2025 ACCP STEP & ESP Webinar: Navigating PK Bridging: Essential Strategies for Streamlining Change in Route of Administration in Drug Development

Live Session: Wednesday, June 25^th, 2025, from 1:00 to 2:30 PM ET

On Demand: June 25^th, 2025 to June 25^th, 2028

Target audience:

Interprofessional team of MDs, PharmDs, PhDs and other healthcare professionals across the spectrum of academia, industry, regulatory and clinical settings who are interested in the use of PK bridging strategies in therapeutic drug monitoring.

Objectives

After completing this activity, the learner will be able to:  

• Recognize the importance and need for PK bridging during therapeutic development;
• Identify key scenarios requiring PK bridging strategies between IV and SC formulations drug drug development;
• Discuss the challenges and opportunities for model-informed PK bridging strategies;
• Describe the multidisciplinary perspectives on PK bridging in practice.

Description:

This webinar will explore how pharmacokinetic (PK) bridging is a cornerstone of successful formulation changes, with a specific focus on intravenous (IV) to subcutaneous (SC) transitions. Industry and regulatory experts will examine how the PK landscape has evolved and share practical, forward-looking strategies—including model-informed drug development approaches—to address the complexities of bridging. Real-world case studies will provide insight into what has worked, what hasn’t and why. Whether you're in early development or managing a late-stage formulation shift, this session will equip you with the scientific, regulatory and strategic knowledge needed to implement effective PK bridging and streamline development. Attendees will gain a clear understanding of when PK bridging is essential, how to recognize key decision points and what tools and cross-functional perspectives are shaping the future of route transition in drug development. Learners who complete this activity will have enhanced knowledge in the use of PK bridging strategies in therapeutic drug monitoring.