Insights from our
experts
Filter or search insights
-
FDA vs EMA Orphan Drug Designation: Key Differences
Planning FDA and EMA orphan designations? Learn the key eligibility and strategy differences for efficient dual-region execution.
Kailee Johnson
-
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
-
Driving Efficiency in Early‑Phase Drug Development with Clinical Pharmacology
Thoughtful early phase planning, including bioanalytical method validation, in vitro ADME/DDI screening, in vivo PK, food effects, and QT assessment, lays the groundwork for a cohesive clinical pharmacology package and efficient progression into patient studies.
Kristin Vasmanis, RAC-U.S.
-
How Wegovy Became the First FDA‑Approved Oral GLP‑1 for Weight Management
In‑depth analysis of the FDA approval of the first oral GLP‑1 for weight management, examining formulation strategy, regulatory precedent, and implications for future oral peptide development.
Emily Weil
-
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
-
How a Nonclinical Program Can Help Identify and Mitigate Risks
Transitioning a new drug candidate from discovery to the clinic is a significant leap, and a strong nonclinical development plan is critical to...
Melissa Pegues, PhD