Asking the Right Questions of Your Data: Experiences in Model Informed Drug Development

Posted by Cytel

Nov 6, 2017 5:28:43 AM

 At the Chief Medical Officer Summit earlier this year, Cytel's Director of Quantitative Pharmacology and Pharmacometrics Cecilia Fosser, and Senior Director, Business Development, Chuck Gelb presented on how model-informed drug development (MIDD) techniques can improve decision-making and Probability of Success ( PoS) of clinical trial programs.  In this blog, we share some highlights and the informative10-minute video replay of their talk which includes a modeling and simulation case study. 

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Topics: Clinical Development Strategy, pharmacometrics, biostatistics, model-informed-drug-development


Innovative posters unveiled at ACoP8

Posted by Cytel

Nov 2, 2017 9:05:00 AM

 

Last month was the eighth American Conference on Pharmacometrics (ACoP8) in Florida, a key event on the calendar for Cytel’s Quantitative Pharmacology and Pharmacometrics subject matter experts.

Cytel was delighted to contribute to the event this year and present two posters. This was excellent opportunity to share our knowledge and innovative research, alongside networking with likeminded industry professionals.  

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Topics: Clinical Research Services, Phase 1, Clinical Data, pharmacometrics, clinical development, pharmacology, model-informed-drug-development


4 Questions to Explore in Model-Informed Drug Development (Infographic)

Posted by Cytel

Aug 10, 2017 1:18:46 PM

Model-informed drug development has been defined by Richard Lalonde ( Lalonde, 2007) (1) as “Development and application of pharmaco-statistical models of drug efficacy and safety from preclinical and clinical data to improve drug development knowledge management and decision-making”. It has  been identified by the FDA as an important way to help reduce attrition and uncertainty in drug development.
In a recent FDA Voice article,(2) FDA Commissioner Scott Gottlieb noted the critical role which modeling and simulation can play in making clinical development more efficient.

He commented that:
“FDA’s Center for Drug Evaluation and Research (CDER) is currently using modeling and simulation to predict clinical outcomes, inform clinical trial designs, support evidence of effectiveness, optimize dosing, predict product safety, and evaluate potential adverse event mechanisms. We’ll be putting out additional, updated guidance on how aspects of these in silico tools can be advanced and incorporated into different aspects of drug development.”

In this blog, we share a new Cytel infographic highlighting 4 key questions a sponsor can explore to apply these approaches within their development programs.

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Topics: pharmacometrics, Simulations, pharmacology, model-informed-drug-development


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