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Thursday, March 16, 2017

Rawls-Palmer Progress in Medicine Award Lecture
Analyzing text to extract information about gene-drug-disease interactions
Russ B. Altman, MD, PhD
Stanford University, Stanford, CA

Symposium
Finding the Right Dose in the Right Patients for Oncology and Immunooncology: Are We There Yet and How Have antitative Pharmacology, Translational
and Precision Medicine Been Utilized?

Chair:
Yan Ji, PhD
Novartis Pharmaceuticals, East Hanover, NJ

Challenges and Opportunities for Modeling and simulation in Late Phase Oncology Development: Combinations, Cancer Immunotherapy, and More 
Jin Jin, PhD
Genentech, Inc., South San Franscisco, CA

Precision and Translational Medicine in Dose and Patient Selection in Oncology 
David Hyman, MD
Memorial Sloan Kettering Cancer Center, New York, NY

Oncology Dose Finding for Small Molecules and Biologics: Perspective of the FDA-AACR Oncology Dose Finding Workshops
Geoffrey Kim, MD
US Food and Drug Administration, Silver Spring, MD

Using Biomarkers to Predict Registration Endpoints: A Look Inside the Crystal Ball
An Overview of Current Progress towards an Evidentiary Framework for Biomarker Qualification
John A. Wagner, MD, PhD
Takeda Pharmaceuticals International Co., Cambridge, MA

Role of Biomarkers and Quantitative Models in Drug Development
Yaning Wang, PhD
CDER, US Food and Drug Adminstration, Silver Spring, MD

Early Clinical Development Planning via Biomarkers, Clinical Endpoints, and Simulation: A Case Study to Optimize for Phase 3 Dose Selection
Bret Musser, PhD
Merck, Kenilworth, NJ

Linking Exploratory Clinical Development Endpoints to Phase 3 Endpoints: A Quantitative Basis for Decision-making
Richard Lalonde, PharmD
Pfizer, Groton, CT

Featured Speaker
Bridging the Gap Between Pharmacometricians and Statisticians in Clinical Pharmacology and Therapeutics
France Mentré, MD, PhD
University of Paris Diderot, Paris, France

Workshop
Integrating Big Omics Data: Applications and Challenges
Antihypertensive Response and Precision Medicine: Novel Insights from Genomics and Metabolomics Integration
Mohamed Shahin, PhD
University of Florida, Gainesville, FL

Computational Approaches for Omics Data Integration 
Jianguo Xia, PhD
McGill University (Macdonald Campus), Quebec, Canada

Roundtable
Communicating Complex Information to Influence Decisions: What Works and What Doesn’t

Chair:

Virginia (Ginny) Schmith, PhD, FCP
Nuventra Pharma Sciences, Durham, NC

Communication of Complex Information: Stakeholder Feedback
Norman Stockbridge, MD, PhD
US Food and Drug Administration, Silver Spring, MD

Communicating Complex Information in the Journal Anesthesiology
Michael Avram, PhD
Northwestern University Feinberg School of Medicine, Chicago, IL

Practical Tips for Communicating Complex Information and Analyses in Drug Development
Danny Howard, PhD
Novartis, East Hanover, NJ

Preparing our Future Leaders to be Effective Communicators
Kim L. R. Brouwer, PharmD, PhD
University of North Carolina at Chapel Hill, Chapel Hill, NC

Innovation Forum
Martín J. Sepúlveda, MD, MPH
Retired, VP IBM Health Systems and Policy Research, IBM Research, Southbury, CT

Erin Moore
Eli Lilly and Company, Cincinnati, OH

Nick Dougherty
MassChallenge, Boston, MA

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