This document discusses the need for new policies to address the global burden of age-related diseases. It notes that longevity research is highly specialized across different countries. It also shows that non-communicable diseases account for a large share of deaths globally, especially in higher income countries, and this share is projected to increase further by 2030. The document advocates for three main policy changes: 1) increasing funding for research on the biology of aging, 2) providing beneficial regulation for biotechnologies aimed at preventing aging, and 3) reforming clinical trial processes to make them less costly and better support the development of preventive medicines and anti-aging interventions.

1. New Policies Needed to Reduce the
Global Burden of Ageing Related
Pathologies
Daria Khaltourina,
India Future Society
October 1st, 2014

2. 1. Longevity Research – Global
Specialization

3. Countries’ Impact on Research in Aging Biochemistry and
Molecular Biology (1996-2013) (H Index, Scimago Lab)

4. Map of Biogerontology Researchers
Source: http://whoswho.senescence.info/people.php

5. Citable Papers in in Aging Biochemistry and Molecular
Biology per million people in 1996-2013, Scimago Lab
0 10 20 30 40 50 60 70 80 90
Finland
Sweden
Denmark
Israel
Switzerland
Italy
Netherlands
Canada
United Kingdom
Austria
Australia
Ireland
Belgium
Spain
United States
Norway
France
Germany
Japan
South Korea
Brazil

6. Map of Science – the Western Countries

7. Map of Science – India

8. Map of Science – East Europe

9. Map of Science – China

10. Share of Deaths due to Non-communicable Diseases
0 20 40 60 80 100
40.1
58.9
81.6
87.4
51.8
67.4
85
87.1
Low-income countries
Lower-middle-income countries
Upper-middle-income countries
High-income countries
2015
2030

11. Ageing
Socially
• Personal growth
• Professional growth
• Accumulation of knowledge
• Greater prestige
• Better social relationship
Biologically
• Cognitive decline
• Motor skill function decline
• Vision impairment
• Frailty
• Illness
• Mortality

12. Cumulative Mortality Rates in Men and Women
in the rural Vietman (Minh et al., 2006)

13. Legal Background
• “The Right to Health” is granted
by a number of international
treaties, as well as the national
constitutions
• By signing this Constitution, the
Parties of the WHO
acknowledged that
"governments have a
responsibility for the health of
their peoples which can be
fulfilled only by the provision of
adequate health and social
measures".
• Non-Communicable Diseases are
one of the top priorities of the
World Health Organization and
national governments.

14. Initiatives to Develop Aging Prevention
Technologies
• A number of researchers managed to extend lives
or control degenerative aging in mammals
• Google opened a new company “Calico” to
develop
• A number of biomedical companies claimed that
they aim to develop drugs and therapies to
control degenerative aging processes (Geron, In
Silico, Quantum Pharmaceuticals, AstraZeneca,
etc.)

15. Key Problems
• Low priority of preventing ageing degenerative
processes
• Low funding comparing to disease oriented research
• Prohibitively expensive and complex process of new
drug approval
• Even more restrictive approaches to the innovative
technologies to compensate for ageing-related
degeneration
• Lack of established clinical practice methods
• Lack of educational materials in biology of ageing

16. Policy 1. Naming the problem
• Degenerative ageing processes should be
acknowledged as the major threat for public
health which needs to be addressed
ageing is a
disease
ageing is a
syndrome
ageing is not a
disease, but it
needs to be
addressed

17. Preventing Degenerative ageing
Process Can Be More Effective Than
Treating ageing-related NCDs
• Positive example: preventing cardiovascular
damage through statins intake
• Pharmacological blood pressure control
among elderly people
• Vaccination of the elderly people against
pneumonia

18. Policy 2. Ensure Greater Funding of
Research in the Biology of Ageing
• Right now biomedical science is funded on the
principle of “Fight on Disease X”
In an ageing world,
the single disease
model may have
already run its course
– the time has
arrived for a new
model.
Jay Olshansky

19. Positive Examples from the USA: National
Institute of Health and The Geroscience
Interest Group
NIA
NIH
Geroscience
Interest
Group
NIDDK
NINDS
NEI
NCI
NIAID
NIAMS
NIGMS
NICHD
NIEHS
NHGRI
OD
NIAAA
NIBIB NHLBI
NIDA
NIMH
NIDCR CSR
NCCAM
by Felipe Sierra, National Institute of Aging, the USA

20. Education in Biology of Ageing
• Some countries have law capacity in
biomedical education in general, it is not a
priority
• There is only one university course on biology
of ageing online
• There are no textbooks on ageing biology
• Governments should promote inclusion of
ageing biology courses into the biology
programs

21. Policy 3. Provide Beneficial Regulation for Biomedical
Technologies to Prevent Ageing
Promising Interventions Problems of Translation
Life-style interventions The cost is not covered by insurance
programs for the elderly in most cases
Medicines (substances) Enormous cost of clinical trials
Food supplements Supplement effectiveness is often uncertain,
as the producers do not invest into clinical
trials fearing the regulation
Cell-based medical products Stem cell treatments are treated by FDA as
prohibitively as drugs.
Personalizes medicine, including genetic
testing
Genetic testing company is challenged
legally in the USA. China introduces some
regulation
Innovative methods for drug delivery
(nano-delivery)
Every application requires another set of
clinical trials
Artificial tissues and organs to replace the
ill ones
Some governments bad xenotransplantation

23. Registering drugs and therapies to prevent and treat
ageing is legally impossible in most countries
It is only possible to register drugs and therapies to cure certain
diseases (with some exception)
Companies trying to provide ageing control treatments often get
challenged legally by the governments
As a result, pharmaceutical industry does not invest into the
research in biology of ageing
Low investments results in low governmental funding as well
Problems result in the delay of translational research

24. Solutions
 Anti-aging treatments should be considered
legitimate and desirable pharmacological
interventions
 Ageing-related degenerative process should
be considered disease or syndromes (like
atherosclerosis or metabolic syndrome)
 Develop specific diagnostic criteria (ageing
biomarkers) for ageing and ageing related
degenerative processes

25. Stagnation in Preventive Medicines
 It is generally not possible legally to register
medicines to prevent a disease in healthy
individuals
 Very few exceptions: vaccines, antimalarials
- Statins and polypil are prescribed for
atherosclerosis, which is considered a disease
- It would be very problematic to register a new
medicine to which is proved to prevent ageing
- This comes from the outdated model of health
which ignores the ageing-associated health risks

26. Clinical trial process is extremely expensive, yet
necessary
 The US pharmaceutical industry produces 20-40 new
registered drugs per year
 The average cost to develop new drugs increased up to
1.3 billion dollar in 2005; phase III takes about 40% of
the cost
 Most biomedical companies cannot afford this kind of
investment, which affects their financial performance
 Food supplements do not get tested sufficiently for health
effects due to prohibitive cost of clinical trials
 Clinical trials of anti-ageing cures can drag on for
decades, which is financially unendurable

27. Solution 1. Development and legal
adoption of alternative intervention
testing mechanisms
Biomarker systems:
 Morphological
 Pathological
 Metabolic
 Epigenetic
 Cellular level biomarkers
 Cognitive
 Etc.

28. Solution 2: Advocating for expansion of
conditional approval practice for
gerontoprotective drugs and therapies
 There can be different modes of conditional registration
depending upon effectiveness and safety data
 One possible solution is to postpone Phase III clinical
trial to post-market stage
 Transparency and informed consent of the patient is
necessary

29. Examples of conditional therapy registration
 Federal Food, Drug, and Cosmetic Act (FD&C
Act), Art. 356 offers fast track review of such a
drug if it is intended for the treatment of a serious
or life-threatening condition (cancer, HIV)
 HPVs vaccines prevent pre-cancer conditions but,
there is not enough data to claim cancer
prevention. At the same time, over 100 million
doses have been distributed
 The Japanese Government has stated that
conditional approval or commercial use will be
adopted for stem cell therapies

30. Conditional registration initiatives:
The US Senator Kay Hagan
sponsored the Transforming
the Regulatory Environment
to Accelerate Access to
Treatment (TREAT) Act in 2012
to accelerate the review and
approval process for
medicines;
Japanese Government
proposed conditional
registration of stem cell based
therapies