Report: Antibiotic R&D: Resolving the Paradox between Unmet Medical Need and Commercial Incentive TOC

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

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

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

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

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)

Antibiotic R&D: Resolving the Paradox between Unmet Medical Need and Commercial Incentive