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Wednesday, June 26 • 8:00am - 9:15am
#316: Implementation of Innovative and Adaptive Designs in Clinical Trials

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Component Type: Session
Level: Advanced
CE: ACPE 1.25 Knowledge UAN: 0286-0000-19-656-L04-P; CME 1.25; IACET 1.25; RN 1.25

The use of innovative designs and possible adaptations can help reduce the number of patients required for trial recruitment, thereby shortening drug development time. Experts from FDA and the industry will provide feedback on the complex innovative designs and how they inform regulatory decision making.

Learning Objectives

Outline the advances in adaptive designs; Utilize newly developed innovative designs in clinical trials.

Chair

Aloka Chakravarty, PhD

Speaker

Recent Advances in Group Sequential and Adaptive Designs for Unblinded Sample Size Re-estimation and Seamless Phase 2/3 Pivotal Trials
Sandra Bihary-Waltz, BSN, MSN

EMA Update
Andrew Thomson, PhD, MA, MS

FDA Update
Meiyu Shen, PhD



Speakers
MS

Meiyu Shen

Expert Mathematical Statistician, Office of Translational Sciences, CDER, FDA
A team leader and a senior statistical reviewer at the Center of Drug Evaluation and Research, Food and Drug Administration (FDA). She obtained her Ph.D. in statistics from Statistics Program of Department of Mathematics at University of Maryland at College Park in 2015 and her Ph.D... Read More →
AT

Andrew Thomson

Statistician, Biostatistics and Methodology Support Office, European Medicines Agency (EMA)
Andrew Thomson is a statistician in the Office of Biostatistics & Methodology at the European Medicines Agency. He provides methodological advice and guidance across all stages of development, and across all therapeutic areas. He also is the lead of the Statistics subgroup of ICH... Read More →
SB

Sandra Bihary-Waltz

Senior Director, Global Regulatory Affairs, PRA Health Sciences
Sandra joined Idis as the Global Head of REgulatory Affairs in 2012, after spending over 24 years in the pharmaceutical industry, predominantly in regulatory affairs. She has extensive experience in all phases of drug development, through post-approval activities, including EAP p... Read More →
SB

Sandra Bihary-Waltz

Senior Director, Global Regulatory Affairs, PRA Health Sciences
Sandra joined Idis as the Global Head of REgulatory Affairs in 2012, after spending over 24 years in the pharmaceutical industry, predominantly in regulatory affairs. She has extensive experience in all phases of drug development, through post-approval activities, including EAP p... Read More →
avatar for Aloka Chakravarty

Aloka Chakravarty

Acting Director, Office of Biostatistics, Office of Translational Sciences, CDER, FDA
Dr. Chakravarty joined CDER in 1992. She served as an Adjunct Faculty in Depart. of Statistics, Foundation for Advanced Education in the Sciences, NIH. She is an internationally recognized thought leader in the area of safety evaluation, surrogate markers and biomarkers in drug development... Read More →


Wednesday June 26, 2019 8:00am - 9:15am
Room 3 San Diego Convention Center 111 W Harbor Drive, San Diego, CA 92101 USA