Genomics


Figure 1 Credit: Understanding Animal Research


months. The development and use of well-defined laboratory mouse strains started in the early 1900s, and mouse geneticists routinely shared mouse strains freely with colleagues through the 1960s. With the advent of transgenic technology starting in the 1970s, the number of mouse strains available began to increase exponentially. The field has gone from hundreds of available strains (all generated using traditional breeding techniques) to hundreds of thousands (most generated using transgenic technology). With the identification of valuable mutant strains, the transfer of mouse and rat strains from institution to institution became more complicated.


From basic research to bioreactor Most GEMs are used in basic research. Knocking out a gene provides a way to study the function and importance of that gene. Adding a reporter permits functional tracking, whether for gene expression or of the physical location of certain cell types. But GEMs can also be used as bioreac- tors to create new drugs. Mice and rats which pro- duce human monoclonal antibodies can serve as bioreactors to generate new biologic drugs which can be evaluated and advanced into clinical devel- opment. Several different companies have devel- oped such mouse systems, including Ablexis LLC, OMT, Inc (now Ligand Pharmaceuticals, Inc), Regeneron Pharmaceuticals, Inc and Trianni, Inc. For mouse models that produce clinical drug can- didates, the intellectual property is complex and the licensing value and use restrictions are corre- spondingly high. With such a range in value from basic research tools through models which gener-


Drug Discovery World Fall 2018


ate lead drugs, a range of distribution mechanisms is appropriate.


Distribution terms between individual institutions GEMs are typically distributed under some type of legally-binding agreement. This is often a Materials Transfer Agreement (MTA), but other types of licences may also be used.


Material Transfer Agreements (MTAs) GEMs are commonly shared between non-profit researchers under MTAs. MTAs are legally binding agreements that govern the terms under which bio- logical materials such as GEMs, cell lines and anti- bodies are shared and used. These agreements are typically between two parties, a provider and a recipient, but may have more parties if additional IP rights are involved or in cases where collabora- tive research is performed across multiple recipient institutions. MTAs between non-profit institutions usually have the following restrictions:


lMaterials are provided for use NOT in humans. l Materials are only for non-for-profit research use by the named recipient researcher. l Materials may not be further distributed by the recipient organisation without written permission from the provider.


Other items which may or may not be addressed in MTAs include the following:


l Further distribution of modifications made to materials by recipient.


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