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Wednesday, June 30 • 10:00am - 11:00am
#316 SL: It’s Like Building the Airplane While Flying it: Biomarker Discovery and Development in Clinical Trials

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Component Type: Session
Level: Intermediate
CE: ACPE 1.00 Knowledge UAN: 0286-0000-21-606-L04-P; CME 1.00; IACET 1.00; RN 1.00

To facilitate drug development, both FDA and EMA have established qualification programs for drug development tools and novel methodologies, which include biomarkers. Qualified biomarkers that have gone through these formal qualification processes can be relied upon for making regulatory decisions within the stated Context of Use. This session will inform the common review issues and considerations in the Biomarker Qualification evaluations and provide an example to illustrate how biomarker identification, quantification and integration using a novel methodology can facilitate drug development.

Learning Objectives

Describe the common review issues in the Biomarker Qualification evaluations in US and EU; Discuss the importance of integrating continuous cerebrospinal fluid (CSF) sampling in early phase drug development.

Chair

Lynn Tuan, MS

Speaker

Biomarker Development: What Can We Learn from Qualified Biomarkers?
Lynn Tuan, MS

Targeting Cerebrospinal Fluid (CSF) in Early-Phase CNS Drug Development
Svetlana Semenova, PhD

FDA Update
Christopher Leptak, MD, PhD


Speakers
avatar for Svetlana Semenova

Svetlana Semenova

Director Scientific Affairs, Parexel International, United States
Dr. Svetlana Semenova, PhD, is a neuroscientist by training with 25+ years of experience in translational research in psychiatry. At Parexel Int, she supports program development from Phase 1 through Proof-of-Concept Phase 2 clinical trials for CNS and general medicine indications... Read More →
LT

Lynn Tuan

Senior Specialist, Global Regulatory Affairs, Alexion Pharmaceuticals , United States
CL

Christopher Leptak

Director, CDER BIomarker Qualification Program, Office of New Drugs, CDER, FDA, United States
Dr. Leptak received his MD and PhD in Microbiology/Immunology from the University of California, San Francisco. He completed his residency in Emergency Medicine at the Harvard program at the Brigham and Mass General Hospitals. He joined FDA in 2007 as a Medical Officer in the GI division... Read More →
CL

Christopher Leptak

Director, CDER BIomarker Qualification Program, Office of New Drugs, CDER, FDA, United States
Dr. Leptak received his MD and PhD in Microbiology/Immunology from the University of California, San Francisco. He completed his residency in Emergency Medicine at the Harvard program at the Brigham and Mass General Hospitals. He joined FDA in 2007 as a Medical Officer in the GI division... Read More →

Wednesday June 30, 2021 10:00am - 11:00am EDT
TBD Virtual Event Horsham, PA 19044
  06: PreClin Dev-EarlyPhaseCR, Session