SPS is proud to offer the recorded Continuing Education (CE) Courses as part of our enhanced educational opportunities. The online CE Courses are available to SPS members and nonmembers. If you attended any of the courses listed below during the annual meeting, you may access it online free of charge. For those who did not participate in the course at the annual meeting there is a registration fee of $75.
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|AM3|| Supplemental Safety Pharmacology Studies
|AM4|| Microsampling Techniques and Novel Applications in Exposure Assessment
|PM5|| Drug Abuse Liability Testing
|AM2|| Safety Pharmacology Endpoints in Toxicology Studies
|PM4|| SAFETY Biomarkers—What Every Safety Pharmacologist Should Know!
(Click on course title to show/hide description)
Co-Chairs:Alfred Botchway, MSc, PhD, Xenometrics, Stilwell, KS, United States, and Jeffrey McKee, PhD, MS, PhD, DABT, Baxter, Round Lake, IL, United States
The ICH S7A guidelines have recommended that when concerns arise from core battery studies, clinical trials, post marketing surveillance, or from other nonclinical studies, then it is prudent to conduct supplemental safety pharmacology studies. These supplemental studies are designed to evaluate potential adverse pharmacodynamic effects on organ system functions not addressed by the core battery or repeated dose toxicity studies. This course will provide to individuals involved in the development of therapeutic agents. The session will focus on study designs and sample results used to evaluate the renal/urinary, autonomic and gastrointestinal system, and understanding the physiological basis of the supplemental tests.
Gastrointestinal Assessment—In Vitro and In Vivo Models
Stephane Milano, PhD, Ricerca Biosciences, Lyon, France Stephane
Integrative Assessment of Drug-Induced Kidney Injury and Function Changes
Yafei Chen, MD, MS, AstraZeneca Pharmaceuticals, Waltham, MA
Evaluation of the Effects of Pharmaceuticals on the Immune System
Jacques Descotes, MD, PhD, PharmD, FATS, Poison Center and Pharmacovigilance Department, Lyon, France
Stephane Milano, Alfred Botchway, Yafei Chen, and Jacques Descotes
Co-Chairs: Stephen Ploch, PhD, DABT, Covance Laboratories, Madison, WI, United States and Russell Bialecki, PhD, AstraZeneca, Wilmington, DE, United States
This course will deliver general principles and technologies of modern pharmacokinetic sampling, data acquisition, manipulation and interpretation, and current status of microsampling/dried blood spot technologies for safety pharmacologists. Recent advances in microsampling and enhanced bioanalytical assay sensitivity afford opportunities to improve study data quality, reduce animal study numbers (Refinement and Reduction improvements) and to identify biomarkers with which to mitigate risk in human clinical trials. Participants will: 1) Identify the reasons to consider inclusion of test article exposure measurements in safety pharmacology study plans; 2) Identify regulatory guidance and regulation pertinent to test article exposure monitoring in safety pharmacology study designs; 3) Identify specific strategies, advantages and disadvantages for exposure monitoring in study plans; and 4) Identify new technologies and techniques that reduce or eliminate obstacles to test article exposure monitoring in safety pharmacology studies.
Introduction to Toxicokinetics
Simon Parry, GlaxoSmithKline, Ware, United Kingdom
Dried Blood Spot (DBS) and Other Micro-volume Sampling Strategies: Applications in Exposure Assessment
Stephen Ploch, PhD, DABT, Covance Laboratories, Madison, WI, United States
Leveraging Radio Telemetry and Automated Blood Sampling Capabilities in Pharmaceutical Drug Discovery and Safety Assessment: An Integrative Pharmacological Approach
Russell Bialecki, PhD, AstraZeneca, Wilmington, DE, United States
Chair: Greet Teuns, DVM, MSc, MSc Applied Toxicology, Janssen R&D, Drug Safety Sciences, Beerse, Belgium
Drug abuse liability testing has become a hot topic in drug development and in particular within the nonclinical safety evaluation area since the release of the EMEA guideline (March 2006), the ICH guideline (June 2009) and recently the U.S. FDA draft guidance January 2010). This course is meant to give a broad overview of the various aspects on drug abuse liability and the implications hereof on drug development. New technologies that might help in the evaluation of withdrawal will be demonstrated. Given some case studies, the impact of a preclinical abuse liability assessment of new compounds will be discussed with regard to the translational approach and the possible ways to move forward in late drug development and beyond.
Drug Abuse Liability: An Overview
Greet Teuns, DVM, MSc, MSc Applied Toxicology, Janssen R&D, Drug Safety Sciences, Beerse, Belgium
Preclinical Testing of Drug Abuse: Physical Dependence and Methods to Evaluate Withdrawal Effects in Rats
Paul Moser, PhD, Institut de Recherche Pierre Fabre, Castres, France
The Development and Evolution of an Abuse Liability Package: Demonstration through Case Studies
Andy Mead, PhD, Pfizer Inc., Groton, CT, United States
Interpretation and Resolution of Intermediate Levels of Responding on Abuse Liability Assays: A Case Study
Theodore Baird, PhD, MPI Research Inc, Mattawan, MI, United States
Translation of Preclinical Abuse Liability Assessment
Mary Jeanne Kallman, PhD, Covance Laboratories, Inc., Greenfield, IN, United States
Co-Chairs: Scott R. Tiesma, Data Sciences International, St. Paul, MN, United States, and Robert Austin LaFrance, Pfizer, Inc., Groton, CT, United States
Stand-alone safety pharmacology studies are typically conducted by exposing subjects to a single administration of a test article at multiple dose levels. Such dedicated studies provide invaluable information to assess potential risk to vital organ systems of participants in first-in-human studies. Integration of safety pharmacology assessments into repeat-dose toxicity studies enables evaluation of functional changes following the administration of multiple doses. Such an evaluation may provide for a more robust safety evaluation—better predicting potential risk in later clinical trials where exposure to the test article is of longer duration. The course will focus on considerations when combining studies, examples of successful integrations for new chemical and biological entities, and conclude with a preview of the forthcoming safety pharmacology recommendations on this topic.
Frederick J. Sannajust, Pharm., PhD, Prof., 3P-CA Consulting Services, Inc., Pleasanton, CA, United States
Considerations When Combining Studies
Mike Foley, DVM, PhD, Covance Laboratories, Madison, WI, United States and Robert A. Kaiser, PhD, DABT, Charles River, Reno, NV, United States
Case Study: Functional Endpoints in Repeat-Dose Toxicity Studies on Conventional NCEs
William S. Redfern, PhD, FSB, AstraZeneca, Macclesfield, London, United Kingdom
Case Study: Large Molecule Safety Pharmacology: Collecting JET ECGs from the NHP in a Repeat-Dose Toxicology Study—Specific Issues Related to Large Molecules
Michael Engwall, DVM, PhD, Amgen Inc., Thousand Oaks, CA, United States
Case Study: Large Molecule Safety Pharmacology: Collecting JET ECGs from
the NHP in a Repeat-Dose Toxicology Study—Blood Pressure Data Collection in Toxicology Settings
Stephen C. Foote, PhD, Pfizer Global R&D, Groton, CT, United States
Summary and Wrap-Up
Simon Authier, DVM, MBA, PhD, CiToxLAB, Laval, QC, Canada, and Mark Holbrook, PhD, Covance, Harrogate, North Yorkshire, United Kingdom
Co-Chairs: Lewis B. Kinter, PhD, DABT, AstraZeneca, Wilmington, PA, United States, and David K. Johnson, DVM, DACLAM, Cascades Biosciences Consultants, Inc., Sisters, OR, United States
SAFETY Biomarkers: What Every Safety Pharmacologist Should Know is an introduction to safety biomarker science and applications in nonclinical safety studies, with emphasis upon the ICH S10 Safety Pharmacology Core Battery Organ Systems. Faculty will address the origins, science, current status and regulatory expectations for safety biomarkers used in nonclinical and clinical settings, and include considerations for using traditional safety pharmacology endpoints as biomarkers, and inclusion of new biomarkers as safety pharmacology endpoints. Current status of safety biomarkers for drug-induced injury of cardiac/cardiovascular, CNS/neuromuscular, and renal systems will be presented.
David K. Johnson, DVM, DACLAM , Cascades Biosciences Consultants, Inc., Sisters, OR, United States
Biomarkers of Cardiovascular Stress
Pamela Gayheart-Walsten, PhD, Xenometrics, Stilwell, KS, United States
Next Generation Kidney Injury Biomarkers
Lewis B. Kinter, PhD, DABT, AstraZeneca, Wilmington, PA, United States, and Matthew Wagoner, PhD, AstraZeneca Pharmaceuticals, Waltham, MA, United States
Functional Biomarkers of Drug-Induced CNS Adverse Effects
Carlos Fonck, PhD, AstraZeneca Pharmaceuticals, Waltham, MA, United States
Novel Fluid-Based Biomarkers of Neurotoxicity
Andreas Jeromin, PhD, Banyan Biomarkers, Inc., Alachua, FL, United States
Lewis B. Kinter, PhD, DABT, AstraZeneca Pharmaceuticals, Wilmington, PA, United States