References
J. Abraham and T. Reed. 2002. Progress Innovation and Regulatory Science in Drug Development: The Politics of International Standard-Setting Social Studies of Science 32: 3 337 - 69 (PubMed)
P. Agre and B. Rapkin. 2003. Improving Informed Consent: A Comparison of Four Consent Tools IRB: Ethics and Human Research 25: 6 1 - 7
K. Ahmad. 2001. Brazil and USA at Loggerheads over Production of Generic Antiretrovirals Lancet 357: 453
R. M. Anderson and R. M. May. 1990. Immunization and Herd Immunity Lancet 335: 641 - 45 (PubMed)
F. E. Andre. 2002. How the Research-Based Industry Approaches Vaccine Development and Establishes Priorities Developmental Biology 110: 25 - 29
R. J. Barrett and D. B. Parker. 2003. Rites of Consent: Negotiating Research Participation in Diverse Cultures Monash Bioethics Review 22: 2 9 - 26 (PubMed)
Baylor, N. W., and L. D. McVittie. 2003. "Changes in the Regulations for Vaccine Research and Development." In The Jordan Report 20th Anniversary, 45-49. Washington, DC: U.S. Department of Health and Human Services.
J. Biehl. 2002. Biotechnology and the New Politics of Life and Death in Brazil: The AIDS Model Princeton Journal of Bioethics 5: 59 - 74 (PubMed)
CDC (U.S. Centers for Disease Control and Prevention). 1999. Achievements in Public Health 1900-1999: Impact of Vaccines Universally Recommended for Children in the United States, 1990-1998 Morbidity and Mortality Weekly Report 48: 12 243 - 48 (PubMed)
Clarke, B. 2002. Presentation for the National Vaccine Advisory Committee, Washington DC.
P. Coll, M. Garrigo, C. Moreno and N. Marti. 2003. Routine Use of Gen-Probe Amplified Mycobacterium Tuberculosis Direct (MTD) Test for Detection of Mycobacterium Tuberculosis with Smear-Positive and Smear-Negative Specimens International Journal of Tuberculosis and Lung Disease 7: 9 886 - 91 (PubMed)
Danzon, P., and A. Towse. 2005. "Theory and Implementation of Differential Pricing for Pharmaceuticals." In International Public Goods and Transfer of Technology under a Globalized Intellectual Property Regime, ed. K. Maskus and J. Reichman. Cambridge, U.K.: Cambridge University Press.
J. A. DiMasi, R. W. Hansen and H. G. Grabowski. 2003. The Price of Innovation: New Estimates of Drug Development Costs Journal of Health Economics 22: 151 - 85 (PubMed)
J. A. DiMasi, R. W. Hansen, H. G. Grabowski and L. Lasagna. 1991. Cost of Innovation in the Pharmaceutical Industry Journal of Health Economics 10: 2 107 - 42 (PubMed)
"Drugs for the Poor: Exotic Pursuits." 2003. Economist, January 30, p. 52.
E. T. Emanuel, D. Wendler, J. Killen and C. Grady. 2004. What Makes Clinical Research in Developing Countries Ethical? The Benchmarks of Ethical Research Journal of Infectious Diseases 89: 930 - 37
FDA (U.S. Food and Drug Administration). 2004. Biological Products, Bacterial Vaccines, and Toxoids: Implementation of Efficacy Review Federal Register 69: 1 - 23
Galambos, L., and J. C. Sewell. 1995. Networks of Innovation. New York: Cambridge University Press.
D. A. Garber, G. Silvestri and M. B. Feinberg. 2004. Prospects for an AIDS Vaccines: Three Big Questions, No Easy Answers Lancet Infectious Diseases 4: 397 - 414 (PubMed)
GATB (Global Alliance for TB Drug Development). 2001. The Economics of TB Drug Development. New York: GATB.
H. Grabowski. 1997. The Effect of Pharmacoeconomics on Company Research and Development Decisions Pharmacoeconomics 11: 389 - 97 (PubMed)
Hansen, R. W. 1979."The Pharmaceutical Development Process: Estimates of Current Development Costs and Times and the Effects of Regulatory Changes." In Issues in Pharmaceutical Economics, ed. R. I. Chien, 151-87. Lexington, MA: Lexington Books.
S. Herrera. 2004. U.S. Rejiggers Bioshield Bill Nature Biotechnology 22: 792
Hilleman, M. R. 1996."Three Decades of Hepatitis Vaccinology in Historic Perspective: A Paradigm of Successful Pursuits." In Vaccinia, Vaccination, Vaccinology: Jenner, Pasteur, and Their Successors, ed. S. A. Plotkin and B. Fantini, 199-209. New York: Elsevier.
———2000. Vaccines in Historic Evolution and Perspective: A Narrative of Vaccines Discoveries Vaccine 18: 1436 - 47 (PubMed)
Hilts, P. J. 2003. Protecting America's Health: The FDA, Business, and One Hundred Years of Regulation. New York: Alfred A. Knopf.
Institute of Medicine. 2004. Financing Vaccines in the 21st Century. Washington, DC: National Academy Press.
S. Jayaramann. 2003. Indian Biogenerics Industry Emerges Nature Biotechnology 21: 1115 - 16
R. D. Klausner, A. S. Fauci, L. Corey, G. J. Nabel, H. Gayle, S. Berkley , et al. , et al.. 2003. The Need for a Global HIV Vaccine Enterprise Science 300: 2036 - 39 (PubMed)
Kou, U. 2002. Guidelines for Estimating Costs of Introducing New Vaccines into the National Immunization System. Geneva: World Health Organization, Department of Vaccines and Biologicals.
B. B. Lohray. 2003. Medical Biotechnology in India Advances in Biochemical Engineering/Biotechnology 85: 215 - 81 (PubMed)
A. Lyles. 2003. Public-Private Partnerships at the National Institutes of Health from Discovery to Commercialization Clinical Therapeutics 25: 11 2900 - 2 (PubMed)
A. Mahmoud. 2004. The Global Vaccination Gap (editorial) Science 305: 147 (PubMed)
G. H. Mazurek and M. E. Villarino. 2003. Guidelines for Using the QuantiFERON-TB Test for Diagnosing Latent Mycobacterium Tuberculosis Infection Morbidity and Mortality Weekly Report Recommendations and Reports 52: RR-2 15 - 18 (PubMed)
J. R. McMillan and C. Conlon. 2004. The Ethics of Research Related to Health Care in Developing Countries Journal of Medical Ethics 30: 204 - 6 (PubMed)
Mercer Management Consulting. 1995. "Report on the United States Vaccine Industry." Report for the Department of Health and Human Services, Washington DC.
———. 2002. "Lessons Learned: New Procurement Strategies for Vaccines." Report for the Global Alliance for Vaccines and Immunization Board, Geneva.
Miller, M .A., and A. R. Hinman. 1999."Cost-Benefit and Cost-Effectiveness Analysis of Vaccine Policy." In Vaccines, 3rd ed., ed. Stanley Plotkin and Walter Orenstein, 1074-87. Philadelphia: W. B. Saunders.
J. Milstien and L. Belgharbi. 2004. Regulatory Pathways for Vaccines for Developing Countries Bulletin of the World Health Organization 82: 128 - 33 (PubMed)
MMV (Medicines for Malaria Venture). 2002. Annual Report 2002. Geneva: MMV.
R. M. Nakamura, M. A. Velmonte, K. Kawajiri, C. F. Anf, R. A. Frias, M. T. Mendoza , et al. , et al.. 1998. MPB64 Mycobacterial Antigen: A New Skin Test Reagent through Patch Method for Rapid Diagnosis of Active Tuberculosis International Journal of Tuberculosis and Lung Disease 2: 7 541 - 46 (PubMed)
H. Nederbragt. 2000. The Biomedical Disciplines and the Structure of Biomedical and Clinical Knowledge Theoretical Medicine and Bioethics 21: 6 553 - 66 (PubMed)
G. J. V. Nossal. 2000. The Global Alliance for Vaccines and Immunization: A Millennial Challenge Nature Immunology 1: 5 - 8 (PubMed)
———2004. A Healthier Climate for Funding of Vaccine Research Nature Immunology 5: 457 - 59 (PubMed)
Y. Ohno. 2002. ICH Guidelines: Implementation of the 3Rs (Refinement, Reduction, and Replacement)—Incorporating Best Scientific Practices into the Regulatory Process Institute for Laboratory Animal Research Journal 43: Suppl. 595 - 98
C. E. O'Sullivan, D. R. Miller, P. S. Schneider and G. D. Roberts. 2002. Evaluation of Gen-Probe Amplified Mycobacterium Tuberculosis Direct Test by Using Respiratory and Nonrespiratory Specimens in a Tertiary Care Center Laboratory Journal of Clinical Microbiology 40: 5 1723 - 27 (PubMed)
M. D. Perkins. 2000. New Diagnostic Tools for Tuberculosis International Journal of Tuberculosis and Lung Disease 4: 12 S182 - 88 (PubMed)
E. Pignatti, H. Boone and I. Moulon. 2004. Overview of the European Regulatory Approval System Journal of Ambulatory Care Management 27: 89 - 97 (PubMed)
R. Rappuoli, H. Miller and S. Falkow. 2002. The Intangible Value of Vaccination Science 297: 937 - 39 (PubMed)
R. Ridley. 2003. Product R&D for Neglected Diseases: 27 Years of WHO/TDR Experiences with Public-Private Partnerships European Molecular Biology Organization Reports 4: S43 - 46 (PubMed)
Sachs, J. 2001. Macroeconomics and Health: Investing in Health for Economic Development. Geneva: World Health Organization.
Sander, A. 2004. "The Emerging Landscape of Public-Private Partnerships for Product Development." In Combating Diseases Associated with Poverty: Financing Strategies for Product Development and the Potential Role of Public-Private Partnerships, ed. R. Widdus and K. White, 79-80. Geneva: Initiative for Public-Private Partnerships for Health, Global Forum for Health Research.
E. F. Schmid and D. A. Smith. 2002. Should Scientific Innovation Be Managed? Drug Discovery Today 7: 941 - 45 (PubMed)
P. Trouiller, P. Olliaro, E. Torreele, J. Orbinski, R. Laing and N. Ford. 2002. Drug Development for Neglected Diseases: A Deficient Market and a Public-Health Policy Failure Lancet 359: 2188 - 94 (PubMed)
U.K. Commission on Intellectual Property Rights. 2002. Integrating Intellectual Property Rights and Development Policy. London: U.K. Commission on Intellectual Property Rights.
UNAIDS (Joint United Nations Programme on HIV/AIDS). 2003. Accelerating Action against AIDS in Africa. Geneva: UNAIDS.
U.S. Congress, Office of Technology Assessment. 1993. Pharmaceutical R&D Costs, Risks, and Rewards. OTA-H-522. Washington, DC: U.S. Government Printing Office.
H. Varmus, R. Klausner, E. Zerhouni, T. Acharya, A. S. Daar and P. A. Singer. 2004. Public Health: Grand Challenges in Global Health Science 303: 168 - 69
J. Walsh, A. Arora and W. Cohen. 2003. Working through the Patent Problem Science 299: 1021 (PubMed)
D. Webber and M. Kremer. 2001. Perspectives on Stimulating Industrial Research and Development for Neglected Infectious Diseases Bulletin of the World Health Organization 79: 735 - 41 (PubMed)
R. Widdus. 2001. Public-Private Partnerships for Health: Their Main Targets, Their Diversity, and Their Future Direction Bulletin of the World Health Organization 79: 713 - 20 (PubMed)
———. 2004. "Historical Context: Why Public-Private Partnerships for Product Development Emerged and How." In Combating Diseases Associated with Poverty: Financing Strategies for Product Development and the Potential Role of Public-Private Partnerships, ed. R. Widdus and K. White. Geneva: Initiative for Public-Private Partnerships for Health, Global Forum for Health Research.
WTO (World Trade Organization). 2003. "The General Council Chairperson's Statement," August 30. http://www.wto.org/english/tratop_e/trips_e/t_news_e.htm.
