Alzheimer`s Disease and Other Dementias: The Way Forward

Transcription

“Enhancing Translational Research and Clinical Development in
Alzheimer’s Disease and Other Dementias: The Way Forward”
11-12 November 2014, Lausanne
Dr. Inhee Mook-Jung
Department of Biomedical Sciences
Seoul National University College of Medicine
Strengthening biomedical research and health innovation for
Alzheimer’s disease: Lessons learned from Korea
1
Alzheimer’s Disease and Other Dementias: The Way Forward –
Session 4: Perspectives from Stakeholders: Challenges & Options in Making a
Paradigm Shift
Contents
1.
Full support of Korean government for
dementia research
2.
How Korea moved onto diagnosis and
prevention for dementia
3.
Active clinical trials of dementia in Korea
4.
Need for globalization
2
Paradigm Shift
Government Support in Korea : Pros and Cons
•
•
•
•
Big Tent under good finance and risk sharing
Focus on basic research
Build sustainability
Develop innovative new tools
•
•
•
•
Lack of leadership and direction in the field
No incentive to produce practical outcome in a timely fashion.
Grant supports based on publication record, not the product
Need collaboration with private sector and between basic and clinic
 Competition and Collaboration should be harmonized in an
effective way
3
Projected number of people with dementia
(in millions)
Paradigm Shift
Estimated number of people with dementia worldwide
2000
2011
Year
2030
2050
Dementia: a public health priority, 2012,
World Health Organization and Alzheimer’s Disease International
4
Paradigm Shift
Estimated number of people with dementia in south Korea
Millions of
Hundreds
patients
2012 research
3
Percentage of patients
9.39
9.58
9.79
9.99
10.39 10.03 11.90
1.5
1
0.5
2.0
In 2024: 1 million
0.6
0.6
0.7
2013
2014
2015
2016
0.8
8
4
1.3
0.6
(billions US$)
16
2.7
Estimated number of patients
with dementia in 2043: 2 millions
2030
15.06
2.5
2
Estimated costs of dementia
2020
2010
2
Millions of patients
0
1
2020
2030
2040
2050
More social costs of dementia than those of other three major disorders
Cancer
Stroke
Cardiac disorder
Dementia
Nationwide study on the prevalence of dementia
In Korea elders, Ministry for Health, Welfare and Family Affairs, 2012
Paradigm Shift
Number of outpatients for dementia in South Korea
Number of patients
Annual number of outpatients for dementia
(created from data from Health insurance company)
Men
2001
2002
2003
Women
2004
2005
Year
2006
2007 62008
Paradigm Shift
Comparison of cost spent between social and R&D by four major diseases
Percentage
Health and social costs
Costs for research and
development
Dementia
Cancer
Stroke
Cardiac disorder
Dementia 2010, 2011
7
Paradigm Shift
2014 Korea R&D budget
Basic science
1.6
Others
3.7
Construction/Transportation
/Safety
0.6
Basic materials/Nano
0.9
Environments
0.7
Space/Air/Ocean
1.7
(in billions US$)
Information and Electronics
2.6
Total
17.7
Life science
2.3
Machinery/manufacture
1.7
Energy/Resources
1.8
8
Paradigm Shift
Proportion of fund by the state of Dementia research
Others
Development
Application
Basic
R&D Trends for Dementia
Korea Health Industry Development Institute (KHIDI), 20149
Paradigm Shift
The distribution of fund from each ministries in Korean government
(in thousands US$)
Basic
Application
Development
Others
Ministry of
Science, ICT &
Knowledge Economy
Land, Infrastructure and Transport
Future Planning
Health and Welfare
Agriculture and Forestry
10
Paradigm Shift
Proportion of fund by Institutes (2008-2011)
(in millions US$)
2008
2009
2010
2011
Total
University
7
13
17
16
53 (51%)
Government-funded
Institute
2
4
11
17
34 (33%)
National, Public Institute
0.01
0.3
0.2
1
1.5 (1%)
Large company
1
0.2
0
0
1.2 (1%)
Small and medium industry
2
2
4
3
11 (11%)
Others
0.1
1.5
0.02
0.2
1.8 (2%)
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Paradigm Shift
Distribution of fund allocated to new technologies (2008-2011)
(in millions US$)
Technology
Fund
Technology
Fund
Neurosciences
36
Applied oriental medicine
5
Functional bio-materials
10
Treatment of intractable disorder
4
Applied health and medical
technology
8
Biology focusing on applied functions
3
Food and biotechnology
6
Other basic technology
2
Medical sciences and engineering
5
Bio-energy
2
New drug development
5
Evaluation of Safety and validity of products
created from biotechnology
2
12
Paradigm Shift
Trend of increasing fund for dementia in Korean government (2009-2013)
(in millions US$)
Ministry of
2009
2010
2011
2012
2013
Total
Health & Welfare
8
6
6
13
13
46
Science, ICT, and Future
Planning
16
16
15
18
18
83
Trade, Industry and Energy
3
4
0.4
3
0.6
11
National Science & Technology Information Service (NTIS)
13
Paradigm Shift
Fund spent in different aspects of dementia in Korea
: Paradigm Shift
14
Paradigm Shift
Impact of prevention on delaying the onset of dementia
Year
No delay
0.5-year delay
1-year delay
2-year delay
5-year delay
2030
100%
94.6
89.5
80.1
57.6
2050
100%
94.4
89.4
79.5
56.3
Jorm AF et al., 2005. Projections of future numbers of dementia cases in
Australia with and without prevention. Australian and New Zealand journal of
psychiatry
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Paradigm Shift
Proportion of patients with dementia by severity
: Prevention is the most effective way
CDR
Patients
Costs
Costs per patient
CDR=0
76.1%
39.5%
0.52
CDR=0.5
2.7%
2.0%
0.75
CDR=1 (mild)
10.8%
15.4%
1.43
CDR=2
5.2%
17.2%
3.28
CDR=3
5.2%
25.9%
4.94
3.5 times
* CDR (Clinical Dementia Rating)
16
Paradigm Shift
Diagnostic research in different countries for dementia:
(Patent applications for diagnostic imaging technology for dementia)
(2001-2011)
Japan,
226 patents,
36%
EU, 12 patents,
Korea, 152
2%patents, 24%
USA,
243 patents,
38%
Imaging technology development for Early diagnostic of Dementia,
Ministry for Health, Welfare and Family Affairs, 2011
17
Paradigm Shift
Korea Clinical Trial
• Ranked 7th in Industry Sponsored Trials by protocol number.
• Ranked 10th in Industry Sponsored Trials by number of sites.
• Seoul ranked as world number 1 city for Industry Sponsored Trials by number of sites (2012-2013).
City
Korea share of study sites for CTs registered
in clinicaltrials.gov
18
Paradigm Shift
Performance
76% of trials involving KR were successful
Source: Trialtrove® and Trialpredict®, Aug. 2013
Paradigm Shift
Number of patents for new drug development for Alzheimer’s Disease
worldwide
(1990-2012)
Number
EU,
Korea, 196
Japan, 148
57 patents,
patents, 20%
patents, 15%
6%
US, 563
patents, 59%
1986-1992
1993-1997
1998-2002 2003-2007 2008-2012
Patent trends for AD drug developments
Korean Intellectual Property Office (KIPO), 2013
20
Paradigm Shift
The state of development of new drugs for dementia in South Korea
Pharmaceuticals
Startups·Institutes
Materials
Development stage
Kwang Dong Pharm.
Elcomscience
Natural substance
Phase II
Natural substance
Phase III
SK Chemicals
Whanin Pharm.
Scigenic
Natural substance
Phase III
Hanwha Dream Pharm.
NEUMED
Natural substance
Phase II
Daewoong Pharm.
Medifron
Synthetic materials
Clinical Trial Approved
Neurotech
Synthetic materials
Phase I
Bioland
Natural substance
Phase II
MEDIPOST
Neural stem cells
Technology patent
21
Paradigm Shift
Regulation of diagnostic tools and clinical trials
for dementia in Korea : Pros and Cons
•
•
•
•
KFDA’s emphasis on safety
Government supports for clinical trials system
High public awareness of dementia and high availability of clinical trial volunteers
Government’s cooperation in globalization
• KFDA is slow process
• Passive involvement of private sector for new drug development
• Need for both government and private sector to share the risks.
22
Paradigm Shift
SWOT analysis for Korea AD research
SWOT analysis
Strengths
Internal
Environment
• Highly motivated and well-disciplined
man power both in clinical and basic
research fields
• Possess new & advanced technologies
on IT & NT  good facility for research
• Government initiatives for international
collaborations (Korea-UK consortium,
Korea-US NIH collaboration, ……)
• Relatively low labor cost
opportunities
External
environment
• Increase in social need due to an aged
society
• recognized as blue-ocean area of the future
• Sustained growth in the medical devices
and pharmaceutical markets
Weakness
• No AD brain bank in Korea
• Weak connections between basic
and clinical research groups
• Insufficient researchers in AD field
• Short term grant renewal system
difficulty in publication in high profile
journals
Threats
• Lack of stable funding source
compared to US or Japan
• Intensive international competition
23
Paradigm Shift
Prevention
Drug
Development
Early
Diagnosis
Innovative
methods
Systemic Innovation and Global Collaboration is important
Paradigm Shift
Example of Global Collaboration: Korea-UK AD Consortium
25
Paradigm Shift
Conclusion
1. The Korean government has shown consistent support for
basic research in dementia
2. Korea has moved onto diagnosis and prevention for
dementia research.
3. Korea has the ideal environment for clinical trials
4. In order to achieve the goal of cure for dementia rapidly,
the globalization is needed.
26
Paradigm Shift
27

Alzheimer`s Disease and Other Dementias: The Way Forward

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