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

 
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Dallas, TX -- (SBWIRE) -- 10/05/2012 -- “Pathways to Efficient Drug Development – Advances in Modeling and Simulation Outcomes to Fuel Pipeline Productivity” 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 Research’s 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 FDA’s 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

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List Of Tables

Table 1: Pathways to Efficient Drug Development, Clinical and FDA Approval Times across Therapeutic Classes (2005-2009)
Table 2: Pathways to Efficient Drug Development, Transition Probability at Each Stage of Clinical Drug Development
Table 3: Pathways to Efficient Drug Development, Overall FDA Approval Success Rate for New Chemical Entities by Therapeutic Area
Table 4: Pathways to Efficient Drug Development, Loss of US Sales Revenues Due to Patent Expiries ($m; 2010–2013)
Table 5: Pathways to Efficient Drug Development, Drugs Withdrawn from the Market in the US (1992–2010)
Table 6: Pathways to Efficient Drug Development, Ongoing Projects of the Critical Path Institute
Table 7: Pathways to Efficient Drug Development, Proposed Network for Evaluating PPPs in the Pharmaceutical Sciences
Table 8: Pathways to Efficient Drug Development, Biomarkers qualified by the FDA for use in drug development
Table 9: Pathways to Efficient Drug Development, Biomarkers qualified by the EMA for use in drug development
Table 10: Pathways to Efficient Drug Development, Ongoing Public-Private Partnerships for Biomarker Identification and Qualification
Table 11: Pathways to Efficient Drug Development, Pharmaceutical Companies Involved in the Predictive Safety Testing Consortium, IMI SAFE-T Project and the Biomarkers Consortium Kidney Project
Table 12: Pathways to Efficient Drug Development, Ongoing and Completed Projects being Undertaken by The Biomarkers Consortium
Table 13: Pathways to Efficient Drug Development, Open Innovation Platforms to Enhance Drug Discovery
Table 14: Pathways to Efficient Drug Development, Disease Specific Models Developed by the FDA
Table 15: Pathways to Efficient Drug Development, Pharmacometric Consultancies
Table 16: Pathways to Efficient Drug Development, Examples of Companies Offering Accelerator Mass Spectrometry Services
Table 17: Pathways to Efficient Drug Development, Eli Lilly’s Long-Term Service Providers
Table 18: Pathways to Efficient Drug Development, Open Innovation Business Models that Place Research Results in the Public Domain
Table 19: Pathways to Efficient Drug Development, Examples of Pharmaceutical Corporate Venture Capital Funds
Table 20: Pathways to Efficient Drug Development, New Companies Launched by Enlight Bioscience
Table 21: Pathways to Efficient Drug Development, Projects Funded by Pfizer’s Centers for Therapeutic Innovation
Table 22: Pathways to Efficient Drug Development, Examples of Recent Collaborations Between Academia and the Pharmaceutical Industry
Table 23: Pathways to Efficient Drug Development, AstraZeneca Compounds Made Available for Research (December 2011)

List Of Figures

Figure 1: Pathways to Efficient Drug Development, Key Areas of Precompetitive Research
Figure 2: Pathways to Efficient Drug Development, Number of New Drug and Biologic FDA Approvals and Global R&D Expenditure by the Pharmaceutical Industry (2004-2011)
Figure 3: Pathways to Efficient Drug Development, Drivers for Innovation in the Pharmaceutical Industry
Figure 4: Pathways to Efficient Drug Development, The Rising Cost of Drug Development 1975-2005
Figure 5: Pathways to Efficient Drug Development, Changes in Clinical Trial Parameters between 2000-2003 and 2004-2007
Figure 6: Pathways to Efficient Drug Development, Failure Rates According to Therapeutic Area in Phase II and Phase III/Submission
Figure 7: Pathways to Efficient Drug Development, History of the European Innovative Medicines Initiative and its Strategic Research Agenda
Figure 8: Pathways to Efficient Drug Development, European Innovative Medicines Initiative: Strategic Research Agenda (updated 2012)
Figure 9: Pathways to Efficient Drug Development, New Drug Applications Filed with the FDA Centre for Drug Evaluation and Research (1996-2011)
Figure 10: Pathways to Efficient Drug Development, Key Areas of Precompetitive Research
Figure 11: Pathways to Efficient Drug Development, Disease, Drug and Trial Models: Pharmacometrics in Drug Development
Figure 12: Pathways to Efficient Drug Development, The I-SPY2 Adaptive Clinical Trial

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