2013 Archived Content

SC12 First-in-Human Study and Risk Mitigation Strategy for Biologics 


Target Audience:

The session will be useful for basic and clinical scientists, clinical pharmacologists, physicians, pharmacists and other healthcare professionals who are interested in early drug development and want to increase their understanding of first in human study starting dose estimation, dose escalation scheme, and risk evaluation and mitigation strategy (REMS) for biologics.

Presentation outlines:

  • To overview the basic concepts and study designs for early drug development including Phase I First in Human (FIH) Single Ascending Dose (SAD), Food Effect (EF), Multiple Ascending Dose (MAD) and Phase IIa Proof of Concept (POC) studies.
  • Using Tegenero first in human (FIH) incident as a case study, to review the evolving process of biologic FIH starting dose estimation from No Observed Adverse Effect Level (NOAEL) to Minimum Anticipated Biological Effect level (MABEL) approach. 
  • FIH study in Oncology will be reviewed separately due to its uniqueness and significant unmet medical needs.
  • To introduce the Biologic FIH Study Risk Evaluation and Mitigation Strategy (REMS).

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