GIP in Research Informatics

by Eric Jamois, Director of Business Development Inpharmatics

The use of informatics is widely spread in the pharmaceutical and healthcare industries. Applications range across drug discovery and development, medical devices, diagnosis and treatment. Considerable efforts are being made by LSIT to bring consistency in informatics processes. While the benefits of GIP may be obvious in a regulated environment, they may not be as straightforward in a research environment where maximum productivity and flexibility are required. We have investigated possible benefits from GIP applied to research.

It is clear that research requires considerable flexibility and should not be slowed down by cumbersome processes. There have been many arguments made to the effect that research is exploratory in nature and that a considerable percentage of data generated sees no further use. This is case for projects that do not progress to later stages or are simply abandoned for lack of resources or other reasons. No one would normally worry about this data but times are changing.

Companies have been looking for ways to better leverage their research data in the present but also in the future. Studies in pharmaceutical research have shown that as much as 10% of the research work done is repeat work which with proper tracking of history could have been avoided. Those 10% can be a lot for an industry which is currently struggling for higher productivity. The question: "Has anyone ever performed a similar experiment in the company and what was the outcome" is in many settings a difficult one to answer. Although it may be simple to assess in a Biotechnology startup, is it much more difficult in a multi-national company with multiple sites and decades of corporate history. The answer often lies in lab books which have been transferred to secure storage. It may also be in the head of colleagues who have moved on to other positions.

Companies have recognized the need to better capture their research data and capitalize on it. A number of them have deployed research informatics systems with Electronic Lab Notebook front ends in both research and development activities. Those systems do introduce some amount of process in the research lab but provide the needed ancestral memory to the organization. They provide considerable flexibility in searching through chemical structures, drug targets, gene sequences, keywords or a combination thereof. Within a few keystrokes, it is now possible to answer the question above and access all experimental details. One concern however has emerged on the ability of these systems to comply with 21 CFR Part 11 requirements as electronic documents need to satisfy proof of authenticity and traceability analogous of that of printed documents.

There is a considerable diversity in research informatics systems. Different database systems (Oracle, DB2 or other), schemas, chemistry cartridges, front ends...etc. The total number of ways that those can be assembled grows exponentially. Organizations build considerable dependencies on these systems. One issue, of course, is that of compatibility. A considerable number of mergers and acquisitions have happened in the pharmaceutical industry. Companies can spend years integrating systems that were developed and evolved independently. Even with considerable efforts, they struggle to make sense of disparate databases, data types...etc.

One can easily imagine the advantage gathered from defining common guidelines for informatics, even in research. For example, they can define the first common steps towards the authenticity and traceability requirements mentioned earlier. These are essential to all research organization as part of establishing IP strong positions which will withstand interference investigations. Defined practices in research informatics would also facilitate in the M&A scenario described previously.

More specific guidelines could also easily circle out incompatibilities, difficult integration scenarios or technologies that are being discontinued by their suppliers. They can circle situations where vendors have made a commitment to support each other's technology. At a more detailed level, one could also consider addressing complex versioning issues that can arise in integration scenarios.

LSIT is a non-profit organization dedicated to the development of Good Informatics practice for life and health sciences industries. For more information, visit: www.lsit.org

Eric Jamois is Director of Business Development for Inpharmatica Ltd, a company providing discovery technology and contract services to the pharmaceutical and biotechnology industry. Inpharmatica Ltd also pursues several internal drug discovery projects. Prior to this position, he supported the life science technology licensing effort at Accelrys Inc., a leading provider of computational drug discovery software.