, it was thought that even target identification could be viewed as competitive, restricting the field of research.

"We realized you can push the boundaries of precompetitive space," Chlebus said. IHI will likely start modestly, looking at early stage research. But, said Chlebus, "We are confident as we acquire experience, we can push the boundaries further and further."

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