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Orphans and Incentives : Developing Technology to Address Emerging Infections.

Detalles Bibliográficos
Clasificación:Libro Electrónico
Autor principal: Harrison, Polly F.
Otros Autores: Lederberg, Joshua
Formato: Electrónico eBook
Idioma:Inglés
Publicado: Washington : National Academies Press, 1997.
Temas:
Acceso en línea:Texto completo
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 ProtectionTechnology 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 StudiesSurrogate 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 CollaborationThe 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 & D Priorities
  • Implementation
  • CollaborationsBudget Allocations
  • Future Challenges/Concerns/Issues
  • DEFENSE ADVANCED RESEARCH PROJECTS AGENCY (DARPA)
  • R & D Priorities
  • Implementation
  • Collaborations
  • Budget Allocations
  • Future Challenges/Concerns/Issues
  • NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES (NIAID)
  • R & D Priorities
  • Implementation
  • Collaborations
  • Budget Allocations
  • Future Challenges/Concerns/Issues
  • UNITED STATES DEPARTMENT OF STATE (DOS)
  • R & D Priorities
  • Implementation
  • Collaborations
  • Budget Allocations