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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

Regulatory Health Project Manager, OHOP, CDER, FDA
Pamela Balcazar is Regulatory Project Manager in the Office of Oncology and Hematology Products (OHOP) at the FDA. In OHOP, her responsibilities include developing policies and overseeing regulatory initiatives related to the review of oncology products including guidances and process... Read More →
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

Chief Medical Officer, WIRB-Copernicus Group (WCG)
Lindsay McNair, MD, MPH, MSBioethics is the Chief Medical Officer for the WIRB-Copernicus Group. She oversees the physician team within the WCG IRBs, and provides consultation to institutions and biopharma companies on a wide range of issues related to clinical protocol design, regulatory... Read More →


Monday June 24, 2019 2:15pm - 3:15pm
Room 2 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA