White Point Systems: Reducing Risk With NAPIS

Reducing risk with NAPIS ^®

In addition to the operational requirements associated with natural products drug discovery, where efforts must be coordinated amongst chemists, molecular biologists, microbiologists and field biologists, there are now legal requirements that control sample acquisition and processing. With the NAPIS ^® (NAtural Products Information System) technology it is possible to convert these requirements to assets for managing the discovery process and enhance the probability of success.

Compliance Assurance
The 'science' of natural products drug discovery was coupled with the 'politics' of drug discovery when the Convention on Biological Diversity (CBD) was signed by more than 150 nations in 1992. The CBD establishes sovereign national rights over biological resources which the GATT-TRIPS Agreement (1994) extends by setting minimum standards for protecting intellectual property. Documenting these samples is critical. The risk of non-compliance is a weakened patent position based on the 'tainted research' doctrine.

The benefit provided by NAPIS ^® lies in the ability to show a 'chain of custody' for biological samples and 'commercial best efforts' in complying with new stewardship laws and policies by managing associated data within one comprehensive system. Aggressive discovery programs that source from a variety of international groups can receive and directly upload data in NAPIS ^® format which accompany biological samples.

NAPIS ^® Lite is now an industry standard with more than 7,000 users from more than 70 different countries since it's release in 1997.

Active Lead Prioritization
Natural products drug discovery is commonly referred to as the science of finding the 'unknown' in the 'unseen'. Tracking the isolation of new chemical entities requires integration with analytical chemistry studies and bioassay results, in compliance with good laboratory practice (GLP) and the Food and Drug Administration's electronic records and signatures rule, 21 Code of Federal Regulations (CFR) Part 11. Prioritizing active leads in the drug discovery and development pipeline requires meeting short timetable deadlines. The process is complicated by classes of nuisance compounds which cause false positives or metabolites that are already known to science. The risk lies in the 'opportunity cost' of prioritizing those active leads with known activity, or those that may not be feasible for drug development.

The benefits provided by NAPIS ^® include SQL-powered data mining tools for performing chemical dereplication, source organism dereplication, generating bioassay selectivity profiles and ease of navigation for drill-down on related data from any stage of the process.

Recollection
Wild-biomass recollection of macroorganisms as a bridge to the scale-up development of active leads is required in nearly every case. This requirement is viewed as a shortcoming, especially when compared to parallel synthesis or combinatorial chemistry libraries. In addition, documenting the detailed ecology of an initial collection is not feasible because most biological samples come from widely different organism groups. The ability to confidently recollect is viewed as a risk in most discovery programs.

The benefit provided by NAPIS ^®, together with our related geographic information system (GIS) mapping services, is the ability to track field collections and integrate a predictive model of species occurrence with the database. This relieves the burden of documentation at the initial collection stage and provides extended power to query the database during follow-on studies. For an example of the use of GIS, contact our office for a copy of a WPS study on the occurrence of Taxus brevifolia, the source of Taxol ^®, presented at the American Society of Pharmacognosy.

This technology holds potential for greater efficiency in the drug discovery process.

There are many more ways that NAPIS ^® can help your organization reduce the risks associated with natural products drug discovery. Please contact our office to discuss your special requirements and the solutions we can provide.