LEADER 08962nam 2200769 a 450 001 9910957208503321 005 20251017110053.0 010 $a9786610187157 010 $a9780309174411 010 $a0309174414 010 $a9781280187155 010 $a1280187158 010 $a9780309591331 010 $a0309591333 010 $a9780585021157 010 $a0585021155 035 $a(CKB)110986584752188 035 $a(OCoLC)42328824 035 $a(CaPaEBR)ebrary10055547 035 $a(SSID)ssj0000216527 035 $a(PQKBManifestationID)11222315 035 $a(PQKBTitleCode)TC0000216527 035 $a(PQKBWorkID)10198626 035 $a(PQKB)10688482 035 $a(MiAaPQ)EBC3376373 035 $a(Au-PeEL)EBL3376373 035 $a(CaPaEBR)ebr10055547 035 $a(OCoLC)923263251 035 $a(Perlego)4736537 035 $a(DNLM)840292 035 $a(BIP)47505933 035 $a(EXLCZ)99110986584752188 100 $a19971217d1997 uy 0 101 0 $aeng 135 $aurcn||||||||| 181 $ctxt 182 $cc 183 $acr 200 00$aOrphans and incentives $edeveloping technologies to address emerging infections : workshop report /$fForum on Emerging Infections, Division of Health Sciences Policy, Institute of Medicine ; Polly F. Harrison and Joshua Lederberg, editors 205 $a1st ed. 210 $aWashington, D.C. $cNational Academy Press$d1997 215 $a1 online resource (112 p.) 300 $aBibliographic Level Mode of Issuance: Monograph 311 08$a9780309059411 311 08$a0309059410 320 $aIncludes bibliographical references. 327 $aOrphans 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. 327 $aPatent 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 -- Collaborations -- Budget 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 -- Future Challenges/Concerns/Issues -- DEPARTMENT OF VETERANS AFFAIRS (VA) -- R& -- D Priorities -- Implementation -- Collaborations -- Budget Allocations -- Future Challenges/Concerns/Issues -- WORLD BANK -- R& -- 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. 327 $aBackground -- 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. 330 $aInfectious diseases remain a leading cause of prolonged illness, premature mortality, and soaring health costs. In the United States in 1995, infectious diseases were the third leading cause of death, right behind heart disease and cancer. Mortality is mounting over time, owing to HIV/AIDS, pneumonia, and septicemia, with drug resistance playing an ever-increasing role in each of these disease categories. This book, a report from a Forum on Emerging Infections workshop, focuses on product areas where returns from the market might be perceived as being too small or too complicated by other factors to compete in industrial portfolios with other demands for investment. Vaccines are quintessential examples of such products. The lessons learned fall into four areas, including what makes intersectoral collaboration a reality, the notion of a product life cycle, the implications of divergent sectoral mandates and concepts of risk, and the roles of advocacy and public education. The summary contains an examination of the Children's Vaccine Initiative and other models, an industry perspective on the emerging infections agenda, and legal and regulatory issues. 606 $aEmerging infectious diseases 606 $aCommunicable diseases 606 $aVaccines 615 0$aEmerging infectious diseases. 615 0$aCommunicable diseases. 615 0$aVaccines. 676 $a614.4/4 701 $aHarrison$b Polly F$01803611 701 $aLederberg$b Joshua$095738 712 02$aInstitute of Medicine (U.S.).$bForum on Emerging Infections. 801 0$bMiAaPQ 801 1$bMiAaPQ 801 2$bMiAaPQ 906 $aBOOK 912 $a9910957208503321 996 $aOrphans and incentives$94365142 997 $aUNINA