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Useful Metrics and Their Application for Outsourcing Drug Discovery Ch...

Useful Metrics and Their Application for Outsourcing Drug Discovery Chemistry

Outsourcing Drug Discovery

Robert A. Goodnow, Jr., Head of Global Medicinal Chemistry Outsourcing, Roche Research Center

As the outsourcing of drug discovery chemistry continues to be commonly employed in meeting project milestones,
focus in this endeavor has shifted from the initial novelty to its efficient application for impact [1]. In any continuing
endeavor, one aspect for enhancing efficiency is the identification and interpretation of meaningful performance metrics.
Each chemistry outsourcing collaboration should be evaluated with a mutually well-understood set of performance
metrics that capture data on valued aspects of the collaboration. Since well run collaborations tend to respond and
deliver results according to stated performance metrics, it is important to start with the metrics that reflect the intrinsic
values for both partners.

Recent estimates of the market size for the outsourcing of chemistry as it is applied to the discovery of drugs has been estimated at US$ 2
billion [2]. Further, it is estimated that 15% of US drug research and development investment is done outside the country [3]. These numbers
make clear the seriousness with which many organizations approach this strategy option for overcoming the multiple hurdles of drug
discovery. The challenging economic environment in which pharmaceutical and biotechnology companies must operate today will continue to
make the outsourcing of chemistry research an important strategy. As with any strategy, there are important considerations that one must take into account and
resolve in order to establish metrics for measuring and driving performance improvements of chemistry outsourcing for drug discovery. A set of objective metrics
is particularly important when comparing collaborations for best fit and performance.

1st Consideration: What to Outsource

A first step in developing performance excellence is to specify which types of drug discovery chemistry work will be outsourced (Figure 1). Early days of drug
discovery outsourcing during which only the simplest, nonurgent types of work were outsourced, have evolved to a situation where many diverse types of
chemistry research are now routinely done by external partners. Recently, not only are pharma companies comfortable enough to externalize the synthesis of
building blocks and reference compounds, but increasingly they share in the business of making hit-to-lead and lead optimization libraries. As confidence in the
diverse research capabilities of providers grows, one anticipates running externally entire projects (medicinal chemistry, bioassay, etc). Clearly, one sees this
situation already in the collaborations between virtual pharma companies and outsourced chemistry providers. The different types of chemistry work which might
be outsourced must be considered, each in their own realistic timeframe for completion. Chemistry efforts which may require many years to complete cannot be
viewed in the same manner as those which require only a few days or weeks to complete. For example, a company's compound library building is a long-term
strategic initiative that might be done in part through outsourcing collaborations. Such activity will likely require several years of effort for the design, synthesis
and shipment of many thousands of compounds from the sourcing company, whereas the re-synthesis of a few known compounds may take only a few weeks.
The metrics for these two activities will be correspondingly different. The type of planning and decision-making will also vary for the type of outsourced job.
Long-term, large-scale outsourced activities should be considered as part of a strategic plan of the company. Whereas, at the other extreme, the synthesis of a
known compound is really more of a tactical consideration.

2nd Consideration: Drivers for Outsourcing Decisions

When developing meaningful metrics to measure performance, it is first important to understand the expected outcomes by externalizing chemistry labor and
research. In that way, providers are able to position their companies and employees to deliver against stated expectations. Large pharmaceutical companies

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Useful Metrics and Their Application for Outsourcing Drug Discovery Ch...

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