Monday, June 8

9:00am-12:00pm

(SC1) CARDIAC SAFETY: IMPROVING PRE-CLINICAL PREDICTIONS TO BETTER CLINICAL OUTCOMES
Cardiotoxicity is one of the major forms of drug toxicity and accounts for most recalls and delays experienced in drug approvals. One of the biggest challenges is how to predict cardiac risk early and accurately in the drug development process. This course will provide an overview of the recent technical and scientific advances in pre-clinical and clinical safety testing, such as improvements in assay design and reagents, use of new cell lines and animal models for toxicity screening and the use of biomarkers for determining cardiac safety. The discussion is intended to get researchers and clinicians thinking about ways to improve the predictors of cardiac safety by effectively combining the intelligence gathered from pre-clinical screens, with clinical data and post-marketing pharmacovigilance studies. This course provides you with the information to question the validity of the tools for cardiac assessment that are in use today.
Course Instructor: J. Rick Turner, Ph.D., PGCE, President and Chief Scientific Officer, Turner Medical Communications LLC

(SC2) HIGH CONTENT SCREENING – INTEGRATED SOLUTIONS FOR ACCELERATED DRUG DISCOVERY
High Content Screening (HCS) has become an increasingly powerful tool for cell-based target validation, screening, and lead optimization, and has enabled the application of sophisticated assays for large-scale compound screening. We will examine how HCS has evolved into an integrated solution for accelerated drug discovery. We will look at the workflow components of HCS, including assay design, instrumentation for automated fixed-end-point assays and examine the application and benefits of HCS in live cell kinetic analysis. We will also examine advanced BioApplications that produce information on drug responses from cell image data, informatics/bioinformatics solutions and how to deal with data-management issues related to HCS. This course provides you with a foundation in high-content screening and its applications.
Course Instructor: Jie Zheng, Ph.D., Associate Professor, Physiology and Membrane Biology, University of California at Davis School of Medicine

(SC3) AVOIDING PITFALLS IN ALZHEIMER’S CLINICAL TRIAL DESIGN
The design of clinical trials for Alzheimer’s therapeutics has historically suffered from many pitfalls. These include adequate evaluation of cognitive decline, choosing accurate biomarkers, and downfalls in methods for the trials. By avoiding these common errors, more definitive and reproducible results may be obtained. This course provides you with the information you need to design and execute effective Alzheimer’s clinical trials.
Course Instructors: To be announced

2:00-5:00pm

(SC4) ION CHANNEL ASSAYS FOR SAFETY SCREENING
Ion channels are involved in a complex and intricate signaling system that plays an important role in affecting the cellular response to a drug, and hence, to the overall patient safety. Drug-induced alterations in the translation and trafficking of ion channel proteins and drug-induced blockade of channels are all thought to contribute to drug-related adverse events. In vitro assays using isolated cells, cell lines, and expression systems cloned for specific ion channels are now routinely used, alongside electrophysiology experiments, to identify potential drug liabilities. This course provides a detailed overview of the types of ion channel-based screening assays and technologies that are currently in use and how they are being applied to effectively monitor and predict drug safety. This course provides you with an overview of current and emerging ion channel-based assays and when and how to use them.
Course Instructors:
Gary Gintant, Ph.D., Senior Group Leader, Integrative Pharmacology, Abbott Laboratories
Harry Witchel, Ph.D., Senior Lecturer in Physiology, Brighton and Sussex Medical School

(SC5) COLLABORATING TO ACCELERATE THE ADOPTION OF NOVEL TECHNOLOGIES IN THE PRECLINICAL R&D PROCESS
How much does the ‘Not Invented Here’ mentality inhibit new technology assessment/implementation in your organization?
What can be done to lower the barriers for new technology or novel platform adoption?
Can we simplify the technology evaluation process?
Collaborative projects - Is this the solution?
This course provides you with benchmark data techniques to use collaboration options to more efficiently adopt novel technologies.
Course Instructors: Ernie Bush, Ph.D., Vice President,
Collaborative Projects, Drug Safety Executive Council
Judith Marquis, Ph.D., Group Vice President, Pharmacology and Preclinical Development, Genzyme
George McCormick, Ph.D., Vice President, Drug Safety & Disposition, Cephalon
Jack Reynolds, Ph.D., Chairman, Advisory Board, Drug Safety Executive Council

(SC6) ANIMAL MODELS FOR PAIN – IMPROVING TRANSLATION TO THE CLINIC 
This 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 vs. irritant, disease specific vs. general). The instructors 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. This course provides you with the latest progress that has been made in improving animal models of pain.
Course Instructors: To be announced

*Separate registration required