Drug-Disease Modeling and Clinical Trial Simulation
Drug-Disease Modeling (DDM) and Clinical Trial Simulation (CATD) are proven ways to understand drug action and optimize clinical trial design.
Used properly, DDM and CATD have yielded more informative clinical trials, better dose selection, lower risk of late-stage failures, better understanding and management of development risk, and faster commercialization of follow-on indications. In addition, there is a growing view among regulatory bodies that DDM and CATD should play an increasingly important role in their review of sponsor submissions. (See some recent FDA publications.)
Rosa extends the range of application of traditional DDM and CATD techniques with its PhysioPK™ and PhysioPD™ capabilities. PhysioPK and PhysioPD allow our clients to incorporate physiologic and mechanistic knowledge with proven statistical approaches such as dose-response or PK/PD modeling. With this ability Rosa makes it possible for its clients to confidently extend their understanding and predictive capabilities beyond existing clinical data sets and gain deeper scientific understanding of variability and uncertainty.
Rosa’s leaders have conducted over 100 DDM and CATD projects and have experience with the organizational adoption of DDM and CATD at numerous organizations. Rosa leaders also developed the first commercial physiologic drug-disease models and have led the creation of dozens more in the past two decades, including the world’s most comprehensive physiology models of respiratory, metabolic, infectious, and other major disease conditions. Rosa’s advisors and staff bring broad clinical development experience, a unique perspective on the recent appreciation for drug-disease modeling within regulatory agencies, and a history of strategic management consulting related to the adoption of new analytic technologies.
For more information, see the following specification sheets:
- Population Pharmacokinetics
- Understanding Mechanism of Action
- Dose Response Analysis
- Early Clinical Development: Novel Mechanism
- Early Clinical Development: Established Mechanism
- Dose Response Trial Design
- Phase III Trial Design
- Phase IV Trial Design
- Program Design
- Trial Design Advisory
To discuss how Rosa & Co might help your company, please contact:
Ron Beaver, PhD
Executive Vice President
services@rosapharma.com