Insights from our
experts
Filter or search insights
-
Healthy Volunteers or Patients? A Key First-in-Human Decision
“Can we go straight into patients?” This Insight highlights strategic reasons why healthy volunteers may or may not be the right first in human choice.
Allison Humble, PharmD
-
Nonclinical Modernization: Reducing Animal Use
New approach methodologies (NAMs) are nonclinical tools that offer potential to improve biological relevance and predictive accuracy of safety and efficacy assessments, while...
Melissa Pegues, PhD
-
The Strategic Role of Regulatory Intelligence and Agency Meetings
Essential to the critical path to approval of a new drug or biologic product is understanding the expectations of regulatory authorities such as...
Allison Humble, PharmD