抗生物質R&D：同時滿足潛在需求及商業化的目的

抗生物質R&D：同時滿足潛在需求及商業化的目的 是由出版商Insight Pharma Reports在2008年07月所出版的。 這份英文市場調查報告書包含172 Pages 價格從美金2995起跳。

簡介

目錄

Abstract

The current crisis in antibiotic R&D is attributed to an industry pipeline with few late-stage candidates capable of combating the emergence and spread of novel, drug-resistant bacterial strains. This new report offers in-depth analysis of:

• Factors driving the field forward and opportunities for large and small pharma
• The key scientific challenges to antibiotic drug discovery
• The economic and regulatory realities of antibiotic R&D
• The broad range of antibacterial approaches being taken across the industry
• Select compounds in clinical development

Many experts consider the emergence and spread of antibiotic resistance to be a paramount public health threat of the 21st century. While most resistant microbes continue to emerge in the hospital setting, more resistance is being found outside of the hospital environment. Nonetheless, only 2 new classes of antibiotics have reached the market over the past 30 years. This report explores the interrelated factors leading to the current crisis.

The rapid emergence and spread of resistance is a challenge shared by no other type of drug-one that companies must consider from both a scientific and economic standpoint. The need for more regulatory clarity regarding drug approval standards is another great challenge that many antibiotic companies currently face, as is examined in this report.

Antibiotic R&D: Resolving the Paradox between Unmet Medical Need and Commercial Incentive explores the lucrative potential of antibiotic commercialization, despite the popular conception that antibiotic R&D is too great an economic risk to become involved in. As is described, dealing with the economic realities of antibiotic development and commercialization will require a shift away from the blockbuster model toward niche-market products.

From a scientific standpoint, combating resistance will require the discovery and development of new antibiotics with novel potential to inhibit bacterial growth, reproduction, and resistance. This report features some of the more promising late-stage products with novel mechanisms of action. Scientists and industry leaders are taking as many different approaches as there are companies. Among those described in this report:

• Entirely different antibacterial approaches, such as phage enzyme therapy and innate defense regulation
• Looking to the natural world for more complex bioactive molecules that would be less likely to induce resistance than small-molecule inhibitors
• Combinations of antibacterial/antibiotic agents

Antibiotic R&D: Resolving the Paradox between Unmet Medical Need and Commercial Incentive includes interviews with experts from companies engaged in both early and late-stage antibiotic R&D, including companies that have a marketed product. Additionally, it provides an analysis of results from a recent survey relating to the research, development, and commercialization of antibacterial agents.

Table of Contents

Chapter 1 Antibiotic Research and Development: An Industry in Transition

• 1.1. Drivers of Antibiotic R&D
• 1.2. Resistance
  • MRSA in the Media
  • MRSA: Just the Tip of the Iceberg
  • Resistance among Gram-Negative Bacteria
  • Resistance is Not New
• 1.3. Economics of Antibiotics: Contrary to Popular Opinion, Antibiotics Can Be Lucrative
• 1.4. Other Unmet Medical Needs: The Emergence and Spread of Non-Resistant Bacterial Strains
  • C. difficile and CDAD
• 1.5. Changing Demographics of the Global Population
• 1.6. Biodefense and Other Antibacterial-Related US Federal Funding Initiatives
  • Other, Non-Biodefense US Federal Funding Initiatives of Relevance
• 1.7. The Risky Nature of Antibiotic R&D
  • Large Pharma Exodus from Antibiotic R&D
  • Challenges Facing Small Pharma
    • Basilea
    • Novexel
  • Smaller Firms Seeking Single-Indication Products
• 1.8. Big Pharma Shows Renewed Interest

Chapter 2 The Difficult Science of Antibacterial Discovery

• 2.1. What Makes Antibiotics Unique?
• 2.2. Looking for New Leads: Back to Nature?
  • A Brief History of the Antibiotic Era: From Its Natural Roots to the High-Throughput Search for Synthetics
  • Target-Based High-Throughput Screening: Still Fine-Tuning the Approach
  • Antibiotics au Naturel: Exploring Untapped Natural Resources
  • Screening Uncultivable Bacteria
  • Beyond Microbes
  • Other Select Companies Involved in Natural Product Screening
    • InterMed Discovery
    • Albany Molecular Research (AMRI)
  • Conventional Analogue Improvement: Still the Discovery Method of Choice for Many Companies
• 2.3. Discovery Is Not Enough: Getting to the Target
  • Knowing the Target Is Not Enough: Issues of Permeability and Penetration
• 2.4. Prolonging the Inevitability of Resistance
  • Combination Antibiotic Therapy
  • Procarta Biosystems: A Different Type of Combination Therapy

Chapter 3 The Antibacterial Pipeline Today

• 3.1. Diversity among Products in Development: Gram-Positive Thinking
  • Advanced Life Sciences' Cethromycin
  • Arpida' s Iclaprim
  • Inimex Pharmaceuticals: Taking a Different Antibacterial Approach by Stimulating the Innate Immune Response
  • Novozymes' Novel Peptide Approach
  • Profos: Re-Visiting Phages
  • Targanta Therapeutics' Oritavancin
  • Theravance' s Telavancin
• 3.2. Drug-Resistant Gram-Negative Bacteria: An Emerging Storm on the Horizon
  • New Antibacterial Agents for the Treatment of Gram-Negative Infections: The Development Pipeline
  • Beta-Lactams and Beta-Lactamase Inhibitors
    • Novexel' s NXL104, a Novel Beta-Lactamase Inhibitor
    • Basilea' s BAL30376: Another Novel, Combination Beta-Lactamase Inhibitor

Chapter 4 Blockbuster or Bust? Economic Opportunities, Regulatory Challenges

• 4.1. Alternatives to the Blockbuster Model
  • The Value of Single-Indication Antibiotics
• 4.2. Antibiotics for Biotech
  • Replidyne
  • Trius Therapeutics
  • 4.3. Challenges from a Biotech Perspective
  • Regulatory Hurdles and Moving Goalposts: The Need for Clearer Regulatory Guidelines
    • FDA Stance on Non-Inferiority
    • Clinical Endpoints: Patient- or Parent-Reported Outcome Measures
• 4.4. Redefining Innovation

Chapter 5 Company Portraits & Expert Interviews

• 5.1. Interview with Ron Najafi, PhD, Chairman and CEO, NovaBay Pharmaceuticals (Emeryville, CA)
• 5.2. Interview with Graham Johnson, PhD, Chief Research Officer, Rib-X Pharmaceuticals (New Haven, CT)
• 5.3. Interview with Kenneth J. Collins, MBA, Co-Founder, President, and Chief Executive Officer; Roger M. Echols, MD, Chief Medical Officer; and Peter W. Letendre, PharmD, former Chief Commercial Officer; Replidyne (Louisville, CO)
• 5.4. Interview with Steven Gilman, PhD, Senior Vice President, Discovery & Nonclinical Development and Chief Scientific Officer, Cubist Pharmaceuticals (Lexington, MA)
• 5.5. Interview with Thomas J. Dougherty, PhD, Senior Principal Scientist, Infection Discovery, AstraZeneca R&D Boston (Waltham, MA)

Chapter 6 Results From CHI' s Antibacterial R&D and Commercialization Survey: March-April 2008

• 6.1. Types of Organizations
• 6.2. Titles of Respondents
• 6.3. Focus on Antibiotics
• 6.4. Antibiotic Discovery Technology
• 6.5. Antibiotic Products
• 6.6. Challenges and Regulatory Issues

References

Company Index with Web Addresses

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