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Accelerating Drugs to Market - Despite Challenges, Adaptive Clinical Trials Reduce Drug Development Costs and Time to Market

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  • 1. Accelerating Drugs to Market - Despite Challenges, AdaptiveClinical Trials Reduce Drug Development Costs and Time toMarketReport Details:Published:September 2012No. of Pages: 63Price: Single User License – US$3500GBI Research’s new report, “Accelerating Drugs to Market - Despite Challenges, Adaptive ClinicalTrials Reduce Drug Development Costs and Time to Market”, presents various tools andstrategies which can accelerate a drug to the market. In this report, GBI Research has studiedvarious hurdles at different stages of drug development that can halt a drug’s development. Thereport provides detailed information about the need for accelerated drug development. DecliningR&D productivity is highlighted as one of the major needs to be addressed. The report outlinesmisconceptions regarding accelerated drug development; one such major misconception is thecost of development. The cost of an accelerated development program can be effectivelymanaged by implementing a structured and complete program. The report highlights majorstrategies adopted by pharmaceutical companies to accelerate drug development. The adoption ofthe latest technologies in lead generation, preclinical stages, and the use of adaptive designs inlate phase studies are regarded as tools to accelerate drugs through these stages of development.This report is built using data and information sourced from proprietary databases, primary andsecondary research, and in-house analysis by GBI Research’s team of industry experts.The process of drug development starts from the initial discovery and ends with a final medication.This is an expensive, lengthy and incremental process. The main objective of the process is toidentify a molecule with the potential for producing the desired effect in the human body, and toestablish the quality, safety and efficacy of the molecule for treating patients. In the presentscenario drug development takes about 12 years, for a molecule to progress from the laboratoryand enter the pharmaceutical market. It is estimated that out of 5,000 compounds which enter thepreclinical stage of development, only five compounds will be successful enough to be tested onhumans, and only one among them will be approved. The slow pace of drug development greatlyaffects the pharmaceutical industry and patients who are in need of new therapeutics to treat theirillness.
  • 2. The current process of drug development begins with the synthesis of molecules, which targetsspecific proteins in living cells. It is followed by in vitro tests to identify any specific toxicityassociated with the synthesized molecules. The compounds which make it through this stage willgo further and will be tested for in vivo toxicology studies. The information gathered from thesestudies is utilized for planning and conducting clinical trials in human subjects.It is important for biopharmaceutical companies to launch their products more quickly in themarket, as this will lead to early revenue generation from the product. As a large number of drugsfail at the later stages of drug development, pharmaceutical companies try to maintain theirrevenues by launching new drugs at the earliest possible time. The decline in the total number ofnew drug approvals by the regulatory bodies and the patent expirations for major blockbusterdrugs are forcing pharmaceutical companies to consider ways in which the time and cost of clinicaltrials can be reduced without affecting their quality.Scope•The report presents various tools and strategies which can help to accelerate a drug to market.•The report provides detailed information about the need for accelerated drug development.•The report outlines misconceptions regarding accelerated drug development.•The report provides information on trends in drug transition and strategies and models adopted to accelerate drug transition through the various stages of development.•Description of the methods for optimum patient recruitment and retention in a clinical trial.•Analysis of efficient clinical trial site management so that completion of a trial is done on time.Reasons to buy•Develop strategies to implement the use of various technologies for advancing drug discovery and development in an efficient manner.•Understand the use of biomarkers and surrogate endpoints, improvised clinical trial designs and better recruitment and retention of subjects in clinical trials, in order to avoid drug lags in various phases of development.•Prioritize design elements of study protocols and balance the overall protocol.•Ensure efficient clinical trial outcomes by implementing CDISC standards.•Understand the utility of operationally seamless Phase II/III design for instantaneous transition of the drug from Phase II to Phase III.Get your copy of this report @http://www.reportsnreports.com/reports/192514-accelerating-drugs-to-market-despite-challenges-adaptive-clinical-trials-reduce-drug-development-costs-and-time-to-market.htmlMajor points covered in Table of Contents of this report includeTable of Contents1 Table of Contents 61.1 List of Tables 8
  • 3. 1.2 List of Figures 82 Introduction 93 Accelerating Drugs to Market - Overview 103.1 Drug Development Process 123.1.1 Early Stage Drug Discovery 123.1.2 Clinical Development Time and Protocol Amendments 133.1.3 Phase I 143.1.4 Phase II 143.1.5 Phase III 143.1.6 Registration 143.1.7 Phase IV 143.2 Need to Accelerate the Drug Development Process 153.2.1 Strict Regime in Regulations of Drug Approvals 153.2.2 Declining Returns on R&D Investment 163.2.3 Low R&D Productivity 173.3 Misconceptions of Accelerated Drug Development 173.3.1 Completeness of the Drug Development Process 173.3.2 Cost of Accelerated Drug Development 173.3.3 Quality of Study in Accelerated Drug Development 173.4 Causes of Delay in Drug Development 183.4.1 Delay during the Nonclinical Stage of Drug Development 183.4.2 Delay During the Clinical Stage of Drug Development 184 Accelerating Drugs Through the Lead Generation Phase 204.1 Process of Lead Generation 204.1.1 Pre-Discovery 204.1.2 Target Identification 214.1.3 Target Validation 214.1.4 Lead Identification 224.1.5 Early Safety Tests 224.1.6 Lead Optimization 234.2 Traditional Strategies of Lead Generation 244.2.1 High Throughput Screening 244.2.2 In Vitro Studies of Drug Absorption 254.2.3 In Vitro Studies of Protein Binding 254.2.4 Fragment-Based Lead Discovery 264.2.5 Antisense Technology 274.2.6 Iterative Focused Screening 284.3 Emerging Strategies of Lead Generation 284.3.1 Improving High Throughput Screening 28
  • 4. 4.3.2 Improving In Vitro Assays for HTS 294.3.3 Whole Animal Imaging and Microscopy 294.3.4 Computerized Combinatorial Chemistry and 3D Molecular Modeling 304.3.5 Molecular Bioimaging 324.3.6 Omics-Technology and Bioinformatics 334.3.7 Outsourcing of Lead Generation 365 Accelerating Drugs Through the Preclinical Stage 385.1 Preclinical Studies - An Overview 385.2 Preclinical Study Design and Planning 385.2.1 Preclinical Study - Strategic Planning 385.2.2 Key Considerations During Preclinical Study Design 385.3 Strategies and Models to Accelerate the Transition from Preclinical Phase to Clinical Phase I395.3.1 In Vitro ADMET Screening Models 405.3.2 In Vivo ADMET Screening Models 405.3.3 In Silico ADMET Screening Models 415.3.4 Accelerating Drugs to Market through Effective Documentation in the Preclinical Phase 415.4 Recent Technology Developments 425.4.1 Biomarkers 425.4.2 Nanotechnology 425.4.3 In Vivo Imaging 435.5 Accelerating Drugs to Market - Preclinical Models: Case Studies 435.5.1 Apredica’s Customized In Vitro ADMET Screening Assays 435.5.2 AVEO Pharmaceuticals’ Breakthrough with Transgenic Mouse Model for Human BreastCancer 445.5.3 Preclinical Models of Hepatocellular Carcinoma and Biomarker Strategy by Pfizer 445.5.4 Simulation Modeling to Treat Spinal Cord Injuries by Novartis 456 Accelerating Drug Transition in Phase I Studies 466.1 Phase I Clinical Studies - An overview 466.2 Phase I Study Design and Planning 466.2.1 Standard Design 466.3 Strategies and Models to Accelerate Transition from Phase I to Phase II 466.3.1 Site Selection and Management 466.3.2 Strategies to Minimize Site Initiation Delays 486.3.3 Role of the Site Management Organization in Decreasing Timelines 496.3.4 Optimizing Clinical Trial Supply through a Clinical Trial Management System 506.3.5 Patient Recruitment Strategies 517 Accelerating Drug Transition in Phase II Studies 537.1 Phase II Clinical Studies - An Overview 53
  • 5. 7.2 Phase II Study Design and Planning 537.3 Strategies and Models to Accelerate Transition from Phase II to Phase III 537.3.1 Selection of Primary Endpoint 537.3.2 Randomization of Phase II Trials 537.3.3 Use of Biomarkers 547.3.4 Statistical Designs in Phase II Trials 547.3.5 Increasing Patient Recruitment through the Use of Social Media 547.3.6 Seamless Phase II/III Designs 558 Accelerating Drug Transition in Phase III Studies 568.1 Trends in Drug Transition from Phase III to NDA Filing 568.2 Issues and Challenges in Drug Transition 568.3 Strategies and Models to Accelerate Transition from Phase III to NDA Filing 568.3.1 Adaptive Trial Designs 568.3.2 Recruitment and Retention of Patients in Phase III Clinical Trials 579 Accelerating Drugs to Market - Appendix 589.1 Market Definitions 589.2 Abbreviations 589.3 Bibliography 599.4 Research Methodology 629.4.1 Coverage 629.4.2 Secondary Research 629.4.3 Primary Research 629.4.4 Expert Panel Validation 639.5 Contact Us 639.6 Disclaimer 63List of TablesTable 1: Accelerating Drugs to Market, NME Approvals By The FDA, 2004-2011 15Table 2: Accelerating Drugs to Market, Pharmaceutical and Biotech R&D Expenditure ($bn)versus Number of NME/BLA Approvals, the US, 2004-2011 16Table 3: Accelerating Drugs to Market, Comparison of Microdialysis with Ultrafilteration 25Table 4: Accelerating Drugs to Market, Factors for Minimizing Time Delays in Site Initiation, 201048List of FiguresFigure 1: Accelerating Drugs to Market, Development Timeline for New Drugs 10Figure 2: Accelerating Drugs to Market, Stages of Drug Development 12Figure 3: Accelerating Drugs to Market, Amendments per Protocol and Changes per Amendment
  • 6. 13Figure 4: Accelerating Drugs to Market, NME Approvals By The FDA, 2004-2011 15Figure 5: Accelerating Drugs to Market, Pharmaceutical and Biotech R&D Expenditure ($bn)versus Number of NME/BLA Approvals, the US, 2004-2011 16Figure 6: Lead Generation Strategies and Technologies in Drug Discovery, Drug DiscoveryProcess 21Figure 7: Lead Generation Strategies and Technologies in Drug Discovery, Applications of LeadGeneration Process 22Figure 8: Accelerating Drugs to Market, Pathways For Optimizing Lead Through Screening 23Figure 9: Lead Generation Strategies and Technologies in Drug Discovery, HTS Absorption,Distribution, Metabolism and Excretion Assay 24Figure 10: Lead Generation Strategies and Technologies in Drug Discovery, Evotec’s Approach toIdentifying Novel Beta Secretase-1 Inhibitor Using the Fragment-Based Approach 26Figure 11: Accelerating Drugs to Market, Benefits And Challenges In Imaging Technique 29Figure 12: Accelerating Drugs to Market, Service Providers in Combinatorial Chemistry and 3DMolecular Modeling 31Figure 13: Accelerating Drugs to Market, Service Providers of Omics Technology andBioinformatics 34Figure 14: Accelerating Drugs to Market, Strategic or Tactical Advantages in Early Stage DrugDevelopment Outsourcing 36Figure 15: Accelerating Drugs to Market, Preclinical ADMET Studies - Current System 39Figure 16: Accelerating Drugs to Market, Site Initiation Process, 2011 47Figure 17: Accelerating Drugs to Market, Key Factors Responsible for Study Timeline Reductionby SMOs 49Figure 18: Accelerating Drugs to Market, Clinical Trial Supply Management System 51Contact: sales@reportsandreports.com for more information.