SPS 2008 Sponsors

Diamond
($15,000+)

Emerald
($10,000 to $14,999)

Ruby
($6,000 to $9,999)

Opal
($3,000 to $5,999)

Sapphire
(Up to $2,999)

Lewis B. Kinter & Terry Timberlake-Kinter

Continuing Education

Monday, September 22, 2008

Morning Courses: CE(1), CE(2), CE(3), CE(4)
Afternoon Courses: CE(5), CE(6), CE(7), CE(8)

Intro to SP (S7A)
Chaired by: Jay Gizzi, Data Sciences International, and Jeff McKee, Baxter

The discipline of Safety Pharmacology contributes to the overall risk assessment of novel therapeutics by identifying potentially adverse physiological effects and defining a safe starting dose in man.  The governing document is the ICH Harmonised Tripartite Guideline titled “Safety Pharmacology Studies for Human Pharmaceuticals (S7A).”  This document serves as a guideline and provides recommendations regarding the approach to evaluate the risk potential of new therapeutics with respect to core organ systems (e.g., cardiovascular, respiratory and central nervous systems), supplemental organ systems (e.g., GI and renal) and follow-up studies to further describe effects and mechanisms of action.  The objective of this course is to provide a basic, broad overview of Safety Pharmacology to individuals involved in the development of therapeutics.  Although geared more toward new scientists in the discipline, this course will hopefully serve as an effective refresher for individuals whose expertise is limited to a particular organ system.  This course will include presentations from principal investigators in the discipline emphasizing the principles and current methods specific to the relevant organ systems and will conclude with small-group evaluations of selected case studies.

Intermediate CV (S7B)
Chaired by: Angela Jenkins, Research Associate, Safety Pharmacology, Covance Laboratories, Madison, WI USA

Focusing on the fundamentals of cardiovascular Safety Pharmacology studies, this course is intended for individuals with previous knowledge of cardiovascular Safety Pharmacology and interested in learning more about cardiovascular safety studies.  This is an “everything you want to know about the cardiovascular system” course.  Electrophysiology, electrocardiography, cardiac function, and practical applications used in non-clinical safety assessment studies are examples of topics covered in this course.  Each lecture will include case studies where participation from the attendees will be highly encouraged. 

Respiration Safety Pharmacology: An Advanced Course
Chaired by: Steve Hachtman, Data Sciences International

This course is intended for scientists and researchers interested in obtaining a more in-depth understanding of the pharmacology, physiology, and measurement methods related to the respiratory system.  Participants are expected to have a fundamental understanding of the respiratory system.  Current approaches and methodologies used to assess respiratory dynamics in laboratory animal model studies and the interpretation and significance of the endpoints obtained by these modern measures will be addressed.  The mechanics of common respiratory disorders will also be explored and will include discussion of ventilatory, airway, alveolar and interstitial lung pathophysiology.   Body responses to injury and effects of system changes to airway resistance and air flow mechanisms will be linked with oxygen transport and the time course of body changes in function.   Implications of system changes to airway resistance and airflow mechanisms which are associated with respiratory safety assessment will be discussed in the context of current methods and measures.   Cardiac respiratory interactions as expressed in the relationships between pulmonary functional changes and their impact on cardiovascular function will be explored.   Non human primate modeling of asthma for safety and new compound assessment will be presented with the focus on methods and techniques that maximize outcome and predictability.   Session participants will gain an improved understanding of the mechanics of respiratory function, the influence of drugs on respiratory function, and the utility of current methodologies to assess respiratory function in contemporary laboratory animal models.

Integrated SP & Organ Systems
Chaired by: Alfred Botchway, Ph.D., Xenometrics and Dave Johnson, DVM, Harlan

Gastrointestinal effects are recognized as a prominent side effect of therapeutic agents across several indications. The first lecture will focus on physiology and methodology available to safety pharmacologists. Case studies will be presented and attendee participation is essential.  Safety Pharmacology in Discovery/Development will provide an overview to drug discovery and development with particular emphasis to the role of Safety Pharmacology.  The final session, titled Animal Welfare for Safety Pharmacologists: A Survival Guide will feature -

• Current Regulations and trends: North America
• Current Regulations and trends in Europe and Rest of World
• Safety Pharmacologists' Survival Guide

Intermediate CNS
Chaired by: JoAnne Saye, AstraZeneca Pharmaceuticals

This course will explore some more advanced behavioral and electrophysiological techniques available for evaluation of key nervous system functions that are not adequately addressed by the core battery.  These include assessment of abuse potential, visual function, EEG, and nerve conduction velocity measurements.  In Europe, guidelines were adopted in 2006 outlining a suggested strategy for evaluating the abuse/dependence potential of new CNS active compounds; this course will discuss this strategy and appropriate assays to use with a discussion on data interpretation.  Retinal toxicity is generally a ‘show stopper’ in preclinical development program, accounting for approximately 7% of candidate drugs that fail in development.  The second lecture will describe techniques to assess visual function in vivo, including the development of a new, convenient method of quantifying visual acuity in rodents, suitable for inclusion in early Safety Pharmacology and toxicology studies.  This course will also address the use of EEG to evaluate effects of NCEs on CNS function relating to seizure and sleep-wake patterns.  The course will conclude with a discussion on peripheral neuropathies and how they can be evaluated, including the use of nerve conduction velocity measurements.  Some case studies will be discussed to illustrate the relevance of the non-clinical data to clinical data.

ECG Reading and Interpretation
Chaired by: R. Dustan Sarazan, DVM, Ph.D., Covance

This course will be team taught by two world leaders in the fields of human and veterinary cardiology.  This will be a combined lecture & workshop, covering basic electrocardiography, including qualitative and quantitative assessment of ECGs.  By the end of the day, attendees are expected to be able to:

1. Identify the components of a normal ECG
2. Recognize common arrhythmias
3. Perform quantitative measurement of PR, QRS and QT durations and intervals

Participation in the morning CE course, Intermediate Cardiovascular, is strongly recommended prior to attending this class.

PK/PD, Array, Spotfire®: What Are the Data Solutions for SP?
Closing the gap between biological relevance and statistical significance: 
Ideas/methods for experimental design, data collection and data analysis.
Chaired by: Brad Main, Eli Lilly & Company

How can an assessment of safety be accomplished earlier in drug development without increased cost?  What are some ways to improve the sensitivity of test systems?  How can innovation be used to make Safety Pharmacology more about selecting safe compounds rather than the process of describing pharmacology on already selected candidates? This class will look at ways to accomplish the challenges we have today by exploring how to use such tools as PK/PD models and experimental design to increase sensitivity without increasing the number of test subjects on studies.  Additionally we will look at the challenge of dealing with very large data sets, and novel ways to evaluate safety data by visually exploring parameter relationships.  This course is targeted at individuals who are familiar with the basics of Safety Pharmacology, but would like to gain insight into using novel approaches to data collection and analysis.

Advanced Topics in SP: Case Studies from Drug Selection to NDA
Chaired by: Richard Briscoe, Ph.D., and Pierre Morisette, Ph.D., Merck & Co., Inc.

This course is designed as an advanced level course and will focus on the results of non-clinical Safety Pharmacology studies and how these studies impact drug selection, clinical development and registration of pharmaceuticals. To realize the most benefit from the course, attendees should have a general Safety Pharmacology background and understand the basic core battery assessments described in ICH S7A and S7B guidelines. A basic understanding of the stages of clinical development would also be useful.  A mixture of topics from various stages of drug development will be presented and discussed in the context of how to work through problematic Safety Pharmacology data utilizing follow-up Safety Pharmacology and/or clinical studies. Scenarios in chronopharmacokinetics, cardiovascular, respiratory and central nervous systems will be discussed. The intent of this course is as an interactive facilitated discussion. The course instructors will present scenarios and facilitate the discussion with course participants. Course participants are encouraged to submit brief cases (3 to 4 PowerPoint slides) to the course facilitators prior to the meeting to allow broader experiences for the discussion.