Infectious Disease: Strategic Modeling and Simulation Services
Drug development for infectious diseases faces unique challenges including compliance, viral dynamics, and drug resistance. Certara has extensive experience in infectious disease projects, including many HIV and HCV viral dynamics/kinetics modeling projects over the past decade, in all clinical development phases. We have covered critical issues in trial design, dose selection, and development strategy. We also have helped achieve IND approval for two systemic antibiotics. Our recent experience covers most mechanisms of action including protease inhibitors, NNRTIs, NRTIs, and novel mechanisms. In addition, Certara has taken a leadership role at over a dozen industry conferences, has published in peer-reviewed journals, and has other publications and collaborations in progress.
- Genotype 1-4 HCV infection
- HIV-1 infection
- HBV infection
- Complicated urinary tract infection (cUTI)
- Human monkeypox
- Respiratory syncytial virus infection
- Severe sepsis and coagulopathy
- Shiga toxin-producing Escherichia Coli hemolytic uremic syndrome (STEC-HUS)
- Skin infections
- Staphylococcus aureus infections
- Community-acquired bacterial pneumonia
- Severe infections due to multidrug resistant Gram-negative bacteria
- Complicated intra abdominal infections, MRSI infections
- Prevention of Staphylococcus aureus nasal carriage
- Human rhinovirus
- Security sensitive biological agents
- Various NIAID emerging infectious diseases/pathogens
- Various biodefence pathogens
Clinical Trial Outcomes Databases
The market place for HIV and HCV drugs is highly competitive. In the area of HCV, many companies are currently developing small-molecule new therapies for this disease due to limitations of the current standard-of-care. Our HCV Clinical Outcomes Database contains up-to-date trial outcome information on these new drugs in development and therefore provides our scientists with a powerful tool for comparative analysis, trial design, and product positioning.
Certara Strategic Consulting uses the power of model-informed drug development technology to help our clients maximize knowledge of drug safety and efficacy for anti-infectives.