Table of Contents
Chapter 1
- INTRODUCTION: CHALLENGES TO DRUG DEVELOPMENT TODAY
- 1.1. Responding to Industry Challenges by Corporate Restructuring
- 1.2. Responding to Industry Challenges by Large-Scale Mergers and
Acquisitions
- 1.3. Attrition in Drug Development
- The Kola and Landis Paper on Drug Attrition, 2004
- Drug Approvals, R&D Costs, and Attrition Rates Since 2003
- Strategies for Attacking the Phase II Attrition Problem
Chapter 2
- DRUG DISCOVERY STRATEGIES AIMED AT REDUCING PHASE II ATTRITION
- 2.1. Summary of the Target Evaluation Process
- 2.2. Strategies for Moving Beyond the Target Validation Paradigm
- Developing Agents That Address Multiple Targets
- Whole-Pathway Approaches to Drug Discovery
- Biology-Driven Drug Discovery
- Other Means of Going Beyond the Target Validation Paradigm
- 2.3. Target Generation at Pfizer' s Biotherapeutics & Bioinnovation Center
- 2.4. Novartis' Pathway-Based Drug Discovery Strategy
- 2.5. Genomic Analysis of Multiple Genes, Pathways, and Networks Involved
in Complex Diseases
- 2.6. Network Pharmacology and Rational Discovery of Multitargeted Drugs
Chapter 3
- IMPROVING ANIMAL MODEL STUDIES TO REDUCE PHASE II ATTRITION
- 3.1. Introduction
- A Notorious Case of the Failure of Animal Studies to Predict Toxicity in
Humans
- The Focus of This Chapter
- 3.2. Case Studies on the Inadequacy of Animal Studies in Neurodegenerative
Diseases
- Animal Studies in Amyotrophic Lateral Sclerosis (ALS)
- Animal Studies Using the "Standard Model" of ALS
- Can Researchers Develop A Better Model of Sporadic ALS?
- Implications of the ALS Animal Model Case for Alzheimer' s Disease (AD)
- Studies in Mouse Models Transgenic For Tau
- 3.3. Lessons from Animal Model Studies in ALS and AD
- 3.4. Another Therapy for AD Based On Targeting Tau
- 3.5. Case Study on Adoption of Improved Mouse Models of Cancer by Industry
- Aveo Pharmaceuticals and Mouse Model Technology Transfer Between Academia
and Industry
Chapter 4
- OVERVIEW OF TRANSLATIONAL MEDICINE AND ITS USE IN DRUG DEVELOPMENT
- 4.1. Defining Responder and Nonresponder Populations
- 4.2. Defining the Optimal Dosing Regimen
- 4.3. Identifying Early, Sensitive Markers of Efficacy
- 4.4. Identifying Patients Who Are Likely to Experience Adverse Effects
- 4.5. Translational Medicine Is Changing the Organization of Clinical
Trials in Some Companies
- Lilly' s Chorus
- Wyeth' s "Learn and Confirm" Organization of Drug Development
- Lessons from the Lilly and Wyeth Cases
Chapter 5
- BIOMARKERS AND THEIR ROLE IN TRANSLATIONAL MEDICINE
- 5.1. Introduction
- 5.2. Types of Biomarkers
- Translational (Bridging) Biomarkers
- Toxicity Biomarkers
- Stratification Biomarkers in Cancer: Case Studies on Epidermal Growth
Factor Receptor (EGFR) Antagonists in Non-Small Cell Lung Cancer (NSCLC) and
Colorectal Cancer
- 5.3. Biomarkers Still an Early-Stage Technology
- 5.4. The Biomarkers Consortium and Improving Biomarker Science
Chapter 6
- NEW STRATEGIES FOR EARLY-STAGE CLINICAL TRIAL DESIGN
- 6.1. Phase 0 Clinical Trials
- Phase 0 Studies at the National Cancer Institute
- European-Based Phase 0 Studies Led by Xceleron
- The Ethics of Phase 0 Studies
- What Can Be Expected From Phase 0 Microdosing Studies?
- 6.2. Adaptive Clinical Trials
- 6.3. Proof-of-Concept Clinical Trials
Chapter 7
- OUTLOOK FOR STRATEGIES TO REDUCE PHASE II ATTRITION
- 7.1. Discussion of Insight Pharma Reports' Phase II Attrition Survey -
January/February 2009
- 7.2. General Conclusions
References
Appendix
EXPERT INTERVIEWS
- A.1. Charles Gombar, PhD, Vice President, R&D Strategy and Business
Improvement, Wyeth Evan Loh, MD, Vice President, Clinical R&D, Wyeth
- A.2. Peter Lassota, PhD, Divisional Vice President, Imaging Biology &
Oncology, Caliper Life Sciences
- A.3. Bruce H. Littman, MD, President, Translational Medicine Associates,
LLC
- A.4. Daniel M. Skovronsky, MD, PhD, Founder and CEO, Avid
Radiopharmaceuticals Company Index with Web Addresses
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