Notes and references
1. PATH Malaria Vaccine Initiative. First results from ongoing Phase III trial show malaria vaccine candidate, RTS,S reduces the risk of malaria by half in African children aged 5 to 17 months [press release]. October 18, 2011.
2. Walker LM, Huber M, Doores KJ, et al. Broad neutralization coverage of HIV by multiple highly potent antibodies. Nature. 2011;477:466–470.
3. US Centers for Disease Control and Prevention (CDC). CDC trial and another major study find PrEP can reduce risk of HIV infection among heterosexuals [press release]. Atlanta, GA: CDC; July 13, 2011.
4. Global Alliance for TB Drug Development (TB Alliance). CPTR yields rogress: new six-way agreement among pharmas and NGOs will speed development of TB drug combinations [press release]. Brussels, Belgium: TB Alliance; November 9, 2011.
5. Aeras. Vaccine targeting latent TB enters clinical testing [press release]. Rockville, MD: Aeras; December 1, 2011.
6. Drugs for Neglected Diseases initiative (DNDi). Major project launched to support India and Bangladesh's national control programmes in implementing new treatments to boost kala-azar elimination strategies [press release]. Geneva, Switzerland: DNDi; November 7, 2011.
7. Storms D, Gubareva LV, Su S, et al. Oseltamivir-resistant pandemic (H1N1) 2009 virus infections, United States, 2010–11. Emerging Infectious Diseases. 2012;18(2):308–311.
8. Barry PM, Gardner TJ, Funk E, et al. Multistate outbreak of MDR TB identified by genotype cluster investigation. Emerging Infectious Diseases. 2012;18(2):113–115.
9. Radke EG, Gregory CJ, Kintziger KW, et al. Dengue Outbreak in Key West, Florida, USA, 2009. Emerging Infectious Diseases. 2012;18(2):135–137.
10. International AIDS Vaccine Initiative (IAVI). Product development public-private partnerships (PDPs): a driving force for new vaccines and drugs [fact sheet] (PDF 395 KB). New York, NY: IAVI; 2006.
11. The 16 products produced in collaboration with product development partnerships include tools to combat malaria, sleeping sickness, cholera, Japanese encephalitis (JE), meningitis, visceral leishmaniasis, and tuberculosis (TB) in low- and middle-income countries. They are: Drugs for Neglected Diseases initiative: artesunate/amodiaquine, artesunate/mefloquine, nifurtimox eflornithine combination therapy, stibogluconate and paromomycin combination therapy (Africa); Foundation for Innovative New Diagnostics: fluorescence microscopy, Xpert® MTB/RIF (or automated nucleic acid amplification), liquid culture, rapid speciation for multidrug-resistant TB, line probe assay; Infectious Disease Research Institute: Kalazar Detect™; Institute for One World Health: paromomycin; International Vaccine Institute: killed whole-cell oral cholera vaccine; Medicines for Malaria Venture with Novartis (regulated by SwissMedic): Coartem® Dispersible; Medicines for Malaria Venture with Guilin Pharmaceuticals: injectable artesunate; Meningitis Vaccine Project: MenAfriVac™; PATH: JE vaccine (India).
12. Henderson DA, Moss B. Smallpox and vaccinia. In: Plotkin SA, Orenstein WA, eds. Vaccines. Philadelphia, PA: Saunders; 1999.
13. LC16m8 attenuated smallpox vaccine [fact sheet] (15 KB PDF). World Health Organization website.
14. Collier LH. The development of a stable smallpox vaccine (3 MB PDF). University of London; 1952.
15. The World Health Organization Smallpox Eradication Programme. University of Toronto website.
16. Leadership interview: A leader anticipates and prepares for change. Roll Back Malaria website.
17. Sharma SK, Upadhyay AK, Haque MA, et al. Wash resistance and bioefficacy of Olyset net—a long-lasting insecticide-treated mosquito net against malaria vectors and nontarget household pests. Journal of Medical Entomology. 2006;43(5):884–888.
18. Graham K, Kayedi MH, Maxwell C, et al. Multi-country field trials comparing wash-resistance of PermaNet and conventional insecticide-treated nets against anopheline and culicine mosquitoes. Medical and Veterinary Entomology. 2005;19(1):72–83.
19. PermaNet® 3.0—Combination Net. Vestergaard Frandsen website.
20. PATH. Hope for less than 50 cents a dose: a revolutionary model for developing low-cost vaccines [fact sheet]. Seattle, WA: PATH; 2010.
21. Consolidated Appropriations Act, 2012 (bill summary and status). HR 2055. 112th Congress, 1st session (2011).
22. Rogers: Final appropriations package will move forward [press release].Washington, DC: US House of Representatives Committee on Appropriations; December 15, 2011.
23. For instance, a joint House-Senate Conference Committee in December 2011 reached agreement on final Fiscal Year 2012 appropriations legislation, which includes funding for global health programs through the Department of State, US Agency for International Development (USAID), US Centers for Disease Control and Prevention (CDC), and US National Institutes of Health (NIH). Under the agreement, the Global Health and Child Survival Account—which funds global health work at the Department of State and USAID, including all of USAID's support for global health research and development—was provided with $US8.167 billion, an increase of about 4 percent compared with Fiscal Year 2011 levels. The CDC's global health account was funded at $US348.9 million, a 2.5 percent increase compared with Fiscal Year 2011. And funding for the NIH overall increased to about $US30.7 billion for Fiscal Year 2012, with the NIH's Fogarty International Center seeing an increase of about 0.3 percent. See the Henry J. Kaiser Family Foundation website, Kaiser Family Foundation Policy Tracker.
24. All funding amounts included in the G-FINDER report are adjusted for inflation and reported as 2007 dollars so that they may be compared to previous G-FINDER reports, which date back to 2007. Moran M, Guzman J, Abela-Oversteegen L, et al. Neglected Disease Research and Development: Is Innovation Under Threat? (19 MB PDF). Sydney, Australia: Policy Cures; 2011.
27. Beyers B, Devine J, Weatherford S, Hagopian A. Economic Impact Assessment of Global Health on Washington State's Economy (508 KB PDF). Seattle, WA: University of Washington; 2007.
28. Garcia‐Mosqueira A, Tang S, Chapman Page K, Becker C. Why Global Health Matters to North Carolina: The Economic Impact of the Global Health Sector on North Carolina's Economy (380 KB PDF). Durham, NC: Duke Global Health Institute; 2009.
29. Nandi A. The Importance of the Global Health Sector in California: An Evaluation of the Economic Impact (PDF 2 MB). Riverside, CA: University of California Global Health Institute; 2009.
30. Porter JE, Rowley SH. A Hidden Prescription for Jobs: Global Health R&D. Huffington Post website.
31. Research!America. Global health R&D: a smart investment for New Jersey [fact sheet] (1 MB PDF). Alexandria, VA: Research!America; 2011.
32. Moses H, Martin B. Biomedical research and health advances. New England Journal of Medicine. 2011; 364:567–571.
33. For instance, in the United States alone, polio vaccination over the past 50 years has resulted in a net savings of $US180 billion, funds that would have otherwise been spent to treat those suffering from polio. For every dollar spent on measles-mumps-rubella vaccine, more than $US21 is saved in direct medical costs. New therapies to treat drug-resistant tuberculosis could reduce the price of treatment by 80 to 90 percent, in addition to significantly cutting health system costs.
34. Departments of Labor, Health and Human Services, and Education, and Related Agencies Appropriation Bill, 2012. S 1599. 112th Congress, 1st session (2011).
35. National Institutes of Health Feedback NIH. National Institute of Health website.
36. Restructuring the NIAID Clinical Trials Networks. National Institute of Allergy and Infectious Diseases website.
37. Administrator Rajiv Shah, NIH Barmes Lecture, US National Institutes of Health, Bethesda, MD; February 15, 2011. Global Health Technologies Coalition website.
38. Researchers Present Much-Anticipated Correlates Data from RV144. International AIDS Vaccine Initiative website.
39. US Centers for Disease Control and Prevention. CPTR yields progress: new six-way agreement among pharmas and NGOs will speed development of TB drug combinations [press release]. Brussels, Belgium: TB Alliance; November 9, 2011.
40. Advancing Regulatory Science at FDA: A Strategic Plan. US Food and Drug Administration website.
41. Global Partnerships Act of 2011 (1.4 MB PDF). Draft legislation. 112th Congress, 1st session (2011).
42. 21st Century Global Health Technology Act (bill text). HR 2144. 112th Congress, 1st session (2011).
43. Consolidated and Further Continuing Appropriations Act, 2012 (bill text). HR 2112. 112th Congress, 1st session (2011).
44. Global Health Technologies Coalition. The FDA's role in global health: Helping safe, effective health tools reach people in need worldwide [fact sheet] (201 KB PDF). Washington, DC: PATH; 2011.
45. Safer, Faster, Cheaper: Improving Clinical Trials and Regulatory Pathways to Fight Neglected Diseases (event video). Center for Global Development website.
46. WHO Prequalification of Diagnostics Programme. World Health Organization website.
47. Prequalification Programme: A United Nations Programme Managed By WHO. World Health Organization website.
48. FDA Announces Agency Restructuring: A Change For The Better? FDAImports.com website.
49. US Department of Health and Human Services, Food and Drug Administration Center for Biologics Evaluation and Research (CBER). Strategic Plan FY 2012–2016: Innovative Technology Advancing Public Health (225.8 KB PDF). Rockville, MD: CBER; 2011.
50. Advancing Regulatory Science at FDA: A Strategic Plan. US Food and Drug Administration website.
51. Chagas disease is not included in the guidance, as the diseases covered in the guidance were established by Congress in the Federal Food, Drug, and Cosmetic Act, which does not list Chagas. It is noteworthy that the US Food and Drug Administration released this guidance in an effort to aid neglected disease drug development, and it is also critical that Chagas be included in the future. See Guidance for Industry: Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (193.7 KB PDF). US Food and Drug Administration website.
52. US Department of Health and Human Services, Food and Drug Administration Center for Biologics Evaluation and Research (CBER). Guidance for Industry: General Principles for the Development of Vaccines to Protect Against Global Infectious Diseases (PDF 57.3 KB).
53. Incentives and innovative financing for global health product development [fact sheet] (508.2 KB PDF). Global Health Technologies Coalition website.
54. Pull mechanisms can include Advance Market Commitments, priority review vouchers, and prizes. See Advance Market Commitments: Frequently Asked Questions (244.4 KB PDF); Priority Review Vouchers: Companies can benefit from global health investment, BIO Ventures for Global Health website; and Prizes for Global Health Technologies, Results for Development Institute website.
55. Push mechanisms can include grants, transferring or sharing research costs, special funds and fundraising, and tax credits. See U.S. Global Health Policy—Innovative Financing Mechanisms for Global Health: Overview & Considerations for U.S. Government Participation (1.17 MB PDF). Washington, DC: Kaiser Family Foundation; 2011.
56. Unveiling of the Mobile Alliance for Maternal Action. US Department of State website.
57. Advance Market Commitment. Center for Global Development website.
58. Wilson P, Palriwala A. Prizes for Global Health Technologies: An Assessment with a Case Study on TB Diagnostics. Results for Development Institute website.
59. Priority Review Vouchers: Companies Can Benefit from Global Health Investment. BIO Ventures for Global Health website.
60. U.S. Global Health Policy—Innovative Financing Mechanisms for Global Health: Overview & Considerations for U.S. Government Participation (PDF 1.17 MB). Washington, DC: Kaiser Family Foundation; 2011.
61. Creating Hope Act of 2011 (bill text) (152 KB PDF). Amendment to the Federal Food, Drug, and Cosmetic Act. HR 3059. 112th Congress, 1st session (2011).
62. Saving Lives at Birth: A Grand Challenge for Development, list of finalists. A Grand Challenge for Development website.
63. US Department of State. Africa: USAID on 19 Innovations to Save Moms and Babies [press release]. July 28, 2011.
64. Saving Lives at Birth: A Grand Challenge for Development. Saving Lives at Birth: A Grand Challenge for Development website.
65. Grants.gov. Grants.gov website.
66. Prize Authority in the America COMPETES Reauthorization Act. CIO.gov website.
67. World Intellectual Property Organization list of members. World Intellectual Property Organization website.
68. World Health Organization (WHO). Report of the Third Meeting of the Consultative Expert Working Group on Research and Development: Financing And Coordination (64 KB PDF). Geneva, Switzerland: WHO; 2012.
69. Anderson S. Cut Wall Street Down to Size with a Financial Speculation Tax. Institute for Policy Studies website.
70. Epstein PR, Redman J. Taxing Financial Speculation, Raising Funds for Critical Needs. Huffington Post website.
71. USPTO launches effort to incentivize humanitarian technologies [press release]. US Patent and Trademark Office, September 20, 2010.
72. Comments on Incentivizing Humanitarian Technologies and Licensing Through the Intellectual Property System. US Patent and Trademark Office website.
73. Rotavirus Vaccine Development: Projects and Partners. PATH website.
74. Moran M, Guzman J, Henderson K, et al. G-FINDER Report 2010: Neglected Disease Research and Development—Is the Global Financial Crisis Changing R&D? (7.5 MB PDF). Sydney, Australia: Policy Cures; 2011.