Tuberculosis (TB) is a deadly disease, a principal cause of death by infectious disease, and the leading cause of mortality for HIV+ patients. Most available TB drugs are more than 40 years old, have significant side effects and drug interactions, and require a long treatment period. Furthermore, these drugs are becoming less effective as TB strains grow increasingly drug resistant. New tools are desperately needed to help TB drug developers combat this deadly disease.
The Critical Path to TB Drug Regimens (CPTR) Initiative, in partnership with Certara, developed a TB-specific set of lung and granuloma models, together with a library of drug and metabolite files. These models and library files are implemented in Certara’s Simcyp Simulator physiologically-based pharmacokinetic (PBPK) platform, which helps optimize the design of clinical studies for multiple indications and has been widely adopted by industry and regulators.
Attend this webinar with C-Path’s Dr. Klaus Romero to learn how they integrated these components into the latest version of the Simcyp Simulator to establish a robust resource that will help development teams and regulators evaluate the safety and efficacy of novel anti-TB drug regimens.
About Our Speaker
Dr. Klaus Romero is a clinical pharmacologist and epidemiologist by training, with 12 years of experience in clinical research. He is a fellow of the American College of Clinical Pharmacology, a founding member of the International Society of Pharmacometrics, as well as a member of the American Society for Clinical Pharmacology and Therapeutics and the International Society for Pharmacoepidemiology. He has conducted research on endemic channels for non-steroidal anti-inflammatory drug-related gastropathy, antibiotic-related dysglycemia, drug-induced QT prolongation, pharmacoepidemiology, and patient education. Dr. Romero has been with C-Path since January 1, 2008, where he has led clinical pharmacology, pharmacoepidemiology, and modeling and simulation projects for the Coalition Against Major Diseases, the Polycystic Kidney Disease Outcomes Consortium, and the Critical Path to TB Drug Regimens Consortium, achieving major milestones such as the first regulatory endorsement by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) of a clinical trial simulation tool for mild and moderate Alzheimer’s Disease. He is fluent in English, Spanish, German, and Portuguese, and has published in the areas of clinical pharmacology, pharmacometrics, cardiovascular drug safety, and pharmacoepidemiology.