Accelerating ADCs’ development pipeline using Simcyp PBPK
With nearly 10 million deaths in 2020 and despite great progress, cancer remains the leading…
Jim Gallagher2021 年 10 月 15 日
External Control Arms – The Case for a Standardized Lexicon and Toolkit
Both the FDA and EMA have made statements that support the concept of using real…
Jim Gallagher2021 年 10 月 12 日
A Day in the Life of a Clinical Pharmacology Consultant
Strategic consulting within drug discovery and development is an exciting career choice for many. Unlike…
Jim Gallagher2021 年 10 月 8 日
Model-based DDI Extrapolation Strategy from Adults to Children – A Case Study with Risdiplam
Risdiplam (EVRYSDI) is approved for the treatment of patients with spinal muscular atrophy ≥ 2…
Jim Gallagher2021 年 10 月 7 日
FDA’s Digital Transformation: The Future of Technology and How to Prepare
As Life-Science manufacturers embrace new technologies to speed time to market and products become more…
Jim Gallagher2021 年 10 月 5 日
Organizing Complex Virology Datasets into FDA-Ready Format using SAS Programming
运用先进 SAS 编程技术优化病毒学数据集整理流程。
Jim Gallagher2021 年 9 月 23 日
The Scary Future of Rare Disease Management
In a world of rising healthcare costs, the greatest nightmare for payers is reimbursing drug…
Jim Gallagher2021 年 9 月 23 日
Building a Robust Clinical Pharmacology & Model-Informed Drug Development Strategy for New Alzheimer’s Disease Drugs
Alzheimer's disease (AD) is one of the most common forms of neurodegenerative dementia in the…
Jim Gallagher2021 年 9 月 20 日
