THE NON-BIOLOGICAL FACTORS THAT IMPACT BIOTECH INNOVATION Hennie Groenewald Focus on non-biological to emphasise in a biotech R&D environment that innovation success is also dependent on many other factors not related to biology. ICABR, Berkeley, 30 May – 2 June 2017 Department: Science and Technology REPUBLIC OF SOUTH AFRICA

CONTEXT Framework for the development and support of an integrated innovation value-chain for bio-based products and services aimed at addressing national priorities We focus on innovation support. 2 © Biosafety SA

BIOTECH INNOVATION proof of concept product development market success idea marketing Sustainable products Diverse activities & role players 3 © Biosafety SA

DEFINING SUSTAINABLE BIOTECH Health Environment safe viable sustainable Socio-political Economic 4 © Biosafety SA

INTEGRATED SUSTAINABILITY ASSESSMENT FRAMEWORK FOR GM CROPS Wild type organism Biology, history of safe use, anti-metabolites, etc. Trans-molecules Source, regulation of expression, structure/ function, etc. GMO safety assessment Toxicity & allergenicity, equivalence, nutritional analyses, food processing, etc. Monitoring Purity, possible long-term effects, labelling, etc. Food/Feed Biosafety assessment Preparative assessment Receiving environment, GM trait, GMO, wild relatives, persistence, risk hypotheses , etc. Environmental risk assessment Potential pathways to harm, generate data required to falsify risk hypotheses, develop appropriate mitigation strategies to manage risks & uncertainties, etc. Monitoring & risk management Hypothesis driven &/or general surveillance, risk management, etc. Environment Product concept Gene discovery Crop transformation Line selection Development & testing Crop production Marketing & export GMO R,D&C Sustainability assessment communication Relevance & Value Technology & trait, demand, alternatives, real benefit, etc. Performance Agronomy, comparative, GM trait impart, clear benefit, etc. Deployment Constrains, logistics, timeframes, etc. Growth & Maturation Performance, endurance, profitability, etc. Economic Viability assessment Regulatory environment Legislative framework, precedents, indigenous, etc. Accessibility & acceptability Product, IP, markets, deployment, etc. Implementation Support systems, capacity, constraints, structures, etc. Stewardship Responsible management from creation to withdrawal, etc. Socio-political 5 © Biosafety SA

SYSTEMIC CHALLENGES Contrasting innovation systems Well integrated, market driven product development pipeline with unifying oversight and ownership GMO R,D&C A single, well integrated, affluent company (conducive to innovation) Product ideas informed by real market exposure Contrasting innovation systems GMO R,D&C The fragmented national system of innovation (non-conducive to innovation) “Product” ideas developed from research interests Disconnected product development “pipeline” with varying skill levels, knowledge gaps, competitive overlaps & lack of ownership Short-term, risk adverse market focus Biosafety, IP, commercialisation, etc. Unifying technology platforms such as BSA 6 © Biosafety SA

BIOSAFETY FRAMEWORKS & CAPACITY Absolute requirement – also for cross-border trade Highly variable, low priority, politically loaded, perceived as external Lack of capacity / experience / confidence 7 © Biosafety SA

ENSURE AN APPROPRIATE GM PERSPECTIVE Consumer Regulatory framework Developer 2o Consumer GM product vs. Regulatory framework Market (need) Developer (GM) product 8 © Biosafety SA

IMPLEMENTATION PITFALLS Makhathini Flats cotton & Eastern Cape maize Product misalignment in small-scale environment Sweeping judgements based on limited, imperfect options 9 © Biosafety SA

PERFORMANCE BEYOND THE GM TRAIT Sudan’s bacterial blight susceptibility Burkina Faso’s low lint quality 10 © Biosafety SA

2016 COMMUNICATION & ENGAGEMENT Public perception of biotechnology in South Africa 2016 ↓ knowledge stratified not polarised 11 © Biosafety SA

COMMUNICATION & ENGAGEMENT Goal of the biosafety communication initiative AWARENESS & CONFIDENCE in South African biosafety system Public engagement by developers / regulators now a required to ensure success 12 © Biosafety SA

Dr Hennie Groenewald  hennie@biosafety.org.za  www.biosafety.org.za THANK YOU Dr Hennie Groenewald  hennie@biosafety.org.za  www.biosafety.org.za 13 © Biosafety SA