Guide to Drug Development, A Comprehensive Review & Assessment

Written by one of the foremost authorities on clinical trials, drug development, and regulatory affairs, Guide to Drug Development is a comprehensive review of the principles and activities involved in developing new drugs, devices, and other medical products. The book covers many topics not discussed in any other textbook and includes timely discussions on electronic clinical trials, registries of clinical trials, data mining, computer simulations and modeling, and changing regulatory standards.

Each chapter includes practical tips, lessons, guides, firsthand stories, quotes from experts, and three to six questions for group discussion. The last three chapters present twelve case studies each on clinical trials, regulatory affairs, and management of drug development.

Spilker's Guide to Drug Development will be the standard reference text for everyone working on or studying drug discovery or development, in industry, academia, hospitals, government, and independent laboratories.


Table Of Contents
SECTION 1

Introduction and Overview of a Company and the Industry
Introduction to Drug Development

Pharmaceutical Industry: Definitions

The Big Picture

Standards: Types, Uses, and Issues

Pharma-think, Academic-think, and Government-think

Pharma Sense versus Common Sense

Section 2

Basic Principles, Strategies, and Approaches

Overview of Factors Affecting Drug Discovery

The Drug Discovery Process

Golden Rules of Drug Discovery

The Drug Development Process

Golden Rules of Drug Development

Biotechnology

Extrapolating Animal Safety and Efficacy Data to Humans

Evaluating and Interpreting Data

Stimulating Innovation and Increasing Efficiency with the Right Questions, People, Milieu, and Approaches

A New Paradigm of Drug Development

Future Environments for Drug Discovery and Development

Section 3

Corporate Organization and Management Issues

Models of International Operations

Organization at the Corporate Level

Corporate Management

Reducing Pharmaceutical Risk

Enhancing Communication

Personnel and Staffing Issues

Competitive Intelligence

Conflicts of Interest and Bias

Crisis Management

Mergers, Joint Ventures, and Alliances

Pharmacopolitics

Institutional Memory

Differences among Pharmaceutical Companies

Section 4

External Corporate Relationships and Interactions

Interactions and Relationships between Academicians and Industry

Investigator-sponsored Research Proposals Submitted to Industry

Technology Transfer from Academia to Industry

Interactions between Pharmaceutical Companies

Interactions with Trade Associations

Interactions with Legislators and Government Agencies

Interactions and Relationships with Healthcare Professionals

Interactions with Patients and the Public

Patient Package Inserts

Interactions and Relationships with the Media

Section 5

Research and Development Organization, Management, and Assessments

Organizing Research and Development

Managing Research and Development and Avoiding Tangents

Personnel Issues in Drug Discovery and Development

Myths about the Pharmaceutical Industry and Drug Development

Fads and Fashions in Drug Development

The Many Facets of Reality: Approaches to Issues and Problems

International Organization and Management

Project Management: Balancing Line Function and Matrix Approaches

Choosing the Number and Types of Drugs to Develop

Choosing Standards for Developing Drugs

Creating and Using Benchmarks

Evaluating a Portfolio of Investigational Drug Projects

Compassionate Use Programs

Virtual Drug Development

Developing and Marketing Orphan Drugs for Rare Diseases

Productivity and Project Success

Overview of Safety and Risk Management

Developing Standard Operating Procedures

Section 6

Clinical Activities and Issues

Introduction to Clinical Trials

Creating a Clinical Strategy and Development Plan for a New Drug or Indication

Designing and Implementing a Clinical Trial

Questions to Ask about a Clinical Trial Protocol

Dose-esponse Relationships in Clinical Trials

Collecting and Interpreting Life Events Data in Clinical Trials

Quality of Life and Pharmacoeconomics in Clinical Trials

Overview of Phase 4 and Postapproval Clinical Activities

Phase 4 Trials and Postapproval Pharmacovigilance Methodologies

Feasibility of Multinational Trials

Groups that Influence Protocol Design

Monitoring and Auditing a Clinical Trial