Lake Nona Leadership Council Meeting

LOCATION: UF Research and Academic Center in Lake Nona, Fla.

DATE: February 24, 2016

2016 Scientific Symposium for the University of Florida Center for Pharmacometrics and Systems Pharmacology Lake Nona Leadership Council Meeting


Schedule of Events

8 a.m. Welcome and Opening Remarks

Lawrence J. Lesko, Ph.D.,
Clinical Professor and Director of the Center for Pharmacometrics and Systems Pharmacology
College of Pharmacy, University of Florida

Julie Johnson, Pharm.D.
Dean and Distinguished Professor
College of Pharmacy, University of Florida

Hartmut Derendorf, Ph.D.
Chair and Distinguished Professor of Pharmaceutics Department of Pharmaceutics
College of Pharmacy, University of Florida

Megan Gibbs, Ph.D., Symposium Co‐Chair Executive Director
Global Head of Clinical Pharmacology, Modeling and Simulation


Session I: Translational Research in Limited Resource Populations: Rare Diseases and Pediatric Indications

Co‐Chairs: Mark Rogge, Ph.D., Senior Director, Early Development Sciences, Clinical Pharmacology and Pharmacometrics, Biogen and Virna Schuck, Associate Director, Oncology Clinical Pharmacology, Novartis

8:15 a.m. Steven Ryder, M.D. FACP Chief Development Officer Alexion Pharmaceuticals: “Dominant Challenges in the Rare/Ultra‐rare Bio‐innovation Space: Implications and Actions for Clinical Pharmacology”

8:45 a.m. Samuel Maldonado, M.D., M.P.H, FAAP, Vice President and Head of the Pediatric Drug Development Center of Excellence Johnson & Johnson: “Trials and Tribulations of Pediatric Drug Development”

9:15 a.m. Gilbert Burckart, Pharm.D. Associate Director for Pediatrics, Office of Clinical Pharmacology, U.S. Food and Drug Administration: “How do we get to zero (failed pediatric trials)?”


Session II: Clinical Pharmacology as a Foundation for Translational Science

Co‐Chairs: Amita Joshi, Ph.D., Vice President Global Head, Clinical Pharmacology, Genentech Inc. and Alexander Staab, Ph.D., Head of Global Pharmacometrics, Boehringer Ingelheim Pharma

9:45 a.m. Peter Stopfer, Ph.D., Translational Medicine and Clinical Pharmacology, Boehringer Ingelheim Pharma GmbH & Co KG: “Pharmacokinetic evaluation of a drug transporter cocktail consisting of digoxin, furosemide, metformin and rosuvastatin”

10:15 a.m. Break

10:45 a.m. Vikram Sinha, Ph.D., Director, Division of Pharmacometrics, Office of Clinical Pharmacology, CDER, FDA: “Benefit/Risk Assessment in Chronic and Rare Diseases: Modeling and Simulation in the Development and Approval of Drugs”

11:15 a.m. Yusuke Tanigawara, Ph.D. Professor Department of Clinical Pharmacokinetics and Pharmacodynamics School of Medicine, Keio University Tokyo: “The New Japanese Guideline on Population PK and PD Analysis: Compare and Contrast with FDA and EMA Guidance”


Session III: CPSP Translational Research Presentations and Posters by CPSP Trainees Co‐Chairs:     

Co-Chairs: Stephan Schmidt, Ph.D., Assistant Professor, Center for Pharmacometrics and Systems Pharmacology, University of Florida in Lake Nona and John Davis, BPharm, Ph.D., Senior Director, Head, Clinical Pharmacology, Regeneron

11:45 a.m. Podium Presentations by Doctoral Students and Post‐Doctoral Research Associates.

Sonja Hartman, Ph.D.
Development of a Quantitative Systems Pharmacology Model to Predict the Effects of Warfarin and Rivaroxaban on the Human Coagulation Network

Felipe Hurtado, Ph.D.
A Mechanism-based Model for Type 2 Diabetes Incorporating Drug Effects and Disease Progression

Kumpal Madrasi, Ph.D.
Development of a Drug-disease Model for Bisphosphonates in the Area of Post-menopausal Osteoporosis

Amy Meng, Ph.D.
Application of Pharmacokinetic/Pharmacodynamic Modelling to Simulate Potential Differences in Bioequivalence Between Generic and Brand-name Anti-epileptic Products

12:30 p.m. Lunch


Session IV: Systems Pharmacology: Translational Science in Practice

Co‐Chairs: Lisa Benincosa, Ph.D., Global Head Drug Metabolism and Pharmacokinetics, Non‐Clinical Safety, Hoffman‐LaRoche, and Sandra Allerheiligen, Vice President Predictive and Economic Modeling at Merck Research Laboratories

1:15 p.m. V.A. Shiva Ayyadurai, Ph.D., Chairman & CEO of Cytosolve, Inc.: Identifying Drug Combinations in Oncology Using In Silico Systems Pharmacology Models

1:45 p.m. Sihem Bihorel, M.S., Pharm.D., Ph.D., Assistant Professor, Department of Pharmaceutics, College of Pharmacy, University of Florida: “Case studies in systems pharmacology: Improving Drug Delivery and Translational Research in Oncology”

2:15 p.m. Mirjam N. Trame, Pharm.D., Ph.D., Assistant Professor, Department of Pharmaceutics, College of Pharmacy, University of Florida: “Novel data mining methodologies and systems pharmacology for adverse drug event discovery and analysis”

2:45 p.m. Break


Session V: Transforming Translational Science via Digital Medicine

Co-Chairs: Kathryn Blake, Pharm.D., Principal Research Scientist, Center for Pharmacogenomics and Translational Research, Nemours’s Children Clinic and Aubrey Stoch, Merck, Vice President, Translational Pharmacology at Merck

3:15 p.m. Eric Buffkin, MBA, Co‐founder and President of eTect, Inc.: “Behavioral Insights and Therapeutic Opportunities Enabled by Digital Medicine”

3:45 p.m. Michael Dillhyon, Founder healthbank: “Emerging Trends in Data-Driven Wellness”

4:15 p.m. Aubrey Stoch Symposium Co‐Chair, Vice President, Translational Pharmacology at Merck: Closing Remarks