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Saturday, March 12, 2016 Presentations

Saturday, March 12, 2016 Speaker Presentations

SYMPOSIUM Adherence: Assessing and Mitigating the Perpetual Fly in the Ointment in Drug Development and Utilization
Impact of Non-Adherence on Drug Development & Therapeutics
Terrence Blaschke, MD, Bill and Melinda Gates Foundation, Seattle, WA

Pharmacometric Approaches to Adherence Assessment
Michael Fossler, PharmD, PhD, Trevena, Inc., King of Prussia, PA

New Technologies for Assessing Adherence
John Mendelson, MD, California Pacific Medical Center Research Institute, San Francisco, CA

Interventions for Adherence Enhancement
Ariane van der Straten, PhD, MPH, RTI International, San Francisco, CA

ORAL ABSTRACT SESSION Advances in Model Based Drug Development: Application to Translational Medicine
A JOINT MODEL RELATING CHANGES IN PROSTATE SPECIFIC ANTIGEN (PSA) TO SURVIVAL IN CASTRATE RESISTANT PROSTATE CANCER (CRPC).
T. H. Mai, E. Gray, M. R. Sharma; 
University of Chicago, Chicago, IL.

DEVELOPMENT OF A MECHANISM-BASED DRUG-DISEASE MODEL TO QUANTIFY POSTMENOPAUSAL OSTEOPOROSIS.
K. Madrasi1, S. Samant2, M. Kim1, F. Li1, S. Voss1, T. Kehoe1, S. Schmidt2, L. Li1
1US Food and Drug Administration, Silver Spring, MD, 2University of Florida, Orlando, FL.

IMPACT OF CORRELATION STRUCTURE ASSUMPTIONS ON MODEL-BASED META-ANALYSIS OF AGGREGATE LONGITUDINAL DATA.
C. N. Lim1, J. Ahn2, T. Tensfeldt3, S. Duvvuri2, A. Birnbaum1, T. Nicholas3
1University of Minnesota, Minneapolis, MN, 2Pfizer, Inc., Cambridge, MA, 3Pfizer, Inc., Groton, CT.

SYMPOSIA Clinical and Translational Pharmacology of Emerging Modalities of Therapeutics: RNA and Gene Therapies

Translational Pharmacology and Biology of Gene Therapy
David Gordon, PhD, Bristol-Myers Squibb, Princeton, NJ

WORKSHOP Dose Selection for Biologics Combination Therapies

Dose Selection Approaches for Combination Oncology/ImmunoOncology Agents
Manish Gupta, PhD, Bristol-Myers Squibb, Princeton, NJ

Two Birds with One Stone: Promises and Challenges for Bispecific Molecules
Bing Wang, PhD, MedImmune, Gaithersburg, MD

SCIENCE AT SUNRISE Genome Wide Association Studies Reveal Important Transporter Polymorphisms as Biomarkers for Pharmacokinetics and Pharmacodynamics
Chairs
Sook Wah Yee, PhD, University of California San Francisco, San Francisco, CA
Kazuya Maeda, PhD, The University of Tokyo, Tokyo, Japan

In Vitro and In Vivo Methodologies for Studying Transporter Polymorphisms
Kathleen M. Hillgren, PhD, Eli Lilly and Company, Indianapolis, IN

WORKSHOP Lessons Learned from Failed Pediatric Trials
Chairs
Jeffrey Barrett, PhD, Sanofi, Bridgewater, NJ
Lily (Yeruk) Mulugeta, PharmD, US Food and Drug Administration, Silver Spring, MD

Guanfacine for ADHD in adolescents—Utility of Clinical Trial Simulation
Marc Gastonguay, PhD, Metrum Research Group, Tariffville, CT

Challenges in Developing Biologics for Pediatric Diseases: Approaches to Dose Selection
Sameer Doshi, MS, Amgen, Thousand Oaks, CA

Failed Trials and Design Considerations in Pediatric Oncology
Brenda Weigel, MD, University of Minnesota, Minneapolis, MN

Failed Trials and Design considerations in Pediatric Type 2 Diabetes
William Tamborlane, MD, Yale University, New Haven, CT

ORAL ABSTRACT SESSION Pharmacogenomics: From Discovery to Implementation

GENOMIC IDENTIFICATION AND FUNCTIONAL CHARACTERIZATION OF METFORMIN-RESPONSIVE REGULATORY ELEMENTS.
M. R. Luizon, W. L. Eckalbar, Y. Wang, S. L. Jones, R. P. Smith, L. Lin, S. Yee, K. M. Giacomini, N. Ahituv; 
Department of Bioengineering and Therapeutic Sciences and Institute for Human Genetics, University of California San Francisco, San Francisco, CA.

ERICH3 GENETIC VARIATION ASSOCIATED WITH PLASMA SEROTONIN AND CHANGE IN PLASMA SEROTONIN AFTER SSRI THERAPY: PHARMACOMETABOLOMICS-INFORMED PHARMACOGENOMICS.
D. Liu1, D. R. Neavin1, J. Zhang1, J. M. Biernacka1, H. Zhu2, G. D. Jenkins1, K. R. Kalari1, T. Mushiroda3, Y. Nakamura4, M. Kubo3, W. Matson5, L. Wang1, R. Kaddurah-Daouk2, R. Weinshilboum1
1Mayo Clinic, Rochester, MN, 2Pharmacometabolomics Research Network, Duke University School of Medicine, Durham, NC, 3RIKEN, Yokohama, Japan, 4University of Chicago, Chicago, IL, 5Bedford VA Medical Center, Bedford, MA.

PHARMACOGENETIC ASSOCIATION OF ß1-ADRENERGIC RECEPTOR SER49GLY POLYMORPHISM WITH OUTCOMES IN THE SECONDARY PREVENTION OF SMALL SUBCORTICAL STROKES (SPS3) TRIAL.
O. Magvanjav1, C. W. McDonough1, Y. Gong1, L. A. McClure2, R. L. Talbert3, R. B. Horenstein4, B. D. Mitchell4, A. R. Shuldiner4, O. R. Benavente5, J. A. Johnson1
1University of Florida, Gainesville, FL, 2Drexel University, Philadelphia, PA, 3University of Texas, Austin, TX, 4University of Maryland, Baltimore, MD, 5University of British Columbia, Vancouver, BC, Canada.

ANALYSIS OF CLINICALLY ACTIONABLE PREEMPTIVE PHARMACOGENOMIC (PGx) INFORMATION TO IMPACT IN-HOSPITAL PRESCRIBING.
Y. Lee, K. Danahey, M. J. Ratain, D. O. Meltzer, P. H. O'Donnell; 
The University of Chicago, Chicago, IL.

SPECIAL SESSION Pursuing the Management Track in a Scientific Organization: Learn From the Experts
Chairs
Catherine M. T. Sherwin, BSc(Hons), PhD, University of Utah School of Medicine, Salt Lake City, UT
Patricia Slattum, PharmD, PhD, Virginia Commonwealth University, Richmond, VA

Guidance in Moving Through the Ranks of Industry
Raafat Bishai, MD, AstraZeneca R&D, Gaithersburg, MD

The Hard Truth About Soft Skills: Leadership and Promotion at the US Food and Drug Administration
Issam Zineh, PharmD, MPH, US Food and Drug Administration, Silver Spring, MD

Opportunities for the Management Track at NIH
Anne Zajicek, MD, PharmD, National Institutes of Health, Bethesda, MD

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