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Tuesday, June 26 • 4:15pm - 5:30pm
#292: Complex Innovative Designs and Model-Informed Drug Development Related: PDUFA VI Pilot Programs

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-18-619-L04-P; CME 1.25; IACET 1.25; RN 1.25

Under PDUFA VI, FDA committed to developing two pilot programs. The goal of the Complex Innovative Designs (CID) pilot is to facilitate the advancement and use of complex, Bayesian, and other novel clinical trial designs and will focus on highly innovative trial designs for which analytically derived properties (e.g., Type I error) may not be feasible, and simulations are necessary to determine trial operating characteristics. The Model-Informed Drug Development (MIDD) pilot is intended to facilitate the development and application of exposure-based and biological models derived from preclinical and clinical data sources. Drug development programs where clinical data are limited such that integration across non-traditional sources may be needed as well as programs for which MIDD can assess uncertainties about dosing, duration, patient selection, and other factors will be considered for the pilot. In this session, we will discuss the importance of these two PDUFA VI pilot programs, explain the agency’s goals for these programs, and highlight the difference between these two pilot programs.
Three speakers from FDA are invited to share their expectations and visions for these programs which launch in 2018.

Learning Objectives

Discuss the importance of these two PDUFA VI pilot programs; Explain the agency’s goals for these programs: Identify the difference between these two pilot programs.


Yeh-Fong Chen, PhD


Laura Lee Johnson, PhD

Issam Zineh, PharmD, MPH

Dionne Price, PhD

Xun Chen, PhD

avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician (Team Lead), Office of Translational Sciences, CDER, FDA
Dr. Chen is the Team Leader of the Division of Biometrics IX within CDER of FDA, supervising reviewers for the Division of Non-Malignant Hematology Products. She joined FDA in 2000 after receiving her Ph.D. from the University of Iowa. She has had years' experience in reviewing drug... Read More →

Xun Chen

Deputy Global Head Of Statistics and Programming, Sanofi
Xun Chen is Deputy Global Head of Biostatistics and Programming Department at Sanofi, leading statistical strategy and execution of clinical development in therapeutic areas including Oncology, Immunology, Rare Disease, Neurology, and Gene Therapy. She is also in charge of Statistical... Read More →
avatar for Laura Lee Johnson

Laura Lee Johnson

Director, Division of Biometrics III, Office of Biostatistics, OTS, CDER, FDA, United States
Laura Lee Johnson, Ph.D. is a division director in the Office of Biostatistics at the U.S. Food and Drug Administration (FDA) Center for Drug Evaluation and Research (CDER). She specializes in design, logistics, and analysis of research from clinical outcome assessment (COA) qualification... Read More →
avatar for Dionne Price

Dionne Price

Deputy Director, Office of Biostatistics, OTS, CDER, FDA, United States
Dr. Price is the Deputy Director of the Office of Biostatistics. In her role at FDA, she promotes collaborative efforts to advance the use of complex innovative trial designs. An invited speaker at conferences world-wide, she has served as Chair of ASA’s Biopharmaceutical Section... Read More →
avatar for Issam Zineh

Issam Zineh

Director, Office of Clinical Pharmacology, OTS, CDER, FDA
Dr. Zineh is Director of the Office of Clinical Pharmacology (OCP) at the U.S. FDA. He has held various leadership positions at FDA including Associate Director for Genomics in OCP (2008-2012), Co-Director of the CDER Biomarker Qualification Program (2009-2015), voting member of the... Read More →

Tuesday June 26, 2018 4:15pm - 5:30pm EDT
Room 256 Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA
  11: Statistics, Session