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Virtual Event

Jun 14, 2020 9:00 AM - Jun 18, 2020 5:00 PM

(Eastern Standard Time)

Fort Washington, PA 19034

DIA 2020 Global Annual Meeting

ON DEMAND - Combination Therapies of Investigational Agents

Session Chair(s)

Lan  Mu, PhD, RAC

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)

Whitney  Helms, PhD

Nonclinical Considerations for the Development of Combinations: An Oncology Perspective

Whitney Helms, PhD

FDA, United States

Pharmacology Supervisor, OOD, CDER

Katherine A Laessig, MD

Combination Product Development: Lessons Learned from Antimicrobials

Katherine A Laessig, MD

IQVIA, United States

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