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