At the University of Pittsburgh, Yoram Vodovotz, PhD, is a professor in the Department of Surgery with secondary appointments in the Department of Computational & Systems Biology, the Department of Bioengineering, the Department of Immunology, the Department of Communication Science and Disorders (of the School of Health and Rehabilitation Science), and the Clinical and Translational Science Institute. He also is the director of the Center for Inflammation and Regenerative Modeling at the McGowan Institute for Regenerative Medicine. In this latter role, his research interests, carried out in the context of an interdisciplinary research team, include systems biology and mathematical modeling of inflammation and wound healing in various disease states, especially infection, trauma/hemorrhage, wound healing, and liver failure, as well as the application of these computational approaches (i.e. in silico) to regenerative medicine, biomarker discovery, and rational drug/device design. In silico study in medicine is thought to have the potential to speed the rate of discovery while reducing the need for expensive lab work and clinical trials.
Dr. Vodovotz and his colleagues have published two recent papers pertinent to in silico research. They are:
A computational, tissue-realistic model of pressure ulcer formation in individuals with spinal cord injury. Cordelia Ziraldo, Alexey Solovyev, Ana Allegretti, Shilpa Krishnan, M. Kristi Henzel, Gwendolyn A. Sowa, David Brienza, Gary An, Qi Mi, Yoram Vodovotz. PLoS Computational Biology: 2015 Jun 25;11(6):e1004309. eCollection 2015.
Trauma in silico: individual-specific mathematical models and virtual clinical populations. Brown D, Namas RA, Almahmoud K, Zaaqoq A, Sarkar J, Barclay DA, Yin J, Ghuma A, Abboud A, Constantine G, Nieman G, Zamora R, Chang SC, Billiar TR, Vodovotz Y. Science Translational Medicine: 2015 Apr 29;7(285):285ra61.
An in silico clinical trial is an individualized computer simulation used in the development or regulatory evaluation of a medicinal product, device, or intervention. While completely simulated clinical trials are not feasible with current technology and understanding of biology, its development is expected to have major benefits over current in vivo clinical trials, and research on it is being pursued.
Noted by the Virtual Physiological Human Institute for Integrative Biomedical Research in Belgium, regulators in the US are beginning to recognize the potential for modeling and simulation technologies to improve the delivery of safe and efficacious biomedical products. The following text is taken from the Senate Fiscal Year 2016 FDA Appropriations Bill (S. 1800) & Report (S. Rept. 114-82):
“In Silico Clinical Trials. – In silico clinical trials use computer models and simulations to develop and assess devices and drugs, including their potential risk to the public, before being tested in live clinical trials. Advanced computer modeling may also prove useful in helping to predict how a drug or device will behave when deployed in the general population or when used in particular circumstances, thereby helping to protect the public from the unintended consequences of side effects and drug interactions. In silico trials may potentially protect public health, advance personalized treatment, and be executed quickly and for a fraction of the cost of a full scale live trial. The FDA has advocated the use of such systems as an additional innovative research tool. Therefore, the Committee urges FDA to engage with device and drug sponsors to explore greater use, where appropriate, of in silico trials for advancing new devices and drug therapy applications.”
Dr. Vodovotz recognizes this is a significant step for in silico medicine and the future benefits of it.