More than a century after the discovery of the bacteria that causes tuberculosis (TB), TB continues to be the world’s deadliest infectious disease. Despite being preventable and curable, TB killed 1.4 million people in 2019, according to the World Health Organization (WHO), in large part due to global poverty, drug resistance, and co-infection with HIV/AIDS. Furthermore, the treatment of TB requires months to years of treatment with complicated and often expensive regimens which burden patients and caregivers alike. Fortunately, although it has been a neglected therapeutic area for many decades, there has been an uptick in investment in TB drug development, leading to recent advances in the treatment of multidrug-resistant TB.
A key challenge in the development of these new TB treatments is identifying effective dosing regimens for the multiple drugs required for these therapies—a challenge that model-informed drug discovery and development strategies are well equipped to meet.
Simulations Plus is committed to supporting global health initiatives, including advancing the development of new drugs for neglected and under-served therapeutic areas such as TB. Spearheaded by Alexander (Al) Berg, PharmD, PhD, FCP, Vice President of Operations for the Cognigen division of Simulations Plus and former Scientific Director for the Critical Path to TB Drug Regimens (CPTR) Initiative, the Simulations Plus team is bringing their expertise in modeling and simulation (M&S) to bear on development of new TB drugs and treatment regimens. Taking advantage of Dr. Berg’s extensive network within the TB community, our scientists have built partnerships with academia, pharmaceutical industry, clinical research organizations, and government agencies. These partnerships span multiple initiatives that bring M&S-based solutions to address gaps and challenges related to TB regimen development. These mathematical model-based efforts include application of M&S to improve the design and analysis of non-clinical efficacy studies, translational modeling of non-clinical data to predict efficacious human doses of novel compounds, clinical biomarker assessment and qualification, as well as clinical trial simulations to evaluate alternative designs for efficacy studies in TB.
Through these innovative strategies, Cognigen along with the rest of the Simulations Plus Family, and its partners in global health continue to advance the development of safe and effective therapeutics with the ultimate goal of curbing the worldwide TB pandemic.