How much time does it take and how much does it cost to successfully develop a hybrid with one or more transgenic traits from conception to commercial release. Can you categorize the portion of costs that are incurred as a result of meeting regulatory approvals and those that would be incurred even if there were no regulatory approvals required. My understanding is that it takes several years and tens of millions of dollars to obtain regulatory approvals thus effectively excluding public sector and universities, trade associations and other groups from developing and offering traits in the public domain.
Submitted by: Rickinreallife
Expert response from Wendelyn Jones
Global Regulatory Affairs, DuPont Crop Protection
Thursday, 11/07/2013 15:10
You are correct that it requires a tremendous investment of both time and resources to bring a new biotech crop to market. A survey completed in 2011 found the cost of discovery, development and authorization of a new plant biotechnology trait introduced between 2008 and 2012 was $136 million. On average, about 26 percent of those costs ($35.1 million) were incurred as part of the regulatory testing and registration process. The same study found that the average time from initiation of a discovery project to commercial launch is about 13 years. The longest phase of product development is regulatory science and registration activities, at about 5.5 years for traits introduced in 2011.
While that price tag is significant, so are the losses from pests, diseases and other issues that these new traits are designed to help farmers combat. For example, the U.S. Department of Agriculture has estimated corn rootworm causes $1 billion dollars in damage to the U.S. corn crop alone each year. By delivering traits that can fight these pests, it increases farmers’ productivity.
The high costs of commercializing new plant biotechnology can be a challenge to the public sector, universities and others parties. That is where public-private partnerships are essential. DuPont and DuPont Pioneer have a long tradition of taking a collaborative approach to problem-solving. There are numerous examples of organizations working together to further the development of a promising trait or technology, including DuPont-supported initiatives such as the African Biofortified Sorghum and Improved Maize for African Soils projects.
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