Economic analysis of opportunities to accelerate Alzheimer's disease research and development

Annals of the New York Academy of Sciences

Volumn 1313, Issue 1, 2014, Pages 17-34

  Scott, Troy J ^a   O'Connor, Alan C ^a   Link, Albert N ^b   Beaulieu, Travis J ^a  

^a RTI INTERNATIONAL   (United States)

^b UNIVERSITY OF NORTH CAROLINA AT GREENSBORO   (United States)

Author keywords

Alzheimer's disease; Biomarkers; Dementia; Drug development; Infrastructure; Public private partnership; R D; efficiency

Indexed keywords

ALZHEIMER DISEASE; ARTICLE; COGNITION; DISEASE COURSE; DISEASE MARKER; DRUG DEVELOPMENT; HUMAN; INTERVIEW; MEDICAL RESEARCH; MONOTHERAPY; PHASE 1 CLINICAL TRIAL (TOPIC); PHASE 2 CLINICAL TRIAL (TOPIC); PHASE 3 CLINICAL TRIAL (TOPIC); PIPELINE; RISK REDUCTION; UNITED STATES;

ALZHEIMER'S DISEASE; BIOMARKERS; DEMENTIA; DRUG DEVELOPMENT; INFRASTRUCTURE; PUBLIC-PRIVATE PARTNERSHIP; R&D; EFFICIENCY;

ALZHEIMER DISEASE; BIOMEDICAL RESEARCH; CHOLINESTERASE INHIBITORS; CLINICAL TRIALS AS TOPIC; DRUG DISCOVERY; HUMANS; UNITED STATES;

EID: 84898830867     PISSN: 00778923     EISSN: 17496632     Source Type: Book Series    
DOI: 10.1111/nyas.12417     Document Type: Article

References (39)

1. Hebert, L.E., J. Weuve, P.A. Scherr & D.A. Evans. 2013. Alzheimer disease in the United States (2010-2050) estimated using the 2010 Census. Neurology 80: 1778-1783.
2. Hurd, M.D., P. Martorell, A. Delavande, et al. 2013. Monetary costs of dementia in the United States. New England Journal of Medicine 368: 1326-1334.
3. World Alzheimer Report 2009, available from www.alz.co.uk/worldreport.
4. Qaseem, A., V. Snow, J.T. Cross, et al. American College of Physicians/American Academy of Family Physicians Panel on Dementia. 2008. Current pharmacologic treatment of dementia: A clinical practice guideline from the American College of Physicians and the American Academy of Family Physicians. Annals of Internal Medicine 148: 370-378.
5. Raina, P., P. Santaguida, A. Ismaila, et al. 2008. Effectiveness of cholinesterase inhibitors and memantine for treating dementia: Evidence review for a clinical practice guideline. Annals of Internal Medicine 148: 379-397.
6. Cummings, J.L. 2008. Controversies in Alzheimer's disease drug development. International Review of Psychiatry 20: 389-395.
7. Center for Drug Evaluation and Research (CDER), Food and Drug Administration, U.S. Department of Health & Human Services. 2013. Guidance for industry. Alzheimer's disease: Developing drugs for the treatment of early stage disease. Retrieved from http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM338287.pdf
8. Cummings, J.L. 2013. Alzheimer's disease drug development: Translational neuroscience strategies. CNS Spectrum 18: 128-138.
9. Greenberg, B.D., M.C. Carrillo, J.M. Ryan, et al. 2013. Improving Alzheimer's disease Phase II clinical trials. Alzheimer's & Dementia 9: 39-49.
10. Combs, K.L. & A.N. Link. 2003. Innovation policy in search of an economic foundation: The case of research partnerships in the United States. Technology Analysis & Strategic Management 15: 177-187.
11. Link, A.N. & J.R. Link. 2009. Government as entrepreneur. New York: Oxford University Press.
12. Tassey, G. 2005. Underinvestment in public good technologies. Journal of Technology Transfer 30: 89-113.
13. Link, A.N. & J.T. Scott. 2011. Public Goods, Public Gains: Calculating the Social Benefits of Public R&D. New York: Oxford University Press.
14. Alzheimer's Association Expert Advisory Workgroup on NAPA. 2012. Workgroup on NAPA's scientific agenda for a national initiative on Alzheimer's disease. Alzheimer's & Dementia, 8: 357-371.
15. Khachaturian, Z.S., R.C. Petersen, S. Gauthier, et al. 2008. A roadmap for the prevention of dementia: The inaugural Leon Thal symposium. Alzheimer's & Dementia 4: 156-163.
16. Khachaturian, Z.S., A.S. Khachaturian & W. Thies. 2012. The draft 'national plan' to address Alzheimer's disease-National Alzheimer's Project Act (NAPA). Alzheimer's & Dementia 8: 234-236.
17. Khachaturian, Z.S. 2009. A roadmap for the prevention of dementia II: Leon Thal symposium 2008. Alzheimer's & Dementia 5: 85-92.
18. Naylor, M.D., J.H. Karlawish, S.E. Arnold, et al. 2012. Advancing Alzheimer's disease diagnosis, treatment, and care: Recommendations from the Ware invitational summit. Alzheimer's & Dementia 8: 445-452.
19. Trojanowski, J.Q., S.E. Arnold, J.H. Karlawish, et al. 2010. Design of comprehensive Alzheimer's disease centers to address unmet national needs. Alzheimer's and Dementia 6: 150-155.
20. U.S. Department of Health and Human Services. 2012. Alzheimer's disease research summit offers research recommendations. Retrieved from http://www.nia.nih.gov/newsroom/announcements/2012/05/alzheimers-disease-research-summit-offers-research-recommendations
21. U.S. Department of Health and Human Services. 2013. 2013 recommendations of the public members of the Advisory Council on Alzheimer's Research, Care, and Services. Retrieved from http://aspe.hhs.gov/daltcp/napa/2013AdvCounRec.pdf
22. U.S. Department of Health and Human Services. 2013. Interim milestones to complete the first goal of the National Alzheimer's Plan by 2025. Retrieved from http://aspe.hhs.gov/daltcp/napa/2013AdvCounRec-A.pdf
23. Barker, A.D., C.C. Sigman, G.J. Kelloff, et al. 2009. I-SPY 2: An adaptive breast cancer trial design in the setting of neoadjuvant chemotherapy. Clinical Pharmacology & Therapeutics 86: 97-100.
24. U.S. Department of Health and Human Services. 2013. National plan to address Alzheimer's disease: 2013 update. Retrieved from http://aspe.hhs.gov/daltcp/napa/NatlPlan2013.pdf
25. DiMasi, J.A. & H.G. Grabowski. 2007. The cost of biopharmaceutical R&D: Is biotech different? Managerial and Decision Economics 28: 469-479.
26. Paul, S.M., D.S. Mytelka, C.T. Dunwiddie, et al. 2010. How to improve R&D productivity: the pharmaceutical industry's grand challenge. Nature Reviews Drug Discovery 9: 203-214.
27. Harrington, S.E. 2012. Cost of capital for pharmaceutical, biotechnology, and medical device firms. In P.M. Danzon & S. Nicholson (Eds.), The Oxford handbook of the economics of the biopharmaceuticals industry (pp. 75-99). New York: Oxford University Press.
28. Brookmeyer, R., S. Gray & C. Kawas. 1998. Projections of Alzheimer's disease in the United States and the public health impact of delaying disease onset. American Journal of Public Health 88: 1337-1342.
29. Brookmeyer, R., E. Johnson, K. Ziegler-Graham & H.M. Arrighi. 2007. Forecasting the global burden of Alzheimer's disease. Alzheimer's & Dementia 3: 186-191.
30. McKhann, G., D. Drachman, M. Folstein, et al. 1984. Clinical diagnosis of Alzheimer's disease. Report of the NINCDS-ADRDA work group under the auspices of Department of Health and Human Services task force on Alzheimer's disease. Neurology 34: 939-939.
31. Dubois, B., H.H. Feldman, C. Jacova, et al. 2010. Revising the definition of Alzheimer's disease: A new lexicon. The Lancet Neurology 9: 1118-1127.
32. McKhann, G.M., D.S. Knopman, H. Chertkow, et al. 2011. The diagnosis of dementia due to Alzheimer's disease: Recommendations from the National Institute on Aging-Alzheimer's Association workgroups on diagnostic guidelines for Alzheimer's disease. Alzheimer's & Dementia 7: 263-269.
33. Weiner, M.W., D.P. Veitch, P.S. Aisen, et al. 2012. The Alzheimer's Disease Neuroimaging Initiative: A review of papers published since its inception. Alzheimer's & Dementia 8: S1-S68.
34. Cummings, J.L. 2010. Integrating ADNI results into Alzheimer's disease drug development programs. Neurobiology of Aging 31: 1481-1492.
35. DiMasi, J.A., R.W. Hansen & H.G. Grabowski. 2003. The price of innovation: New estimates of drug development costs. Journal of Health Economics 22: 151-185.
36. U.S. Census Bureau. 2012. National population projections: Downloadable files. Table 1: Middle Series. Retrieved from http://www.census.gov/population/projections/data/national/2012/downloadablefiles.html
37. Fillit, H.M., A.W. O'Connell, W.M. Brown et al. 2002. Barriers to drug discovery and development for Alzheimer disease. Alzheimer Disease & Associated Disorders 16: S1-S8.
38. National Institute of Science and Technology Planning Report 07-1. Economic Analysis of the Technology Infrastructure Needs of the U.S. Biopharmaceutical Industry. Available online: www.nist.gov/director/prog-ofc/report07-1.pdf
39. Henderson, R. & I. Cockburn. 1996. Scale, Scope, and Spillovers: The Determinants of Research Productivity in Drug Discovery. The RAND Journal of Economics 27: 32-59.