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Wednesday, June 21 • 2:00pm - 3:15pm
#350: Innovative Designs and Statistical Approaches for Small Trials: Rare Disease or Pediatric Indications

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Component Type: Session
Level: Intermediate
CE: ACPE 1.25 Knowledge UAN: 0286-0000-17-547-L04-P; CME 1.25; IACET 1.25; RN 1.25

With the advance of the computer technology, developing personalized medicine is not an unachievable dream in the 21st century, although it remains a challenging task to efficiently conduct clinical trials with a limited number of patients. It is important to develop new methods by utilizing all available information and resources without lowering the current standard for assessing drug safety and efficacy.

Learning Objectives

Discuss how implementation of innovative designs and newly developed statistical approaches for small clinical trials such as rare disease or pediatric populations will aid the drug development process and draw all relevant stakeholders’ attention and interests.

Chair

Susan Wang, PhD

Speaker

Adaptive Cloud Based eClinical Design Vital to Embrace Value-Based Outcomes in Rare Disease
MaryAnne Rizk

Innovative Statistical Methods for Measuring Benefit to Patients with Rare Diseases
Munish Mehra, PhD

Leveraging Available Information in Pediatric Trial Designs
Susan Wang, PhD

Statistical Challenges in Assessing Treatment Efficacy from Small-Sized Clinical Trials
Yeh-Fong Chen, PhD



Moderators
avatar for Susan Wang

Susan Wang

Director, Biostatistics, Boehringer Ingelheim Pharmaceuticals Inc.
Dr. Susan Wang is a Director in Biostatistics at Boehringer-Ingelheim Pharmaceuticals, Inc., in Ridgefield, Connecticut. She has many years of experiences working on global drug registrations as the lead statistician. She received her Ph.D. in statistics from State University of... Read More →

Speakers
avatar for Yeh-Fong Chen

Yeh-Fong Chen

Mathematical Statistician, Office of Translational Sciences, CDER, FDA
Dr. Yeh-Fong Chen is the statistical team leader supporting the Division of Gastroenterology and Inborn Errors Products at the Division of Biometrics III at US Food and Drug Association. She joined FDA in 2000 immediately after graduation with a PhD degree in Statistics from the... Read More →
avatar for Munish Mehra

Munish Mehra

Executive Director, Tigermed Co., Ltd.
Munish Mehra, is a Sr. Biostatistician and drug development expert who heads up Tigermed's India operations. During a career spanning over 30 years, Dr. Mehra, setup Biometrics operations in China for a US CRO, started a SMO in India and helped grow two multinational CRO’s, one... Read More →
avatar for MaryAnne Rizk

MaryAnne Rizk

Vice President, Global BioPharma Partnerships, Oracle
Dr. MaryAnne Rizk is an industry experienced alliance strategist in optimizing clinical outsourcing partnerships across biopharma and CRO organizations by accelerating value gained when powered by innovative technologies. Dr. Rizk received her Bachelor of Engineering and Master i... Read More →
avatar for Susan Wang

Susan Wang

Director, Biostatistics, Boehringer Ingelheim Pharmaceuticals Inc.
Dr. Susan Wang is a Director in Biostatistics at Boehringer-Ingelheim Pharmaceuticals, Inc., in Ridgefield, Connecticut. She has many years of experiences working on global drug registrations as the lead statistician. She received her Ph.D. in statistics from State University of... Read More →


Wednesday June 21, 2017 2:00pm - 3:15pm
S502ab McCormick Place 2301 South Martin Luther King Jr. Drive, Gate 4 Chicago, IL 60616