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Thursday, June 18 • 5:00pm - 6:00pm
#537 OD: ON DEMAND - Combination Therapies of Investigational Agents

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Component Type: Session
Level: Intermediate

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 Objectives

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.


Lan Mu, PhD, RAC


Nonclinical Considerations for the Development of Combinations: An Oncology Perspective
Whitney Helms, PhD

Combination Product Development: Lessons Learned from Antimicrobials
Katherine A Laessig, MD

avatar for Lan Mu

Lan Mu

Vice President, Bio-Thera Solutions
Dr. Lan Mu has over 20 years of experience in medicinal product discovery, development and global registration in various therapeutic areas. She was a principal research investigator at Sanofi prior to earning the Regulatory Affairs Certification (RAC). Subsequently, she held roles... Read More →

Whitney Helms

Pharmacology Supervisor, OOD, CDER, FDA, FDA
Whitney Helms is a pharmacology supervisor in the Division of Hematology Oncology Toxicology for the team supporting the Division of Oncology 2 in CDER's Office of Oncologic Diseases at the FDA. She started at the Agency as a pharmacologist in the Division of Drug Oncology Products... Read More →
avatar for Katherine Laessig

Katherine Laessig

Vice President, IQVIA
Board certified infectious disease physician with more than 20 years combined industry and regulatory experience. Provide strategic regulatory and integrated product development advice from PreIND to marketing application and label expansion across a broad range of therapeutic areas... Read More →

Thursday June 18, 2020 5:00pm - 6:00pm EDT
TBD Virtual Event Horsham, PA 19044