Fall 2018
Genetically engineered models GEMs, mouse image main
Genetically-Engineered Models: The Value of Precious GEMs
By Dr Megan M. MacBride
Fall 2018

Genetically-engineered animal models (GEMs) are critical tools for drug discovery and development, but intellectual property (IP) concerns can complicate access.

As pharma and biotech increasingly outsource R&D activities to universities, careful scrutiny is required to ensure adherence to IP restrictions on research tools across those collaborative activities. As demonstrated by recent high-profile lawsuits, the stakes are higher than ever for all parties.

Despite improvements to in vitro assays, animal models are a critical part of preclinical drug discovery and development and will remain so for the foreseeable future. In particular, GEMs are specialised reagents with value across R&D stages. These tools often have significant upfront costs to generate and characterise, but awareness of their value for research and/or commercial applications, and of the intellectual property associated with GEMs, may vary among researchers, particularly in academia.

What are GEMs?

GEMs are animals which have a genetic alteration artificially introduced by humans. Most commonly these are mice and rats, but advances in transgenic technology over the past decade have made possible the development of genetically-engineered zebrafish, pigs and even non-human primates.

Examples of genetic alterations carried by GEMs are gene deletions, added sequences such as reporter genes, or replacement of a native gene with the human version. A wide variety of techniques exist to make GEMs, and quite sophisticated mutations can be made. According to the International Mouse Strain Resource (IMSR), more than 200,000 genetic modifications have been made in mouse embryonic stem cells, so the number of existing GEMs across all animal species and transgenic technology types is significant.....

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