Research Project on the Construction and Use of a Model for an International Public-Private Partnerships (PPP) in Dementia Research

Research Summary

This research was conducted with support from Japan Agency for Medical Research and Development (AMED) through the joint participation of Kiyoshi Kurokawa, Chairman of Health and Global Policy Institute, as research and development representative and co-researchers Hiroaki Yoshida, Vice Chairman of Health and Global Policy Institute, and Yoshiki Niimi, Assistant Professor of Fujita Health University, School of Medicine.
This research program aims to propose the best possible way to establish International Public-Private Partnerships (PPP) that promote dementia research in an effective and efficient manner and to incorporate that into a concrete framework in Japan. It also aims to spread Japan’s knowledge so that international initiatives can be included in frameworks created abroad when they are proposed to related governmental entities and international organizations.


Proposals for the establishment of an international PPP model and policy

In this report, three key approaches were identified that will enable Japan to establish an international PPP model. Firstly, the PPP must provide a platform for data collection and assessment that can facilitate discussion among organizations from various sectors including people with dementia, their families, healthcare facilities, government authorities, academia, private companies, and NPO/NGOs, etc. Secondly, efforts should be made to establish a high-quality dementia registry which can enable Japan’s participation in large-scale international clinical trials, and also to standardize and develop an effective and feasible evaluation framework for dementia care. Last but not least, the PPP should function as an organization that can raise awareness among the public on dementia and thereby promote understanding and acceptance, and further to demonstrate leadership in Asia as a society experiencing advanced aging.

 

Stakeholders for promoting PPP

The promotion of a PPP for dementia policy will require not only cooperation between stakeholders and people with dementia and their families, but also mutual cooperation among stakeholders. Furthermore, people with dementia should not be positioned to only receive unilateral support; rather, we should aim to create a world in which those with dementia can also actively contribute to tackling the challenges dementia presents to society.

 

The ideal dementia PPP suggested by this research

Shown below is a vision of the dementia field and society of the future that the dementia PPP regime proposed by this research aims to realize. Focusing on the future, we need to set up a vision and mission and create a PPP roadmap.

  • In pursuit of an effective and efficient PPP – Ideally, in the future this PPP will:
    • Develop research themes and activities based on the needs of people with dementia and their families.
    • Appropriately prioritize research funding and activities based on an understanding of the issues surrounding dementia and evaluate the effects of research constantly.
    • Enable all stakeholders to access and share data and knowledge from the dementia researches and related services.
    • Encourage the private sector to invest actively in dementia policy and motivate further participation in this area.
    • Actively adopt and utilize scientific and technical innovations for its work, including innovations related to ICT and robots.
  • Goals of the dementia PPP – The PPP should aim to:
    • Solve latent social issues in Japan that are at the backdrop of dementia related problems (low birthrate and aging population issues; issues that women face, issues related to the need to leave jobs to take care of family members, etc.). Multifaceted and systematic solutions should be developed.
    • Take the initiative in creating global policy and serve as a hub for global research as a PPP based in the country with the most elderly population in the world (linkage with the Government’s Asia Health and Human Well-Being Initiative)

 

The functions that Japan’s PPP platform on dementia should have, and the course of action that it must take

In order for Japan to successfully manage the social challenges brought about by the long life expectancy of the Japanese people, and to demonstrate leadership in Asia as a country already experiencing population aging, we will establish a PPP platform on Dementia.

This platform shall:
  1. Offer a space for stakeholders, including people with dementia and their families, to cooperate together, and to conduct discussions, evaluations, and inspections of dementia issues using objective data.

  2. Work to raise awareness and understanding of dementia in society, and to disseminate information internationally.

  3. Prioritize the development and objective evaluation of new technologies relating to dementia care.

  4. Strengthen the implementation base for clinical trials via initiatives such as the development of a registry to promote international cooperation, including participation in large-scale clinical trials.

Results

Research on projects and organizations related to dementia that make use of the PPP model in Japan and worldwide

We conducted a survey of research projects and organizations related to dementia that make use of the PPP model, and on the representative organizations that are making progress in research on how to form PPPs.

■Dementia research programs around the world-Large-scale, multi-institutional joint studies and partnerships

AbbreviationWW-ADNI DIANA4 study
Official NameWorld Wide Alzheimer's Disease Neuroimaging InitiativeDominantly Inherited Alzheimer NetworkAnti-Amyloid Treatment in
Asymptomatic Alzheimer’s study
Year of
Establishment
200320082014
ManagementAlzheimer's AssociationWashington University School of MedicineAlzheimer's Therapeutic Research
Institute
Collaborated
organizations
25 companies, 150 academic
organizations, Foundation for the
National Institutes of Health
The National Institute on Aging
The National Institute on AgingThe National Institute on Ageing,
Eli Lilly and Company,
Philanthropic institutions
AimsTo help define the rate of
progression of mild cognitive
impairment and Alzheimer’s disease
To develop improved methods for identifying the appropriate patient populations to participate in clinical trials.
To standardize the methods used for conducting imaging scans and
gathering and testing fluid samples
To find solutions to treat or prevent Dominantly Inherited Alzheimer’s
Disease (A rare form of Alzheimer’s), and potentially, all forms of Alzheimer’s
To test whether a new investigational treatment, called solanezumab, an anti-amyloid antibody, can slow memory loss caused by Alzheimer’s disease

■Dementia research programs around the world-Large-scale study-funding organizations

Abbreviation IMI EPADDPUKGAPAMP IADRPGAAIN
Official NameInnovative Medicines InitiativeEuropean Prevention of Alzheimer Dementia ConsortiumThe MRC Dementias Platform UKGlobal Alzheimer's PlatformAccelerating Medicine
Partnership
International Alzheimer's and Related Dementias Research PortfolioThe Global Alzheimer’s
Association Interactive Network
Year of Establishment2008201520142013201420102010
ManagementEuropean Union、European Federation for Pharmaceutical Industries and Associations(EFPIA)Dr. Serge Van der Geyten Medical Research CouncilThe GAP FoundationFoundation for the National Institutes of Health(FNIH)NIH, National Institute on Aging and the Alzheimer’s AssociationUSC Laboratory of Neuro Imaging, USC Mark and Mary Stevens Neuroimaging and Informatics institute, Keck School of Medicine of USC
Collaborated organizationsJanssen Pharmaceutical, Eisai Pharma, Bayer Pharma, etc 35 organisations including Eurpean Union, EFPIA companies and Universities, and research organisationsThe National Institute on Aging (NIA), the National Institute of Bioimaging and Bioengineering
(NIBIB), Araclon Biotech,
Cambridge Cognition,
MedImmune, the global biologics research & development arm of AstraZeneca, GlaxoSmithKline,
Invicro, Ixico, Janssen
Pharmaceuticals, in collaboration with Johnson & Johnson
Innovation, SomaLogic.
Janssen, Eli Lilly and Company, Roche, Lundbeck Food and Drug dministration(FDA),
National Institutes of Health (NIH), AbbVie, Biogen, Bristol-Myers
Squibb, GlaxoSmithKline, Johnson
& Johnson, Eli Lily and Company,
Merck, Pfizer, Sanofi, Takeda
Pharmaceutical Company, Alzheimer‘s Association,
Alzheimer’s Drug Discovery,
American Diabetes Association, etc.
40 organizations from 10 countries including, Administration on Ageing, CDC, Alzheimer’s Association, BrightFocus Foundation, Canadian Institute of Health Research, Alzheimer’s Research UK24 organizations including, Alzheimer’s Association, DIAN, Aibl, ADNI, I-ADNI, CAMD
AimsTo develop next generation vaccine, medicine, treatmentsTo improve the understanding of the early stages of Alzheimer’s disease and deliver new preventative treatmentsTo help define the rate of progression of mild cognitive impairment and Alzheimer’s disease
To develop improved methods for identifying the appropriate patient populations to participate in clinical trials.
To standardize the methods used for conducting imaging scans and gathering and testing fluid samples
To speed up the delivery of innovative therapies to those afflicted with Alzheimer’s by reducing the time and cost of Alzheimer’s disease (AD) clinical trialsTo transform the current model for developing new diagnostics and treatments by jointly identifying and validating promising biological targets for therapeuticsEnable public and private funders of Alzheimer’s research to coordinate research planning, leverage resources, avoid duplication of funding efforts and identify new opportunities in promising areas of growthPromotes big data sharing among a federated, global network of data partners who are studying Alzheimer’s disease and other dementias.
To address the need to coordinate and leverage existing resources to advance research into the root causes of the disease, improve diagnostics and discover novel therapeutics, and find better ways to deliver care

■Dementia research programs in Japan – Large-scale, multi-institutional joint studies, partnerships, and large-scale study-funding organizations

Abbreviation J-ADNIIROOPORANGE Registry
Official NameJapanese-Alzheimer’s Disease
Neuroimaging Initiative
Integrated Registry Of Orange PlanOrganized Registration for the Assessment of dementia on Nation-wide General consortium toward Effective treatment in Japan
Year of
Establishment
200720162015
ManagementUniversity of TokyoNational Center of Neurology and Psychiatry (NCNP), Japan Agency for Medical Research and DevelopmentNational Center for Geriatrics and
Gerontology, National Center of
Neurology and Psychiatry (NCNP), Tokyo dementia care research and training
center, Ministry of Health, Labor and
Welfare
Collaborated organizations30 academic organizationsNational Center for Geriatrics and Gerontology, Yokohama Brain and Spine Center, Osaka City University Faculty of Medicine30 academic organizations
AimsTo conduct joint clinical studies with other facilities to develop criteria for evaluating the efficacy of AD drugs. To track healthy elderly patients, MCI patients, and early AD patients for 2 to 3 yearsTo clarify symptoms that appear
before the onset of dementia and to elucidate risk factors by improving
lifestyles, habits, etc.
To promote clinical research and
clinical trials for the development of
drugs expected to improve cognitive function
To establish an appropriate care method for dementia by collecting information on people in various stages of health including: Healthy, Preclinical stage, MCI, Mild dementia, Moderate dementia, and Advanced dementia

This research identified that the essential element of an effective PPP is clarity in organizational values, mission, and goals. Furthermore, those interviewed commented on the strong need for Japan to be involved in international research collaborations including those using the PPP model. To achieve this, it is important to strengthen the basic foundations of clinical trial research in Japan, including the practices by which participants and workers who can collaborate internationally are recruited. It is also crucial to secure stable funding streams to make all of this possible.


Collection of case studies on dementia research and research promotion efforts led by PPPs

In a study of fields that can be expected to be promoted by PPPs excluding drug discovery, we conducted interviews and other surveys with care and related service providers, local governments, town planning experts, robotics experts, and IoT researchers. We also conducted a survey of precedent cases of research promoted by PPPs on topics other than dementia and decided to use them as references for modeling the construction of a dementia PPP.

■Challenges and needs of stakeholders undertaking advanced efforts in areas related to dementia

StakeholderChallenges and needs
People with dementia and their families
  • Lack of support other than public services.
  • Lack of understanding towards individuals with dementia from industry.
  • The need of a society that is designed towards responding to people with dementia and that is comfortable for the entire ageing population.
  • The desire for recognition that individuals with dementia are capable of supporting society rather than just needing support.
Medical and care service providers
  • The desire to adopt proven services and technology.
  • The need of technology that reduces the burden on caregivers.
Companies and academia involved in clinical trials and clinical research
  • The need of a long period, large sample, and generous funding to collect evidence and develop medicines needed for dementia treatment.
  • The need of clinical research funding due to preclinical trial tests and medicines being exempt from health insurance.
  • The difficulties of recruiting participants in preclinical trials (and the need for recruitment not only be done in clinics).
  • The need of standardization in test procedures and diagnostic standards.
  • The lack of infrastructure to give integrated support during large-scale multi-institutional joint studies.
Companies providing technology and services that promote and improve care
  • The difficulty in clearly presenting evidence of effects, and the cost effectiveness of doing so.
  • The need to promote and disseminate services of reputable private services with verified effectiveness.
  • The need of investments in private services and research plans in accordance with their societal achievements.
  • The lack of communication between the research institutes and those in the field (such as at care facilities).
Self-governing bodies that implement progressive initiatives
  • The difficulty for effects to spread across regions, such as through the lateral development of efforts undertaken by local governments and NPOs.
  • The need of collaboration between the community, social networks, and healthcare institutions.
  • The need to effectively utilize data collected by the private sector.
As a whole
  • The need to have a clear, shared vision and mission across the various stakeholders.
  • The need of neutral management that involves outside professionals while keeping conflicts of interest under consideration.
  • The difficulty of covering the registry’s security and operational maintenance costs with annual public research expenditures.

■Suggestions for the PPP mechanism in Japan

ClassificationSuggestions for PPP mechanism
Vision, Mission, Value
  • It is necessary to set clear goals to be achieved. These goals and the methods for achieving them should be differentiated from other efforts to avoid difficulties when fundraising.
  • It is necessary to be transparent and independent so that the decision making process regarding project implementation and fund provider intent can be explained clearly.
Business model
  • To make a sustainable business model, the it is necessary to involve fund providers who can eventually fund the model. It is possible that government and foundations bear the initial investment.
  • The continuous promotion of the construction of evidence-based scientific programs is most important.
Operation System
  • A strong fundraising team and a communication team is required.
  • As dementia has issues related to multiple fields (such as treatment, care to housing, and mobility), multi stakeholders should be involved in planning. If this is done, it will be necessary to make a continuous effort to create a unified sense of purpose among members.
  • To develop the next generation of human resources, it is necessary to involve multiple generations.
  • It is important to decide how to enable people with dementia and their families to actively participate in decision-making.
Publicity campaigns
  • Collaboration between the public and private sectors is required to raise awareness and educate the general public.
  • Publicity campaigns with messages based on scientific knowledge are important in encouraging the correct understand of dementia within society.
Collaboration with other organizations
  • Organizations such as private insurance companies have conducted various investigations and research. A system that enabled the government to make use of their research findings would be useful.
  • Evidence collected in each field should be shared as much as possible so that it may be utilized.
Institutional design
  • There is no definite answer or system for formulating PPPs and long-term care providing systems. It should be of a design that enables bottom-up consideration of the culture of each country and region, with discussions between multi-stakeholders.
  • As for the medical and nursing care fields, the private sector is easily influenced by changes in the government system. Therefore, a system that enables the private sector to collaborate with the government during the institutional design stage is necessary.

Interviews identified the need for a PPP to facilitate knowledge sharing within the research community and to assess new technology. Also, interviews highlighted the importance of having a clear shared vision and mission within the PPP and of promoting transparency and impartiality in project management.


Collaboration with the World Dementia Council (WDC)

After conducting interviews with stakeholders, it was revealed that they are highly interest in Japan’s expected role in the WDC and in other global policy planning endeavors. After sharing opinions with the WDC on this matter, the WDC decided to investigate the current situation and future topics in each field it focuses on.

■Suggestions and expectations for Japan from the WDC

ElementsSuggestions and expectations towards Japan
Finance
  • At only 0.2% of the total research fund, Japan’s investment into dementia research is the smallest among G7 countries. Therefore, Japan is expected to rapidly increase its investment into dementia research as well as to actively adopt a successful, revolutionary private and public collaboration model like the Dementia Discovery Fund (DDF).
Integrated Drug Development
  • Continuing with the Pharmaceutical and Medical Device Agency (PMDA) as the main constituent, the Japanese government should form partnerships with regulatory authorities in each Asian country and establish itself as a leader in the region.
  • Furthermore, the Ministry of Health, Labour and Welfare and insurers should make concrete proposals for drug prices and the extent to which insurance should cover dementia drugs. Policy direction should be decided after consulting with other countries to examine which approaches should be taken (for example, to look at drug evaluation methods).
Research, Open Science and Data
  • Japan should actively strengthen its partnerships with research centers in other countries. As one solution to this, AMED suggested participation in the Neurodegenerative Disease Research (JPND). Furthermore, the it is desirable that a platform which enables the sharing of various data is established.
Care
  • As a super ageing society, Japan should share best practices for dementia care and its experience with the world. It was pointed out that there are no examples of policies that involve society like the New Orange Plan. Japan is also getting attention for its utilization of ICT in treatment.
  • The efforts of Dementia Friends in Japan can be greatly appreciated. In order to expand similar programs in other countries, the evaluation of related programs in Japan should be promoted.
Risk Reduction
  • Japan should follow the risk reduction recommendations raised by the World Health Organization (WHO). In addition, since Japan is unique in that it has a super ageing society, it should actively conduct research related to identifying risk factors to delay the progression of the disease.

This conversation allowed for opinions on the concept of the PPP model to be exchanged and it reaffirmed the need for an active Japanese contribution to the WDC. The conversation also stressed the importance of long-term strategic efforts for effective drug discovery and the standardization of care and evaluation methods.


Multinational comparative analysis of the current state of PPPs for dementia

A multinational comparative analysis was carried out regarding the current status of international PPPs for dementia research. It identified elements and functions required for the cooperation between industry, government, and academia regarding dementia research in our country.

  • The number of patients with dementia

    According to the estimate for the number of patients with dementia in member nations of the Organization for Economic Co-operation and Development (OECD) reported in the Health at a Glance 2015 published by the OECD, the prevalence and future rate of growth in Japan is high. Western Europe and the Nordic countries mostly had high levels of dementia among the OECD member states, and countries such as Chili, South Korea, and Brazil were estimated to have high growth rates in the future.

  • Dementia-related research and development funding

    Although funding for the Government Budget Appropriations or Outlays on Research and Development (GBAORD) in Japan is around the same as countries excluding the United States and the United Kingdom, the amount of funding for dementia and neurodegenerative disease-related research and development is very low.

Source: OECD Health Policy Studies Addressing Dementia

  • Cost of Dementia in Japan

    The overall cost of dementia in Japan is 14.5 trillion yen (2014 estimation). The breakdown of costs reveals that the costs of nursing and informal care together account for a much larger proportion (87%) of total costs than medical treatment.

    Regarding the dementia related cost ratio around the world, Asian countries have especially low medical costs, and Western countries often have high cost ratios for social centers.

     

Source: World Alzheimer Report 2015

  • Status of development of national strategies and guidelines

    The United States signed the National Alzheimer’s Project Act (NAPA) into law as a national project on Alzheimer’s, while Britain and Japan have implemented policy measures as part of their national strategies. It is necessary for Japan to consider establishing basic laws in the future like the United States. Furthermore, Japan’s guidelines on clinical trials are inadequate compared to Western countries, and therefore their improvement will be a goal for the future.

Dementia-related national strategies and guidelines in Western countries and Japan

  United StatesUnited KingdomJapan
Dementia related national strategiesThe National Alzheimer’s Project Act(NAPA)Living well with dementia: A National Dementia StrategyComprehensive Strategy to Accelerate Dementia Measures
(New Orange Plan)
Guidance/ GuidelinesNameGuidance for Industry, Alzheimer’s Disease : Developing Drugs for the Treatment of Early Stage DiseaseDraft guideline on the clinical investigation of medicines for the treatment of Alzheimer’s disease and dementiaGuideline on the clinical evaluation of medicines for the treatment of Alzheimer’s Disease (AD)
ExplanationThe FDA’s current approach covers areas such as: diagnostic methods for early-stage Alzheimer’s disease patients who are participating in clinical trials; patient selection and diagnostic methods for patients for whom the disease has the possibility of progressing; directions for setting the endpoints of clinical trials; and directions for using biomarkers to measure treatment outcomesCreating new diagnostic criteria for AD including early stage and asymptomatic AD patients based on the results of impact assessments; selection of treatments by outcomes for each stage of progress of AD; effective use of biomarkers; and designing trials to determine the long - term effectiveness and safety of dementia treatment drugsCurrently being produced

The results of this project emphasized the need for Japan to become involved in improving relevant guidance and guidelines for dementia, and the importance of developing a registry framework for clinical trials in order to further advance global collaborations on dementia research.


Organization of meetings between people with dementia and their families with representatives from government, academia, and the private sector

An advisory board and an expert committee that brought representatives from industry, government, and academia together with patients with dementia and their families was established in order to exchange opinions regarding the promotion of research by PPP. (*All affiliations and titles are current at the time of writing)

Expert committee

Roles

Provide technical expertise, advice and guidance on the dementia research

Members (Titles omitted):

  • Haruhiko Akiyama (Chair, the Board of Directors, Japan Society for Dementia Research)
  • Shuichi Awata (Director of Research, Tokyo Metropolitan Institute of Gerontology) 
  • Takeshi Iwatsubo (Professor, Dept. of Neuropathology, Graduate School of Medicine, University of Tokyo)
  • Mitsuhiro Sado (Lecturer, Department of Neuropsychiatry, School of Medicine, Keio University)
  • Takehito Tokuda (President, Smart Aging Ltd./ Board member, NPO Dementia Friendship Club)
  • Satoko Hotta (Professor, Division of Health and Social Service, International University of Health and Welfare Graduate School)
  • Shinsuke Muto (President, Tetsuyu Institute Medical Corporation)
  • Tomofumi Yamamoto (Patient /Editor Shukan Asahi Weekly Magazine)

 

Advisory board

Roles

Provide advice and suggestions for the research based on the needs of researchers

Members (Titles omitted):

  • Hiroko Akiyama (Professor, Institute of Gerontology, University of Tokyo)
  • Hiromichi Iwasa (Chairman of the Board and CEO, Mitsui Fudosan Co., Ltd.)
  • Yoshiharu Otsuka (Vice-President, The Japanese Red Cross Society)
  • Akira Kashima (Chairman and Group Managing Partner, PwC Consulting LLC.)
  • Masaru Kitsuregawa (Director General, National Institute of Informatics)
  • Hidehito Kotani (President/CEO, Panasonic Healthcare Holdings Co., Ltd.)
  • Kunio Takami (President, Alzheimer’s Association Japan)
  • Yasutake Tango (Chairman, Japan Tobacco Inc.)
  • Kenji Toba (President, National Center for Geriatrics and Gerontology)
  • Haruo Naito (Representative Corporate Officer and CEO, Eisai Co., Ltd.)
  • Ryozo Nagai (President, Jichi Medical University)
  • Yasuchika Hasegawa (Director, Chairman of the Board, Takeda Pharmaceutical Co., Ltd.)
  • Tatsuo Higuchi (President, CEO & Representative Director,Otsuka Holdings Co., Ltd.)
  • Yoshinori Hiroi (Professor, Kokoro Research Center, Kyoto University)
  • Kazuko Fujita (Co-Chair, Japan Dementia Working Group)
  • Hidehiro Mizusawa (President, National Center of Neurology and Psychiatry)
  • Mitsuru Miyata (Executive Leader Writer, Nikkei Business Publications, Inc.)
  • Teruji Yamamura (President & CEO, Duskin Co., Ltd.)
  • Yoshitake Yokokura (President, Japan Medical association)
  • Danny Risberg (CEO, Philips Electronics Japan Ltd.)
  • Patrik Jonsson (President and General Manager, Eli Lilly Japan K.K.)


*The contents of this page is based on the information as of March 2017 when we published our research results.