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Monday, June 24 • 2:15pm - 3:15pm
#143: Opportunities and Challenges with First-In-Human Multiple Expansion Cohort Designs in Oncology

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-19-543-L04-P; CME 1.00; IACET 1.00; RN 1.00

Use of the multiple expansion cohort design in oncology trials offers advantages and challenges. This session presents views on the success and hurdles of this design by regulators and industry. Implications for global development are also raised.

Learning Objectives

Discuss the important differences between phase 1 FIH studies and the FIH multiple expansion cohort design; Identify key safety challenges and risk mitigation steps; Discuss ethical consideration with oncology studies involving expansion cohorts; Identify examples of implementation challenges and opportunities of this design; Describe lessons learned from industry and regulators.

Chair

Sherry Leonard, RAC

Speaker

The Use of Expansion Cohorts in First-in-Human Clinical Trials to Expedite Oncology Drug Development
Pamela Balcazar, MS

Implementation Challenges and Opportunities with FIH Multiple Expansion Cohorts
Sherry Leonard, RAC

Ethical Considerations in Oncology Studies Involving Expansion Cohorts
Lindsay McNair, MD, MPH, MSc


Speakers
PB

Pamela Balcazar

Health Scientist, Oncology Center of Excellence, OC, FDA, United States
Pamela Balcazar is a Health Scientist in the Oncology Center of Excellence at the FDA. In the OCE, her responsibilities include developing policies and overseeing regulatory initiatives related to the review of oncology products including guidances and process management.
avatar for Sherry Leonard

Sherry Leonard

Director, Regulatory Affairs, Celgene Corporation
Sherry A. Leonard, RAC, Director, Regulatory Affairs, Celgene Corporation Sherry joined Celgene Corporation in 2014 where she is a Director Regulatory Affairs within the Hematology/Oncology Franchise. She is the global regulatory lead for new chemical entities and biologic products... Read More →
avatar for Lindsay McNair

Lindsay McNair

Principal Consultant, Equipoise Consulting, United States
Lindsay McNair, MD, MPH, MSB is Principal Consultant at Equipoise Consulting. She was previously the Chief Medical Officer for WCG. In role she oversaw WCG IRB, and provided consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol... Read More →

Monday June 24, 2019 2:15pm - 3:15pm PDT
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA
  06: PreClin Dev-EarlyPhaseCR, Session |   02: ClinTrials -ClinOps, Session