Progress 02/29/00 to 02/28/05
Outputs
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 Agreement (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, health and productivity should impact the entire chain from production through consumption. 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. 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 $15.4 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. 3a List the milestones that were scheduled to be addressed in FY 2005. For each milestone, indicate the status: fully met, substantially met, or not met. If not met, why. 1. Identify and fund the development of technologies that offer promise of commercial opportunity. Milestone Fully Met 2. Successfully complete the development of technologies as measured by granting commercial licenses. Milestone Fully Met 3. Establish a diverse and dynamic research and development portfolio that addresses the market needs of the agribusiness. Milestone Fully Met 4. Adjust the R&D portfolio, on an ongoing
basis, to properly reflect market needs. Milestone Fully Met 3b List the milestones that you expect to address over the next 3 years (FY 2006, 2007, and 2008). What do you expect to accomplish, year by year, over the next 3 years under each milestone? This project concluded in FY 2005. New milestones for FY 2006-2008 are described in project 0500-00030-004-00D. 4a What was the single most significant accomplishment this past year? In 2005 BRDC executed two separate license agreements to two individual companies for a technology developed at the National Animal Disease Center. The technology is a new vaccine that will have across species application, e.g. cattle, swine, fowl etc. 4b List other significant accomplishments, if any. Four new patents were filed by sponsored institutions. These filings resulted from BRDC funded research. BRDC also executed four new license/option to license agreements. 5. Describe the major accomplishments over the life of the project, including their
predicted or actual impact. 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. A metric for success in this endeavor is the number of commercial licenses issued. In many instances the licensees are still engaged in product development and actual commercial sales have not occurred. In other instances tools and methods were licensed that were used to develop a variety of products. It would take too much space to itemize all of them so a few specific examples are provided. However, over the lifetime of the project BRDC has executed twelve commercial agreements and has received over $2.11 million dollars in licensing revenue. Live Vaccine for Cattle Shipping Fever: Shipping fever costs the North American cattle industry approximately $1 billion per year. The disease, which is a bacterial respiratory illness, is generally caused by stress when feeder calves are shipped to
feed lots. BRDC sponsored scientists at the USDA-ARS National Animal Disease Center (NADC) have developed a live vaccine that has been shown to be significantly more effective than prior vaccines. The vaccine was developed using novel genetic engineering methods on the three most common causative agents. This technology has been licensed to a BRDC shareholder and is currently under accelerated development for product introduction in 2002. ESR Pig Fecundity Test: A test has been developed that allows swine breeders to test individual females for the propensity to produce larger than normal litters. The test is based on a molecular polymorphism in the pigs gene for the estrogen receptor. Presence of one of the polymorphic alleles means that the females carrying it will produce, on average, five to seven more offspring during a breeding lifetime than females that do not possess the marker. This technology was developed at Iowa State University and is licensed to a BRDC shareholder. To
date PIC has tested over a hundred thousand of the females in their breeding herd and sell selected females as proficient breeders. This technology received an R&D 100 Award in 1999. F18+E.coli Test: ARS scientists at NADC, under the auspices of BRDC funding, developed a simple test for susceptibility/ resistance to the common swine disease F18+E.coli infection. This disease is a major problem to swine breeders throughout the world as it causes potentially lethal diarrhea in post weaned piglets. A simple test for a genetic polymorphism has been developed that will allow breeders to select for resistant animals and breed the trait into their colonies. The technology has been licensed to a BRDC shareholder and the worlds largest supplier of swine breeding stock. BRDC has made a significant commitment to study the expression of swine genes involved in the immune response after infection with several economically important swine pathogens. These studies are designed to follow both the
expression of pathogen and host genes and analyze the interactions between host and pathogen. The goal is to define the macromolecular events and the genetic responses to these events during the course of an infection in order to better model effective methods of early diagnostics and interdiction of the infectious pathology. The program involves a close collaboration of a well known nucleic acid biochemist and his laboratory, the NADC and several BRDC shareholders. The pathogens under current study are Porcine Reproductive and Respiratory Syndrome Virus, Mycoplasm hyopneumoniae and Staphylococcus aureus. To date over three thousand expressed sequence tags (EST) have been identified and mapped to the existing swine genome map. Future work is expected to produce several thousand more of these sequences. BRDC shareholders are already accessing the database and BRDC intends to make the database available to the NADC collaborators at no cost. In FY 02 BRDC granted a worldwide exclusive
license for vaccine technology developed at NADC. This technology involves the use of mutant strains of Pasteurellacia sp. that carry a deletion in the structural gene for leukotoxin. Field trials conducted by the licensee proved the vaccine to be very promising. In FY 2005 scientists at NADC developed a totally new and proprietary live vaccine for P. multocida by deleting a portion of the hyaE gene. A patent was filed and the patent has now been licensed. In addition several new genetic markers were discovered in swine that will be used in breeding programs. 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? Technologies have been transferred to a range of industries for the following products: Methods and Compositions for Producing Transgenic Swine
Genetic Markers for Pig Litter Size Construction of Pasteurella Hemolytic Vaccines Construction of Haemopjilus Somnus Vaccines Temperature Sensitive Plasmid Certain Biological Materials Methods and Compositions to Identify Swine Genetically Resistant to F18 E.coli Associated Diseases for Swine Methods and Compositions to Identify Swine Genetically Resistant To F 18 E coli Associated Diseases for Swine Method For Producing Metagenomic Libraries Metagenomic Libraries Selected Cultures Alaskan Soil Microorganisms U.S. Patent Application No. 60/519,418 Multocida Vaccine Multocida Vaccine Swine Markers Bacterial Culture Collection
Impacts
(N/A)
Publications
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Progress 10/01/03 to 09/30/04
Outputs
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 Agreement (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 $15.4 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 three (3) commercial licenses and/or options for license. d.) 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. d.) 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: During FY 2004, BRDC/Animal Health Consortium executed three commercial licenses and two 'Project Technology Agreements' (options for license to BRDC shareholders) for a total of five commercial license/option agreements. During FY 2004, BRDC licensing
activities generated $325,000 in cash and an additional $195,050 in accrurals (obliged future receipts). As FY 2004 draws to an end, BRDC is close to finalizing an additional three license agreements. BRDC's technical accomplishments exceeded expectations. During FY 2004, BRDC and its collaborators filed ten new patent applications in the U.S. alone. A significant number of these applications will be foreign filed as well. Patent filing is an indicator of the success of a research project. B. Other significant accomplishment(s), if any: none. 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. 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. A metric for success in this endeavor is the number of commercial licenses issued. In many
instances the licensees are still engaged in product development and actual commercial sales have not occurred. In other instances tools and methods were licensed that were used to develop a variety of products. It would take too much space to itemize all of them so a few specific examples are provided. However, over the lifetime of the project BRDC has executed twelvecommercial agreements and has received over $2.11 million dollars in licensing revenue. Live Vaccine for Cattle Shipping Fever: Shipping fever costs the North American cattle industry approximately $1 billion per year. The disease, which is a bacterial respiratory illness, is generally caused by stress when feeder calves are shipped to feed lots. BRDC sponsored scientists at the USDA-ARS National Animal Disease Center (NADC) have developed a live vaccine that has been shown to be significantly more effective than prior vaccines. The vaccine was developed using novel genetic engineering methods on the three most common
causative agents. This technology has been licensed to BRDC shareholder Schering Plough Animal Health Corporation and is currently under accelerated development for product introduction in 2002. ESR Pig Fecundity Test: A test has been developed that allows swine breeders to test individual females for the propensity to produce larger than normal litters. The test is based on a molecular polymorphism in the pigs gene for the estrogen receptor. Presence of one of the polymorphic alleles means that the females carrying it will produce, on average, five to seven more offspring during a breeding lifetime than females that do not possess the marker. This technology was developed at Iowa State University and is licensed to Pig Improvement Company (PIC), a BRDC shareholder. To date PIC has tested over a hundred thousand of the females in their breeding herd and sell selected females as proficient breeders. This technology received an R&D 100 Award in 1999. F18+E.coli Test: ARS scientists at
NADC, under the auspices of BRDC funding, developed a simple test for susceptibility/ resistance to the common swine disease F18+E.coli infection. This disease is a major problem to swine breeders throughout the world as it causes potentially lethal diarrhea in postweaned piglets. A simple test for a genetic polymorphism has been developed that will allow breeders to select for resistant animals and bred the trait into their colonies. The technology has been licensed to Pig Improvement Company, a BRDC shareholder and the worlds largest supplier of swine breeding stock. BRDC has made a significant commitment to study the expression of swine genes involved in the immune response after infection with several economically important swine pathogens. These studies are designed to follow both the expression of pathogen and host genes and analyze the interactions between host and pathogen. The goal is to define the macromolecular events and the genetic responses to these events during the
course of an infection in order to better model effective methods of early diagnostics and interdiction of the infectious pathology. The program involves a close collaboration of a well known nucleic acid biochemist and his laboratory, the NADC and several BRDC shareholders. The pathogens under current study are Porcine Reproductive and Respiratory Syndrome Virus, Mycoplasma hyopneumoniae and Staphylococcus aureus. To date over three thousand expressed sequence tag (EST)s have been identified and mapped to the existing swine genome map. Future work is expected to produce several thousand more of these sequences. BRDC shareholders are already accessing the database and BRDC intends to make the database available to the NADC collaborators at no cost. In FY 02 BRDC granted a worldwide exclusive license to Schering Plough Animal Health Co. for vaccine technology developed at NADC. This technology involves the use of mutant strains of Pasteurellacia sp. That carry a deletion in the
structural gene for leukotoxin. Field trials conducted by the licensee proved the vaccine to be very promising and product introduction is expected within a few years. 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? The list of transferred technologies in Animal Healthcare follows: Licensee/Technology Alexion Pharmaceuticals, Inc./ Methods and Compositions for Producing Transgenic Swine Pig Improvement Company, Inc./ Genetic Markers for Pig Litter Size Mallinckrodt Veterinary, Inc./ Construction of Pasteurella Hemolytic Vaccines Construction of Haemopjilus Somnus Vaccines Temperature Sensitive Plasmid Eli Lilly and Company/ Certain Biological Materials Pig Improvement Company, Inc./ Methods and Compositions to Identify Swine Genetically Resistant to
F18 E.coli Associated Diseases for Swine Fort Dodge Animal Health Division of Wyeth Methods and Compositions to Identify Swine Genetically Resistant To F 18 E coli Associated Diseases for Swine Fort Dodge Animal Health Division of Wyeth Method For Producing Metagenomic Liraries Fort Dodge Animal Health Division of Wyeth Metagenomic Libraries Fort Dodge Animal Health Division of Wyeth Selected Cultures Alaskan Soil Microorganisms Fort Dodge Animal Health Division of Wyeth U.S. Patent Application No. 60/519,418
Impacts
(N/A)
Publications
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