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

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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 Document Transcript

  • Pathways to Efficient Drug Development - Advances inModeling and Simulation Outcomes to Fuel PipelineProductivityReport Details:Published:September 2012No. of Pages: 66Price: Single User License – US$3500Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes toFuel Pipeline ProductivitySummaryGBI Research, the leading business intelligence provider, has released its latest research report,“Pathways to Efficient Drug Development - Advances in Modeling and Simulation Outcomes toFuel Pipeline Productivity”. The report examines the reasons why the pharmaceutical industry islooking for improvements in efficiency whilst acknowledging that pharmaceutical R&D remains along and risky process. It looks in detail at precompetitive research and evaluates how the industryis pulling together to research solutions to problems that are common to all companies. The reportinvestigates innovation in the clinical drug development arena, documenting modeling andsimulation 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 industryto 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 withexperts in the field.GBI Research’s analysis shows that collaboration and open innovation will play increasinglyimportant roles in the future by enabling research that would not be possible for companies toundertake individually. Many examples exist, driven in large part by the FDA’s Critical PathInitiative and the European Innovative Medicines Initiative, and experiences gained by earlyconsortia will help facilitate the logistical challenges of setting up new collaborations. Withincompanies, innovations including the increased use of modeling and simulation throughout thedrug development process, adaptive clinical trials and exploratory clinical trials have all beenstudied 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, companiesare hoping not only to refuel their pipelines but to regain the confidence of investors and the publicin their ability to deliver meaningful treatments for patients at the same time as generating profitsin 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 collaborationis 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 innovationand extensive academic collaborationsReasons 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-baseddrug development, adaptive clinical trials and exploratory clinical trials, from the viewpoints ofcompanies and regulators- Explore the business models and partnerships of the largest pharmaceutical companies tosupport new drug development strategiesGet your copy of this report @http://www.reportsnreports.com/reports/195911-pathways-to-efficient-drug-development-advances-in-modeling-and-simulation-outcomes-to-fuel-pipeline-productivity.htmlMajor points covered in Table of Contents of this report include1 Table of Contents1 Table of Contents 51.1 List of Tables 71.2 List of Figures 82 State of the Industry 92.1 Introduction 92.1.1 The Rising Costs of Drug Development 102.1.2 Drug Attrition 122.1.3 Patent Expiries 142.1.4 Regulatory Hurdles 15
  • 2.1.5 The Fourth Hurdle: Reimbursement 162.2 Innovation in the Drug Development Paradigm 162.2.1 The Critical Path Initiative 162.2.2 The Innovative Medicines Initiative 182.3 Improving Drug Development 192.4 2012 and Beyond 203 Collaboration in the Precompetitive Space 213.1 Defining Precompetitive Research 213.2 Building Successful Consortia 233.2.1 Choosing the Research Topic 233.2.2 The Set-Up Phase 233.2.3 Project Management 243.2.4 Measuring Success 253.2.5 Case Study of a Successful Private Public Partnership: The Alzheimer’s DiseaseNeuroimaging Initiative 263.3 Qualification of Biomarkers of Efficacy or Safety 263.3.1 Case Study: Biomarkers of Kidney Injury 293.3.2 Case Study: The Biomarkers Consortium 313.4 Open Innovation Platforms 323.4.1 Case Study: OpenPHACTS 333.4.2 Case Study: Sage Bionetworks 343.5 Data Standards 353.5.1 BioSharing: Standard Cooperating Procedures 353.5.2 Clinical Data Standards 363.5.3 Data Standards and the FDA 363.6 Conclusions 374 Improving Drug Development Efficiency 384.1 Modeling and Simulation 384.1.1 Modeling and Simulation: A View from the Regulators 394.1.2 Model Qualification 404.1.3 Modeling and Simulation Expertise and Consultancy 404.2 Innovative Approaches to Clinical Trials 414.2.1 Adaptive Clinical Trials 424.2.2 Case Study: The I-SPY 2 Trial 444.2.3 Exploratory Clinical Trials 454.3 Engaging Stakeholders 464.3.1 Patients 464.3.2 Regulators 474.3.3 Payers 474.4 Conclusions 475 Business Models 485.1 Introduction 48
  • 5.2 R&D Reorganization 485.2.1 Mimicking the Biotech Environment 485.2.2 The Fully Integrated Pharmaceutical Network Model 495.3 Open Innovation 505.3.1 Case Study: An Open Innovation Incubator 515.3.2 Case Study: Open Innovation Drug Discovery at Eli Lilly 525.4 Funding for External Innovation 535.4.1 Collaborative Commercialization 545.5 Academic Partnerships and Translational Medicine 555.5.1 Translational Science in the US 575.5.2 Case study: Medical Research Council/AstraZeneca 585.6 Conclusions 596 Appendix 606.1 Abbreviations 606.2 Methodology 616.2.1 Primary Research 616.2.2 Secondary Research 626.3 References 626.4 Contact Us 666.5 Disclaimer 661.1 List of TablesTable 1: Pathways to Efficient Drug Development, Clinical and FDA Approval Times acrossTherapeutic Classes (2005-2009) 11Table 2: Pathways to Efficient Drug Development, Transition Probability at Each Stage of ClinicalDrug Development 12Table 3: Pathways to Efficient Drug Development, Overall FDA Approval Success Rate for NewChemical Entities by Therapeutic Area 12Table 4: Pathways to Efficient Drug Development, Loss of US Sales Revenues Due to PatentExpiries ($m; 2010–2013) 14Table 5: Pathways to Efficient Drug Development, Drugs Withdrawn from the Market in the US(1992–2010) 15Table 6: Pathways to Efficient Drug Development, Ongoing Projects of the Critical Path Institute17Table 7: Pathways to Efficient Drug Development, Proposed Network for Evaluating PPPs in thePharmaceutical Sciences 25Table 8: Pathways to Efficient Drug Development, Biomarkers qualified by the FDA for use in drugdevelopment 27Table 9: Pathways to Efficient Drug Development, Biomarkers qualified by the EMA for use in drugdevelopment 27Table 10: Pathways to Efficient Drug Development, Ongoing Public-Private Partnerships forBiomarker Identification and Qualification 28
  • Table 11: Pathways to Efficient Drug Development, Pharmaceutical Companies Involved in thePredictive Safety Testing Consortium, IMI SAFE-T Project and the Biomarkers Consortium KidneyProject 30Table 12: Pathways to Efficient Drug Development, Ongoing and Completed Projects beingUndertaken by The Biomarkers Consortium 31Table 13: Pathways to Efficient Drug Development, Open Innovation Platforms to Enhance DrugDiscovery 33Table 14: Pathways to Efficient Drug Development, Disease Specific Models Developed by theFDA 39Table 15: Pathways to Efficient Drug Development, Pharmacometric Consultancies 41Table 16: Pathways to Efficient Drug Development, Examples of Companies Offering AcceleratorMass Spectrometry Services 45Table 17: Pathways to Efficient Drug Development, Eli Lilly’s Long-Term Service Providers 49Table 18: Pathways to Efficient Drug Development, Open Innovation Business Models that PlaceResearch Results in the Public Domain 51Table 19: Pathways to Efficient Drug Development, Examples of Pharmaceutical CorporateVenture Capital Funds 53Table 20: Pathways to Efficient Drug Development, New Companies Launched by EnlightBioscience 54Table 21: Pathways to Efficient Drug Development, Projects Funded by Pfizer’s Centers forTherapeutic Innovation 55Table 22: Pathways to Efficient Drug Development, Examples of Recent Collaborations BetweenAcademia and the Pharmaceutical Industry 56Table 23: Pathways to Efficient Drug Development, AstraZeneca Compounds Made Available forResearch (December 2011) 581.2 List of FiguresFigure 1: Pathways to Efficient Drug Development, Number of New Drug and Biologic FDAApprovals and Global R&D Expenditure by the Pharmaceutical Industry (2004-2011) 9Figure 2: Pathways to Efficient Drug Development, Drivers for Innovation in the PharmaceuticalIndustry 10Figure 3: Pathways to Efficient Drug Development, The Rising Cost of Drug Development 1975-2005 10Figure 4: Pathways to Efficient Drug Development, Changes in Clinical Trial Parameters between2000-2003 and 2004-2007 11Figure 5: Pathways to Efficient Drug Development, Failure Rates According to Therapeutic Area inPhase II and Phase III/Submission 13Figure 6: Pathways to Efficient Drug Development, History of the European Innovative MedicinesInitiative and its Strategic Research Agenda 18Figure 7: Pathways to Efficient Drug Development, European Innovative Medicines Initiative:Strategic Research Agenda (updated 2012) 19Figure 8: Pathways to Efficient Drug Development, New Drug Applications Filed with the FDA
  • Centre for Drug Evaluation and Research (1996-2011) 20Figure 9: Pathways to Efficient Drug Development, Key Areas of Precompetitive Research 21Figure 10: Pathways to Efficient Drug Development, Disease, Drug and Trial Models:Pharmacometrics in Drug Development 39Figure 11: Pathways to Efficient Drug Development, The I-SPY2 Adaptive Clinical Trial 44Contact: sales@reportsandreports.com for more information.