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Friday, March 17, 2017

Science at Sunrise Session
Databases 101 for Clinical Pharmacologists: What You Need to Know
Tools and Resources for Genomewide
Studies Sook Wah Yee, PhD
University of California San Francisco, San Francisco, CA

Pharmacogenomics Knowledgebase 
Michelle Whirl-Carrillo, PhD
Stanford University, Department of Genetics, CA

FDA Pharmacogenomics and Biomarker Databases
Anuradha Ramamoorthy, PhD
US Food and Drug Administration, Silver Spring, MD

Science at Sunrise Session
How Inert are Excipients? What Clinical Pharmacologists Need to Know
Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System (BCS)
Robert Lionberger, PhD
US Food and Drug Administration, Silver Spring, MD

Transporter-Mediated Interactions of Drugs with Excipients
Kathleen M. Giacomini, PhD
University of California, San Francisco, San Francisco, CA

Workshop
Biomarkers of CYP3A Activity: What Have We Learned and are We Ready to Utilize Biomarkers to Replace Clinical DDI Studies?

Review of the Biology of Emerging Endogenous Biomarkers of CYP3A
Yvonne Lin, PhD
University of Washington, Seattle, WA

Perspectives and Case Examples from Industry 
Helen Gu
DMPK - Novartis Institute for Biomedical Research, East Hanover, NJ

Regulatory Perspectives on the Use of CYP3A Biomarkers for Assessing DDI
Lei Zhang, PhD
US Food and Drug Administration, Silver Spring, MD

Panelists
Jialin Mao, PhD
Genentech, South San Francisco, CA

Bindu Murthy, PharmD
Bristol-Myers Squibb, Lawrenceville, NJ

Symposium
Integration of Genomics and Translational Clinical Pharmacology to Guide Development of Precision Medicines

Bridging the Gap Between the Laboratory and Clinic in Precision Medicine
Sara Van Driest, MD, PhD
Vanderbilt University, Nashville, TN

Opportunities and Challenges in the Development and Regulatory Evaluation of Precision Medicines
Issam Zineh, PharmD, MPH
US Food and Drug Administration, Silver Spring, MD

Clinical Practice, Hurdles and Expectations in the Individualized Treatment Route to Optimizing Therapy for Biologics
Clinician’s Guide to Optimizing Therapy in Inflammatory Bowel Disease
Brian Feagan, MD, FRCPC
Robarts Clinical Trials, Inc., Western University, London, ON, Canada

Individualized Dosing Sequences in Dynamic Precision Medicine
Robert Beckman, MD
Georgetown University, Washington, DC

Therapeutic Drug Monitoring: Overcoming the Hurdles 
Diane Mould, PhD
Projections Research Inc., Phoenixville, PA

Regulatory Perspectives of Implementing TDM: Challenges and Opportunities
Yow-Ming Wang, PhD
 US Food and Drug Administration, Silver Spring, MD

Featured Speaker
Precision Therapeutics for Children
J. Steven Leeder, PharmD
PhD, Children’s Mercy Hospital, Kansas City, MO

Workshop
Physiologically Based Pharmacokinetics (PBPK) Modeling to Support Dosing Recommendations for Patients with Renal Impairment: Are We There Yet?

Chair:
Ying Ou, PhD
Amgen, South San Francisco, CA 

The Readiness and Specific Paths of Using PBPK to Support Dosing Recommendation in Patients with Renal Impairment
Ping Zhao, PhD
US Food and Drug Administration, Silver Spring, MD

Tumor Cell Drug Penetration for Individualized Cancer Treatment
Chair: 
Imke Bartelink, PharmD, PhD
University of California, San Francisco, San Francisco, CA

MALDI-MS Imaging of Targeted Therapies in Cellular and Necrotic Tissues
Brendan Prideaux, PhD
Rutgers New Jersey Medical School, Newark, NJ

Sheiner-Beal Pharmacometrics Award Lecture
Pharmacometrics @ 45; What’s Next?
Carl C. Peck, MD
UCSF Center for Drug Development Science, San Luis Obispo, CA

Oral Abstract Session
Drug Development

OI-001
METABOLOMIC AND GENOMEWIDE ASSOCIATION STUDIES REVEAL POTENTIAL ENDOGENOUS BIOMARKERS FOR OATP1B1.
Presenter: Sook Wah Yee, PhD, University of California, San Francisco

OI-002
COMPARISON OF NONCOMPARTMENTAL ANALYSIS (NCA) ESTIMATION AND POPULATION PHARMACOKINETIC (PPK) PREDICTIONS OF EXPOSURE CHANGES AS A FUNCTION OF RENAL IMPAIRMENT.
Presenter: Mariam Ahmed, PhD, University of Minnesota

OI-003
AN EXEMPLAR OF A SYSTEMS PHARMACOLOGY APPROACH FOR A DETAILED INVESTIGATION OF AN ADVERSE DRUG EVENT AS A RESULT OF DRUG-DRUG INTERACTIONS.
Presenter: Sarah Kim, PhD, University of Florida

OI-004
REPORTS OF TORSADES DE POINTES (TDP) ASSOCIATED WITH INTRAVENOUS (IV) DRUG FORMULATIONS THAT CONTAIN THE PRESERVATIVE CHLOROBUTANOL (CB).
Presenter: Raymond D. Woosley, MD, PhD, AZCERT, Oro Valley, AZ

Workshop
Leveraging Limited Data for Innovative Drug Development and Utilization Analyses

Optimizing Maternal Influenza Immunization Timing to Best Protect Infants
Michael Dodds, PhD
Quantitative Solutions, Seattle, WA

Model-Based Biomarker Qualification: Optimizing Decision-Making in Polycystic Kidney Disease
Klaus Romero, MD
The Critical Path Institute, Tucson, AZ

Leon I. Goldberg Early Investigator Award Lecture
Elucidating the Pharmacology and Toxicology of Anti-HIV Drug Metabolites
Namandje N. Bumpus, PhD
Johns Hopkins University School of Medicine, Baltimore, MD



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