Cytel Blog

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.

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. 

In this blog, we talk with Robert Greene, Founder and President of the HungerNDThirst Foundation, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck in Darmstadt, Germany. Robert will bring a fresh perspective to the discussion of the role statisticians can play in enhancing the position of patients in clinical trials. Patient-centricity is a key topic in modern drug development, and this session aims to encourage statisticians to question the importance of a more patient-centric approach within their field.

In this blog, we talk with Simon Kirby, former Senior Director at Pfizer, about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. Simon will address the topic of Selection Bias for Treatments with Positive Phase 2 Results and in this blog he explains why this is a key topic of particular relevance for pharmaceutical companies in today’s climate of accelerated development. He also talks with us about his career in statistics, current research, and his book Quantitative Decisions in Drug Development.

We are delighted that Stephen Senn will be joining us at the EUGM on November 14th and 15th in Darmstadt, Germany. In this blog, we sit down for a discussion with Stephen about his career in statistics, his advice for early career statisticians, his upcoming research, and the topic of his presentation at the East User Group Meeting “70 Years Old and Still Here: the Randomized Clinical Trial and its Critics”.

In this blog, we talk with Heiko Götte, Senior Expert Biostatistician at Merck about his upcoming presentation at Cytel’s East User Group Meeting on 14th and 15th November at Merck Darmstadt, in Germany. The topic Heiko will address is Decision Making in Development Programs with Targeted Therapies and he explains to us why this is a key topic for pharmaceutical companies today as they strive to improve their decision-making, and what delegates can expect to take away from the presentation.

Single ascending dose (SAD) and multiple ascending dose (MAD) studies are typically the first in human studies.  They seek to gain information on safety and tolerability, general pharmacokinetic (PK) and pharmacodynamic ( PD)  characteristics, and of course identify the maximum tolerated dose (MTD).

Conventionally, SAD  and MAD studies were conducted separately, but increasingly are combined into an ‘umbrella’ protocol which addresses both SAD and MAD objectives.