Orphans and incentives : developing technologies to address emerging infections : workshop report / / Forum on Emerging Infections, Division of Health Sciences Policy, Institute of Medicine ; Polly F. Harrison and Joshua Lederberg, editors

• Record Nr.: UNINA9910812043303321
• Pubbl/distr/stampa: Washington, D.C., : National Academy Press, 1997
• ISBN: 0-309-17441-4; 1-280-18715-8; 9786610187157; 0-309-59133-3; 0-585-02115-5
• Edizione: [1st ed.]
• Descrizione fisica: 1 online resource (112 p.)
• Altri autori (Persone): HarrisonPolly F; LederbergJoshua
• Disciplina: 614.4/4
• Soggetti: Emerging infectious diseases; Communicable diseases; Vaccines
• Lingua di pubblicazione: Inglese
• Formato: Materiale a stampa
• Livello bibliografico: Monografia
• Note generali: Bibliographic Level Mode of Issuance: Monograph
• Nota di bibliografia: Includes bibliographical references.
• Nota di contenuto: Orphans and Incentives: Developing Technologies to Address Emerging Infections -- Copyright -- Preface -- THE FORUM -- THE TOPIC -- THE REPORT AND ITS ORGANIZATION -- ACKNOWLEDGMENTS -- NOTES -- Contents -- Summary -- LESSONS -- Introduction -- BACKGROUND -- THE WORKSHOP -- Workshop Summary -- THE CHILDREN'S VACCINE INITIATIVE* -- A Brief History -- Defining and Implementing Cross-Sectoral Collaboration -- Defining, Creating, and Stabilizing the Market -- Situation Analysis -- Market Segmentation -- Centralized Procurement -- Tiered Pricing -- Intellectual Property and Its Protection -- Technology Transfer -- Individual Product Experiences -- A More Heat-Stable Polio Vaccine -- The Hepatitis B Vaccine -- OTHER MODELS* -- The Malaria Vaccine Development Board -- The International AIDS Vaccine Initiative (IAVI) -- AN INDUSTRY PERSPECTIVE ON THE EMERGING INFECTIONS AGENDA* -- Industry's ; Response to HIV/AIDS -- The Emerging Infections Scenario and HIV/AIDS -- Barriers -- LEGAL AND REGULATORY ISSUES* -- Accelerated Approval and Development of Drugs for Serious and Life-Threatening Illnesses -- Clinical Studies -- Surrogate Endpoints -- Restricted Distribution and the Matter of Antimicrobial Resistance -- Product Labeling -- Product Availability -- International Harmonization of Technical Requirements to Register Pharmaceuticals -- Intellectual Property Rights Revisited -- Orphan Drug Legislation -- PUBLIC-SECTOR AGENDAS AND PRIORITIES* -- LESSONS LEARNED AND ISSUES FOR RESOLUTION -- Lessons from the Children's Vaccine Initiative -- Divergent Sectoral Mandates and Notions of Risk -- The Product Life Cycle and the Role of Market Analysis -- Authentic Collaboration -- The Pivotal Roles of Advocacy and Public Information -- Issues for Resolution -- Agendas and Priorities -- Funding -- Multi-Tiered Pricing -- Restricted Distribution -- Surrogate Endpoints.; Patent Extensions -- Technology Transfer and Local Production -- Orphan Drug Designation -- Other Topics -- A Final Observation -- NOTES -- APPENDIX A Emerging Infectious Diseases Research and Development Agendas: Principal Public-Sector In ... -- CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) -- R&amp -- D Priorities -- Implementation -- Collaborations -- Budget Allocations -- Future Challenges/Concerns/Issues -- DEFENSE ADVANCED RESEARCH PROJECTS AGENCY (DARPA) -- R&amp -- D Priorities -- Implementation -- Collaborations -- Budget Allocations -- Future Challenges/Concerns/Issues -- NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID) -- R&amp -- D Priorities -- Implementation -- Collaborations -- Budget Allocations -- Future Challenges/Concerns/Issues -- UNITED STATES DEPARTMENT OF STATE (DOS) -- R&amp -- D Priorities -- Implementation -- Collaborations -- Budget Allocations -- Future Challenges/Concerns/Issues -- DEPARTMENT OF VETERANS AFFAIRS (VA) -- R&amp -- D Priorities -- Implementation -- Collaborations -- Budget Allocations -- Future Challenges/Concerns/Issues -- WORLD BANK -- R&amp -- D Priorities -- Implementation -- Collaborations -- Budget Allocations -- Future Challenges/Concerns/Issues -- APPENDIX B Workshop Agenda -- APPENDIX C Public-/Private-Sector Collaboration in Pharmaceutical Research and Development: Inventor ... -- LEGISLATIVE AND REGULATORY MECHANISMS -- Bayh-Dole Act -- Background -- Outcomes -- Issues -- References -- Orphan Drug Act -- Background -- Outcomes -- Issues -- References -- National Vaccine Injury Compensation Program -- Background -- Outcomes -- Issues -- References -- Cooperative Research and Development Agreements -- Background -- Outcomes -- Issues -- References -- Small Business Innovation Research Program -- Background -- Outcomes -- Issues -- References -- Small Business Technology Transfer.; Background -- Outcomes -- References -- Intellectual Property Rights/Patent Protection -- Background -- Outcomes -- Issues -- References -- Product Liability Protection -- Background -- Outcomes -- Issues -- References -- NIH Legislative Proposal for Product Liability Exemption for Public Health Service IND and IDE Research -- Background -- Issues -- References -- Prescription Drug User Fee Act -- Background -- Outcomes -- References -- Drug Approval Process Alternatives: Treatment Investigational New Drugs -- Background -- Outcomes -- Issues -- References -- Drug Approval Process Alternatives: Parallel Tracking -- Background -- Outcomes/Issues -- References -- Drug Approval Process Alternatives: Off-Label Use/Supplemental New Drug Applications -- Background -- Outcomes ; -- Issues -- References -- FINANCIAL MECHANISMS -- Tiered Pricing/Bulk Procurement -- Background -- Outcomes -- Issues -- References -- Research and Development Tax Credit -- Background -- Outcomes -- Issues -- Puerto Rico/Possessions Tax Credit (Sec. 30a/Sec. 936) -- Background -- Outcomes -- Issues -- CAMPAIGN AND DISEASE-FOCUSED MECHANISMS -- Breast Cancer -- Background -- Outcomes -- Issues -- References -- Hiv/Aids -- Background -- Outcomes -- Issues -- References -- Juvenile Diabetes Foundation -- Background -- Outcomes -- Issues -- References -- ORGANIZATIONAL MECHANISMS -- International Vaccine Institute -- Background -- Outcomes -- Issues -- References -- International AIDS Vaccine Initiative (IAVI) -- Background -- Outcomes -- Issues -- References -- Inter-Company Collaboration for Aids Drug Development -- Background -- Outcomes -- Regional System for Vaccines/Sistema Regional Para Vacunas -- Background -- Outcomes -- References.