Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity - GBI Research Reports

Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity

Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity - GBI Research Reports
Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity
Published Sep 30, 2012
66 pages — Published Sep 30, 2012
Price US$ 3,500.00  |  Buy this Report Now

About This Report

  
Abstract:

Summary

GBI Research, the leading business intelligence provider, has released its latest research report, Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity. The report examines the reasons why the pharmaceutical industry is looking for improvements in efficiency whilst acknowledging that pharmaceutical R&D remains a long and risky process. It looks in detail at precompetitive research and evaluates how the industry is pulling together to research solutions to problems that are common to all companies. The report investigates innovation in the clinical drug development arena, documenting modeling and simulation based approaches to improving efficiency, as well as novel clinical trial designs. Lastly, the report examines innovation in business models within the industry that aim to help the industry to achieve its mantra of doing more with less, which will be critical for its future success.

The report is built using information from primary and secondary research including interviews with experts in the field.

GBI Researchs analysis shows that collaboration and open innovation will play increasingly important roles in the future by enabling research that would not be possible for companies to undertake individually. Many examples exist, driven in large part by the FDAs Critical Path Initiative and the European Innovative Medicines Initiative, and experiences gained by early consortia will help facilitate the logistical challenges of setting up new collaborations. Within companies, innovations including the increased use of modeling and simulation throughout the drug development process, adaptive clinical trials and exploratory clinical trials have all been studied for some years, suggesting that innovation is hard, but important. Innovation is also occurring in the business models applied within individual companies to enable them to achieve more with less. Through adoption of new scientific approaches and business models, companies are hoping not only to refuel their pipelines but to regain the confidence of investors and the public in their ability to deliver meaningful treatments for patients at the same time as generating profits in the coming years.

Scope

- Detailed analysis of the reasons for the industry to be looking closely at improving efficiency
- Definition of precompetitive collaboration, analysis of areas in which precompetitive collaboration is occurring, and discussion of the expansion of this space in the future
- Explorations of the key challenges facing consortia and the factors that make them successful
- Case studies of key innovations in drug development including model-based drug development, adaptive clinical trials and exploratory clinical trials
- Detailed insights into innovation in business models, including virtual networks, open innovation and extensive academic collaborations

Reasons to buy

- Identify key projects in the precompetitive space
- Learn the most important factors for successful precompetitive collaborations
- Develop strategies and priorities for participating in precompetitive collaborations
- Understand current thinking on innovative areas of drug development, including model-based drug development, adaptive clinical trials and exploratory clinical trials, from the viewpoints of companies and regulators
- Explore the business models and partnerships of the largest pharmaceutical companies to support new drug development strategies

  
Source:
Document ID
GBIHC260MR
Industry
Format:
PDF Adobe Acrobat
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Sections

TitleStarting PageNumber of Pages
Table of Contents54
  List of Tables71
  List of Figures81
State of the Industry912
  Introduction91
    The Rising Costs of Drug Development102
    Drug Attrition122
    Patent Expiries141
    Regulatory Hurdles151
    The Fourth Hurdle: Reimbursement161
  Innovation in the Drug Development Paradigm161
    The Critical Path Initiative162
    The Innovative Medicines Initiative181
  Improving Drug Development191
  2012 and Beyond201
Collaboration in the Precompetitive Space2117
  Defining Precompetitive Research212
  Building Successful Consortia231
    Choosing the Research Topic231
    The Set-Up Phase231
    Project Management241
    Measuring Success251
    Case Study of a Successful Private Public Partnership: The Alzheimer s Disease Neuroimaging Initiative261
  Qualification of Biomarkers of Efficacy or Safety263
    Case Study: Biomarkers of Kidney Injury292
    Case Study: The Biomarkers Consortium311
  Open Innovation Platforms321
    Case Study: OpenPHACTS331
    Case Study: Sage Bionetworks341
  Data Standards351
    BioSharing: Standard Cooperating Procedures351
    Clinical Data Standards361
    Data Standards and the FDA361
  Conclusions371
Improving Drug Development Efficiency3810
  Modeling and Simulation381
    Modeling and Simulation: A View from the Regulators391
    Model Qualification401
    Modeling and Simulation Expertise and Consultancy401
  Innovative Approaches to Clinical Trials411
    Adaptive Clinical Trials422
    Case Study: The I-SPY 2 Trial441
    Exploratory Clinical Trials451
      Microdosing451
      Studies of Drug Metabolism in Early Development461
  Engaging Stakeholders461
    Patients461
    Regulators471
    Payers471
  Conclusions471
Business Models4812
  Introduction481
  R&D Reorganization481
    Mimicking the Biotech Environment481
    The Fully Integrated Pharmaceutical Network Model491
  Open Innovation501
    Case Study: An Open Innovation Incubator511
    Case Study: Open Innovation Drug Discovery at Eli Lilly521
  Funding for External Innovation531
    Collaborative Commercialization541
  Academic Partnerships and Translational Medicine552
    Translational Science in the US571
    Case study: Medical Research Council/AstraZeneca581
  Conclusions591
Appendix607
  Abbreviations601
  Methodology612
    Primary Research611
    Secondary Research621
  References624
  Contact Us661
  Disclaimer661

Table Of Contents

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Cite this Report

  
MLA:
GBI Research Reports. "Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity" Sep 30, 2012. Alacra Store. May 05, 2025. <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Pathways-to-Efficient-Drug-Development-Advances-in-Modeling-and-Simulation-Outcomes-to-Fuel-Pipeline-Productivity-2115-499>
  
APA:
GBI Research Reports. (2012). Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity Sep 30, 2012. New York, NY: Alacra Store. Retrieved May 05, 2025 from <http://www.alacrastore.com/storecontent/GBI-Research-Reports/Pathways-to-Efficient-Drug-Development-Advances-in-Modeling-and-Simulation-Outcomes-to-Fuel-Pipeline-Productivity-2115-499>
  
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