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ON DEMAND - Combination Therapies of Investigational Agents
Session Chair(s)
Lan Mu, PhD, RAC
Senior Vice President
Bio-Thera Solutions, United States
What is required to support the development of combination therapies of investigational (novel) drugs/agents? To what extent should the therapeutic advantages of the combination over its components be demonstrated? Which toxicology and/or clinical data from individual components are necessary to initiate a FIH combination study? How do you determine the optimal regimen in the combination dose escalation? This session aims to provide clarity on those topics. Relevant US regulations will be discussed with insights from 1) four cases in oncology development where different nonclinical and clinical evidence were used to support IND; 2) combination product study designs at different phases of clinical development; 3) four examples of antimicrobial combination product commercial registration.
Learning Objective : Identify technical and regulatory challenges in developing combination therapies of investigational drugs; Describe the level of evidence needed to support an initial IND of novel combination product; get insight into the supporting evidence used for investigational combination product commercial registrations.
Speaker(s)
Nonclinical Considerations for the Development of Combinations: An Oncology Perspective
Whitney Helms, PhD
FDA, United States
Pharmacology Supervisor, OOD, CDER
Combination Product Development: Lessons Learned from Antimicrobials
Katherine A Laessig, MD
IQVIA, United States
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