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Contents: Introduction (I. Farquhar, K. Summers, A. Sorkin). INNOVATION IN REGULATORY AND OUTCOMES RESEARCH APPLICATIONS (1) After-Market Drug Regulation: Promoting Public Trust in Innovation (R. Field); (2) Transcending Tradition: Quality of Life as the Inextricable Link Between Activities of Daily Living and Specific Organ and Disease States (E. Vinik and A. Vinik); (3) Development and Validation of Eleven Symptom Indices to Evaluate Response to Chemotherapy for Advanced Cancer: Measurement Compliance with Regulatory Demands (S. Rosenbloom, D. Cella et al.); (4) Confounding in Health Services Research: Issues and Solutions (F. Shaya and A. Gu). ECONOMICS OF INNOVATIVE BIOPHARMACEUTICALS (5) Prices, Regulation and Innovation in Pharmaceuticals and Biotechnology (J. Hay); (6) The History and Economics of Pharmaceutical Patents (A. Wertheimer and T. Santilla). INNOVATION IN SYSTEM-OF-SYSTEMS APPLICATIONS (7) Modernization of the Joint Forces Ammunition Logistics Information System: Agile, Adaptive, Serving the Modular Forces (I. Farquhar and A. Sorkin); (8) Innovation in Health, Environmental and Safety Research Infrastructure (I. Farquhar et al); (9) The Value of Information Technology Innovation in Healthcare (M. Bhor et al); (10) Costing Innovation (N. Hulkower).