Navigating the Drug Discovery Landscape: A Strategic Overview of Pharmaceutical R&D

Navigating the Drug Discovery Landscape: A Strategic Overview of Pharmaceutical R&D published by Decision Resources, Inc. in March, 2008. This report consists of 28 Pages and the price starts from US $ 2250.

Introduction

Abstract

Introduction:

Pharmaceutical companies must fi nd successful strategies for future drug discovery. Increased market pressures, looming drug patent expirations, and dramatically increasing drug development costs have caused pharmaceutical companies to search for new ways to increase R&D productivity. To improve their output of NMEs per year, companies are reshaping their operational infrastructure and relying on new technologies to stay competitive.

Get the Answers You Need to Shape Your Strategy:

• Companies must decide how to take advantage of new technologies and devise new strategies to improve drug discovery. What corporate changes are being made at some of the largest pharmaceutical companies to change their R&D infrastructure? How will theses changes speed the time from discovery to approval? What reforms are needed to accelerate the clinical trials system?
• The pharmaceutical industry has adopted a spectrum of high-throughput and high-content technologies for lead and target identifi cation. How are these approaches being applied to drug discovery and development, and how will these technologies increase the number of compounds screened annually?
• Several pharmaceutical companies are tapping external sources for innovation: What companies have created partnerships with U.S. Universities?

Scope:

• Overview: Innovative drug discovery strategies are critical to the growth of pharmaceutical R&D productivity; increase output of NMEs needed to justify billions spent on development.
• High-throughput and high-content technologies: decrease cycle times and costs to increase productivity; lead identifi cation technologies produce approved drugs; microarray technologies used in basic research; toxicity prediction using in vitro signature profi ling; patient-specifi c therapies play a dominant role as translational research ties mechanism of action and effi cacy to biomarkers; major reforms expected in the U.S. clinical trials system.
• Review of organizational and operational strategies: team approach to drug discovery and development at GSK is based on interdisciplinary, autonomous Centers for Excellence in Drug Discovery (CEDDs); Merck decentralizes R&D to extend responsibilities to its satellite facilities; Disease Biology Area Leadership Teams at Roche progress leads from early discovery through medical proof-of-concept; Novartis Institutes for BioMedical Research focus on disease-relevant molecular pathways; Teamwork at Wyeth is based on performance metrics.
• External sources of innovation: pharmaceutical companies establish research centers near academic research sites; corporate partnerships with biotech companies produces new sources for leads; venture capital fi rms help companies tap into innovation.

Table of Contents

• Strategic Considerations
• Stakeholder Implications
• Overview of Pharmaceutical R&D
• Tactical Uses of High-Throughput and High-Content Technologies
  • Decreasing Cycle Times and Costs
  • Lead Identifi cation Technologies
  • Target Identifi cation and Validation Technologies
• Strategic Uses of High-Throughput and High-Content Technologies
  • Learning from Approved Drugs
    • Integrating RNA Signature Profi les with Drugs, Cellular Mechanisms, and Disease
    • Predicting Target Druggability
    • Chemical Filters
  • Predictive Toxicology
  • Patient-Specifi c Therapies
  • New Ways to Perform Clinical Trials
• Organizational and Operational Strategies
  • Team Approaches to Drug Discovery and Development
    • GlaxoSmithKline
    • Merck
    • Roche
    • Novartis
    • Wyeth
  • Information Sharing
• External Sources of Innovation
  • Academic Resources
  • Biotechnology Companies
  • Pharmaceutical Venture Capital
• Outlook for Pharmaceutical R&D

Tables

• 1. FDA-Approved Drugs Derived from Combinatorial Chemistry and/or High-Throughput Screening
• 2. Select Clinical Candidates Derived from Target Identifi cation or Validation Programs
• 3. Select Biomarkers Included in FDA-Approved Drug Labels
• 4. Comparison of Conventional and Adaptive Clinical Trials
• 5. Select Pharmaceutical Research and R&D Centers
• 6. Select Pharmaceutical Drugs Originating from Biotechnology Companies
• 7. Select Pharmaceutical/Biotechnology Venture Capital Funds

Figures

• 1. FDA New Molecular Entity Approvals, 1990-2007, vs. R&D Spending by PhRMA Members, 1990-2006
• 2. Drug Development Models: Conventional Development vs. Translation and Experimental Medicine
• 3. Comparison of Pharmaceutical R&D Structures During Discovery and Development

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