Contents

Introduction 1

1. Health Care and Industry Overview and Challenges 5

Ronald P. Evens

Health Care Issues 5

Industry Statistics (The Pharma and Biotech Industries) 11

Research Activities and Costs 14

R&D Productivity 16

Organization of a Pharmaceutical Company 19

R&D Challenges and Issues 24

Summary of Research and Development Approaches 29

References 31

2. R&D Planning and Governance 33

Ronald P. Evens and Joel Covinsky

Development Schemas and Leadership 34

Clinical Development Strategy 36

Leadership 38

Product Development Paradigm 39

Portfolio Planning Management (PPM) Description 43

PPM Process Components 47

PPM Analyses (Examples) 54

Project Management 60

Summary 62

References 64

Ronald P. Evens

Public/Patient Outcomes 66

Product Outcomes 70

Research Outcomes 73

Data/Information Outcomes 76

Company/Business Outcomes 79

References 82

4. Discovery and Nonclinical Development 84

Stephen F. Carroll

The Discovery Process 85

Targets 93

Products 95

Nonclinical Development and Testing 98

IND-Enabling Studies 102

Added Discovery Work 103

References 106

5. Types of Clinical Studies 107

Lewis J. Smith

Introduction 107

Phase 1 Studies 107

Phase 2 Studies 108

Phase 3 Studies 109

Phase 4 Studies 111

Special Studies 112

Summary 120

References 121

6. Metabolism and Pharmacokinetics 123

Jun Shi, Shashank Rohatagi, and Vijay O. Bhargava

Introduction 123

Value of PK/PD 124

PK/PD Concepts 126

Drug Development Value Chain 132

References 147

7. Laws and Regulations: The Discipline of Regulatory Affairs 148

Elaine S. Waller and Nancy L. Kercher

Regulatory Authorities and the Laws 149

Protecting the Public Health 149

Advancing the Public Health 150

Helping the Public Get Accurate, Science-Based Information 150

Regulatory Development Strategies 157

Fast-Track Program 157

Priority Review 157

Rolling Submission 157

Accelerated Approval 158

Orphan Drugs 158

Rx to OTC Switch 159

Submissions to Regulatory Authorities 160

Product Review 165

Package Insert 167

Advertising 167

Postapproval Maintenance 168

Compliance/Quality Assurance 171

General References 177

8. Clinical Trial Operations 178

Carl L. Roland and Paul Litka

Introduction 178

Clinical Trial Conduct 181

Contract Research Organizations (CROs) 193

Selected Issues in Clinical Development 197

Summary 200

References 200

9. Formulation and Manufacturing 202

Leo Pavliv and James F. Cahill

Dosage Form Decisions 202

Formulation Development 205

Early Manufacturing 214

Process Development 216

General References 221

10. Commercial Division 222

Thomas Lytle

Challenges 222

Framework 224

Commercialization Process 228

Practical Approaches 235

Commercial Responsibilities 237

References 239

11. Medical Affairs and Professional Services 240

Ronald P. Evens

Introduction 240

Departmental Issues 241

Medical Information Services 245

"Standard Letter" Generation 246

Product Package Insert 246

Patient Package Insert 246

Pipeline Product Information 247

FDAMA "Safe Harbor" 247

Medical Inquiries (Off-label) to Sales Representatives 247

Scientific Publication Tracking 248

Formulary Material Development 248

Scientific Meeting Support 248

Disease State Management 248

Patient Assistance Programs 249

Research Questions to be Addressed 249

Special Patient Registries 249

Communication Triage 249

Industry Requirements for Postmarket Safety Surveillance 250

MedWatch 251

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