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

Published by: Decision Resources

Published: Mar. 14, 2008 - 28 Pages

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

Abstract

• 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 technolo- gies for lead and target identification. 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?

• 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 identification technologies produce approved drugs; microarray technologies used in basic research; toxicity prediction using in vitro signature profiling; patient-specific therapies play a dominant role as translational research ties mechanism of action and efficacy 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 firms help companies tap into innovation.

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