FROM CONCEPT TO PRODUCT:
An Examination of Issues Related to the
Commercialization of Biotech Crops
Presented at the XI International Rice Conference for
Latin America and the Caribbean
Cali,
Cali Colombia
Sept. 21-24, 2010
Dr. Judith Chambers
Director, Program for Biosafety Systems
International Food Research Institute

A FEW POINTS TO KEEP IN MIND
Trends and the continuing need for innovation
Role of Biotechnology
Product development issues
Evolving market forces and demographics – local,
regional, and global
Controversy, politics, policy and regulation
Complex and diverse institutional players
When considering where we are for
commercialization of biotech crops, there is a need
i li i f bi h h i d
to consider historical context and role of
integration

THE GLOBAL CHALLENGE
Increased demand for Food, Feed, Fiber and Fuel
• World population will grow from
current 6.5B to 8B by 2025 and 9.2B
by 2050
• Affluence in emerging economies
will drive meat, cereals, edible oil
consumption up
• Climate change will alter land, water
availability and quality; introduce
new pests
• Increase in biof el cons mption
biofuel consumption
Source: Leaver, 2008; FAO, 2009

THE GLOBAL CHALLENGE – CLIMATE CHANGE
By 2050, climate changes will reduce Asian irrigated rice production by 27%
2050

TECHNOLOGY HAS BEEN AN IMPORTANT TOOL TO
INCREASE AGRICULTURAL PRODUCTIVITY
For example: At the turn of the century, the U.S.
farmer fed 7 people.
p p
Today, the U.S. farmer feeds 96 people, due to:
New seed = increased yields
• Conventional breeding
C ti lb di
• Biotechnology traits
Fertilizer
Crop protection
Efficient machinery
Supportive government policy
pp g p y
And, globally, new innovations in biotechnology
have delivered
yield increases from 9 to 31%
pesticide application decreases from 39 to 60%
income increases from $117 to $250 per acre

GLOBAL AREA OF BIOTECH CROPS
1996 to 2008
By Crop (mil ha)
Source: James 2009
Page 12

EXPERIENCE WITH GM CROPS IN
THE DEVELOPING WORLD
Global Area of Biotech Crops, 1996 to 2008:
Industrial and Developing Countries (million ha)
Source: James 2009

THE GLOBAL COMMERCIALIZATION PICTURE

INDIA: BT COTTON --A SUCCESS STORY
--A
contributed to doubling of yields in 5 years
Source: Cotton Advisory Board

IMPACT
India emerged as 2nd largest exporter of cotton
g g p
Source: Cotton Advisory Board 2009

IMPACT AT THE FARM LEVEL
Average effects of Bt cotton vs. non-Bt in India
non-
Based on peer-reviewed published studies
Yield Increase 39%*
Reduction in insecticide 33%*
sprays
Profit Increase/ha 70.9%*
* Significantly different from zero at 5% level
Source: Gruere, Mehta-Bhatt and Sengupta 2008
Page 11

DEVELOPING COUNTRY CROPS IN THE
PIPELINE
Insect resistant cowpea – Africa
p
Virus resistant cassava – Africa
Virus resistant papaya
Nutrient enhanced cassava, rice,
banana and sorghum
Water efficient maize
ff
Rice - salt tolerant, disease &
insect resistant, enhanced
resistant
nutrition
Water and fertilizer efficient
maize

BIOTECHNOLOGY BENEFITS AND IMPACT
• Economic Benefits
>>>productivity>>>>income leading to <<<$food
• Protection of biodiversity
• Protection of Natural Resources and climate change
conservation tillage/carbon sequestration
ti till / b t ti
reduced pesticide load
reduced time to breed adaptive varieties
• Poverty alleviation
for ~13 million small scale farmers
Social b
S i l benefits
fit
gender positive impacts
more disposable income for health care, education
nutritionally enhanced crops
Source : ISAAA

AND YET…….
The 8 years preceding adoption in India
were characterized by:
major public controversy
burning of field trials
accusations of multi-national domination
continuing regulatory uncertainty
While today, most developing countries,
esp. in sub-Saharan Africa, are non-
adopters and not commercially
growing biotech crops

It’s not just about the science !
Markets/Policy Political/Socio
M k t /P li -P liti l/S i -cultural
Markets/Policy-Political/Socio- lt l
Product development considerations
Links to markets – local, regional and global
Trade competition and retaliation
p
Enabling policy/regulatory climate
Complex and diverse institutional
p
players
Technological gaps & science
literacy
Concerns about food system
control, risk, consumer rights
t l i k i ht

INTEGRATION OF FACTORS AFFECTING
PRODUCT DEVELOPMENT
Source: ABSP-II, Cornell University

Unique to or
greater emphasis
for biotech crops
Stakeholder
outreach Stewardship
Regulatory throughout
and Variety value chain
Certification

GENE DISCOVERY
Identification of gene/construct with marketable or
beneficial trait
Small scale transformation, evaluate research
plants in greenhouse (containment)
Prescreen research events and produce seed for
further evaluation
Begin stakeholder analysis at product concept

PLANT AND SEED PRODUCTION
Regulatory trials in target countries
Continued variety development
Continued seed production
Further development of validated detection
methods (marker) for commercial quality
control
Sta e o de dialogue a p g
Stakeholder d a ogue ramping up
Marketing and technical support intensified

PLANT AND SEED PRODUCTION cont.
Quality Management System
Implement or adapt QMS to maintain plant product integrity
and quality
segregation of plant material in storage
accurate tracking of all planted and harvested plant material
prevent the inadvertent during planting or harvest
previous and subsequent land use
maintain plant product integrity in the fi ld
i i l d i i i h field
equipment is cleaned and any harvested plant materials are used
and/or disposed of appropriately

PLANT AND SEED PRODUCTION cont.
Licensing/Contract Production:
appropriate steward ship requirements – awareness,
pp p p q ,
training, verification
Regulatory Compliance: Compliance with regulations
including transport, production, treatment, and storage of
plant materials
Product Launch: regulatory approvals required (as opposed
to simply plant variety certification)

CROP PRODUCTION AND UTILIZATION
Commercialization requires management across value chain
Commercialization requires management across value chain

VALUE CHAIN DISTRIBUTION AND MARKETING
Product launch: develop and implement plan
Distribution of product through a supply chain to
customers.
All necessary regulatory authorizations required.
Quality management
maintain and document plant product integrity,
inventory control and product trace back and recovery
Regulatory compliance
conditions of authorization
monitoring
import/export
phytosanitary

VALUE CHAIN DISTRIBUTION
AND MARKETING cont
MARKETING, cont.
Stewardship education
educate the distribution, value chain and stakeholders
on proper use
enables them to define practices for appropriate product
use
Product withdrawal (?)
controlling materials in supply chains,
recalling and controlling material in commercial
distribution h i
di t ib ti chains (?)
communication

PRODUCT DISCONTINUATION
Commercialization may be abandoned or
products withdrawn due to:
Issues with regulatory registration
Market licensing agreements
Trade issues
Resistance or pressure by stakeholders in the value
chain
Public relations considerations

Successful Technology Adoption and the
Product Development Lifecycle
1 2 3 4 5 6
Product Discovery Early Product Integratio Product Market Post
Concept Testing & n& Ramp Up Introduction Market
Development Product Activities
Selection
Field Trials/Testing
1 – 3 years 1 – 3 years 1 – 3 years
Stakeholder Engagement Intensity

Successful Commercialization Involves
Diverse Players a d Pathways
e se aye s and at ays
Research &
Ext Service Government
Go ernment
Policy
Agriculture
Environment
Market/Consumer
FARMERS Donors & NGO’s
Finance Bank
Distribution
st but o Multinationals
Commitment, Government, Partnerships

Public vs. Private Sector
Contrasting Impacts on Commercialization
STEP IN CYCLE PUBLIC SECTOR PRIVATE SECTOR
Product Concept May not be supported by market Market primary consideration
realities
Construct Constructs – varied owners, IPR; Cross Licensing, IPR may be
legal capacity may be an issue more straightforward; resident
legal capacity
Transformation/ and Scale, capacity Sophisticated capacity, able to
handle large numbers
experimental validation
Regulatory review Limited capacity and resources – Well resourced for larger private
human, financial; lack of sector companies; longer term
framework i target countries
f k in t t ti commitment than conventional
it t th ti l
crops
Delivery, Distribution, Absent, weak, informal Products usually have an
integrated “fit”
Value Chain
Stakeholder Outreach and More credibility but resource Requiring more resources,
intensive expertise; devoted PR and
Communication communications efforts; less
credibility with some
stakeholders
Product Withdrawal, Limited capacity to manage or Capacity exists but liability
pay regimes may prevent product
Liability entry

IFPRI PROGRAM FOR BIOSAFETY
Mission St t
Mi i Statementt
Empowers partner countries to build and
implement functional regulatory systems by
providing:
1. Independent expertise – science and policy
2. Capacity building
p y g
3. Credible information to policy makers, stakeholders,
end users and key opinion leaders for informed
decision making g
4. Experts are regulators from govt. and industry,
scientists, lawyers and economists

CURRENT PARTNER COUNTRIES
PHILIPPINES
NIGERIA
KENYA
UGANDA MALAWI
East Africa: Kenya, Uganda, Ethiopia, COMESA
West Africa: Nigeria
Southern Africa: Malawi, Mozambique
SE Asia: Philippines, Vietnam, Indonesia
Affiliations: IFPRI, Danforth Center, Center for Science in the Public
Interest, ISAAA, Calvin College, U. Minn., Iowa State/BIGMAP

RECENT PBS ACHIEVEMENTS
KENYA
Stakeholder outreach for passage of Biosafety Bill in 2009
draft implementing regulations and training lawyers and
regulators
UGANDA
CFTs (cotton, cassava, banana), regulatory policy,
commercialization strategy and handbook
gy
MALAWI
submission of 1st field trial application pending
NIGERIA
technical input to law
public communication and stakeholder outreach
support passage of biosafety bill through House of
pp p g y g
Representatives
PHILIPPINES
extensive capacity building
specific regulatory issues – IRM, stacked traits
VIETNAM
facilitated first CFT

Biosafety Policy - Developing Country Experiences
Program For Biosafety Systems – Lessons Learned
Balance
Science is NOT static
Transparent, predictable science based fle ible
Transparent predictable, science-based, flexible
Product Evolution
Regulations reflect product development stage
Investment
Regulatory system should promote internal and external investment,
trade
Local Test
Can local organizations/ private companies comply with and afford the
y
system?
Other
Reconciliation with other applicable laws – seed laws, plant variety protection,
food safety laws
Resources
Implementation and capacity building

SUMMARY OF CONSTRAINTS TO GLOBAL BIOTECH
COMMERCIALIZATION
LIMITED PROFIT OPPORTUNITIES – for private sector incentives
DONOR RELUCTANCE - t fito finance long term, expensive,
l t i
controversial research
INSTITUTIONAL CHALLENGES - in working across/with diverse
organizations – no vertical integration; capacity
MARKETS - Weak markets, delivery systems, product stewardship
and management
INTELLECTUAL PROPERTY - may limit access esp. for orphan
y p p
crops
REGULATORY – capacity, cost, trade
COMMUNICATION – consumer resistance, limited stakeholder
outreach at early stages, systematic approach needed

WHAT IS NEEDED TO INCREASE COMMERCIALIZATION OF
BENEFICIAL PRODUCTS, ESP. FOR THE DEVELOPING
WORLD
Less polarized debate: A recognition by industry, govts., NGOs that
there is not a “one size fits all” and that choice is important – (biotech,
nanotech, conventional, organic, etc.)
A rationalized regulatory dialogue; harmonization
Adoption in the context of market and cultural realities; communication is
key!
Capacity building for developing world “players” – for R&D, regulatory
review, stakeholder outreach and risk communication
General market development for agriculture with supporting infrastructure
Additional compelling products
More incentives for technology donation and public/private cooperation

ACKNOWLEDGEMENTS
Colleagues at IFPRI
Drs. Mark Rosegrant
Guillaume Gruere
Jose Falck Zepeda
Donald Danforth Plant Science Center
Dr. Hector Quemada
Donna Ramaeker Zahn, consultant
ISAAA
Margaret Karembu