HEALTH INNOVATION. Health Innovation Innovation for health includes the development of new drugs, vaccines, diagnostics and medical devices, as well as.

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:

• 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

• 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, Top 10 causes of death for SA, 1997 and 20101997 and 2010

Rank Cause No. of deaths % deaths ASDRs Rank Cause No. of

deaths%

deaths ASDRs

%Δ in ASDR

Persons 1997 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%

6 Lower respiratory infections 24585 5.9 72.5 6 Hypertensive heart

disease 23518 4.0 73.4 4%

7 Diarrhoeal diseases 18985 4.6 45.9 7 Diarrhoeal diseases 21080 3.5 42.9 -6%

8 Hypertensive heart disease 18297 4.4 70.3 8 Diabetes mellitus 19310 3.3 54.0 29%

9 Road injuries 15275 3.7 38.4 9 Interpersonal violence 18685 3.1 36.5 -51%

10 Diabetes mellitus 11715 2.8 41.7 10 Road injuries 18480 3.1 37.6 -2%

Top 10 causes 260209 63 Top 10 causes 429933 72

Total 416209 100 1251 Total 594071 100 1402 12%

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Build the Health Innovation System

Translational Architecture(ICTs, Knowledge Management, Modelling, Advanced Statistical Analysis)

New or improved therapeutics & drug

delivery systems

New vaccines and other biologicals

New or improved diagnostics

Market access / Impact

monitoring

New medical devices

Discovery

Development

DisseminationProduct development cycle

Technology development

Capacities & capabilities

Decision support

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

• 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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• 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

Build the health innovation system (2)

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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 PrioritiesImplementation 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 PrioritiesImplementation 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

Limited ability

Some ability

Established ability

Urgent Need

SA Capabiliites

Biop

rosp

ectin

g - I

nput

s

IKS Knowledge database

Gene-bank

Extract library

Compound library

Essential enabling technologies

BioinformaticsGenomics Proteomics

Small scale manufacturing

Phase I

Phase II A

Phase III

Manufacturing & Post market activities

API Manufacturing

Drug manufacturing

GAP Farming

7 years 2 years

Pharmaco-economic data collection

15 - 17 years

Target Discovery

Target identification

Target Validation

Assay Development

Lead discovery

Assay development

High Throughput Screening

Biochemistry & Enzymology

Medicinal Chemistry

Library development

Structure-based Drug design

Medicinal Chemistry

Cellular & Molecular Pharmacology

In Vitro drug activity

Cellular Disease Models

Drug Mechanism of Action

Preclinical Development

GLP upscaling

GLP Toxicology

ADMETox

Formulability CMC

Extended Pharmacological

profiling

Discovery

5 years 2 years

Metabolomics

Development Commercialisation

Phase II B

Registration

MCC

Clinical Trials

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DRUG DEVELOPMENT

WADDP

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VACCINE AND BIOLOGICALS

• Support local vaccine and biomarker discovery and development activities;

• Strengthen local vaccine manufacturing;

• Strengthen local biologics manufacturing capabilities.

7 years 2 years

15 - 17 years

5 years 2 years

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New or improved diagnostics

• 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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MRC

DSTDoH

NRF

Science Councils

PPPs eg Biovac

Small companies

Platforms & service providers

Private sector

Pharmaceutical companies

Private sector not-for-profit

Aeras MMV

EDCTP

IDC -VCs

Research Institutes

Universities

SHIP

DTI

Government Departments

Funding Bodies

R & D

Local & International Private sector funders & Collaborators

ICGEB

GATES FOUNDATION

TIA

Enable partnershipsEnable partnerships

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