A Princeton-based company is working with pharmaceutical researchers in the hopes of developing new drugs to fight cancer, using a technology that works something like a flight simulator.
The American Cancer Society says 1.7 million Americans will receive a cancer diagnosis this year, with 600,000 fated to succumb to the disease. Meantime, the drugs currently available to fight cancer cells can be almost cost-prohibitive to bring to market.
Enter Certara: The 700-employee company and its global team of scientists and researchers are preparing to use a new technological approach to come up with means of fighting the disease – and it’s happening on computer systems using virtual patients.
“What we are doing is pharmacology dynamics, which is what the drug does to the body,” said Certara Vice President Piet van der Graaf. “This is a newer discipline. It is certainly taking off and the confidence and belief that these methods can be used is growing significantly as emphasized by the fact that we have established two consortiums with 12 companies that believe in us enough to invest and work with us on these models.”
The approach, known as quantitative systems pharmacology, taps into an immuno-oncology simulator consortium. That’s a partnership with pharma companies to develop the next generation of cancer-fighting drugs using computer models.
“What we’re trying to do is see if we can use modeling and simulation to help prevent clinical failures or ideally kind of make sure that we are only testing drugs or combinations of drugs to make that are going to work,” said van der Graaf. “The example of an airplane [flight simulator] is a good one, because in that discipline they have been using computer modeling for a very long time and obviously have run simulations thousands and thousands of times before they launch the first prototype.
“So, we are trying to do the same,” he said. “But now we’re replacing the plane with the human body and what we’re really trying to do is develop computer models that mimic human body physiology and pathology of the disease in the human body as best we can.”
Within a few years, Certara, with its development partners, hopes to create the first version of a simulator that uses publically available research data, coupled with information from the participating biopharma companies to create a virtual test program. This program would allow researchers to test individual or a combination of drug treatment therapies to fight cancer in a particular population group, whether that is age-, gender- or race-specific, or any other parameters that are required.
The ultimate goal is to create better drugs to fight cancer while reducing the years and billions of dollars it takes to bring a new treatment to market. Immuno-oncology treatments mobilize a patient’s immune system to fight the cancer affecting their body.
“The combinations are enormous,” said Ellen Leinfuss, Certara chief commercial officer. “No single company could invest in doing all this testing on people or animals. It is too expensive and time consuming.”
Using computer models to fight diseases or study the interaction with the human body is not entirely new. Fifteen years ago, Certara launched its Simcyp Simulator, which now has 36 biopharma members and has supported more than 100 drug label claims. This approach led to the advent of the QSP Immuno-oncology Consortium and last year’s Immunogenicity Consortium.
“The sky is the limit here,” van der Graaf said. “This is really one of the newest branches in modeling and simulating … it includes real details for biological understanding.”
Once the first version of the simulator is operational, the consortium can begin testing how different virtual patient populations react to individual drugs or combinations. Those results could potentially lead to a new medication to fight cancer receiving approval by the FDA and international regulators.
“What model-informed drug development does is it enhances that whole same gold-standard approach that the FDA and other regulators follow by being able to simulate what might happen without entirely putting [as many] humans or animals [into] physically involved evaluation,” said Leinfuss. “It’s like a flight simulator ... we’re just doing it with drug development, and it’s taking off like crazy.”
The FDA has already supported computer modeling in several cases, which gives Certara confidence that the simulator will have a high rate of accuracy.
“Accuracy does depend on the type of the disease. However, the confidence in those models is reflected in the regulators, like the FDA, now using those models and many times have accepted the output of these models as a replacement for running a clinical study,” said van der Graaf.
Computer modeling does not eliminate the need for live testing on humans or animals in the clinical trial phase, but it is leveraged throughout all stages of drug development to provide a faster, and potentially more accurate, way to determine the best possible treatments for patients.
“A lot of these technologies have been around now for close to 20 years, but like any technology it’s been really innovating rapidly on a rapid curve and really almost required in some cases for some of these technologies for drug development,” Leinfuss said.
As new developments to fight cancer continue to emerge, such as the recent reports of a growing number of clinical trials using vaccinations, the computer-modeling process may have an important role in developing those drugs.
“Immuno-oncology is arguably the hottest area in pharma research and development at the moment,” said van der Graaf. “It’s a noble concept, and some very, very exciting and groundbreaking results with the first mechanisms [have happened]. Because of that, people really think this could transform the treatment of cancer. … The medical need is huge.”