Think big picture. Get big results.
Modeling is great. But it’s only a tiny piece of the pharmacology pie. For instance, did you know PK/PD data can guide drug development, regulatory, and commercialization-related decision-making? It’s true. Pharmacometrics can even (and in fact, should) influence protocol design. We’d be more than happy to show you how.
Completing modeling and simulation activities for a development program is an important first step in addressing team questions. The critical next step is to synthesize the modeling results into a compelling story that can inform and guide decision-making. In 2014, Cognigen worked on more than 40 development programs, each with their own story. Cognigen’s experience and expertise can help you prepare for the highly visible stress-inducing presentations to senior management or regulatory agencies.
Thinking of biosimilars and how their development can affect your pipeline? At Cognigen, we can help you use modeling and simulation to simplify your development plan for biosimilars. We can also guide you through the regulatory requirements and questions you should be prepared to address.
Let SimulationsPlus help your due diligence team before or after you in-license or out-license your drug. We assist from performing a gap analysis of what should be in your due diligence package if you are out-licensing your medicinal product. We can also evaluate the gaps in a due diligence package if you are in-licensing a medicinal product. Plus, we can analyze post-transfer information, including in-vitro, pre-clinical, and clinical data, Modeling and analysis results, and reports. In addition, we can perform a forensic assessment and prepare a report of the results for your development teams.
Pediatric drug development increases the challenges in designing clinical trials, due to the care that is necessary for the patient and the research that is needed for this population. Population PK modeling reduces this burden by allowing sparse sampling of blood concentrations to demonstrate the relationship between exposure to the medicine and outcome. At Cognigen, we’re well versed in designing studies optimized to demonstrate efficacy, while minimizing the number of children required in the study and the number of invasive procedures in these subjects. In addition, the methodology allows for bridging from adult subject to pediatric subjects, which will support the justification of the dose selected for pediatric subjects.
We’re also experienced in global regulatory requirements surrounding pediatric drug development. Pediatric development should be taken into consideration when designing your adult studies to get the downstream value of this important population.
Phase 1 studies provide the first indications of a new drug’s pharmacokinetic and safety characteristics in humans, and they set the stage for the design of phase 2 and 3 clinical trials. Consequently, Cognigen understands that careful attention to the design and execution of phase 1 studies, to the analysis and interpretation of data, and to the preparation of reports are essential for successful drug development. Each study must be viewed as an integral part of the knowledge base that accumulates about a drug from discovery to registration. This knowledge base serves as the foundation for decision-making throughout the drug development process.
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Regulatory Agency Interactions
In addition to preparing technical reports suitable for regulatory submission, Cognigen can assist you in preparing for and attending regulatory milestones to support your modeling and simulation and clinical pharmacology evidence used to support your trial designs and product submissions.
Translational PK/PD models provide a quantitative rationale for selecting relevant biomarkers in early development, as well as defining the limiting steps in systems biology. The application of this knowledge can be used to design innovative and effective proof-of-mechanism and proof-of-concept studies, provide a basis for substantiating the selection of dose levels and dosing schedules, and provide tangible rationale for go/no-go decisions in drug development programs. Modeling and simulation in translational medicine improves the productivity of the research and development enterprise – enabling shorter clinical trial timeframes with much higher expected success rates.