Lead Generation Strategies and Technologies in Drug Development - Emerging Techniques Such as Antisense Technology Will Allow Innovators to Minimize Costs

Published by: GBI Research

Published: Jun. 10, 2011 - 77 Pages

Table of Contents

1 Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Introduction

2.1 GBI Report Guidance

3 The Drug Discovery Process: Defining Lead Generation

3.1 Process of Early Preclinical Drug Discovery

3.1.1 Pre-Discovery

3.1.2 Target Identification

3.1.3 Target Validation

3.1.4 Lead Identification

3.1.5 Early Safety Tests

3.1.6 Lead Optimization

3.1.7 Preclinical Testing

3.2 Hit to Lead - Identifying Possible Structure

3.2.1 Strategies Used In Generating Potential Lead from Identified Hits

3.3 Role of Lead Generation in the Path of Drug Development

4 Lead Generation Strategies in the Pharmaceutical Industry

4.1 Massive Decline in Sales - Dependence on Blockbuster Drugs

4.2 Need to Accelerate Lead Generation Process

4.2.1 Stricter FDA Rules and Regulations for Drug Approval

4.2.2 Penetration of Aggressive Generic Companies

4.2.3 The Economic Impact of Compound Attrition at Various Stages of Lead Discovery

4.2.4 Drought in the R&D Pipeline Products (Low R&D Productivity)

4.3 HTS Solutions for ADME Testing

4.3.1 In Vitro Studies of Drug Absorption

4.3.2 In Vitro Studies of Protein Binding

4.4 Fragment-Based Drug Discovery

4.4.1 Differences Between HTS and FBDD

4.4.2 Advantages of Fragment-Based Drug Design over High-Throughput Screening

4.4.3 Applications of Mass Spectrometry in Fragment Library Screening

4.4.4 Recent Advances in Structure-Based Fragment Docking and Virtual Screening

4.4.5 Novel Strategy for the Design of a Fluorinated Fragment Library, Named LEF (Local Environment of Fluorine)

4.4.6 Ligand-Based Approach to In Silico Pharmacology

4.5 Antisense Technology as a Strategy

4.5.1 Isis Pharmaceuticals

4.5.2 CytRx Laboratories

4.6 Iterative Focused Screening as a Strategy

4.6.1 Merck Frosst Canada

5 Emerging Technology in Lead Generation

5.1 Improving High Throughput Screening

5.1.1 Overview

5.1.2 Case Study

5.1.3 Improving In Vitro Assays for HTS

5.1.4 Whole Animal Imaging and Microscopy

5.2 The Parallel Synthesis Approach

5.2.1 In Vitro Methods

5.2.2 In Silico Methods - Structure-Toxicity Relationships

5.3 Computerized Combinatorial Chemistry and 3D Molecular Modeling

5.3.1 Overview

5.3.2 Service Providers

5.3.3 Case Studies

5.4 Molecular Bioimaging

5.4.1 Overview

5.4.2 Service Providers

5.4.3 Case Study

5.5 Omics-Technology and Bioinformatics

5.5.1 Overview

5.5.2 Service Providers

5.5.3 Case Study

6 Lead Generation Now and in the Future

6.1 R&D Models: Influence on Lead Generation

6.1.1 Recent Technology Developments

6.2 A Novel Technology to Enhance Fragment-Based Drug Discovery

6.2.1 ZoBio’s Target Immobilized NMR Spectroscopy Method for Fragment-Based Drugs

7 Pharmaceutical Outsourcing as a Strategy to Accelerate Lead Generation

7.1 Early Stage Drug Development Outsourcing

7.1.1 Strategic or Tactical Advantages of Outsourcing

7.1.2 Case Study

7.2 Emerging Regions in the Global Contract Research Outsourcing Market for Early Stage Drug Development

7.2.1 Latin America

7.2.2 Central and Eastern Europe (CEE)

7.2.3 India

7.2.4 China

8 Major Contract Research Organizations in Drug Discovery

8.1 Cyprotex Discovery Ltd.

8.1.1 Business Overview

8.1.2 Services

8.2 Shanghai ChemPartner

8.2.1 Business Overview

8.2.2 Services

8.3 Covance, Inc.

8.3.1 Business Overview

8.3.2 Services

8.4 Caliper Life Sciences

8.4.1 Business Overview

8.4.2 Services

8.5 GVK BIO

8.5.1 Business Overview

8.5.2 Services

8.6 Jubilant Biosys

8.6.1 Business Overview

8.6.2 Services

8.7 Advinus Therapeutics

8.7.1 Business Overview

8.7.2 Services

8.8 ITR Canada

8.8.1 Business Overview

8.8.2 Services

8.9 MD Biosciences

8.9.1 Business Overview

8.9.2 Services

8.10 PPD, Inc.

8.10.1 Business Overview

8.10.2 Services

8.11 Ricerca Biosciences, LLC

8.11.1 Business Overview

8.11.2 Services

8.12 MPI Research

8.12.1 Business Overview

8.12.2 Services

9 Lead Generation Strategies and Technologies in Drug Discovery - Appendix

9.1 Market Definitions

9.2 Abbreviations

9.3 Research Methodology

9.3.1 Coverage

9.3.2 Secondary Research

9.3.3 Primary Research

9.3.4 Expert Panel Validation

9.4 Contact Us

9.5 Disclaimer

9.6 Sources

1.1 List of Tables

Table 1: Lead Generation Strategies and Technologies in Drug Discovery, Top 20 Patent Expirations During 2010-2014, Based on US Sales in Dollars

Table 2: Lead Generation Strategies and Technologies in Drug Discovery, Comparison of Microdialysis with Ultrafilteration

Table 3: Lead Generation Strategies and Technologies in Drug Discovery, Recent Success Stories in Virtual Screening

Table 4: Lead Generation Strategies and Technologies in Drug Discovery, Application of SPR by Noxxon Pharmaceutical

1.2 List of Figures

Figure 1: Lead Generation Strategies and Technologies in Drug Discovery, Life Cycle of a New Drug

Figure 2: Lead Generation Strategies and Technologies in Drug Discovery, Drug Discovery Process

Figure 3: Lead Generation Strategies and Technologies in Drug Discovery, Applications of Lead Generation Process

Figure 4: Lead Generation Strategies and Technologies in Drug Discovery, Pathways For Optimizing Lead Through Screening

Figure 5: Lead Generation Strategies and Technologies in Drug Discovery, Effective Lead Optimization

Figure 6: Lead Generation Strategies and Technologies in Drug Discovery, Hit Evolution Form Drug-Like Hit

Figure 7: Lead Generation Strategies and Technologies in Drug Discovery, Isosteric Replacement Form Drug-Like Hit

Figure 8: Lead Generation Strategies and Technologies in Drug Discovery, Hit-Fragmentation In Lead Generation

Figure 9: Lead Generation Strategies and Technologies in Drug Discovery, Target Preference In Drug Discovery

Figure 10: Lead Generation Strategies and Technologies in Drug Discovery, Decline In NME Approvals By The FDA, 1996-2010

Figure 11: Lead Generation Strategies and Technologies in Drug Discovery, Original Abbreviated New Drug Application (ANDA) Approvals During 2001-2009

Figure 12: Lead Generation Strategies and Technologies in Drug Discovery, Decision Check Points At Various Stages In Lead Generation

Figure 13: Lead Generation Strategies and Technologies in Drug Discovery, Pharmaceutical and Biotech R&D Expenditure ($bn) versus Number of NME/BLA Approvals, the US, 1995-2009

Figure 14: Lead Generation Strategies and Technologies in Drug Discovery, Proportion of LCM Projects in the Late-Stage Development Pipeline by Therapeutic Area, 2010

Figure 15: Lead Generation Strategies and Technologies in Drug Discovery, Comparison of CAGR of R&D Expenditure versus Turnover for the Top Five Companies, 2003-2008

Figure 16: Lead Generation Strategies and Technologies in Drug Discovery, Effect of First-Pass Metabolism In Bioavailability

Figure 17: Lead Generation Strategies and Technologies in Drug Discovery, HTS ADME Assay

Figure 18: Lead Generation Strategies and Technologies in Drug Discovery, ADMET Screening Technology

Figure 19: Lead Generation Strategies and Technologies in Drug Discovery, Evotec’s Approach of Identifying Novel BACE 1 Inhibitor Using Fragment-Based Approach

Figure 20: Mass Spectrometry in Drug Library Screening

Figure 21: Lead Generation Strategies and Technologies in Drug Discovery, Advantages of Label-Free Cell-Based Assay

Figure 22: Lead Generation Strategies and Technologies in Drug Discovery, Benefits And Challenges In Imaging Technique

Figure 23: Lead Generation Strategies and Technologies in Drug Discovery, Service Providers In Combinatorial Chemistry And 3D Molecular Modeling

Figure 24: Lead Generation Strategies and Technologies in Drug Discovery, Service Providers Of Omics Technology And Bioinformatics

Figure 25: Lead Generation Strategies and Technologies in Drug Discovery, Strategic Or Tactical Advantages In Early Stage Drug Development Outsourcing

Figure 26: Lead Generation Strategies and Technologies in Drug Discovery, Outsourcing to Latin America

Figure 27: Lead Generation Strategies and Technologies in Drug Discovery, Outsourcing to Central and Eastern Europe(CEE)

Figure 28: Lead Generation Strategies and Technologies in Drug Discovery, Outsourcing to India

Figure 29: Lead Generation Strategies and Technologies in Drug Discovery, Outsourcing Scenario in India

Figure 30: Lead Generation Strategies and Technologies in Drug Discovery, Outsourcing to China

Figure 31: Lead Generation Strategies and Technologies in Drug Discovery, Cyprotex - Corporate Profile

Figure 32: Lead Generation Strategies and Technologies in Drug Discovery, Shanghai ChemPartner - Corporate Profile

Figure 33: Lead Generation Strategies and Technologies in Drug Discovery, Covance, Inc - Corporate Profile

Figure 34: Lead Generation Strategies and Technologies in Drug Discovery, Caliper Life Sciences, Inc - Corporate Profile

Figure 35: Lead Generation Strategies and Technologies in Drug Discovery, GVK BIO - Corporate Profile

Figure 36: Lead Generation Strategies and Technologies in Drug Discovery, Jubilant Biosys, Inc - Corporate Profile

Figure 37: Lead Generation Strategies and Technologies in Drug Discovery, Advinus Therapeutics, Inc - Corporate Profile

Figure 38: Lead Generation Strategies and Technologies in Drug Discovery, ITR Canada, Inc - Corporate Profile

Figure 39: Lead Generation Strategies and Technologies in Drug Discovery, MD Biosciences - Corporate Profile

Figure 40: Lead Generation Strategies and Technologies in Drug Discovery, PPD, Inc - Corporate Profile

Figure 41: Lead Generation Strategies and Technologies in Drug Discovery, Ricerca Biosciences, LLC - Corporate Profile

Figure 42: Lead Generation Strategies and Technologies in Drug Discovery, MPI Research - Corporate Profile

Abstract

• Key technological developments and new approaches including case studies.
• Case studies of new technologies and their implementation by companies in drug development industry
• Key drivers and restraints that have a significant impact on the market.
• Competitive benchmarking of leading CROs, covering their offerings and recent deals in drug development

• Compare the key capabilities and models of major technology solution providers with your requirements and optimize your R&D costs
• Develop market entry and market expansion strategies by identifying the key drivers and challenges in the global drug development market
• Develop effective strategies to maximize the advantages through the understanding of drug development and business models.

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