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US Cancer Vaccine Market Analysis
Date:9/17/2012

straints4.2.3.2.1 Engerix-B and Twinrix4.2.3.2.2 Recombivax HB and Comvax4.2.3.2.3 Pediarix5. Potential Cancer Vaccine Candidates: An Opportunity Assessment5.1 Prophylactic Vaccine5.2 Therapeutic Vaccine5.2.1 Prostate Cancer5.2.2 Breast Cancer5.2.3 Lung Cancer5.2.4 Colorectal Cancer6. Regulatory Environment6.1 Vaccine Approval Process6.2 FDA Guidance for Industry: Clinical Considerations for Therapeutic Cancer Vaccines6.2.1 Considerations for both Early and Late Phase Clinical Trials6.2.1.1 Patient Population6.2.1.2 Monitoring the Immune Response6.2.1.3 Biomarkers as Evidence of Efficacy6.2.1.4 Adjuvants Used to Stimulate Immune Response6.2.1.5 Multi-antigen Vaccines6.2.1.6 Disease Progression/Recurrence Immediately or Shortly after the Initial Administration of Cancer Vaccines6.2.1.7 Concomitant and Subsequent Therapies6.2.2 Considerations for Early Phase Clinical Trials6.2.2.1 Starting Dose and Dosing Schedule6.2.2.2 Booster and Maintenance Therapy6.2.2.3 Dose Escalation6.2.2.4 Single-arm versus Randomized Phase-2 Trials in Early Development6.2.3 Considerations for Late Phase Clinical Trials6.2.3.1 Safety Profile from Early Phase Clinical Trials6.2.3.2 Endpoints6.2.3.3 Statistical Issues6.2.3.4 Control Issues6.2.3.5 Delayed Vaccine Effect6.2.3.6 Autologous Vaccine Trials6.2.3.7 Accelerated Approval Regulations7. Competitive Landscape7.1 Merck & Co.7.1.1 Business Description7.1.2 Key Strategy Analysis7.2 GSK7.2.1 Business Description7.2.2 Key Strategy Analysis7.3 Dendreon7.3.1 Business Description7.3.2 Key Strategy Analysis7.4 Bavarian Nordic7.4.1 Business Description7.4.2 Key Strategy Analysis7.5 Celldex Therapeutics7.5.1 Business Description7.5.2 Key Strategy Analysis7.6 Kael-GemVax7.6.1 Business Description7.6.2 Key Strategy Analysis7.7 Oxford BioMedica7.7.1 Business Description7.7.2 Key Strategy Analysis7.8 Galena Biopharma7.8.1 Business Description7.8.2 Key Strategy Analysis

List of Figures:

Figure 3-1: Cancer Prevalence (Million), 2008-2016
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