(SC1) Cardiac Safety: Improving Pre-Clinical Predictions to Better Clinical Outcomes
2:00 – 5:00 pm
Cardiac Safety: Improving Pre-Clinical Predictions to Better Clinical Outcomes
Cardiotoxicity is one of the major forms of toxicity seen in drugs and it accounts for most recalls and delays experienced in drug approvals. One of the biggest challenges is how to predict cardiac risk associated with drug candidates very early and accurately in the drug development process. The course will provide an overview of the recent technical and scientifi c advances in preclinical testing for determining cardiac safety. The instructors will also talk about ways to then effectively combine the intelligence gathered from preclinical screens with clinical data and post-marketing studies to better assess the safety of new drug candidates.
1:00 – 2:00 pm Pre-Conference Short Course Registration
2:00 Introduction to cardiac safety
J. Rick Turner, Ph.D., PGCE, MICR, Chairman, Department of Clinical Research and Director, Cardiac Safety Education Center, Campbell University School of Pharmacy, North Carolina
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Why is cardiac safety so important?
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Introduction to “proarrhythmic” cardiac safety
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Cell biology of cardiovascular adverse events with specific reference to cardiac hERG ion channels
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Usefulness of a lifecycle drug development approach
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Methodologies for designing safety into drug molecules
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QT interval prolongation and Torsades de Pointes history
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Non-clinical and clinical regulatory guidelines: ICH S7A, ICH S7B, ICH E14
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Introduction to “generalized” cardiac safety
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Post-marketing surveillance methodologies and regulations
2:30 Application and current state of non-clinical strategies
Peter Siegl, Ph.D., Independent Consultant (formerly with the Cardiovascular Franchise, Merck & Co.)
3:00 Development of the QT criteria as a “template” for other types of cardiac safety
William Wheeler, M.D., FACC, Global Medical Director, Centralized Cardiac Safety Services, MDS Pharma Services
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Regulatory aspects of QT assessment
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Post-marketing studies
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Lessons learned: What should be emulated and what needs to be changed
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Development of clinical biomarkers for cardiac safety
3:35 – 3:55 Networking Refreshment Break
3:55 – 4:45 Open discussion
4:45 – 5:00 Summary of key takeaways from the course
5:00 (SC1) Cardiac Safety: Improving Pre-Clinical Predictions to Better Clinical Outcomes Adjourns
(SC3) Introduction to Drug Metabolism I - Metabolite Profiling
May 12, 9:00 am – 12:00 pm
Course Organizer: Ala Nassar, Ph.D.
This course will cover novel approaches to performing metabolite identification in drug metabolism, structure toxicity relationships and how useful they are in predicting toxicities of new drugs. This portion of the course will also demonstrate how to improve the decision-making process in structural modification of drug candidates and reduce toxicity and improve metabolic stability and PK.
7:30 am - 6:00 pm Registration Open
8:00 Introduction and Overview –
Anthony Lu, Ph.D., Professor, Chemical Biology, Rutgers University
* Purpose and Goals of Drug Metabolism
* Role of Drug Metabolism in Drug Discovery and Development Logic Plan
* Types of ADME Studies
8:45 Novel Approach to Performing Metabolite Identification in Drug Metabolism
Abdul E. Mutlib, PhD., Director, Drug Safety and Metabolism, Wyeth Research Labs
9:30 Structural Modification of Drug Candidates: How Useful are they in Reducing
Toxicities, and Improving Metabolic Stability and PK of New Drugs?
Ala Nassar, Ph.D., Head, Drug Metabolism, Vion Pharmaceuticals, Inc.
Armin M. Kamel Ph.D., Pharmacokinetics Dynamics and Drug Metabolism, Pfizer, Inc.
10:15 Networking Coffee Break
10:30 FDA Guidelines on DDI, Metabolites Identification, etc.
Kathleen Hillgren, Ph.D., Research Advisor, Drug Disposition, Lilly Research Labs
11:15 Questions and Answer – All Speakers
12:00 pm (SC3) Introduction to Drug Metabolism I - Metabolite Profiling Short Course Adjourns
12:10 Lunch on Your Own
(SC4) Introduction to Drug Metabolism II - Drug Interactions: Concerns and Current Approaches
2:00 – 5:00 pm
Course Organizer: Ala Nassar, Ph.D.
This portion of the course will cover the role of cytochrome P450 enzymes in drug-drug interactions in addition to illustrating how toxicity screening using biosensors that measure DNA damage can be useful. Strategies to assess the drug interactions and future FDA guidelines will be addressed.
7:30 am - 6:00 pm Registration Open
2:00 Toxicity Screening Using Biosensors that Measure DNA Damage
James Rusling, Ph.D., Professor, Chemistry, University of Connecticut - Storrs
2:30 DDI Lecture
Jose Manautou, Ph.D., Associate Professor of Toxicology and Marlene L. Cohen and Jerome H. Fleisch Scholar, Pharmaceutical Sciences, University of Connecticut School of Pharmacy
3:00 Role of Cytochrome P450 Enzymes in Drug-Drug Interactions and the Clinical Implications
Andrew Parkinson, Ph.D., Chief Executive Officer, Xenotech
3:30 Networking Refreshment Break in the Exhibit Hall
4:00 Strategies to Assess the Drug Interactions
Larry Wienkers, Ph.D., Senior Director, Pharmacokinetics and Drug Metabolism, Amgen, Inc.
4:30 Drug-Drug Interactions Due to Inhibition and Mechanism-Based Inactivation
Paul F. Hollenberg, Ph.D., Maurice H. Seevers Collegiate Professor and Chair of Pharmacology, The University of Michigan Medical School.
5:00 Questions and Answers - All speakers
5:10 pm (SC4) Introduction to Drug Metabolism II - Drug Interactions: Concerns and Current Approaches Short Course Adjourns
5:10 Happy Hour in the Exhibit Hall
(SC6) Animal Models for Drug Discovery & Pain
2:00 – 5:00 pm
This short course will highlight specific steps to building better animal models for drug development in the pain area. The session will begin by addressing the ethical considerations of animal research and a framework for identifying appropriate species and models (e.g. surgical v. irritant, disease specific v. general). The tutors will also discuss how to better identify and understand the critical biological, histological and electrophysiological endpoints of your programs. Applications of animal research in inflammatory, neuropathic and cancer pain will be highlighted.
2:00 Ethics, Species & Strains Considerations
Uri Herzberg, D.V.M., Ph.D., Principal Scientist, Johnson & Johnson
2:15 Translational Studies and Behavior-Related Issues in Various Models
Eli Eliav, Ph.D., DMD, Director of Orofacial Pain, UMDNJ – New Jersey Dental School
3:05 Special Issues in Inflammatory & Neuropathic Pain
George L. Wilcox, Ph.D., University of Minnesota Medical School
3:35 Networking Refreshment Break in the Exhibit Hall
3:55 Special Issues in Inflammatory & Neuropathic Pain, (cont'd.)
George L. Wilcox, Ph.D., University of Minnesota Medical School
4:10 Chemotherapy Models
Gary J. Bennett, Ph.D., McGill University
5:00 Animal Models for Drug Discovery & Pain Short Course Adjourns
7:30am – 5:45pm Registration Open
5:45 Daniele Carettoni, Ph.D., Head, Biochemistry, Axxam SpA
6:45-7:45 Dinner
7:45 Xuedong Liu, Ph.D., Associate Professor, Chemistry & Biochemistry, University of Colorado-Boulder
8:45 (DC1) Dinner Course: Development of Tools and Assays Biochemical-Based Screening Dinner Course Adjourns
