Transcript HEALTH INNOVATION Health Innovation

HEALTH INNOVATION
Health Innovation
Innovation for health includes the
development of new drugs, vaccines,
diagnostics and medical devices, as
well as new techniques in process
engineering and manufacturing, (and
new approaches and policies in health systems
and services, including a better understanding of
human health behaviour)
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DST’s role in health innovation guided by:
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The July 2011 National Health Research Summit;
The March 2006 Health Research Conference;
The National Research and Technology Foresight project of the Department of
Arts, Culture, Science and Technology (1998).
The White Paper on Science and Technology, 1996;
South Africa’s NRDS, 2002;
The National Health Act, Act 61 of 2004;
The National Nanotechnology Strategy, 2006;
The Medicine Control Amendment Bill, 2008;
The Ten Year Plan for Science and Technology, 2008;
The Technology Innovation Agency Act, Act 26 of 2008;
The Intellectual Property Rights Act, Act 51 of 2008;
The DST Corporate strategy 2014 – 2019;
The Bio-economy Strategy 2013;
The Industrial Policy Action Plan (IPAP2 2013-2016);
The National Development Plan (NDP 2030);
The Medium Term Strategic Framework (MTSF 2014-2019).
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National Research and Development Strategy
(2002)
Identified areas to form the core of the health research and innovation effort:
• Understanding the social impact of disease;
• Creating an environment and technologies to reduce the effect of poverty on
the spread of disease;
• Developing care and support strategies;
• Understanding the challenges in providing access to prevention and care
measures;
• Developing innovative preventative strategies;
• Developing novel therapeutic regimes, including the utilisation of indigenous
knowledge;
• Developing preventive and therapeutic HIV/AIDS vaccines;
• Creating a viable vaccine manufacturing industry;
• Using appropriate forms of telemedicine to assist in transforming rural
health care provision.
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National Health Research Summit: July 2011
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Increased funding for health research by the DoH to achieve the 2% target
of the national health budget;
Training a new generation of health researchers, especially black people
and women (through a proposed National Health Scholars Programme);
Developing health research infrastructure in the Academic Health
Complexes to facilitate research-based re-engineering of PHC (through
funding of Clinical Research Centres);
Funding of priority research projects designed to increase the lifespan of
citizens (through a National Priority Research Projects Fund);
Improving the national regulatory framework for health research;
Creating a national mechanism for the timeous translation of research
findings into policy, programmes and practice;
Developing a national system for evidence-based planning, monitoring and
evaluation of the effectiveness and impact of the health research system on
the burden of disease in South Africa.
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Top 10 causes of death for SA,
1997 and 2010
Rank
No. of
% deaths ASDRs
deaths
Cause
Rank
No. of
deaths
Cause
Persons 1997
%
deaths
ASDRs
%Δ in
ASDR
Persons 2010
1
HIV/AIDS
55048
13.2
130.2
1
HIV/AIDS
191613
32.3
403.5
210%
2
Cerebrovascular disease
31844
7.7
118.0
2
Cerebrovascular disease
40124
6.8
114.1
-3%
3
Interpersonal violence
30770
7.4
74.5
3
Lower respiratory
infections
36258
6.1
84.6
17%
4
Tuberculosis
28772
6.9
88.2
4
Tuberculosis
31252
5.3
74.0
-16%
5
Ischaemic heart disease
24917
6.0
94.2
5
Ischaemic heart disease
29613
5.0
83.9
-11%
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Lower respiratory
infections
24585
5.9
72.5
6
Hypertensive heart
disease
23518
4.0
73.4
4%
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Diarrhoeal diseases
18985
4.6
45.9
7
Diarrhoeal diseases
21080
3.5
42.9
-6%
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Hypertensive heart
disease
18297
4.4
70.3
8
Diabetes mellitus
19310
3.3
54.0
29%
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Road injuries
15275
3.7
38.4
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Interpersonal violence
18685
3.1
36.5
-51%
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Diabetes mellitus
11715
2.8
41.7
10
Road injuries
18480
3.1
37.6
-2%
Top 10 causes
260209
63
429933
72
Total
416209
100
594071
100
1402
12%
Top 10 causes
1251
Total
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New or improved
therapeutics & drug
delivery systems
New vaccines and other
biologicals
New or improved
diagnostics
New medical devices
Translational Architecture
(ICTs, Knowledge Management, Modelling, Advanced Statistical Analysis)
Development
Discovery
Market
access /
Impact
monitoring
Capacities &
capabilities
Product development
cycle
Technology
development
Dissemination
Decision
support
Build the Health Innovation System
Technology &
knowledge
transfer
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Health Innovation Implementation
• Building the Health Innovation System
• Develop and support the translational architecture
• Support strategic priorities
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Build the health innovation system
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Quadruple Helix collaboration
Market access and impact monitoring
– Engage with govt department responsible for market access (e.g. DoH, dti)
– Establish market monitoring systems
– Foresight exercises
Capacity and capabilities: Training priorities
– Determine and stimulate high priority areas for capacity-building
• Pharmaceutical discovery and development, preclinical testing,
formulation, clinical trials and manufacturing (drugs and
biologics/vaccines)
• Ethics in health research and innovation (human, animal,
environmental);
• Innovation, product development and IP;
• Monitoring clinical trials (both for community protection and to prevent
community push back);
• Process development and scale-up (including the “good practices” GMP, GLP, GCLP).
– Collaborate with Africa and rest of world to build and share expertise
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Build the health innovation system (2)
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Technology development through Technology Platforms
– Conduct an audit of South Africa’s innovation infrastructure
– Create mechanisms for making required technology available (e.g.
platforms)
Technology and knowledge transfer
– Mechanisms, and incentives for international companies, to encourage
knowledge transfer
– Mechanism to monitor and learn from technology and knowledge transfer
activities
– Mechanism to encourage collaboration between local companies (e.g. Cape
Health Technology Park)
Product development cycle
– Promoting the Quadruple Helix approach;
– Mechanisms to incentivise the private sector to engage in product
development
– Stimulate the development of piloting capacity in the public and private
sectors
Decision support
– review and coordinate legislation and regulations, policies, strategies and
guidelines with research community inputs
Monitoring and evaluation
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Translational architecture
• Translational research
– Clinical Research and Clinical Trial abilities
• Tools and data analysis
– Development of ICT-based tools and technologies for
epidemiology and other evidence-based methodologies
– Data analysis on individual genomes, validated biomarkers, and
treatment outcomes
– Use of simple statistical analysis methods
• Information exchange
– Encourage knowledge exchange by research organisations and
researchers
– Develop a knowledge translation framework
• Bioinformatics
• Bio-Portal
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Implementation Priorities
• New or improved drugs, therapeutics and
drug delivery systems;
• New vaccines or other biologicals
• New or improved diagnostics
• New medical devices;
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Implementation Priorities
New or improved drugs, therapeutics and drug delivery
systems
– For diseases that pose the greatest health challenges to South
Africa (HIV, TB, Diabetes, Cancer, neonate)
– Precision medicine, and development of targeted therapies
utilising a pan-omics approach such as genomics,
transcriptomics, and proteomics combined with systems biology
– Reverse pharmacology approach in natural product drug
research, with close link to African Traditional Medicine;
– Genetic manipulation and replacement and stem cell based
therapies ( to reverse damage)
– New and simplified dosing regimes
– Drug delivery systems suited for SA conditions and environment
– Reverse engineering of high priority drugs to stimulate local
manufacturing of APIs.
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DRUG DEVELOPMENT VALUE CHAIN
Bioprospecting - Inputs
Discovery
IKS Knowledge
database
Gene-bank
Development
Commercialisation
Target Discovery
Lead discovery
Medicinal
Chemistry
Cellular &
Molecular
Pharmacology
Preclinical
Development
Target
identification
Assay
development
Library
development
In Vitro drug
activity
GLP upscaling
Small scale
manufacturin
g
Target
Validation
High Throughput
Screening
Structurebased Drug
design
Cellular Disease
Models
Extended
Pharmacological
profiling
Phase I
Assay
Development
Biochemistry &
Enzymology
Medicinal
Chemistry
Drug Mechanism
of Action
GLP Toxicology
Phase II A
Extract library
Clinical Trials
Phase II B
Registration
MCC
Phase III
GAP Farming
API
Manufacturing
Compound library
Metabolomics
Manufacturing &
Post market
activities
Drug
manufacturing
Pharmacoeconomic data
collection
ADMETox
Formulability
CMC
5 years
Essential
enabling
technologies
Genomics
Proteomics
2 years
Bioinformatics
7 years
2 years
15 - 17
years
SA Capabiliites
Urgent Need
Limited ability
Some ability
Established ability
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DRUG DEVELOPMENT
Target ID &
Validation
Lead
Optimisation
Medicinal
chemistry
Preclinical
Development
Clinical Trials
Registration
Manufacturing
& distribution
WADDP
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VACCINE AND BIOLOGICALS
Research and
candidate
discovery
Candidate
design
5 years
Preclinical
Development
2 years
Clinical Trials
7 years
Registration
Manufacturing
& distribution
2 years
15 - 17
years
• Support local vaccine and biomarker discovery and
development activities;
• Strengthen local vaccine manufacturing;
• Strengthen local biologics manufacturing capabilities.
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New or improved diagnostics
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Point of care diagnostics, which need to be:
– Accurate (specific, sensitive, stable);
– Easy to use, access and afford;
– Patient friendly, particularly by being minimally invasive;
– Able to provide multiplex diagnosis.
Personalised diagnostics:
– Genetic (pathogen, host, predisposition);
– Taking the technology required for the identification and characterisation
of infectious diseases to individuals by designing smart swabs, or
portable hand-held devices (e.g. that analyse fluids).
Rapid response capabilities:
– Early detection of emerging diseases;
– Novel ICTs for the capture, analysis and modelling of data for the early
detection of infectious disease events.
Environmental diagnostics:
– Identifying and managing contamination of water, air and food
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New Medical Devices
• Build on excellent history
– CAT scan (computer tomography scanners)
– Lodox
• Develop networks comprising of industry and academia
and the science councils to encourage medical device
innovation
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Enable partnerships
Government Departments
DoH
Funding
Bodies
DST
DTI
Universities
NRF
MRC
Research
Institutes
TIA
R&D
Science
Councils
SHIP
IDC -VCs
ICGEB
PPPs eg
Biovac
Local & International
Private sector funders &
Collaborators
Platforms &
service
Private sector
not-for-profit
Aeras
providers
GATES
FOUNDATION
Small
companies
MMV
EDCTP
Private sector
Pharmaceutical
companies
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