Software

A new tool for drug development and infectious disease research

At the foundation of scientific advancement lies the premise that research builds on the knowledge of its predecessors.This requires collaboration.The implementation of an integrated “whole animal” database would foster collaboration between chemists, microbiologists, cell physiologists, nucleic acid researchers, and animal physiologists by allowing them to share and integrate results into a common animal model protocol and timeline. This article will describe an integrated whole animal database that has the storage and analysis of complex physiological data as its core.

The amount of data available for analysis and interpretation has grown exponentially with the increased computerization of research instrumentation and laboratories over the last few decades. Current laboratory software systems do not adequately address the needs of the scientists bridging the gap between microbiology and clinical trials. LIMS systems have grown to address the needs of the chemistry and analytical laboratories. Bioinformatics databases have been developed for microbiology, nucleic acid, and protein research environments. Clinical databases for human disease and therapeutic research are numerous. The market lacks, however, an integrated, whole animal database for infectious disease, preclinical pharmacology, toxicology, and safety pharmacology research programs. This deficiency reflects the general trends in research funding over the last decades. John Hall states, “the widening gap between basic research and clinical medicine has [contributed to] the gradual demise of integrative physiologists working at the whole animal level who can effectively interact with molecular biologists and clinical researchers.”¹ The work at the whole animal level is still being done—it is just being done by fewer scientists. And with the FDA promulgating guidelines for approval of therapeutics without going through traditional human clinical trials in cases where such trials are immoral or impossible to perform, more focus is being placed on developing comprehensive animal models that accurately reflect the corresponding human disease or challenge.² Therefore, the market requires tools such as a whole animal database, which will make the scientists who perform these studies more efficient.

Shortening the Route from Data to Knowledge
Pharmaceutical companies have modified their research paradigms to “kill compounds faster” thereby clearing resources for investment in bringing the most promising entities to market faster.³ Government funded research and development that targets rapid disease detection and intervention to address biological and chemical threats to both civilian and military personnel has greatly increased. The vast amounts of data collected in whole animal or isolated organ protocols, however, are stored and analyzed in isolation. Manual intervention, often taking weeks and months to consolidate, analyze, reassemble, and reanalyze, significantly drains resources and impairs the rapid assimilation of the full data set that is available from current research methods. The implementation of an integrated and complete whole animal database application could significantly shorten the time from data to knowledge, as well as expand the knowledge gained from each experimental study.

The benefits of the integrated whole animal model in decreasing the time to make decisions may be the most profound effect its implementation can have in the time to market race in both the pharmaceutical and biodefense environments. Hoagland reported an 80%decrease in data analysis cycle when utilizing a precursor data analysis system for collecting, analyzing, and reporting Safety Pharmacology data in a conscious caninemodel.⁴ The complexity of collating and analyzing external data to the automatically-collected physiological data only expands the time between experiment and report for complex animal models and intervention studies when done without the aid of an integrated whole animal database.

Capturing Data
Implementing an integrated whole animal database requires the ability to capture, store, and make available for assimilation external data to a common protocol timeline. This feature is especially important for primary data,which in this case includes physiological information such as blood pressures, heart rate, respiration, temperature, EEG, ECG, and other data relevant to the target condition. The collection of physiological data takes different forms, including anesthetized subject models and ambulatory conscious animal models utilizing telemetry. Ambulatory conscious models using telemetry are required in certain mandated studies, such as cardiac safety studies for IND submission (S7A).⁵