Safety Pharmacology in Drug Development

This two-day course is designed for individuals in the pharmaceutical and biotechnology industry, as well as, those with contract research organizations (CROs) whose responsibilities require an understanding of the importance and options for conducting core safety pharmacology studies in drug development. These include, but are not limited to, personnel in the following areas:

• Pre-Clinical Safety Assessment
• Discovery and Start-up
• Pharmaceutical Consulting
• Pharmaceutical Investments
• Project Compound Development
• Quality Assurance
• Regulatory Compliance and Document Submissions
• Business Development and Client Services

Learning Objectives

Upon completion of this course, each participant will:

• understand ICH S7A and ICH S7B guidelines for the conduct of core safety pharmacology studies
• become familiar with the staging of work in relation to the overall pharmaceutical development package
• understand commonly used experimental models and their significance including prototypical safety pharmacology protocols, SOPs, study notation, assessment of data and review of reports

In addition, issues to be covered will include the importance of the Study Director’s role, compliance with GLP, duties of management personnel and the responsibilities of study technicians.

Course Description

This course provides individuals with an in-depth understanding of the importance of safety pharmacology by minimizing the risk of product failure, predicting potential safety concerns and protecting human subjects, especially Phase I clinical trial volunteers. This training covers the requirements of the safety pharmacology component of the IND in relation to timing of preclinical safety assessment within the drug development process. It provides an expanded knowledge of international regulatory guidelines for safety pharmacology, typical types of safety studies and how to effectively ensure that all work functions are conducted within GLP regulatory guidelines.

The course is designed to provide the attendee with thorough knowledge of the following topics:

• a regulatory historical perspective
• aims of safety pharmacology evaluations
• the pharmaceutical development process and timing of safety pharmacology studies
• overview of safety pharmacology guidance documents
• core safety pharmacology studies
 cardiovascular studies
 nervous system
 respiratory system
 supplemental studies
• design and review of protocol
• in-life and procedural considerations
• study audit
• data and report review

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COURSE AGENDA

DAY ONE

Course Schedule and Introductions

The Role of Safety Pharmacology in the Drug Development Process
• Brief Overview of the Pharmaceutical Development Process
• History of Safety Pharmacology
• Purpose of Safety Pharmacology Evaluations

ICH S7A and S7B Guidelines

Lunch

Types of Safety Pharmacology Studies

Cardiovascular
• hERG and Other Ion Channels
• Action Potential Duration
• Whole Animal Cardiovascular Assessment
• Tier II Studies

Respiratory
• Whole-body Plethysmography
• Tier II Studies

DAY TWO

Types of Safety Pharmacology Studies (cont’d)

CNS
• Irwin Screen
• Functional Observation Battery
• Tier II Studies

Supplemental
• Gastrointestinal Tract
• Renal Function
• Bladder Function

Special Cases
• No Preclinical Species Equivalent for Target Molecule
• Oncology Compounds
• Biotechnology-Derived Pharmaceuticals

Lunch

Study Protocol
• Design Elements
• Review Process

In-life and Procedural Considerations
• Drug Dispensary, Formulation and Solutions
• Animal Care and Facilities
• Study Notebook

Study Audit
• Quality Assurance
• Standard Operating Procedures

Study Report
• Data Evaluation and Presentation
• Scientific interpretation
• Summary
• Management Review