First In Human Dosing: Highlighting the Similarities and Differences Between Small and Large Molecular Pharmaceuticals

Interactive, Team-based Approach to Understanding Drug Development Strategies for Small and Large Molecular Entities.
Learn proven concepts behind First-in-Human (FIH) dose selection and strategic considerations around issues for a spectrum of drug development programs. You will:
• Participate in break-out sessions where teams will discuss nonclinical programs for large and small molecules to support FIH dosing
• Discuss the challenges associated with clinical dosing and the outcomes of additional nonclinical data that may affect continued clinical development
• Develop strategies for consideration of FIH dose and interactions with FDA
• Evaluate toxicological and pharmacological data to provide an estimate of the FIH dose and justify the clinical dose escalation paradigm

Contact Carrie Dunn, Program Developer,

Phone +1.215.442.6181
Fax +1.215.442.6199