This symposium was opened by Prof Shigeto Yamawaki from Japan, who reviewed the involvement of CINP in this important area. CINP, he explained, has been at the forefront of proposals for Public–Private Partnerships (PPPs) for several years. Think tanks were convened to discuss PPPs in 2012 and 2013, with action points published in 2015. These aimed to stimulate and motivate new CNS drug development through collaborations between academia and industry. Initiatives were first developed in the USA and Europe. In Europe, this is exemplified by the Innovative Medicines Initiative, in which academics are collaborating with European Federation of Pharmaceutical Industries and Associations, with financial support from the EU.
To promote a PPP initiative in Asia, the CINP CNS Drug Innovation Summit was held in Tokyo in 2015. This resulted in the establishment of a task force by the Japanese Society of Neuropsychopharmacology. This partnership of government, academia and industry has formed working groups based around the development of imaging biomarkers, biological stratification and diagnosis of mental disorders, a database for clinical trials and research data, and genome and epigenome markers for drug development.
Such a collaboration was discussed by Prof Tetsuya Suhara from Japan. Recently, the National Institute for Quantum and Science and Technology in Japan developed an alliance, based on the concept of PPPs. The aim of this working group was to develop biomarkers in the precompetitive environment. This process needed to respond both to the requirements for sharing of information and research, but also address industry concerns. Therefore, the development of policies (e.g. for the handling of intellectual property, confidential information, and the licensing of biomarkers), standard procedures and contracting constituted a significant piece of work in the setting up of this alliance. Nevertheless, this sharing of information, of research expertise and of libraries of compounds, has led to the development of new imaging biomarkers and their rapid in vitro and in vivo testing. It is anticipated that this type of collaborative work will facilitate the clarification of pathophysiological mechanisms in order to better understand and articulate disease modelling.
Sharing of facilities, of research expertise and of libraries of compounds, has led to the development of new imaging biomarkers
Professor Christer Halldin from Sweden reported on the development of new PET radioligands through collaborations between the center at the Karolinska Institute and industry collaborators. The PET center at Karolinska is one of the world’s oldest, with nearly 35 years of research experience behind it. Such consolidated expertise provides a ‘one-stop shop’, where radioligands can be developed and synthesized, then tested across the spectrum from in vitro models through to human subjects.
Working in tandem with industry, these radioligands can be evaluated using PET techniques to better identify potential candidates for further development. Radioligand marking of drugs themselves can be used to check that the drug does indeed enter the brain in large enough concentrations to have an effect. They can also evaluate drug binding to its target molecule, and investigate the relationship between drug dose, plasma concentration and receptor occupancy in the brain. Such research has led to the development and validation of PET markers for several neuromediator targets.
Several new PET markers for neuromediators have been identified through collaboration between academia and industry
Finally, Prof Johannes Tauscher stated his opinion that PPPs to develop new biomarkers are an extremely good fit for both industry and academia. Biomarkers are used for critical decision-making in drug discovery and development. However, the markers themselves are usually of little commercial value. They, therefore, provide an opportunity for sharing of these compounds across industry and academia. This prevents duplication of effort in developing such markers, and allows them to be used widely, validated and accepted by the public and regulators in the investigation of diseases and testing of candidate drugs. This open, non-confidential development of markers and collaboration between researchers may be particularly useful when evaluating biomarkers with a broad application – for example markers of the final common pathway for disease progression. The advantages of advancing basic research and promoting investigation of the pathophysiology of CNS disorders offsets the potential costs of making available biomarkers, and not protecting the confidentiality of such new molecules within a single company.
For more on the Innovative Medicines Initiative in the EU, please see https://www.imi.europa.eu/