Certara is the largest and most comprehensive provider of biosimulation (modeling and simulation), strategic pharmacometrics, and regulatory writing consulting services. Our multidisciplinary team works alongside clients to inform key drug development decisions and expedite the processes around achieving regulatory milestones.
Certara combines its industry renowned pharmacometric and regulatory consultants with our vast software portfolio to provide services that focus on specific outcomes, therapeutic areas, regulatory milestones, and specific populations.
United States: 1-888-708-7444 or 1-919-852-4685
France: +33 1 56 95 17 10
Germany: +49 89 45 10 300
United Kingdom: +44 (0) 114 292 2322
India: +91 984 500 6625
Interested in Certara's biosimulation solutions? Want to speak to someone in our sales team? Click on the link below!
Rare diseases affect fewer than 1 in 2000 people. Each one affects only a small number of patients. Yet, there are over 7000 rare diseases. And, there are no treatments for 95 percent of them. Thus, many patients suffer from these diseases. The treatments for rare diseases are often referred to as "orphan drugs." Orphan drug developers face distinct challenges with rare diseases, including:
Biosimulation methods include both top-down (empirical) and bottom-up (mechanistic) models. These methods use sparse data from small populations to inform dosing and trial designs. For example, population PK/PD models can test the influence of factors such as age, weight, and disease status on drug exposure and response. Likewise, combining drug and disease models can help distinguish between treatment effects on symptoms vs changes in disease processes. Model based approaches can support accelerated approval pathways that get treatments to patients faster.
Certara has supported the approval of scores of orphan drugs using its pharmacometric portfolio of solutions, including Physiologically-Based Pharmacokinetics (PBPK) and Population PK. Example cases include: