University of Florida Center for Pharmacometrics and Systems Pharmacology 2015 Scientific Symposium Translational Research in Action March 2, 2015 UF Research and Academic Center Auditorium 6550 Sanger Road Orlando, FL 32827 7:45 Welcome—Hartmut Derendorf, PhD, Chair and Distinguished Professor of Pharmaceutics, Department of Pharmaceutics, College of Pharmacy, University of Florida Opening Remarks – Megan Gibbs, Ph.D., Symposium Co-Chair, Executive Director, Amgen, Inc. Session I: Co-Chairs: Academic, Regulatory and Industry Approaches in Translational Research Dennis Dean, Vertex and Stephan Schmidt, UF COP, CPSP 8:00 Julie A. Johnson, Pharm.D., UF COP, Dean, and Distinguished Professor “Advancing Patient Care through Clinical and Translational Research” 8:30 Aubrey Stoch, Merck, Scientific Associate Vice President, Clinical Research “A translational platform to evaluate drug effects on gastrointestinal microbleeding” 9:00 George Drusano, MD, UF COM, Professor and Director Institute for Therapeutic Innovation ”Translation from Bench to Bedside in Infectious Diseases: An example from the ICU” 9:30 Vikram Sinha, Ph.D., Director, Division of Pharmacometrics, Office of Clinical Pharmacology, CDER, FDA Exposure Matching and Exposure Response in Dosing Decisions 10:15 Break 10:30 Yusuke Tanigawara, Ph.D., Professor, Department of Clinical Pharmacokinetics and Pharmacodynamics, School of Medicine, Keio University “Pharmacokinetics, dynamics and toxicity of docetaxel: Why Japanese dose differs from the Western dose?” 11:00 Mark Rogge, Biogen Idec, Sr. Director, Early Development Sciences “Modernizing Approaches to Food-Effect Assessments” 11:30 CPSP Interactive Poster Session, UF Lobby 5-minute Oral Presentations and Interactive Discussion Dr. Schmidt’s Postdocs and student: Dr. Tanay Samant, Postdoctoral Research Associate Dr. Chakradhar Lagishetty, Postdoctoral Research Associate Ms. Snehal Samant, Ph.D student, expected graduation 2016 Dr. Trame’s Postdocs and student: Dr. Francois Combes, Postdoctoral Research Associate Dr. Konstantinos Biliouris, Postdoctoral Research Associate Mr. Brett Fleischer, Pharm.D. Student and Class of 2017 Orlando President 12:15 Lunch Session II: Co-Chairs: Impact of Science and Technology on Clinical Trials and Patients Rick Lalonde, Pfizer and Guenther Hochhaus, UF 1:00 Kathleen Giacomini, Ph.D., Professor and CERSI Co-Director, UCSF “Discovering Targets for Drug-Induced Weight Gain” 1:30 Shashank Rohatagi, Ph.D., MBA, Sr. Director, Think Team and Deborah Profit, Ph.D., Director, Corporate Projects, Otsuka Pharmaceutical Development & Commercialization “Clinical Trial Optimization: The Convergence of Clinical and Digital Data” 2:00 Susan L. Baumgartner, Pharm.D., MBA, Vice President, Business Development SMART Xhale, Inc. “FDA Qualification of Novel Drug Development Tools: A Case Study of the SMART® Breath Biomarker for Definitive Documentation of Treatment Adherence” 2:30 David B. Jackson, Ph.D., Chief Scientific Officer, Molecular Health "Precision medicine – from clinical concept to clinical reality, using systems-level knowledge innovation". 3:00 Thomas A. Pearson, MD, MPH, Ph.D., Executive Vice President for Research and Education, UF Health Sciences (Invited) Symposium Overview 3:15 Megan Gibbs, Ph.D., F.C.P., Amgen and Lawrence J. Lesko, Ph.D., F.C.P. Clinical Professor and Director, CPSP Closing Remarks 3:30 Adjournment