SPECIAL SESSION Bioinnovation Forum
Craig H. Lipset, MBA, Pfizer, Inc., New York, NY
Hugh Rosen, MD, PhD, The Scripps Research Institute, La Jolla, CA
Geoffrey Kim, MD, US Food and Drug Administration, Silver Spring, MD

SYMPOSIUM Characterizing Dose/Exposure Response of Biologics: Are We There Yet?
Chairs
Anne Heatherington, PhD, Pfizer Inc., Cambridge, MA
Ganesh M. Mugundu, MPharm, PhD, AstraZeneca Boston R&D, Waltham, MA

What are the Regulatory Expectations for Characterizing Dose-Response for Biologics
Yaning Wang, PhD, US Food and Drug Administration, Silver Spring, MD

WORKSHOP Discovery and Development of First-in-Class Drugs That Target Membrane Transporters
Targeting SGLT2 Inhibitors for the Treatment of Type 2 Diabetes
Ernest M. Wright, PhD, DSc, University of California Los Angeles, Los Angeles, CA

Transporters Potentiators and Correctors for the Treatment of Rare Diseases: Therapeutic Use of Ivacaftor in Cystic Fibrosis
John P. Clancy, MD, University of Cincinnati, Cincinnati, OH

SYMPOSIUM Epigenetic Biomarkers and Modifications in Clinical Pharmacology
Growth Inhibition of SCLC Cell Lines by Treatment with LSD1 Inhibitor is Associated with Modulation of Neuroendocrine Pathways
Thomas Paul, PhD, Pfizer Inc., San Diego, CA

Overview of the State of Epigenetics
Jonathan Pevsner, PhD, Kennedy Krieger Institute and Johns Hopkins University, Baltimore, MD

Application of Epigenetics for Clinical Immunology
Robert Georgantas, PhD, AbbVie, North Chicago, IL

Histone Deacetylase Inhibitors: Assessing Their Potential for Clinical Use in Neurodegenerative Disorders
Elizabeth Thomas, PhD, Scripps Research Institute, La Jolla, CA

ROUNDTABLE How Should Simulated DDI Results be Communicated in the Label?
Joseph Grillo, PharmD, US Food and Drug Administration, Silver Spring, MD
Jack Cook, PhD, Pfizer Inc., Groton, CT
Carolien Versantvoort, PhD, Medicines Evaluation Board, Utrecht, Netherlands

ORAL ABSTRACT SESSION Old Players, New Game
EVALUATING THE TRANSPLACENTAL TRANSFER OF APIXABAN USING A DUALLY PERFUSED ISOLATED HUMAN PLACENTAL LOBULE.
P. Bapat¹, L. S. Pinto², A. Lubetsky², K. Aleksa², H. Berger³, S. Ito¹, G. Koren¹; 
¹University of Toronto, Toronto, ON, Canada, ²Hospital for Sick Children, Toronto, ON, Canada, ³St. Michael's Hospital, Toronto, ON, Canada.

CALMING THE ROLLER-COASTER RIDE, BIPOLAR DISEASE: A DOUBLE-BLIND, ACTIVE CONTROLLED TRIAL DEMONSTRATES ANTI-MANIC EFFICACY OF A NEW PROTEIN KINASE C INHIBITOR ENDOXIFEN.
A. Ahmad¹, S. Sheikh¹, T. Shah², M. S. Reddy³, B. S. Prasad⁴, K. K. Verma⁵, B. B. Chandrakant⁶, M. Paithankar⁷, P. Kale⁸, R. Solanki⁸, H. Barkate⁷, I. Ahmad¹; 
¹Jina Pharmaceuticals, Libertyville, IL, ²Divyam Hospital, Surat, India, ³Asha Hospital, Hyderabad, India, ⁴Sujata Birla Hospital & Medical Research Centre, Nasik, India, ⁵S. P. Medical College & A G Hospitals, Bikaner, India, ⁶Hatkesh Health Care Foundation, Junagadh, India, ⁷Intas Pharmaceuticals, Ltd., Ahmedabad, India, ⁸Lambda Therapeutic Research Ltd., Ahmedabad, India.

HYPERTENSION (HTN)/BLOOD PRESSURE (BP) SIGNATURE GENES AND BP RESPONSE TO THIAZIDE DIURETICS (TD): RESULTS FROM PEAR AND PEAR-2 STUDIES.
A. C. Sá¹, A. Webb², Y. Gong¹, C. W. McDonough¹, M. H. Shahin¹, T. Y. Langaee¹, S. T. Turner³, A. L. Beitelshees⁴, A. B. Chapman⁵, E. Boerwinkle⁶, J. G. Gums⁷, S. Scherer⁸, R. M. Cooper-DeHoff¹, W. Sadee⁹, J. A. Johnson¹; 
¹Center for Pharmacogenomics and Department of Pharmacotherapy and Translational Research, University of Florida, Gainesville, FL, ²Department of Pharmacology, College of Medicine, Ohio State University, Columbus, OH, ³Division of Nephrology and Hypertension, Mayo Clinic, Rochester, MN, ⁴Division of Endocrinology, Diabetes and Nutrition, University of Maryland, Baltimore, MD, ⁵The Renal Division, Department of Medicine, Emory University, Atlanta, GA, ⁶Division of Epidemiology, University of Texas at Houston, Houston, TX, ⁷Department of Community Health and Family Medicine, University of Florida College of Medicine, Gainesville, FL, ⁸Human Genome Sequencing Center, Baylor College of Medicine, Houston, TX, ⁹Department of Pharmacology, College of Medicine, Ohio State University, Gainesville, FL.

WORKSHOP Pediatric Dose Selection for Pediatric-Specific Diseases
Combining Benefit-Risk Assessment with M&S to Inform Pediatric Dose Selection
Oscar Della Pasqua, MD, PhD, GlaxoSmithKline and Clinical Pharmacology & Therapeutics, University College London, Stockley Park, United Kingdom

Regulatory Experience in Pediatric Dose Selection for Pediatric-Specific Diseases
Gilbert J. Burckart, PharmD, US Food and Drug Administration, Silver Spring, MD

RAWLS-PALMER PROGRESS IN MEDICINE AWARD LECTURE
Genes and the Environment: How they Affect Drug Metabolism and Response
Kenneth E. Thummel, PhD, University of Washington, Seattle, WA

STATE OF THE ART LECTURE II
How Pharmacology and Quantitative Methodologies are Impacting Global Health: A Perspective from the Bill and Melinda Gate Foundation
Dan Hartman, MD, Bill and Melinda Gates Foundation, Seattle, WA