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SCDMDG presents:

Drug Interaction Studies: Differences and Similarities in How to Meet the Regulatory Expectations in FDA Guidance and EMA Guidelines

Tuesday May 14, 2013
Lawrence J. Lesko, Ph.D., F.C.P.
Director, Center for Pharmacometrics and Systems Pharmacology
University of Florida Institute of Therapeutic Innovation
Orlando, FL

There has been an unprecedented level of interaction between the U.S. Food and Drug Administration and the European Medicines Agency over the past 10 years under confidentiality arrangements originally signed in 2003 and updated in 2010. These arrangements enable scientific staff exchanges and visits, regular communication on specific “clusterspecific” areas such as drug interactions, informal dialogue between the respective regulatory leads on draft guidelines, and ad hoc meetings and workshops. Both FDA and EMA separately issued new guidance/guidelines on drug interaction studies in 2012 following a significant amount of interaction between scientist-reviewers at the two agencies. Drug interactions are complex. Pharmaceutical companies struggle with detailed interpretation of guidances/guidelines and must be aware of the subtle differences between the two drug interaction guidelines/guidances in order to develop efficient strategies for drug interactions studies that will impact product label claims and potentially post-marketing requirements. This presentation will focus on some of the major differences and similarities in evaluating drug interactions between the decision-tree laden FDA guidance and the considerably shorter EMA guideline. It will also discuss crucial issues that arise between companies and regulators when discussing drug interactions such as: greater clarity around transporters, validating mechanistic PBPK models, the acceptance PBPK models to waive clinical studies, generating user-friendly labeling, use of CYP and transporter cocktail studies and future system pharmacology approaches to understanding and predicting drug interactions. Aside from the regulations, the laws and the guidance/guidelines which govern the scientific and technical conduct of drug interaction studies, there is the “art” of regulatory decision making based on the “facts” rendered by these studies. This presentation will touch on huge uncertainties that can come into play because of the heterogeneity in judgment and values of individual assessors.


Date:   Tuesday May 14, 2013 – 5:00 p.m. (Buffet), 7:00 p.m. (Presentation)
Location:   Sanford Consortium for Regenerative Medicine
2880 Torrey Pines Scenic Drive
La Jolla, CA 92037
Price:   $20 Registration in advance or at the door (includes buffet dinner and soft drinks/beer/wine)

Space is Limited — Register Early to Guarantee Your Attendance!

Our May 2013 meeting is generously sponsored by:

Silver Sponsors

Corning Life Sciences
Corning Life Sciences
Optivia Biotechnology
Optivia Biotechnology

Bronze Sponsors

Waters Corporation
Waters Corporation

Drug Interaction Studies: Differences and Similarities in How to Meet the Regulatory Expectations in FDA Guidance and EMA Guidelines
Speaker PDF Topic Date
Thomas Tozer, Ph.D.  
Pharmacokinetics of Protein Drugs October 23, 2012
Thomas Tozer, Ph.D.
Pharmacokinetics of Protein Drugs October 23, 2012
Shujuan Chen Application of Animal Models for Human Glucuronidation October 23, 2012
Caroline Decker The Use of Modified Bacterial CYPs for Metabolite Generation October 23, 2012
Mary Dwyer, Ph.D. Cancer Therapeutics: A Novel Approach October 23, 2012
Justin Hoffman PharmD MS Population Pharmacokinetics (PK) of LopinavirDuring Pregnancy and Postpartum October 23, 2012
David A. Yee Observations on the Urine Metabolic Ratio of Oxymorphone to Oxycodone in Pain Patients October 23, 2012
Nabil Hanna, Ph.D.   The Discovery and Development of Rituxan April 10, 2012
Dr. Richard Kim Drug Transporters: In Vitro and Knockout Model Systems, Pharmacogenomics, and Clinical Relevance April 19, 2011
Dr. Jerry Galluppi Biotherapeutic Drug Research and Development: A Growing Role for the DMPK Scientist October 5, 2010
Dr. Dennis Smith Does drug metabolism hold its future in its own hands? April 27, 2010
Dr. Paul F. Hollenberg Mechanism-Based Inactivation of Human Cytochromes P450 October 6, 2009
Dr. Jack H. Dean
Dr. Thomas Baillie
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Eric Johnson, Ph.D.   Characterization of Substrate/Inhibitor Binding to Drug-Metabolizing Cytochrome P450 Monooxygenases using X-ray Crystallography September 30, 2008
Dr. Kenneth E. Thummel, Ph.D.   Regulation Of Intestinal CYP3A By VDR: Implications And Safety Of Oral Therapeutics May 7, 2008
Dr. Anthony Lu, Ph.D.   Why Is The Liver Microsomal Cytochrome P450 Such A Versatile And Unique Enzyme? September 12, 2007
Dr. Scott Obach, Ph.D.   Leveraging ADME Data In Metabolites In Safety Testing (MIST) April 18, 2007
Dr. Sidney Nelson, Ph.D.   Drug Metabolism and Chemical Structural Alerts September 27, 2006
Richard B. Kim, MD   Relevance and Utility of Transporters to Drug Discovery and Development September 21, 2005
Dr. Frederick P. Guengerich, Ph.D.   Human Cytochrome P450 2A6 as a Case History:  Flavors, Smoke, Blue Roses, New Drugs & Basics of a P450 April 27, 2005
Dr. Leslie Benet, Ph.D.   Predicting Drug Disposition via Application of BCS: Transport/Absorption/Elimination Interplay and BDDCS September 29, 2004
Dr. Christopher A. Lipinski, Ph.D.   ADME/Tox: How Low Can You Go And How Do You Recover? April 21, 2004