The Cytel blog keeps you up to speed with the latest developments in biostatistics and clinical biometrics.
Strategic Applications of Pharmacometrics in Clinical Development
Quantitative pharmacology encompasses the many strategic advantages of using complex mathematical models to understand biochemical relationships that ultimately improve clinical decision-making. This includes pharmacometric modeling, familiar to those who have used pharmacokinetic/pharmacodynamic (PK/PD) modeling to improve dosage decisions, and the extension of such models to the performance of meta-analyses, the construction of decision rules, and other uses involving a broad array of cases. In this blog we summarize some key areas of opportunity.
Career Perspectives: Interview with Tina Checchio, Associate Director, Quantitative Pharmacology & Pharmacometrics
QPP 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. Cytel’s expert Quantitative Pharmacology and Pharmacometrics group delivers high quality solutions to help our customers get those decisions right.
In this blog we talk to Tina who lives in Stonington, Connecticut, to find out more about her career path, current role at Cytel, and her interests outside of work.
Podcast: Overcoming Phase 1 Development Challenges
Nand Kishore Rawat is a Director and Head, Early Phase Biostatistics based in the King of Prussia, PA Cytel office. We recently spoke with Nand for the Cytel podcast to gain his thoughts on the unique aspects of Phase 1 development and where innovative approaches supported by thorough planning can meet these challenges head-on. Read on for key insights or listen to the podcast.
How can a strategic pharmacometrics consultant add value to your team?
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 interactions.
5 Reasons to Integrate Model-Based Meta-Analyses (MBMA) Into Your Clinical Development Strategy
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 should consider utilizing model-based meta-analyses ( MBMAs) for your program or portfolio development.
6 Innovative Trial Design Videos
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 to learn more and access the videos.
Round-Up:The 6 Hottest Blog Topics from 2017
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.
Asking the Right Questions of Your Data: Experiences in Model Informed Drug Development
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.
Innovative posters unveiled at ACoP8
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.