1. 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

2. 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
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3. BIOTECH INNOVATION proof of concept product development market success
idea
marketing
Sustainable products
Diverse activities & role players 3
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4. DEFINING SUSTAINABLE BIOTECH
Health
Environment
safe
viable
sustainable
Socio-political
Economic 4
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5. 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
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6. 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
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7. 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
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8. ENSURE AN APPROPRIATE GM PERSPECTIVE
Consumer
Regulatory framework
Developer
2o Consumer
GM product
vs.
Regulatory framework
Market
(need)
Developer
(GM) product 8
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9. IMPLEMENTATION PITFALLS
Makhathini Flats cotton & Eastern Cape maize
Product misalignment in small-scale environment
Sweeping judgements based on limited, imperfect options 9
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10. PERFORMANCE BEYOND THE GM TRAIT
Sudan’s bacterial blight susceptibility
Burkina Faso’s low lint quality 10
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11. 2016 COMMUNICATION & ENGAGEMENT Public perception of biotechnology in
South Africa
2016
↓ knowledge
stratified
not polarised 11
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12. 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
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13. Dr Hennie Groenewald  hennie@biosafety.org.za  www.biosafety.org.za
THANK YOU
Dr Hennie Groenewald   13
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