JOINT RECOMMENDATIONS: Mouse Genomics and Genetics Subgroup and Mouse Models of Human Cancers Subgroup
#1. In concert with the NIH at large, develop and implement political initiatives that set limits on reach-through royalty clauses on technology transfer agreements proffered by the holders of intellectual property, whether in academia or industry. Establish fair and just standards that appropriately reward the developers of new technology, while at the same time providing incentive for such tools to be used widely in biomedical research and in the development of new therapeutics.
i. Develop a solution to the restrictive Dupont patents for the 'oncomouse' and for the cre/lox technology.
ii. Investigate the 'Transgenic Mouse Patent' owned by DNX, which is being aggressively protected, to the extent that smaller biotech companies are stopping the development of transgenic mouse models.
iii. Establish a national standard (and intellectual principles) for compensation associated with the transfer of tools and technologies, including those associated with mouse models, as contrasted to discoveries of specific product candidates that need broad protection to justify their development.
#2. Develop national standards for mouse care and criteria for setting appropriate costs/charges for such care, and design fiscal support mechanisms that enable the widespread use of mice to study cancer mechanisms and to identify and validate preventative and therapeutic strategies for human cancers.
i. Establish uniform criteria for what are right and proper standards for care of mice, and that spell out real cost criteria to be used by institutions to formulate recharge rates for such care in the context of NIH-sponsored research.
ii. Encourage acceptance of the proposal that animal care facilities no longer be considered as 'specialized' and thus inappropriate for support under the indirect cost umbrella, but rather identified as 'general' and thus appropriate.
iii. Investigate other mechanisms to make animal care more efficient and affordable, including animal facility improvement grants to render them larger and/or more cost effective.
iv. Formulate 'peer-reviewed' funding mechanisms that will allow mouse models of every human cancer to be built, and their pathways of tumorigenesis studied, in particular for modifier genes that influence the severity and progression of the cancer, which likely reflect similar genes segregating in the human population.
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RECOMMENDATIONS: Mouse Models of Human Cancers Subgroup
1. Support early-stage development of mouse cancer models and associated technologies.
i. NIH/NCI should establish a funding mechanism for the support of early-stage development of mouse models of cancer and associated technologies.
ii. The review of applications in these areas should be separate from standard Study Section review in order to include individuals knowledgeable in the technical areas in question and to avoid common biases against developmental projects.
2. Facilitate the Establishment and Maintenance of a Mouse Model Database. The NCI is advised to facilitate the development and maintenance of a comprehensive and interactive database (accessible through the internet) of genetically altered mouse strains useful in cancer research. Such a database would include transgenic and "knock out" strains in addition to classically-derived mutant mouse strains. Existing knowledge of the published and unpublished characterization of each strain should be included. A mechanism for continuous updating of information should be developed.
3. Facilitate the Establishment and Maintenance of Regulatory Sequence/Plasmid Tools Database and Repository/Distribution Center.
i. The NCI should facilitate the development and maintenance of a comprehensive and interactive database (accessible through the internet) of known cell-specific regulatory signals.
ii. The NCI should establish a repository/distribution mechanism for the aforementioned reagents which is readily accessible to NIH-funded investigators.
4. Mechanisms for dissemination of information and methodologies relating to the construction and analysis of mouse models of cancer.
i. NIH/NCI should support a meeting or workshop on the current technologies related to genetic manipulation of the mouse and associated methods for the characterization of mouse models of cancer.
ii. NIH/NCI should continue to support meetings, workshops and courses designed for the dissemination of novel technologies related to the generation and characterization of mouse models of cancer.
iii. One specific area of research for which a dedicated course would be beneficial is the use of ex vivo culture methods, including standard tissue culture of cells of epithelial origin, three-dimensional tissue culture, and organ culture.
5. The NCI should establish a mouse cancer model repository (MCMR) to serve as a site for deposition, distribution and archiving of valuable mouse strains used in cancer research. This repository should be sufficiently funded to allow for the importation of approximately 25 strains per year. In addition, the NCI should establish a steering committee of intramural and extramural scientists knowledgeable about mouse models of cancer to evaluate candidate strains for importation and advise the NCI on the continued operations of the repository. It is further recommended that this repository serve as a site for educational and training programs in the generation, maintenance and use of mouse models of cancer.
i. The NCI should establish a mouse cancer model repository with sufficient funds and physical capacity to import approximately 25 strains per year. A critical criterion in choosing the facility that will function as the MCMR is the ability to ensure the health status and genetic identity of the strains to be distributed. The facility must also develop a sophisticated and readily accessible database to inform users about strain availability and characteristics.
ii. The MCMR Steering Committee should be composed of knowledgeable and committed individuals from academic, government and industry laboratories, approximately 6-8 in total, who would serve two-three year terms. This committee will work with the NCI staff and the MCMR to prioritize the mouse strains to be deposited into the repository. They will also serve in an advisory capacity for the MCMR in determining policies and practices, including the choice of the "standard" genetic background or backgrounds onto which alleles will be crossed, the use of embryo and germ cell freezing methods for archiving and distribution, maintenance of health and genetic quality control, and the scope and areas of educational and training programs at the MCMR.
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