FOSTER CITY, Calif.—The patients may not be real, but the results are—and so is the U.S. patent No. 6,983,237 recently issued to Entelos Inc. and titled "Method and Apparatus for Conducting Linked Simulation Operations Utilizing a Computer-Based System Model." Making that mouthful a bit simpler, Entelos has successfully patented its invention of a key technology to effectively develop and use virtual patients—in silico representations of actual patient subpopulations—to rapidly assess the safety and efficacy of drugs in humans.
It's not the end of the road either, with many other patents still pending, though it is an important step in the company's continuing efforts to protect virtual patient innovations.
"This patent represents yet another milestone in Entelos' intellectual property strategy, and indicates the company's commitment to protecting its leadership position in the field of predictive biosimulation," says Dr. Charles Sholtz, vice president of legal affairs and intellectual property at Entelos. "Currently, we have 12 issued patents and over 70 pending applications worldwide directed to our software platform; the methodologies of applying our PhysioLab models to pharmaceutical drug discovery and development; and the PhysioLab models themselves."
This particular patent provides broad coverage for a method Entelos developed to consecutively link biosimulation experiments using a computer model. The software based on this method allows Entelos scientists to rapidly create new virtual patients and effectively use them to validate drug targets, identify biomarkers, translate preclinical data to human outcomes and optimize clinical trial designs.
Having this kind of flexibility and predictive power is important in drug discovery efforts, notes Tom Paterson, co-founder and senior vice president at Entelos.
"There are many ways to design a building that falls down," he says by way of analogy. "Designing a homeostatic building that holds up under high winds, earthquakes and other stresses is more difficult. The same is true of building a disease system. So we first model healthy homeostatic systems and then introduce changes that cause a disease state. In doing so, we have a tremendous opportunity to explore the potential causes of disease."
In the short run, such abilities help Entelos improve the understanding of disease, helping drug companies improve how medicines are discovered and developed, and enabling them to bring new and more effective treatments to market faster, the company notes. Long-term, it may play a role in personalized medicine applications.
"By developing this methodology, Entelos can effectively represent patient variability in a computer on both the individual and population scale," according to James Karis, president and CEO of Entelos. "This ability allows us to address this critical drug development challenge, which is also a key hurdle in fulfilling the promise of personalized medicine. This patent further strengthens our leadership position in biosimulation and lays the framework for Entelos to develop the first-ever virtual human."
