Orphans and incentives : developing technologies to address emerging infections : workshop report

Orphans and incentives developing technologies to address emerging infections : workshop report

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Detalles Bibliográficos
Autor Corporativo: Institute of Medicine (U.S.). Forum on Emerging Infections (-)
Otros Autores: Harrison, Polly F. (-), Lederberg, Joshua
Formato: Libro electrónico
Idioma:Inglés
Publicado: Washington, D.C. : National Academy Press 1997.
Edición:1st ed
Materias:
Emerging infectious diseases.
Communicable diseases.
Vaccines.
Ver en Biblioteca Universitat Ramon Llull:https://discovery.url.edu/permalink/34CSUC_URL/1im36ta/alma991009622131206719
Tabla de Contenidos:
  • 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.

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