Agriculture Reference
In-Depth Information
product or a proces, to a marketplace. The R&D process is not necessarily linear—
i.e. proceeding from basic science, to applied research, and on to development—
and may even begin with users of the technology. Yet, it typically does follow a
causal sequence of operational steps. The term 'R&D pipeline' is commonly used
in industry to describe the full set of candidate innovations currently being worked
on and therefore likely to be forthcoming from the R&D process in the foresee-
able future. A typical characterization of stages in the R&D pipeline for the crop
breeding and biotechnology industry includes: (a) discovery, (b) proof of concept,
(c) early development, (d) advanced development, and (e) regulatory submissions,
and (f) market launch. Of course, not all of these steps are necessary under both the
breeding and transgenic approaches.
The 'discovery' stage includes identification of potentially desirable genes or
plant characteristics with methods such as high throughput screening, model crop
testing, or participatory breeding. Potentially useful identifications can be made
in university, government, and industry laboratories. Basic research can be very
important for generating such discoveries, particularly in agriculture. Indeed, in-
novations are one set of important byproducts of basic research. Yet, discoveries
also may arise from the watchful eyes of farmers who grow diverse varieties, such
as land races cultivated near the center of origin for a given crop.
Next, the genetics underlying a trait, whether from a land race or another type
of organism, must be moved into breeding material. This occurs in the 'proof of
concept' and 'early development' stages, in which crosses or crop transformations
are made. Particularly when the approach is transgenic, additional work is required
to evaluate the viability of the transformation event, improve expression, and test
performance in greenhouse and controlled field conditions. The 'advanced devel-
opment' stage includes combining (or stacking) the new trait(s) with other valued
traits, field testing, agronomic evaluation, and, for transgenic varieties, generation
of necessary regulatory data. When a significantly novel trait, or a transgenic trait,
is involved, bio-safety or environmental impact may be the concerns. In order to
comply with legal requirements controlling the environmental and market release
of novel traits and transgenes, submissions are made in the 'regulatory' stage for
review and approval by regulators.
Finally, at the 'market launch' stage, a successful launch can depend upon inte-
gration into production and distribution systems and a sufficient quantity of stocks
in preparation for distribution and expected sales. Often an initial release is done in
a smaller, controlled manner in regional test markets, in order to collect market data
to guide a subsequent full rollout, as well as to minimize losses in the event the crop
fails to perform as expected. Other work after commercialization includes market-
ing, the informing of potential adopters about the new variety and its characteristics.
For more novel traits, additional work may need to be done together with growers
to help them learn how to manage the crop with the novel trait.
The notion of an unimpeded flow, as suggested by the image of a 'pipeline', is
perhaps misleading. Better metaphors still capturing the notion of a dynamic flow
might be an 'R&D funnel' or an 'R&D sieve'. The R&D process—whether in crop
breeding or biotechnology or, really, any field of technology—consists of progres-
