1.What major problem or issue is being resolved and how are you resolving it (summarize project aims and objectives)? How serious is the problem? What does it matter?
Prior to the passage of the Technology Transfer Act of 1986 there had been a dearth of private sector and federal government laboratory collaborative research with the concomitant lack of technology transfer from the federal laboratory system to the private sector. Since then the level of cooperation has soared as attested by the number of Cooperative Research and Development Agreements (CRADA) executed over the past eighteen years. A fact frequently forgotten is that the concept of this cooperation was fostered by the proposal of a group of Peoria businessmen for the creation of the Biotechnology Research and Development Corporation (BRDC), a research and development consortium designed to foster private sector/federal laboratory/academic cooperative research. Historically, BRDC has strived to identify promising technology concepts in the ARS and academic laboratories and partner the researchers responsible for these concepts with industrial partners for the purpose of directing the BRDC funded research toward commercialization. To achieve this BRDC has enlisted private sector corporations as equity partners and elicited their capital investment, as well as their knowledge of the market needs and opportunities, to drive early stage research toward commercial goals by funding the research and early development activities. The result has been a very high success rate for translation of federal and academic research into commercial opportunities. BRDC was created to foster technology transfer and has been and will continue to be one hundred percent dedicated to that activity. Its principle focus has always been to find new market opportunities for commodity agricultural products, improve efficiency of production, develop new methods of disease control for both plant and animal commodities and facilitate communication between the government and academic scientists and American industry.

American agriculture provides the vast majority of the food our citizens consume. The American agribusiness employs millions including the farmers, corporate agribusinesses, distributors and retailers. Thus, any improvements in performance, yield, heath and productivity should impact the entire chain from production through consumption.

How serious is the problem? Why does it matter? Although greatly improved over the past years, the translation of technology achievements derived from basic research in government and academic laboratories to the market place has been poor. This is due in part to a lack of communication between the two disparate scientific cultures, one dedicated to discovery and the other dedicated to practical application through innovation. In fact, the gap between these entities has often been described as a chasm, one ARS administrator has referred to it as "death valley". It is well understood that basic technological advances are frequently made as a result of market needs, i.e. the market pulls technology not the opposite, or, technology pushing the market. To get a better return for the taxpayers investment in basic research, it stands to reason that knowledge of market needs must be applied to guiding the extension of fundamental discoveries to practical application. Industry brings this knowledge to the table and industry's participation in R&D consortia such as BRDC provides not only the market strategy needed but also a major leverage of the financial investment by the taxpayers. For example, BRDC estimates that in addition to the $15 million of cash payments to it by its shareholders and licensees, they, the shareholders and licensees, have invested over $13 million of 'in kind' research and development activities. This does not include their cost of marketing products. This is a key element of BRDC as it provides a significant leverage of federal funds.

2.List the milestones (indicators of progress) from your Project Plan.
Identify and fund the development of technologies that offer promise of commercial opportunity. Successfully complete the development of technologies as measured by granting commercial licenses. Establish a diverse and dynamic research and development portfolio that addresses the market needs of the agribusiness. Adjust the R&D portfolio, on an ongoing basis, to properly reflect market needs.

3.Milestones:
A. List the milestones that were scheduled to be addressed in FY 2004. How many milestones did you fully or substantially meet in FY 2004, and indicate which ones were not fully or substantially met, briefly explain why not, and your plans to do so.

1.) Milestones that were scheduled to be addressed in FY 2004. a.) Identify and fund at least four (4) new research projects. b.) Terminate research projects that no longer show promise of success. c.) Execute at least two (2) commercial licenses and/or options for license. c.) Generate at least $300,000 of licensing and royalty revenue.

Every milestone was exceeded.

B. List the milestones that you expect to address over the next 3 years (FY 2005, 2006, and 2007). What do you expect to accomplish, year by year, over the next 3 years under each milestone?

2.) Milestones that will be addressed over the next three years. a.) Fund new research projects as identified. b.) Terminate non productive projects c.) Execute five (5) commercial licenses or options to license. c.) Generate $500,000 of licensing and royalty revenue.

4.What were the most significant accomplishments this past year?
A. Single Most Significant Accomplishment during FY 2004.

BRDC executed four new license agreements in 2004 filed six new U.S. patent applications and received $270,000 in cash licensing income plus $225,000 in accrued income (obligated payments over the next three years).

B. Other Significant Accomplishment(s), if any. BRDC successfully launched a new program at USDA-ARS National Center for Agricultural Utilization Research (NCAUR), Peoria, IL, to identify a new fungal expression system for the purposes of both expressing foreign genes and carrying out bioconversions in defined environments. To date the best expression systems available are E.coli and Saccharomyces cervisea, both of which are limited in their ability to produce certain materials as well as carry out bioconversions in extreme environments. This project is anticipated to mesh very well with the new project on screening metagenomic libraries for new and novel materials and metabolic pathways.

C. Significant Activities that Support Special Target Populations. none.

5.Describe the major accomplishments over the life of the project, including their predicted or actual impact.
Over the life of the project BRDC has executed thirty-eight commercial licenses and has received $2.9 million in licensing revenue.

BRDC is an R&D consortium dedicated to identifying promising technologies and providing the funding and corporate partners necessary to take them to the market place. Hence, the major accomplishments are measured in the degree of success we have had in attaining that objective. Significant technological achievements have been realized in all three of the focus areas.

Starch/Thermoplastic Resin Composites: Scientists at NCAUR working in collaboration with scientists from The Dow Chemical Company have developed a family of composite materials that contain proprietary thermoplastic resins and natural polymers derived from commodity cereal and legume starches and flours. These materials exhibit remarkable mechanical and strength properties and can be fabricated into injection and compression molded articles, foams, films and laminates. Recent research results have shown that these basic materials can also be blended with polylactic acid to form new composites with totally new and distinctive physical properties. BRDC has exclusively licensed the Dow Chemical Company for the right to make loose fill packaging materials and has granted Dow an option to license the technology in all other fields of use. At present there is a vigorous research and development program being funded at NCAUR by BRDC. Preliminary studies show these materials to be completely biodegradable. The Super-mas Plant Gene Promoter: Promoters are genetic regulatory elements that turn on/off the expression of a gene. A scientist at Purdue University has developed a proprietary promoter, under the auspices of BRDC funding, that BRDC has granted commercial licenses, or option to license, to nearly every major agriculture biotechnology company in the world. Licensees include Japanese, European, multinational and American companies. BRDC has made the promoter generally available to researches in the field of plant genetic engineering and to date over twenty-five research organizations have taken research licenses. The promoter is already being used in genetic engineered crops that are being prepared for field trials. To date this technology has generated over $1.3 million of BRDC's licensing income. What do you expect to accomplish, year by year, over the next 3 years? BRDC is embarking on a significantly expanded program in plant molecular biology. The goals are to develop transformation systems that will eliminate the need to use antibiotic resistance selectable markers, provide the ability to integrate genes in specific chromosomal sites, limit the copy number of integrated genes, and increase the frequency of transformation with agrobacterium. The latter project has progressed to the point where three patent applications were filed in the past two years.

In FY 02 BRDC entered into an agreement with investigators at the University of Illinois to develop a system for the regeneration of NAD/NADP(H) in redox catalysis. This project involves a system based on a newly discovered proprietary enzyme and a patent is pending. This program is intended to complement the ongoing project designed to molecularly evolve redox enzymes to carry out their enzymatic activities in nonphysiological environments and with the use of cheap cofactor substitutes. In addition, BRDC has requested research proposals to develop new fungal expression systems that will be more facile in carrying out bioconversions of economic importance. These new research projects are expected to begin early in FY 02 and will be reported on in more detail in future reports.

6.What science and/or technologies have been transferred and to whom? When is the science and/or technology likely to become available to the end-user (industry, farmer, other scientists)? What are the constraints, if known, to the adoption and durability of the technology products?
Listed below are the transferred technologies in Biotechnology: Licensee/Technology Amoco Technology Company/ RNA Catalyst for Cleaving Specific RNA Sequences Agricultural Research Service/ Methods and Composition of Adherent Starch Granules for Encapsulating Pest Control Agents Agricultural Research Service/ Adherent Starch Granules * American Cyanamid Company/ Methods and Composition of Adherent Starch Granules for Encapsulating Pest Control Agents* American Cyanamid Company/ Adherent Starch Granules * Gene Shears Pty. Ltd./ RNA Catalyst for Cleaving Specific RNA Sequences Agrigenetics, Inc. d/b/a Mycogen Plant Sciences, Inc./ Novel Plant Activators for Gene Expression in Plants Agrigenetics, Inc. d/b/a Mycogen Plant Sciences, Inc./ Transcription in Plants and Bacteria and OCS Element DNA Plant Technology Corporation/ Novel Plant Activators for Gene Expression in Plants Promega Corporation/ A Method for Making and Purifying Proteins The Dow Chemical Company/ Biodegradable Starch Technology for Loose Fill Packaging Material* Planet Biotechnology, Inc./ Novel Plant Activators for Gene Expression in Plants Zeneca Limited/ Novel Plant Activators for Gene Expression in Plants Agricultural Research Service/ Novel Plant Activators for Gene Expression in Plants Suntory Litd./ Novel Plant Activators for Gene Expression in Plants American Cyanamid Company/ Novel Plant Activators for Gene Expression in Plants Plant Breeding International Cambridge Ltd./ Novel Plant Activators for Gene Expression in Plants DowElanco LLC/ Certain Biological Material The Dow Chemical Company/ Certain Biodegradable Polyester Technology * Seminis Vegetable Seeds, Inc./ Novel Plant Activators for Gene Expression in Plants Thermo Trilogy Corporation/ Lignin Encapsulation Technology for Wild-type (non-recombinant) Baculovirus Formulations* BASF Aktiengesellschaft/ Novel Plant Activators for Gene Expression in Plants Novartis Seeds, AG/ Novel Plant Activators for Gene Expression in Plants Biolex, Inc./ Novel Plant Activators for Gene Expression in Plants Baxter Healthcare Corporation/ A Method for Making and Purifying Proteins The Dow Chemical Company/ Biodegradable Starch Technology * Kirin Brewery Co. Ltd./ Novel Plant Activators for Gene Expression in Plants Pioneer Hi-Bred International, Inc./ Novel Plant Activators for Gene Expression in Plants Dow Chemical Company Enhanced Plant Cell Transformation By Addition Of Host Genes Involved In T-Integration Akkadix, Inc./ Novel Plant Activators for Gene Expression in Plants Exelixis Pharmaceuticals, Inc./ Novel Plant Activators for Gene Expression in Plants TRECE Incorporated/ Adherent Starch Granules for Pest Controls* FruitSphere, Inc./ Device for Controlling Pests * CropTech Corporation/ Novel Plant Activators for Gene Expression in Plants Mendel Biotechnology Company/ Novel Plant Activators for Gene Expression in Plants Invitrogen Corporation/ Fusion Proteins ICON Genetics, Inc./ Novel Plant Activators for Gene Expression in Plants Ball Horticultural Company/ Novel Plant Activators for Gene Expression in Plants. University of Missouri St. Louis/ Analogs for Therapeutic Applications North Carolina State University/ Chromatin Domain Tagging Using Site-Specific Recombinases Purdue Research Foundation/ Plasmid-Host Systems for Gene Structure Function Analysis Metkinen Oy/ Gelvin Promoter Seminis Seed Company Enhanced Plant Cell Transformation By Addition Of Host Genes Involved In T-Integration Memphis Associates Post Harvest Fruit Decay Control * Mallinckrodt Health Company Opiate Analogs Selective The Opioid Receptor

7.List your most important publications in the popular press and presentations to organizations and articles written about your work.
none.