We have written on the blog in the past about the value that a statistical consultant can bring to your team, and to the overall clinical development process. Statistical consultants can be instrumental to the success of your development program, providing a variety of input from creating innovative trial designs that improve information quality and efficiency, to supporting regulatory...

Topics: Cytel Strategic Consulting, pharmacometrics, model-informed-drug-development, quantitative decision-making

By Esha Senchaudhuri

An important trend in clinical development involves integrating strategic pharmacometric analysis with program level decision-making, to make the most use of available data. This can occur in various forms, from leveraging preclinical data for go-no-go decision making [1], to the need for improved comparative effectiveness frameworks [2].

Here we have five reasons why you...

Topics: pharmacometrics, biostatistics, pharmacology, meta-analysis, quantitative decision-making

The  Cytel YouTube Channel hosts a wealth of video presentations from Cytel experts as well as external industry and academic speakers about various aspects of clinical trial designs and their implementation.  In this blog, we've gathered 6 popular resources from the channel on topics from quantitative decision-making through to overcoming challenges in management of oncology trials. Read on...

Topics: East PREDICT, Cytel Videos, Adaptive Clinical Trials, Multi-Arm Studies, pharmacometrics, Multi-Arm Multi-Stage Studies, biostatistics, EAST 6.4, adaptive designs, model-informed-drug-development

As we prepare to close the door on 2017, we thought we would take a look back at the  topics which have been most popular on the Cytel blog this year.  It's an interesting insight on what pain points and opportunities feature highly on our global biopharma audience's radar.  Read on to learn which of our 2017 blogs have received the most interest from our audience so far.

Topics: Oncology, Data Management, Cytel Strategic Consulting, Statistical Analysis, Trial Design Software, pharmacometrics, estimands, NONMEM, data science, R language

 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...

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

 

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...

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

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...

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

The Population Approach Group in Europe (PAGE) represents a community with a shared interest in data analysis using the population approach. Each June, a meeting of the community is held at a different European location. At this year's meeting in Budapest, Hungary, Cytel's Director of Quantitative Pharmacology and Pharmacometrics, Cecilia Fosser, showcased innovative work on creating model...

Topics: Statistical Analysis, pharmacometrics, Simulations, biostatistics, pharmacology

The ASCPT is the largest scientific and professional organization serving the disciplines of Clinical Pharmacology and Translational Medicine, and its annual conference is one of the most important events on the calendar for those involved in Quantitative Pharmacology and Pharmacometrics (QPP).  Cecilia Fosser, Nand Kishore Rawat and Tina Checchio represented Cytel’s expanding QPP team at this...

Topics: Early Phase Trials, Phase 3, pharmacometrics, biostatistics, pharmacology

 

Nonlinear Mixed Effects Modeling (NONMEM) is a type of population pharmacokinetics/pharmacodynamics (popPK/PD) analysis used in Clinical Pharmacology research. The population PK approach combined with pharmacodynamics modeling, allows integrated analysis, interpretation, and prediction of the drug’s safety, efficacy, dose-concentration relationship, and dosing strategy. 

Topics: pharmacometrics, biostatistics, SAS, pharmacology, NONMEM

 

Challenge

Our client had the following key questions which they wanted our pharmacometrics group to address for an upcoming phase 2 trial of their ulcerative colitis compound .

1) Can knowledge from pre-clinical and Phase 1 data inform on the optimal range of doses for an upcoming Phase 2 dose-ranging study?

2) How may the dose response observed in PD markers in Phase 1 healthy volunteers...

Topics: Cytel Strategic Consulting, Case Study, pharmacometrics, biostatistics, PK/PD

Unlike statistics which has been around in some form for hundreds of years, pharmacometrics is, by comparison, a relatively new discipline and only entered the clinical development world in the last 30 years. Situated at the intersection of mathematical modeling, simulation, and big data, pharmacometrics leverages the best practices of translational research to generate clinical development...

Topics: pharmacometrics, Biomarkers, adaptive trials, pharmacology, PK/PD

 

Drug development is an expensive and risky business.  To maximize a compound’s ultimate chances of commercial as well as regulatory success it’s imperative that sponsors are building up a strong understanding of its characteristics relative to competitors.  This knowledge can support critical decisions along the development path, such as optimizing dosing, and selecting the best active...

Topics: Clinical Development Strategy, pharmacometrics, clinical development, pharmacology

 

Exposure-response data gained from clinical studies can provide a basis for model-based analysis and simulation, helping to predict the expected relationships between exposure and response.  Using this approach, it may be possible to optimize dosage regimens and to individualize treatment in specific patient subsets for which there are limited data.  In this blog, we examine a case study of...

Topics: Cytel Strategic Consulting, Phase 3, pharmacometrics, biostatistics, pharmacology, PK/PD

Cytel participated at PharmaSUG 2016 in Denver recently.  A key event on the statistical programming global calendar, the topics included Submission Standards, Application Development and Data Visualizaton. Sharmeen Reza, Associate Director Statistical Programming at Cytel was selected to present a paper presentation in the Statistics and Pharmacokinetics stream on the topic of Scrambled Data-...

Topics: Statistical Programming, pharmacometrics, biostatistics, pharmacology

QPP (sometimes called QP2) remains at the heart of model based drug development. Short for Quantitative Pharmacology & Pharmacometrics, it refers to several types of quantitative modeling including meta-analysis, PK/PD , statistical modeling and the modeling of go-no-go decision rules.

Topics: Simulation & Biomarkers, pharmacometrics, Biomarkers

Topics: Adaptive Clinical Trials, Statistical Innovations in Clinical Development, pharmacometrics