Please note that participation in the Continuing Education course requires attendees to register for the courses. See Continuing Education site for course descriptions.

Morning Courses: CE(1), CE(2), CE(3), CE(4)
Morning Courses include a continental breakfast and refreshments during the break. Morning Course Schedule (may vary depending on course).

Afternoon Courses: CE(5), CE(6), CE(7), CE(8)
Afternoon Courses include a box lunch that can be picked up in the respective meeting room at 12:30 PM and refreshments during the break. Afternoon Course Schedule (may vary depending on course).

Welcoming Reception
Rooftop Terrace

This hour and half reception will be an opportunity to see old friends and make new acquaintances.

All SPS Hosted Functions Adjourn

Continental Breakfast
Exhibit Hall

President’s Keynote Address
Craig T. January, MD, PhD, FACC University of Wisconsin-Madison, Madison, WI, USA
Discovery of hERG: Historical Perspectives and Contemporary Concerns
Ballroom AB

Break
Exhibit Hall

ECG and Blood Pressure as Biomarkers—Orthostatic Hypotension
Speaker: Nancy Poy, DVM, Pfizer, Groton, CT, USA

Ultrasound as a Biomarker of Cardiovascular Function: Valves, Hypertrophy, and Vascular
Speaker: Brian Hoit, MD, Professor of Medicine, Case Western Reserve and Department of Cardiology and Internal Medicine, Case Western Reserve University and University Hospitals of Cleveland, Cleveland, OH, USA

Serum Chemistry Parameters as Cardiovascular Biomarkers
Speaker: David Watson, PhD, Research Advisor Investigative Toxicology, Eli Lilly & Co., Indianapolis, IN, USA

B. Emerging Technologies (Session Co-Chairs, Anthony Bahinski and Craig January)
Ballroom AB

Stem Cells Session Overview:
The field of stem cell research has been rapidly accelerating in the last several years. The development of validated human cell-based in vitro safety screens has the potential to facilitate earlier attrition of compounds with unacceptable safety profiles. This session will focus on recent efforts to develop a new source of pluripotent stem cells from somatic tissue and on the development of in vitro models using stem cell derived human tissue for drug safety evaluation.

Human Induced Pluripotent Stem (iPS) Cells: Implications for Drug Screening
Speaker: James S. Thomson, VMD., PhD, University of Wisconsin-Madison, Madison, WI, USA

Human Pluripotent Stem Cell-Derived Cardiomyocytes for Safety Pharmacology Applications
Speaker: Timothy J. Kamp, MD, PhD, University of Wisconsin-Madison, Madison, WI, USA

Human Embryonic Stem Cells Provide a Robust Source of Neural Cells for Drug Discovery and Toxicity
Speaker:Steven L. Stice, PhD, The University of Georgia and Aruna Biomedical Inc., Athens, GA, USA

C. Integrated Systems Physiology (Session Co-Chairs: Maxim Soloviev and Franz Hock)
Ballroom C

Introduction to Chronobiology
Speaker: Björn Lemmer, MD, PhD, Professor and Director, Institute of Pharmacology and Toxicology, Ruprecht-Karls University, Heidelberg, Germany

Chronopharmacokinetics
Speaker: Björn Lemmer, MD, PhD, Professor and Director, Institute of Pharmacology and Toxicology, Ruprecht-Karls University, Heidelberg, Germany

Vascular Consequences of Sleep Disordered Breathing
Speaker: Barbara Morgan, PhD, PT, University of Wisconsin-Madison, Madison, WI, USA

Mechanisms of Intermittent Hypoxia Induced Respiratory Plasticity: A Guide for Novel Therapeutic Approaches to Sleep Apnea?
Speaker: Gordon Mitchell, PhD, University of Wisconsin-Madison, Madison, WI, USA

Poster Viewing: All Attendees are encouraged to visit the exhibit hall to view the posters and to learn about the latest technology and services available to the field of safety pharmacology.

Poster Presentation Judging.

2:00 PM	OVERVIEW OF THE JOINT PHRMA-FDA DIALOGUE SESSION ON ABUSE POTENTIAL Carrie Markgraf
2:15 PM	STRATEGY TO REDUCE SEIZURE LIABILITY-Hippocampus slices Elizabeth Bell
2:30 PM	EVALUATION OF MORPHINE WITHDRAWAL EFFECTS USING TELEMETRY Paul Moser
2:45 PM	GLP-COMPLIANT DRUG SELF-ADMINISTRATION IN THE NON-HUMAN PRIMATE David V. Gauvin

2:00 PM	CORRELATION BETWEEN EJECTION FRACTION AND DP/DT+ IN CONSCIOUS TELEMETERED DOGS DOSED WITH ATENOLOL Helen Prior
2:15 PM	USE OF EMBRYONIC STEM CELL DERIVED CARDIOMYOCYTES FOR DETERMINATION OF CARDIAC CYTOTOXICITY Silke Schwengberg
2:30 PM	APEX-TO-BASE DISPERSION IS GREATER THAN TRANSMURAL DISPERSION OF REPOLARIZATION IN AN INTACT ISOLATED RABBIT HEART MODEL Nicolas Guerard
2:45 PM	DIFFERENCES IN ECG INTERVALS AND RESTITUTION PARAMETERS IN THE CONSCIOUS SLING-TRAINED CANINE MODEL OF SHORT QT SYNDROME Anusak Kijtawornat

A. Translational (Session Chair, Ian MacKenzie)
Ballroom D

EEG: Relevance in the Evaluation of Sedation and Seizure Risk
Speaker: Joseph Arezzo, PhD, Albert Einstein College of Medicine, Bronx, NY, USA

B. Emerging Technologies (Session Chair, Anthony Bahinski)
Ballroom AB

Session Overview:
With increasing emphasis on mechanistic studies, the emergence of biotherapeutics and earlier involvement in the drug discovery process, there is an increasing need for novel in vivo models beyond the core battery of safety pharmacology assays. This session will focus on recent efforts to use RNAi and transgenic animals to provide early insights into target safety.

Genetically Modified Animals and Safety Testing
Speaker:Sandra J. Engle, PhD, Pfizer, Inc., Groton CT, USA

Enabling Targeted siRNA Delivery In-vivo Using Dynamic PolyConjugate Technology
David L. Lewis, PhD, MirusBio Corporation, Madison WI, USA

Novel In-vivo models—KO Rat Models
Speaker: Alexandre Fraichard, PhD, MBA, genOway, Lyon, France

C. Integrated Systems Physiology (Session Chair, Ted Baird)
Ballroom C

Neural Regulation of the Gastrointestinal Tract
Speaker: Gary M. Mawe, PhD, University of Vermont, Burlington, VT, USA

Mechanisms of Visceral/Cardiac Pain Perception
Speaker: Robert D. Foreman, PhD, Department of Physiology, University of Oklahoma Health Sciences Center, Oklahoma City, OK, USA

Exhibit Hall Closed

All SPS Functions Adjourn

Continental Breakfast
Exhibit Hall

A. Translation: Issues in Personalized Medicine (Session Chair, Dusty Sarazan)
Ballroom D

Mommies Cry Too: A Personal Story of Surviving Post Partum Depression Medication and an Unknown Cytochrome P450 Deficiency
Speaker: Carolyn Brink (http://www.mommiescrytoo.com)

The Science Behind the Story: CYP450 Polymorphisms in Patients
Speaker: Steven Wrighton, PhD, Eli Lilly & Co., Indianapolis, IN, USA

B. Emerging Strategies—Advancement in Modeling of Drug-Induced Torsades des Pointes (Session Co-Chairs, Alan Bass, Neils-Christian Ganderup and Josh Burton)
Ballroom AB

Progress Towards Advancement of Preclinical Modeling for Drug-Induced Torsades des Pointes
Speaker: Alan Bass, PhD, Schering-Plough, Kenilworth, NJ, USA

Ca²⁺ Handling by Ventricular Myocytes is a predictor of Vulnerability to Torsade de Pointes in Drug-Induced Long QT Type 2
Speaker: Guy Salama, PhD, University of Pittsburg, Pittsburg, PA, USA

Alternative Mechanisms of Drug-Induced QT Prolongation—Beyond hERG
Speaker: Jean-Pierre Valentin, PhD, AstraZeneca, Macclesfield, UK

Emerging Issues in Safety Pharmacology—Survey of Industry Identifying Consortia Projects
Speaker: Neils-Christian Ganderup, MSc Biology, Ellegaard Göttingen Minipigs, Dalmose, Denmark

C. Integrated Systems Physiology (Session Chair, Scott Mittelstadt)
Ballroom C

Mechanisms of Platelet-Mediated Thrombosis
Speaker: John Folts, PhD, Professor of Medicine, Director, Coronary Thrombosis Research and Prevention Laboratory, University of Wisconsin-Madison, Madison, WI, USA

Central Mechanisms of Baroreflex Control of Blood Pressure
Speaker: Jeanne Seagard, PhD, Department of Anesthesiology, Zablocki Department of Veterans Affairs Medical Center, Medical College of Wisconsin, Madison, WI, USA

A. Translational (Session Chair, Dusty Sarazan)
Ballroom Room AB

Intent and Current Utilization of ICH S7B Guidelines: Phrma and FDA Perspectives
Speaker: Peter K. S. Siegl, PhD, Siegl Pharma Consulting LLC, Blue Bell, PA, USA and John E. Koerner, PhD, Senior Pharmacologist, Division of Cardiovascular and Renal Products, U.S. Food and Drug Administration, Silver Spring, MD, USA

B. Emerging Strategies: Strategies for Combating Attrition in Discovery (Session Chair, Alan Bass)
Ballroom D

Emerging Drug Safety: Combating Attrition in Discovery as a Way of Mitigating Failure in Development
Speaker: Alan S. Bass, PhD, Schering-Plough, Kenilworth, NJ, USA and Mark E. Cartwright, DVM, PhD, Drug Safety, Schering-Plough, Kenilworth, NJ, USA

Frontloading Safety Pharmacology in Support of Selectiing the Best Compounds for Development
Speaker: Silvana Lindgren, PhD, Safety Assessment, AstraZeneca R&D, Sodertalje, Sweden

C. Integrated Systems Physiology (Session Chair, Dennis Murphy)
Ballroom C

Ventilatory Control: Carotid Body Plasticity and Pharmacology
Speaker: Gerald Bisgard, DVM, PhD, Professor Emeritus Comparative Biosciences, University of Wisconsin-Madison, Madison, WI, USA

Effects of Gender and Age on Ventilatory Control
Speaker: Mary Behan, PhD, Veterinary Medical School, University of Wisconsin-Madison, Madison, WI, USA

Safety Pharmacology Society Annual Meeting & Awards
Ballroom AB

Lunch Break: The buffet lunch will be serviced in the Exhibits Hall.

Poster Viewing:All Attendees are encouraged to visit the Exhibit Hall to view the posters and to learn about the latest technology and services available to the field of safety pharmacology.

A. Invited Oral Communications 3: "Ins and Outs" and "Everything in Between"
Ballroom AB

2:00 PM	FAST, EFFORTLESS AND ACCURATE MEASUREMENT OF GLOMERULAR FILTRATION RATE IN CONSCIOUS MONKEYS Alain-Sticker Krongrad
2:15 PM	URODYNAMICS TELEMETRY: A TOOL FOR INVESTIGATING THE URINARY BLADDER FUNCTION IN CONSCIOUS CYNOMOLGUS MONKEY Stephane Milano
2:30 PM	MOUSE: MORE SENSITIVE THAN RAT OR GUINEA PIG FOR ASSESSING RESPIRATORY DEPRESSANT POTENTIAL OF DRUGS Sandra Picard
2:45 PM	THE SMARTPILL FOR GASTROINTESTINAL MONITORING IN DOGS Helen Penton

B. Invited Oral Communications 4: Predicting Cardiovascular Liabilities: Part 2
Ballroom C

2:00 PM	A HESI CONSORTIUM APPROACH TO ASSESS THE HUMAN PREDICTIVE VALUE OF NON-CLINICAL REPOLARISATION ASSAYS Jean-Pierre Valentin
2:15 PM	EVALUATION OF THE PRO-THROMBOTIC EFFECT OF COX-2 INHIBITOR ROFECOXIB IN DOG MODEL OF ARTERIAL THROMBOSIS Aliaksandr Bulhak
2:30 PM	IKS: ANOTHER CARDIOVASCULAR LIABILITY BESIDES HERG, AND USE OF A NOVEL IKS BLOCKER TO SCREEN FOR IKS BLOCKADE Rob Towart
2:45 PM	HIGH DEFINITION OSCILLOMETRY (HDO): A NOVEL METHOD FOR NON-INVASIVE BLOOD PRESSURE MEASUREMENTS IN CYNOMOLGUS MONKEYS Andrea Mitchell

A. Translation Track (Session Chair, Kristy Bruse)
Ballroom AB

Predictivity Model/Frame—What Are the Tools and How Are They Used for Predicting Liability?
Speaker: Rob Wallis, PhD, Pfizer, Sandwich, UK

Panel Discussion—Predictivity and Personalized Medicine
Speakers: Rob Wallis, PhD, Pfizer, Sandwich, UK, Steven Wrighton, PhD, Eli Lilly and Co., Indianapolis, IN, USA, Peter K.S. Siegl, PhD, Blue Bell, PA, USA, and John E. Koerner, PhD, U.S. FDA, Silver Spring, MD, USA

B. Emerging Strategies—Integration of Toxicity and Safety Pharmacology Studies in Risk Assessment (Session Chair, Sharon Rowton and Alfred Botchway)
Ballroom D

Intergration of Functional Endpoints into Repeat-Dose Toxicity Studies
Speaker: Will Redfern, PhD, Safety Pharmacology UK, Global Safety Assessment, AstraZeneca R&D, Alderley Park, Cheshire, UK

Case Studies to Answer Why You Would/Would Not Consider Cross Discipline Assessment
Speaker: Rich Alper, PhD, Pfizer Drug Safety Research & Development, Groton, CT, USA

CV, CNS, Respiratory: How to Use Established Models for Combined Risk Assessment
Speaker: Mary-Jeanne Kallman, PhD, Eli Lillyand Co., Greenfield, IN, USA

C. Integrated Systems Physiology (Session Chair, Ted Baird)
Ballroom C

Visual Electrophysiology in Pre-Clinical Testing
Speaker: James Ver Hoeve, PhD, University of Wisconsin-Madison, Madison, WI, USA

Long-Term Regulation of Blood Pressure
Speaker: Kim Hoagland, PhD, Merck & Co., Inc., West Point, PA, USA

Drug-Induced Activation of Immune Function: Mechanisms and Potential Adverse Effects
Speaker: Curtis Maier, PhD, GlaxoSmithKline Pharmaceuticals, King of Prussia, PA, USA

Exhibit Hall Closed

All SPS Hosted Functions Adjourn

Introduction to Biologics (Session Chair, Tom Beck)
Ballroom AB

Introduction to Biologics
Speaker: Hugo Vargas, PhD, Amgen, Thousand Oaks, CA, USA

This presentation will give an overview of the commonly encountered biologic molecules and touch on potential complexities these types of molecules present for safety pharmacology.

Point-Counter Point: Integration of Safety Pharmacology Endpoints in Toxicology Studies for Biologics Testing (Session Chair, Tom Beck)
Ballroom AB

Speakers: Derek Leishman, PhD, Lilly Research Laboratories, Greenfield, IN, USA and Noel Dybdal, PhD, Genentech, Southern San Francisco, CA, USA

This discussion will present the advantages and disadvantages of incorporation of Safety Pharmacology endpoints into toxicology studies conducted with large molecules. Each speaker will present his or her view and critically evaluate the others views.

Break

Biologics and Safety Pharmacology: A Regulatory Perspective
(Session Chair, Gregory Friedrichs)

Speaker: Michael S. Orr, PhD, DABT, Pharmacology Reviewer, U.S. Food and Drug Administration, Silver Spring, MD, USA

Biologics and Safety Pharmacology: A Clinical Perspective
(Session Chair, Carrie Markgraf)
Ballroom AB

Speaker: Stephen Flach, PhD, Covance Madison, Madison, WI, USA

Closing Remarks
Ballroom AB

Annual Meeting Adjourns