Optimize Immuno-oncology Drug Discovery and Development Using Quantitative Systems Pharmacology

Immuno-oncology – The Breakthrough in Cancer Therapeutics Cancer immuno-oncology (IO) uses the body’s natural defenses to combat cancer. These therapies stimulate an individual’s immune system and restore its ability to identify and destroy cancer cells. Anti-cancer immune responses are often inhibited during the spread of cancer. Ultimately, IO therapy expedites long term responses against cancer … Continued

Lessons Learned: Case Studies of Apocalyptic Clinical Pharmacology

Apocalyptic clinical pharmacology helps drug developers save resources and time through providing a framework for understanding the interaction of the drug under development with the biological system. This framework also helps answer questions from regulatory authorities who are evaluating the safety and efficacy of the drug. Making informed decisions throughout the drug development process requires … Continued

Using M&S to Evaluate Oncology Drug Dosing

There are numerous challenges in developing oncology drugs: (1) they are often very toxic which precludes conducting clinical trials in healthy volunteers, (2) the PK of a drug may be altered in cancer patients due to demographic and physiological differences as compared to healthy volunteers, and (3) cancer patients face elevated drug-drug interaction (DDI) risk … Continued

The Special Opportunities for Modeling and Simulation in Oncology Drug Development

In his most recent New York Times Magazine piece, “The Improvisational Oncologist,” Dr. Siddhartha Mukherjee, author of The Emperor of All Maladies: A Biography of Cancer, wrote, “In an era of rapidly proliferating, precisely targeted treatments, every cancer case has to be played by ear.” Oncology treatment: yesterday, today and tomorrow Mukherjee begins his article … Continued

An Ethical Imperative to Use Biosimulation in Drug Development

In addition to the strong business case for using biosimulation, there is also a powerful ethical case. Now that we know how biosimulation has proven to inform key drug development decisions, is it ethical to not employ these methods before enrolling patients or healthy volunteers into clinical studies?