Latest Articles

  • Post-Approval Change Management

    Achieving global approval for a single change may take three to five years, but inefficient lifecycle change management rarely registers as a crisis. read more

  • The Human Advantage in ADME Testing

    Animal models do not accurately recapitulate several aspects of human physiology, and these differences lead to variations in drug behaviors across species. Each contributes useful evidence, but what is missing is the connected human biology needed to predict ADME behavior with confidence. read more

  • An Interview With Dave Miller, Ph.D.

    Early formulation decisions can make or break a program, yet they’re often made under significant data constraints. What are the most common mistakes sponsors make when they rush that decision, and what does it typically cost them downstream? read more

  • Beyond Case Management

    In large pharma, a staggering 40 to 50 percent of expert pharmacovigilance time is still consumed by tasks far removed from active, scientific PV - such as the mechanics of scheduling reports, tracking down contributors, and managing documents. read more