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What sampling method and sampling size are needed to estimate the adventitious presence of biotech traits in seeds?
In response to your question, I have found the following information. I found a very useful an introductory paper entitled, "Sampling of Grain & Seed to Estimate the Adventitious Presence of Biotechnology-Derived Seeds in a Lot (PDF)". I recommend reading this paper first. After that, I recommend reading a summary from the International Seed Trade Association on Statistical Tools for Seed Testing. It includes a link to a powerpoint presentation for calculating the percentage of adventitious presence of a biotech trait. Included in this write-up is the use of "Seedcalc8" (copied below) for determining the level of adventitious presence in a given seed sample. I hope you will find these documents useful and if you need further clarity, we will have to find someone who does this routinely. Thanks for the question. Regards, Rashmi
Seedcalc8 - Kirk Remund (US), Robert Simpson (US), Jean-Louis Laffont (FR), Deanne Wright (US), Sylvain Gregoire (FR)
Seedcalc8 is a Microsoft Excel® application that is written for Windows 2000 and XP. It can be used to design seed testing plans for purity/impurity characteristics including testing for adventitious presence levels of biotech traits in conventional seed lots. This application can also be used to estimate purity/impurity in a lot or sample when results are available. All of the capabilities of previous versions of Seedcalc (i.e., Seedcalc3, Seedcalc5, and Seedcalc7) are still available in Seedcalc8. They are described in two articles published in Seed Science Research from the June 2001 issue of Seed Science Research entitled "Statistical considerations in seed purity testing for transgenic traits" (June 2001 issue) and "Testing for adventitious presence of transgenic material in conventional seed or grain lots using quantitative laboratory methods: a new statistical approach and its implementation" (September 2005 issue). Seedcalc8 is enhanced with the ability to design qualitative testing plans using a Bayesian approach. This new capability has been presented at the 28th ISTA Congress 2007 under the title "A Bayesian approach for adventitious presence (AP) semi-quantitative testing in conventional seed lots".
This spreadsheet application contains macros that are necessary for the full implementation of the statistical tools. If the security setting of the computer is set at the "high" level, the macros will automatically be disabled. We suggest that the macros be enabled so that the user can realize the full benefit of this application.
Note that three earlier versions of Seedcalc (i.e., Seedcalc3, Seedcalc5 and Seedcalc7) are also available for download. While these earlier versions do not have as many features as Seedcalc8, they may run better under older MS Windows versions such as Windows 95.
By using both Seedcalc and Qualstat applications, testing plans can be designed for the majority of seed testing situations.
For SeedCalc, there is an Introduction worksheet that is worth reading. You can make impurity estimates on the Impurity Estimation worksheet. I mainly use the older SeedCalc versions (3 or 5) because they are not as complicated if you are just trying to make simple estimates.
Seedcalc8,7,5
Questions for Dr. Dianah Ngonyama
- How do you ensure that premature disclosure is prevented? It is common practice that public institutions, whose R&D programs are funded mostly by the government, have to share information or communicate outputs of R&D to the public.
Yes, US patent filings give us a grace period of 1-year after public disclosure, for inventors to file a US patent application. Even here at ISU, as a public universities we also sometimes experience cases of premature disclosures by our faculty members. Sometimes we have to rush to file the Provisional patent after realizing we only have less than a month or two before the expiry of the grace period, after the faculty member submits their application to ISURF. Hence, ISURF Commercialization managers are encouraged to continuously engage with faculty members/researchers through weekly visits to departments to bring more awareness and identify potential projects for patenting, early as they develop through the pipeline. In some cases, we prefer to file Provisionals early before the product is not fully ready and we still waiting for additional data, if that will help avoid losing the opportunity to patent the technology. In other cases, researchers can negotiate with sponsors early during grant proposal development, to allow for opportunity to protect IP developed from the project. Many sponsors, including Federal agencies do understand and value the importance of protecting IP from the project they fund.
- Can you share more information on the structure of your commercialization office and the expertise/staff complement?
ISURF Staff. The office has experienced many changes recently, including me moving to the Office of the Vice President of Research. The following is the breakdown of key staff at full capacity:
- A total of 5 Commercialization managers (CMs) who generally have PhD’s in their field and some have MBAs in addition. The combination of PhD, MBA and industry experience is critical for positions in Tech transfer. I used to work at Monsanto company, a leading Ag Biotech company now bought by Bayer company, before joining ISU. My colleagues also had similar industry experience from their field. Here is the breakdown for CMs:
- 2 Commercialization managers (CM) for the Life sciences ( where I was one of them responsible for Commercializing plant related technologies, including germplasm licensing), and my partner was responsible for Commercializing animal related technologies including vet med and human vaccine research.
- 2 CMs were responsible for commercializing of engineering and chemistry technologies
- 1 CM responsible for Software, IT, Sensors and Controls
- Technology Marketing manager – who partners with CMs to market the technologies to industry
- Legal counsel and her team of Disclosure coordinator & Patent prosecution coordinator
- IT support
- The Director runs the office
You also talked about the three types of licensing agreements and royalty rates. Can you share more insights on how you determine rates for royalty in non-exclusive and exclusive license agreements, i.e., considerations in setting the rates? You briefly mentioned market forces. Can you expound more on this and your other considerations?
Determining royalty rates requires industry experience, hence reason why we hire CMs with industry experience. Also it’s the job of the CM to develop the Technology Commercialization Assessment report, that includes a determination of the estimated commercial value of the germplasm or trait in your target market. In addition, you also consider royalty rates charged for current competing germplasm already on the market.
For example, we have a soybean variety that we charge a Royalty rate of $3.50/unit (50lb bag of seed sold). If a soybean breeder releases a new improved variety yielding the same but with higher protein required by the Asian tofu market for example, then after assessing the potential impact and it’s value on the market, we may decide to introduce a Royalty rate to seed licensees of $3.75/unit which assumes the additional value of the trait is worth 0.25/unit. We prefer to charge our Royalty rates for licensing soybeans per unit of seeds produced and sold by the licensees. You may decide to use a different system, and again, I would recommend you go through training offered through the professional organizations of Licensing Executive Society (LES). They offer different courses and certifications for Licensing/Commercialization managers.
CRISPR Resources
I have gone through the profile of instructors and I am quite happy to see instructors with expertise on the production of quality seeds of corn and soybean. Two years ago, I proposed developing CRISPR/Cas9 corn hybrid with fixed heterosis effect that solves the critical problem we have faced on hybrid corn seed production. Can we proceed with it together please?
Regarding your inquiry, we have found out that the best offices to get in touch with for joint research projects and other initiatives will be the following:
- The Raymond F. Baker Center for Plant Breeding, dedicated to advance the science of plant breeding through hypothesis driven research, the development of enhanced germplasm of diverse crops, and the education of undergraduate and graduate students and postdoctoral fellows who will be the next generation of breeders in the public and private sectors.
- Plant Sciences Institute. The research focus of this institute is to understand the effects of genotype and environment on phenotypes (traits) sufficiently well so as to be able to predict phenotype of a given genotype in a given environment (i.e., predictive phenomics).
In terms of individual scientists, the following are prominent corn breeders at Iowa State who may be able to assist your efforts:
1. Dr. Thomas Lübberstedt, thomasl@iastate.edu
2. Dr. Patrick S Schnable, schnable@iastate.edu
3. Dr. Kan Wang, kanwang@iastate.edu
4. Dr. Jianming Yu, jmyu@iastate.edu