HEALTH INNOVATION

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)

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).

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.

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.

6. Top 10 causes of death for SA, 1997 and 2010

7. 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) Build the Health Innovation System Development Discovery Product development cycle Dissemination Market access / Impact monitoring Technology development Capacities & capabilities Decision support Technology & knowledge transfer

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

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

10. Build the health innovation system (2) • 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

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

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

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.

14. IKS Knowledge database Gene-bank Bioprospecting - Inputs Extract library Compound library DRUG DEVELOPMENT VALUE CHAIN Discovery Development Commercialisation Target Discovery Lead discovery Medicinal Chemistry Cellular & Molecular Pharmacology Preclinical Development Clinical Trials Registration Manufacturing & Post market activities Small scale manufacturing Phase II B MCC Assay development Library development In Vitro drug activity GLP upscaling GAP Farming Target identification High Throughput Screening Structure-based Drug design Cellular Disease Models Extended Pharmacological profiling Phase I Phase III API Manufacturing Target Validation Drug manufacturing Biochemistry & Enzymology Medicinal Chemistry Drug Mechanism of Action GLP Toxicology Assay Development Phase II A Pharmaco-economic data collection Metabolomics ADMETox Formulability CMC 5 years 2 years 7 years 2 years Essential enabling technologies 15 - 17 years Genomics Proteomics Bioinformatics SA Capabiliites Urgent Need Limited ability Some ability Established ability

15. DRUG DEVELOPMENT WADDP

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

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

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

19. Private sector not-for-profit Private sector Aeras MMV Pharmaceutical companies EDCTP Enable partnerships Government Departments DST DoH DTI Funding Bodies Universities NRF MRC Research Institutes TIA R & D Science Councils SHIP IDC -VCs ICGEB PPPs eg Biovac Platforms & service providers GATES FOUNDATION Local & International Private sector funders & Collaborators Small companies