Areas of Interest:

• Antibacterial agents that can be meaningfully clinically differentiated from current agents in terms of safety, efficacy, route of administration, or activity against resistant bacterial strains. Products / programs should only be considered if compelling data exists, including: resistance frequency, an understanding of the mechanism of action, efficacy in animal models of infection, and preliminary toxicology data*

*Criteria that determine meaningful clinical differentiation may vary by region of the world

Areas of highest interest include:

• Broad-spectrum agents that cover problematic pathogens included on the IDSA ESKAPE list
• Broad-spectrum agents that can cover either intrinsic or acquired resistance to existing agents. Though candidates with broad G+ and G- coverage are preferred, agents that cover a side spectrum of G+ or G- pathogens will be considered
• Narrow spectrum agents are lower priority due to: (1) the need for rapid, accurate, and affordable diagnostics to succeed clinically and commercially; and (2) difficulty in designing, conducting, and registering clinical trials
• Agents co-dosed with antibacterials to overcome resistance (eg, beta-lactamase inhibitors) or enhance spectrum of coverage (eg, synergists). Note: beta-lactamase inhibitors should have at least Class A and C coverage, but will be more highly valued if they can also provide Class B or Class D coverage as well
• IV-only dosing is acceptable, but IV / PO is preferred
• Novel approaches to C. difficile that address the recurrence rate

Not Interested in:

• Topical antibiotics
• Antibodies without clinical POC
• Quinolones (mechanism of action for quinolones is of interest, but not the structural class)

Areas of Interest:

• Antifungal agents with compelling data including: an understanding of the mechanism of action, efficacy in animal models of infection, and preliminary toxicology data
  • IV (preferably with oral formulation) broad-spectrum agents with activity superior to azoles and echinocandins against Candida, Aspergillus, and rare molds for hospital use
  • Aspergillus- or mold-specific small molecule or mAb (therapeutic and / or prophylactic, clinical POC required)

Late-stage opportunities (Phase III-ready and later):

• Candida, Aspergillus, or rare mold antifungals (IV, preferably with oral formulation) that can be meaningfully clinically differentiated from current treatment options*
• Oral agents for community use active against Candida and dermatophytes that can be meaningfully clinically differentiated from current treatment options*

*Criteria that determine meaningful clinical differentiation may vary by region of the world

Not Interested in:

• Incremental improvements upon inhibitors of ergosterol biosynthesis
• Known antifungal structural types unless they are differentiated from current agents by safety, efficacy, route of administration, or activity on resistant strains
• Antibodies without clinical POC

Areas of Interest:

• Preclinical:
  • Novel agents with compelling data including an understanding of the mechanism of action, activity in cell culture, resistance profile, and PK with particular interest in:
    • Inhibitors of viral budding and / or maturation
    • Latency targets
    • HIV gene expression inhibitors
    • Non-nucleoside inhibitors
    • Nucleoside reverse transcriptase inhibitors with differentiated resistance profile to existing agents, QD (or less frequent, eg, once weekly) dosing, >1 month tox
    • PK enhancers
• Phase I or later in development:
  • Integrase inhibitors with new MOA or novel structural scaffold with QD dosing
  • QD protease inhibitors that do not require ritonavir-boosting
  • Non-nucleoside reverse transcriptase inhibitors dosed QD with a high barrier to resistance / efficacy against NNRTI (including 2nd-generation NNRTI)-resistant virus
• Other new mechanisms, eg, host targets
• Late-stage opportunities (Phase III-ready and later):
  • Novel or differentiated agents, ideally combinable in fixed-dose combination with existing in-line or pipeline assets that are complementary to in-house MOAs
  • Global / regional promotional partnerships

Not Interested in:

• Agents administered parenterally, including antibodies

Areas of Interest:

• Preclinical:
  • Novel agents with compelling data including an understanding of the mechanism of action, activity in HCV replicon, and PK in one species with particular interest in:
    • Highest interest in nucleoside inhibitors with acceptable safety / toxicology profile
    • NS5A inhibitors
    • Novel mechanism agents
    • PK enhancers
• Phase I or later in development:
  • Non-nucleoside inhibitors of NS5B
  • Second-generation protease inhibitor with activity against genotypes 1, 2, and 3, and key mutants with preclinical safety data and PK suggestive of QD dosing suitable for development as fixed-dose combinations
• Late-stage opportunities (Phase III-ready and later):
  • Novel or differentiated agents, ideally suitable for fixed-dose combination with existing in-line or pipeline assets that are complementary to in-house MOAs
  • Global / regional promotional partnerships
  • Cyclophillin inhibitors and other host cell factors

Not Interested in:

• Parenterally administered interferons
• TLR agonists or activators
• HCV viral entry inhibitors

Areas of Interest:

• Preclinical or later in development:
  • Novel approaches to HBV with the potential to cure / eradicate
• Phase IIb or later in development:
  • HBV, RSV, CMV, EBV, flu agents with pristine safety profiles
• Late-stage opportunities (Phase III-ready and later):
  • We will continue to consider external licensing and partnership opportunities for differentiated products directed at other viral infections in late-stage development
  • Global / regional promotional partnerships

Not Interested in:

• Agents administered parenterally

Areas of Interest:

• Animal or cellular models of HIV latency
• In vitro tissue models for HCV
• Robust cell culture systems for HCV replication
• Biomarkers / noninvasive assay technology for HIV and HCV with enhanced sensitivity and / or lower cost; particularly interested in prognostics
• Genotyping and phenotyping technologies for HCV polymerase and HCV protease
• HCV and specific gene chimera replicons
• PK enhancers

Antifungal and Antibacterial:

• Rapid (<2 hours), point-of-care, pathogen-specific (ESKAPE organisms), and host-response diagnostic tests
• Molecular biomarkers of susceptibility