AAPS PharmSci 360

Sustaining Partner

Poster Presentation: Comparison of Linker-Payload Cleavage Methods of the Antibody Drug Conjugate Anetumab-MMAE to Determine the Conjugated Payload MMAE Concentration by LC-MS/MS
Chad Christianson, Jennifer Zimmer, James Huggins, Jason Watts
Presented by Jason Watts
November 10, 2025
10:30 – 11:30 AM CT

Partner Presentation: PK/TK Strategy in Drug Development: Optimizing Design, Execution, and Data Integrity
Sara Underwood
November 10, 2025
12:00 – 1:00 PM CT
360 Stage #3

Pharmacokinetic and toxicokinetic data must inform regulatory and development decisions with precision. This session highlights how suboptimal study design, flawed exposure profiles, and operational errors degrade data utility. We’ll explore best practices in dose selection, matrix and timepoint planning, and executional rigor — all within the context of regulatory expectations. Attendees will gain actionable insights to strengthen study design and interpretability across early-phase development.

Learning Objectives:

• Design and justify PK/TK protocols that support IND-enabling objectives and regulatory requirements.
• Identify and mitigate common sources of variability in sampling strategies and protocol execution.
• Evaluate the impact of strategic CRO alignment on data integrity, timeline adherence, and regulatory review readiness.

Want to set up a 1:1 meeting during PharmSci 360? Contact us using the form below.