Of Mice and Men—APACHE®Simulator Helps Reduce Clinical Trial Costs, Speed FDA Approval; Computer Model Simulates Human Drug Testing

Business Wire, August 31, 2000

Business Editors/Hi-Tech & Health/Medical Writers

BIOWIRE2K

McLEAN, Va.--(BW HealthWire)--Aug. 31, 2000

"The drug and device industry is now capable of simulating clinical trials on a very advanced scale thanks to the APACHE(R) Simulator," according to William A. "Bill" Knaus, MD, FACP, president and CEO of APACHE Medical Systems, Inc. (Nasdaq:AMSI). The northern Virginia company is a leading provider of clinical decision support, research and consulting services to the health sector.

The APACHE Simulator--a group of integrated clinical trial simulation services from APACHE's Health Outcomes Research division--is designed to help pharmaceutical and medical device manufacturers "cut clinical trial costs and boost effectiveness," notes Knaus. "Our goal is to help the industry bring consumers safe, effective new therapies more quickly and affordably."

Safeguarding research dollars and subjects with 'evidence-based

clinical trials'

Like the 'Space Cowboys' flight simulator, which spun aging astronauts at breakneck speed before sending them into space, the APACHE Simulator is designed to help the industry "prevent expensive missteps," notes Knaus. "It doesn't make sense to entrust human lives or costly equipment to a pilot or astronaut without first seeing how they perform on a flight simulator. Why shouldn't the health sector employ the same safeguards?"

As founding chair of the health evaluation sciences department at the University of Virginia (UVA) in Charlottesville--and one of the leading developers of the internationally respected APACHE methodology--Knaus has been tireless in his quest to make "evidence-based medicine" the norm rather than the exception. "Increased attention is now being paid to the use of technology to reduce medical errors. This is an ideal time to strive for 'evidence-based clinical trials,' too.

"With the Simulator, we can now apply internationally recognized APACHE 'Gold Standard' science to help the industry develop more precisely targeted new clinical therapies. It's a natural evolution of our company's strengths."

"Designing clinical trials without a simulator is like setting sail without a compass," says Knaus. The APACHE Simulator helps drug and device manufacturers "chart a more direct course so fewer clinical trial patients are needed." At $10,000 or more per trial patient studied, this can significantly reduce costs without reducing quality.

Experts, Proprietary Data and Computer Models . . . and Plain Old

Common Sense

Unlike the 'Space Cowboys' simulator, the APACHE Simulator isn't a machine per se. It's APACHE experts using unique and proprietary databases such as the APACHE HIV Insight(R) database--and proprietary computer models such as the APACHE III methodology--to create powerful computer models that help APACHE clients identify what a particular drug or device can, should, and will do, in the real world.

By modeling and simulating all aspects of new and existing drug and device testing, evaluation and marketing--before the actual clinical trial begins--the APACHE Simulator enables manufacturers to eliminate unnecessary clinical trial costs.

"Drugs and devices are increasingly being designed by experts with in-depth knowledge of precise molecular targets, but little understanding of how new therapeutic agents apply to real-world patients and providers," notes Knaus. "In this environment, it's just plain common sense to simulate human testing

wherever possible before investing in the real thing.

"Once the industry discovers how effective computer models like the APACHE Simulator can be in terms of helping them meet increasing marketplace pressures--from competitors, consumers, payors and government regulators--clinical trial simulation services may soon become a requisite part of the process."

By providing a relatively low-cost computer model designed to be used after the animal model (i.e., mice or other lab animals) and before the human model, the APACHE Simulator helps the industry address such questions as:

-- How big is the market for your new drug or device?

-- Should you even take it to market . . . and if so, should you

move it to the top of the pipeline?

-- How clinically effective must it be in order to improve

existing standards of care?

-- At what price point will product delivery be financially

feasible?

-- What are the study end points--e.g., reduced mortality,

etc.--in your target population?

-- What is the ideal patient cohort for your clinical trial?

-- Are your risk modeling formulas valid--i.e., are you comparing

apples to apples?

New APACHE Experts

"New leadership at APACHE has helped make this new service line feasible," explains APACHE Board Chairman Thomas W. Hodson. "The addition of two internationally known outcomes research experts has given our research division a new edge, enabling us to enhance existing services to create the APACHE Simulator program."

The appointment this July of Knaus as president and CEO, and Jack E. Zimmerman, MD, as director of medical research and applications, "further strengthens APACHE's ability to help safe and effective drugs and devices achieve FDA approval in a timely manner, and get to market faster," says Hodson.