1. HEALTH INNOVATION

2. 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) 2

3. 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). 3

4. 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. 4

5. 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. 5

6. Top 10 causes of death for SA, 1997 and 2010 RankCause No. of deaths % deathsASDRsRankCause No. of deaths % deaths ASDRs %Δ in ASDR Persons 1997Persons 2010 1 HIV/AIDS5504813.2130.2 1 HIV/AIDS19161332.3403.5 210% 2 Cerebrovascular disease318447.7118.0 2 Cerebrovascular disease401246.8114.1 -3% 3 Interpersonal violence307707.474.5 3 Lower respiratory infections 362586.184.6 17% 4 Tuberculosis287726.988.2 4 Tuberculosis312525.374.0 -16% 5 Ischaemic heart disease249176.094.2 5 Ischaemic heart disease296135.083.9 -11% 6 Lower respiratory infections 245855.972.5 6 Hypertensive heart disease 235184.073.4 4% 7 Diarrhoeal diseases189854.645.9 7 Diarrhoeal diseases210803.542.9 -6% 8 Hypertensive heart disease 182974.470.3 8 Diabetes mellitus193103.354.0 29% 9 Road injuries152753.738.4 9 Interpersonal violence186853.136.5 -51% 10 Diabetes mellitus117152.841.7 10 Road injuries184803.137.6 -2% Top 10 causes 26020963 Top 10 causes 42993372 Total 4162091001251 Total 5940711001402 12% 6

7. Build the Health Innovation System Translational Architecture (ICTs, Knowledge Management, Modelling, Advanced Statistical Analysis) 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 Dissemination Product development cycle Technology development Capacities & capabilities Decision support Technology & knowledge transfer 7

8. Health Innovation Implementation Building the Health Innovation System Develop and support the translational architecture Support strategic priorities 8

9. 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 9

10. 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) 10

11. 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 11

12. Implementation Priorities New or improved drugs, therapeutics and drug delivery systems; New vaccines or other biologicals New or improved diagnostics New medical devices; 12

13. 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. 13

14. DRUG DEVELOPMENT VALUE CHAIN Limited ability Some ability Established ability Urgent Need SA Capabiliites Bioprospecting - Inputs IKS Knowledge database Gene-bank Extract library Compound library Essential enabling technologies BioinformaticsGenomicsProteomics Small scale manufacturin g Phase I Phase II A Phase III Manufacturing & Post market activities API Manufacturing Drug manufacturing GAP Farming 7 years2 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 years2 years Metabolomics DevelopmentCommercialisation Phase II B Registration MCC Clinical Trials 14

15. DRUG DEVELOPMENT Target ID & Validation Lead Optimisation Medicinal chemistry Preclinical Development Clinical TrialsRegistration Manufacturing & distribution WADDP 15

16. VACCINE AND BIOLOGICALS Support local vaccine and biomarker discovery and development activities; Strengthen local vaccine manufacturing; Strengthen local biologics manufacturing capabilities. 7 years2 years 15 - 17 years 5 years 2 years 16

17. 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 17

18. 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 18

19. MRC DST DoH 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 partnerships 19