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Principles of Plant Genetics and Breeding

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358 CHAPTER 19<br />

Product concept<br />

Underst<strong>and</strong>ing the needs <strong>of</strong> the customer, in this case the wheat growers, <strong>and</strong> then determining the technical criteria to meet<br />

those needs, are critical components in developing the product concept. In focus group sessions conducted in 2000, spring wheat<br />

growers identified numerous challenges with their current weed control options. These challenges included:<br />

1 Incomplete control <strong>of</strong> many tough weeds.<br />

2 Annual variability in product performance.<br />

3 Crop damage/setback caused by herbicides.<br />

4 The need for multiple products to broaden the spectrum <strong>of</strong> control.<br />

5 Significant price variability based on the quantity <strong>and</strong> type <strong>of</strong> weeds.<br />

The product concept for Roundup Ready® wheat is complete, dependable, cost-effective control <strong>of</strong> all weeds, <strong>of</strong>ten with only<br />

one herbicide application. Four years <strong>of</strong> field trials indicate that a single 26 oz/acre application <strong>of</strong> Roundup UltraMax® over the<br />

top <strong>of</strong> Roundup Ready® spring wheat provides 95–100% control <strong>of</strong> nearly all broadleaf <strong>and</strong> grassy weeds (Figure 2). Before a project<br />

is initiated, a market assessment is completed to underst<strong>and</strong> the commercial potential for that trait/crop combination. If the<br />

results <strong>of</strong> that study are promising, then the project is initiated.<br />

The development team<br />

Because there are so many aspects to bringing a new product to commercialization, a wide diversity <strong>of</strong> expertise is needed<br />

amongst team members. Early-stage development teams usually combine expertise in molecular biology, transformation, genetics,<br />

plant breeding, agronomy, <strong>and</strong> regulatory science. Bench scientists who have expertise in one <strong>of</strong> the team areas <strong>of</strong>ten lead<br />

early-stage teams. For instance, the early-stage Roundup Ready® wheat technical team was led by a molecular biologist. Midstage<br />

development teams evolve to incorporate additional expertise in regulatory affairs, seed production, industry affairs, public<br />

affairs, government affairs, <strong>and</strong> commercial development. People who specialize in managing product development typically<br />

lead these teams. Late-stage development teams evolve again – phasing out the expertise in molecular biology, transformation,<br />

<strong>and</strong> genetics, while adding expertise in marketing. Someone from the commercial arena usually leads these teams.<br />

Transformation<br />

To be commercially successful, a crop not only has to be transformed, but the process has to be amenable to making hundreds<br />

<strong>of</strong> transgenic plants. Monsanto developed a process to transform wheat, using the trait <strong>of</strong> interest – glyphosate tolerance – as<br />

the selectable marker. The transformation<br />

method also must result in transgenic<br />

plants that are “clean” events – meaning<br />

that the DNA insertion is registerable<br />

with many regulatory bodies around the<br />

world. It has been our experience that<br />

Agrobacterium transformation results in<br />

more useful events than does particle gun<br />

transformation (Hu et al. 2003).<br />

Untreated Control<br />

The gene <strong>and</strong> its expression in the<br />

Roundup Ready Wheat<br />

plant<br />

Figure 2 Product concept demonstration: control <strong>of</strong> broadleaf <strong>and</strong> grassy<br />

weeds.<br />

In Roundup Ready® crops, the principal<br />

gene that has been used is the CP4<br />

EPSPS gene, which was isolated from<br />

Agrobacterium. This is the gene present in<br />

Roundup Ready® wheat. The expression<br />

<strong>of</strong> this gene allows the plant to continue to<br />

produce aromatic amino acids after the<br />

application <strong>of</strong> one <strong>of</strong> the Roundup® family<br />

<strong>of</strong> herbicides. The challenge is enabling<br />

the gene to be expressed in the right tissues<br />

at the right time. The promoters control<br />

expression. Some promoters, like the<br />

cauliflower mosaic virus-enhanced 35S

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