PEDIATRIC DRUG DEVELOPMENT: CHALLENGES AND  OPPORTUNITIES IN EXTRAPOLATION

Symposium
Implications of FDARA 2017 on Pediatric Cancer Drug Development
Gregory H. Reaman, MD, US Food and Drug Administration, Silver Spring, MD

Mock-Team Workshop: Extrapolation In Type 2 Diabetes
Pediatrics-Endocrinology: 
Phil Zeitler, MD, PhD
Professor and Section Head, Endocrinology; Department of Pediatrics, University of Colorado, Anschutz Medical Campus; Medical Director, Children’s Hospital, Colorado Clinical & Translational Research Center, Aurora, CO 
Statistician: 
Margaret Gamalo-Siebers, PhD 
Principal Research Scientist, Global Statistics Sciences Statistics SME, Pediatric Steering Committee, Eli Lily, Indianapolis, IN 
Regulators: 
Lynne Yao, MD 
Director, Division of Pediatrics, Office of New Drugs; Chair, Pediatric Review Committee (PeRC),US Food and Drug Administration, Silver Spring, MD 

Summary
Lily (Yurek) Mulugeta, PharmD
US Food and Drug Administration, Silver Spring, MD

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PHARMACOMETRICS MEETS HEALTH ECONOMICS: QUANTITATIVE APPROACHES IN THE TRANSLATION FROM EFFICACY TO REAL WORLD EFFECTIVENESS AND TO COST-EFFECTIVE PATIENT CARE

Opening Remarks 
Jing Liu, PhD, Pfizer, Groton, CT

Background/Introduction: Role of Pharmacometrics and Health Economics for Cost-effective Patient Care 
Richard Willke, PhD, ISPOR, Lawrenceville, NJ

Understanding the Comparative Efficacy and Effectiveness via Meta-Analysis: Health Economics Approach
Jeroen P. Jansen, PhD, Precision Health, Boston, MA

Leveraging Novel Simulation Techniques to Incorporate Pharmacometrics in Pharmacoeconomic Models
Jaime Caro, MDCM, Evidera, Waltham, MA

Industry Perspectives: Examples on How to Assess Values in Drug Development 
Neeta Tandon, MA, Janssen Pharmaceuticals, Titusville, NJ

Panel Discussion: Can Linked Pharmacometric-Health Economic Evidence Improve Early Evaluation of New Medicines?
Leader: Scott Marshall, PhD, Pfizer, Sandwich, Kent, United Kingdom 

Closing Remarks
Jing Liu, PhD, Pfizer, Groton, CT