National Institute of Child Health and Human Development
2008 OPRU Network Meeting August 14–15, 2008 Talaris Conference Center 4000 NE 41st Street Seattle, WA 98105-5428 Meeting Goals This meeting will have four areas of focus and discussion:
o Glyburide o Metformin o Caproate o Diclectin o Thyroid
o Review of status by compound o Planning for manuscripts and data collection
o Study selection o Study development process
Data Coordinating and Analysis Center report on network operations
Meeting Outcomes
Develop and agree on priorities for coming year
Thursday, August 14 7:30 a.m.–5:00 p.m._______________________________ 7:30 a.m.–8:00 a.m.
Opening Introductions and Goals for the Meeting Donald R. Mattison, M.D. Captain, U.S. Public Health Service Senior Advisor to the Directors of NICHD and CRMC Chief, Obstetric and Pediatric Pharmacology Branch (OPPB) Center for Research for Mothers and Children (CRMC) Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Thursday, August 14 (Continued) ______________________________
8:30 a.m.–10:30 a.m. Gestational Diabetes: Glyburide
Using Mathematical Modeling to Determine Individual-Specific In Vivo Metabolic Indices of Glucose-Insulin Regulation in the Context of Gestational Diabetes Paolo Vicini, Ph.D. Associate Professor Department of Bioengineering University of Washington
Can In Vivo Metabolic Indices Help Us With Gestational Diabetes Medication Selection? Paolo Vicini, Ph.D.
Glyburide Pharmacokinetic Changes During Pregnancy and Implications for Dosage Selection in the Treatment of Gestational Diabetes Mary F. Hebert, Pharm.D., F.C.C.P. Professor Departments of Pharmacy and Obstetrics and Gynecology University of Washington
Part 1: Biotransformation of Glyburide During Pregnancy, Implications for the Identification of the Enzymes and the Metabolites Formed Part 2: Placental Transfer of Glyburide Mahmoud S. Ahmed, Ph.D. Professor Department of Obstetrics and Gynecology University of Texas Medical Branch
Bcrp1/Abcg2 Limits Fetal Distribution of Glyburide Qingcheng Mao, Ph.D. Assistant Professor Department of Pharmaceutics School of Pharmacy University of Washington 10:45 a.m.–11:30 a.m. Gestational Diabetes: Metformin and Rosiglitazone
Effects of Pregnancy on Metformin Pharmacokinetics Mary F. Hebert, Pharm.D., F.C.C.P.
Placental Transfer of Metformin and Rosiglitazone Mahmoud S. Ahmed, Ph.D. Thursday, August 14 (Continued) ______________________________
Metformin – The Next Broad Study? – Plusses & Minuses?
Mary F. Hebert, Pharm.D., F.C.C.P. Steve N. Caritis, M.D. Professor Department of Obstetrics, Gynecology, and Reproductive Sciences Magee-Womens Hospital of the University of Pittsburgh Medical Center
What Have We Learned and What is Next Steve N. Caritis, M.D.
Placental Transport, Metabolism and Receptor Binding Mahmoud S. Ahmed, Ph.D. Steve N. Caritis, M.D. Raman Venkataramanan, Ph.D. Professor Department of Pharmaceutical Sciences University of Pittsburgh Lunch (on your own)
Physiologically Based Pharmacokinetics to Integrate Basic Science and Clinical Research Marilee Andrew, M.Eng. Graduate Student and Senior Engineer Applied Physics Laboratory Department of Bioengineering University of Washington Shannon Clark, M.D., M.M.S. Assistant Professor Department of Obstetrics and Gynecology University of Texas Medical Branch 2:15 p.m.–3:15 p.m. Opportunistic Study Review and Discussion
Opportunistic Study Where We Are and Where We Are Going Jason G. Umans, M.D., Ph.D. Associate Professor of Medicine and Obstetrics-Gynecology Georgetown University Scientific Director Penn Medical Lab MedStar Research Institute Thursday, August 14 (Continued) ______________________________
Cyclosporine and Placental P-Glycoprotein Activity Jashvant Unadkat, Ph.D. Professor Department of Pharmaceutics School of Pharmacy University of Washington
Dacarbazine and the Effects of Pregnancy on CYP1A2 Nina Isoherranen, Ph.D. Assistant Professor Pharmaceutics University of Washington
Effects of Pregnancy on Clonidine Pharmacokinetics Mary F. Hebert, Pharm.D., F.C.C.P.
Clonidine Hemodynamic Effects During Pregnancy Thomas R. Easterling, M.D. Professor Department of Obstetrics and Gynecology University of Washington Break
Possible topics/studies Study development process
o Topic/study selection processo Protocol development and approvalo Development of study manual and procedureso Study implementation Donald R. Mattison, M.D. Rick Williams, Ph.D. Principal Scientist Statistics and Epidemiology RTI International Wednesday, August 15 7:30 a.m.–12:00 p.m.______________________________ 7:30 a.m.–8:00 a.m. 8:00 a.m.–8:45 a.m.
Thyroid Disease in Pregnancy: Thyroid PK Offie P. Soldin, Ph.D., M.B.A. Associate Professor Department of Medicine and Oncology Georgetown University Medical Center
o Website o Data capture and management o Specimen tracking and management
Rick Williams, Ph.D. Deborah W. McFadden, M.B.A. DCAC Study Coordinator and Operations Supervisor Statistics and Epidemiology RTI International Debra Fleischmann RTI Data Manager Research Computing RTI International
Data Coordinating and Analysis Center (Continued)
Protection of Lithium-Ion Batteries (for Double-Protect) MM1451 Protection of Lithium-Ion Batteries (for Double-Protect) Monolithic IC MM1451 This IC is used for double-protection of lithium-ion batteries with from one to three cells, and has an ultra-compact package. Short-circuits between cells accommodate series connections of one to three cells. Features 1. Overcharge detection vol
The Full Story of Cholesterol Lowering Drugs Cholesterol lowering drugs is not the first step to fight heart disease. The optimum way to getand remain healthy is through nutrition. NOT nutrition plus pharmaceutical drugs--but nutritionalone. Nutrition should be obtained from whole, natural foods as much as possible. This is foodas found in nature. As Hippocrates so wisely stated, "Let food