Sections
Title | Starting Page | Number of Pages |
---|
Table of Contents | 5 | 4 |
List of Tables | 7 | 1 |
List of Figures | 8 | 1 |
State of the Industry | 9 | 12 |
Introduction | 9 | 1 |
The Rising Costs of Drug Development | 10 | 2 |
Drug Attrition | 12 | 2 |
Patent Expiries | 14 | 1 |
Regulatory Hurdles | 15 | 1 |
The Fourth Hurdle: Reimbursement | 16 | 1 |
Innovation in the Drug Development Paradigm | 16 | 1 |
The Critical Path Initiative | 16 | 2 |
The Innovative Medicines Initiative | 18 | 1 |
Improving Drug Development | 19 | 1 |
2012 and Beyond | 20 | 1 |
Collaboration in the Precompetitive Space | 21 | 17 |
Defining Precompetitive Research | 21 | 2 |
Building Successful Consortia | 23 | 1 |
Choosing the Research Topic | 23 | 1 |
The Set-Up Phase | 23 | 1 |
Project Management | 24 | 1 |
Measuring Success | 25 | 1 |
Case Study of a Successful Private Public Partnership: The Alzheimer s Disease Neuroimaging Initiative | 26 | 1 |
Qualification of Biomarkers of Efficacy or Safety | 26 | 3 |
Case Study: Biomarkers of Kidney Injury | 29 | 2 |
Case Study: The Biomarkers Consortium | 31 | 1 |
Open Innovation Platforms | 32 | 1 |
Case Study: OpenPHACTS | 33 | 1 |
Case Study: Sage Bionetworks | 34 | 1 |
Data Standards | 35 | 1 |
BioSharing: Standard Cooperating Procedures | 35 | 1 |
Clinical Data Standards | 36 | 1 |
Data Standards and the FDA | 36 | 1 |
Conclusions | 37 | 1 |
Improving Drug Development Efficiency | 38 | 10 |
Modeling and Simulation | 38 | 1 |
Modeling and Simulation: A View from the Regulators | 39 | 1 |
Model Qualification | 40 | 1 |
Modeling and Simulation Expertise and Consultancy | 40 | 1 |
Innovative Approaches to Clinical Trials | 41 | 1 |
Adaptive Clinical Trials | 42 | 2 |
Case Study: The I-SPY 2 Trial | 44 | 1 |
Exploratory Clinical Trials | 45 | 1 |
Microdosing | 45 | 1 |
Studies of Drug Metabolism in Early Development | 46 | 1 |
Engaging Stakeholders | 46 | 1 |
Patients | 46 | 1 |
Regulators | 47 | 1 |
Payers | 47 | 1 |
Conclusions | 47 | 1 |
Business Models | 48 | 12 |
Introduction | 48 | 1 |
R&D Reorganization | 48 | 1 |
Mimicking the Biotech Environment | 48 | 1 |
The Fully Integrated Pharmaceutical Network Model | 49 | 1 |
Open Innovation | 50 | 1 |
Case Study: An Open Innovation Incubator | 51 | 1 |
Case Study: Open Innovation Drug Discovery at Eli Lilly | 52 | 1 |
Funding for External Innovation | 53 | 1 |
Collaborative Commercialization | 54 | 1 |
Academic Partnerships and Translational Medicine | 55 | 2 |
Translational Science in the US | 57 | 1 |
Case study: Medical Research Council/AstraZeneca | 58 | 1 |
Conclusions | 59 | 1 |
Appendix | 60 | 7 |
Abbreviations | 60 | 1 |
Methodology | 61 | 2 |
Primary Research | 61 | 1 |
Secondary Research | 62 | 1 |
References | 62 | 4 |
Contact Us | 66 | 1 |
Disclaimer | 66 | 1 |