Articles

Philipson, Tomas, Ernst R. Berndt, Adrian H.B. Gottschalk, et al. Cost-Benefit Analysis of the FDA: The Case of the Prescription Drug User Fee Acts. Journal of Public Economics, 92(5-6): 1306-1325, June 2008. (PDF 245KB)

Thiers, Fabio, Anthony J. Sinskey, Ernst R Berndt. Trends in the Globalization of Clinical Trials. Nature Reviews Drug Discovery, 7: 13-14, January 2008. (PDF 1500KB)

Brownstein, John S, Margarita Sordo, Isaac S. Kohane, et al. The Tell-Tale Heart: Population-Based Surveillance Reveals an Association of Rofecoxib and Celecoxib with Myocardial Infarction. PLoS ONE, 2(9): e840, September 2007. (PDF 215KB)

Goulart, Bernardo H.L., Jeffrey W. Clark, Homer H. Pien, et al. Trends in the Use and Role of Biomarkers in Phase I Oncology Trials. Clinical Cancer Research, 13: 6719-6726, 2007.

Graham, James B. and Ernst R.Berndt. The December Effect in FDA Drug Approvals: Assessing the Submissions Echo Hypothesis. Drug Information Journal, 41(5): 653-659, 2007 (PDF 550KB)

MacNeil, John S. and Frank Douglas. Challenges to Establishing a Regulatory Framework for Approving Follow-on Biologics: A Background Paper Draft. Manuscript / Not for Citation without Permission of Authors, 2007. (PDF 680KB)

McMurry, Andrew, Clint Gilbert, Ben Reis, et al. A Self Scaling, Distributed Architecture for Public Health, Research, and Clinical Care. Journal of the American Medical Informatics Association, 14(4): 527-533, July-August 2007.

Schachter, Asher D., Marco F. Ramoni, Gianluca Baio, et al. Economic Evaluation of a Bayesian Model to Predict Late-Phase Success of New Chemical Entities. Value in Health, 10(5): 377-385, September 2007.

Trusheim, Mark R., Ernst R Berndt and Frank L. Douglas. Stratified Medicine: Strategic and Economic Implications of Combining Drugs and Clinical Biomarkers. Nature Reviews Drug Discovery, 6: 287-293, April 2007. (PDF 300KB)

Berndt, Ernst R. The United States’ Experience with Direct-to-Consumer Advertising of Prescription Drugs: What Have We Learned? Paper presented at the International Conference on Pharmaceutical Innovation, Taipei, Taiwan, May 26-27, 2005. In Frank A. Sloan and Chee-Ruey Hsieh (eds.), Promoting and Coping with Pharmaceutical Innovation: An International Perspective, New York, NY: Cambridge University Press, 2006. (PDF 330KB).

Radley, David C., Stan N. Finkelstein, and Randall S. Stafford. Off Label Prescribing Among Office-Based Physicians. Archives of Internal Medicine, 166(9): 1021-1026, May 2006.

Stallings, Sarah C., Dan Huse, Stanley N. Finkelstein, et al. A Framework to Evaluate the Economic Impact of Pharmacogenomics. Pharmacogenomics, 7(6): 853-62, September 2006. (PDF 241KB)

Stallings, Sarah C., Anthony J. Sinskey, and Stan N. Finkelstein. Considerations in the Economic Assessment of the Value of Molecular Profiling. M. E. Burczynski & J. C. Rockett (eds.), Surrogate Tissue Analysis, Genomic, Proteomic, and Metabolomic Approaches, (Chapter 16, 263-274), Boca Raton, FL: CRC Press, Taylor & Francis Group, 2006.

Berndt, Ernst R., Adrian H.B. Gottaschalk, and Matthew W. Strobeck. Opportunities for Improving the Drug Development Process: Results from a Survey of Industry and the FDA Paper presented at the National Bureau of Economic Research Workshop on Innovation Policy and the Economy. The National Press Club, Washington DC, April 19, 2005. (PDF 328KB)

Berndt, Ernst R. and John A. Hurvitz. Vaccine Advance-Purchase Agreements for Low-Income Countries: Practical Issues. Health Affairs, 24(3): 653-665, May / June 2005. (PDF 131KB)

Berndt, Ernst R. Adrian H. B. Gottschalk, Tomas J. Philipson, et al. Industry Funding of the FDA: Effects of PDUFA on Approval Times and Withdrawal Rates. Nature Reviews Drug Discovery, 4(7): 545-554, July 2005. (PDF 412KB)

Berndt, Ernst R. To Inform or Persuade? Direct-to-Consumer Advertising of Prescription Drugs. New England Journal of Medicine, 352(4): 325-8, January 27, 2005. (PDF 69K)

Farkas Dora, Bhat Vadiraja, Mandapati Saraswathi, et al. Characterization of the Secreted Proteome of Rat Hepatocytes Cultured in Collagen Sandwiches. Chemical Research in Toxicology, 18(7): 1132-9, July 2005. (PDF 307KB)

Farkas Dora and Steven R. Tannenbaum. Characterization of Chemically Induced Hepatotoxicity in Collagen Sandwiches of Rat Hepatocytes. Toxicological Sciences, 85(2): 927-34, June 2005. (PDF 927KB)

Farkas Dora and Steven R. Tannenbaum. In Vitro Methods to Study Chemically-Induced Hepatotoxicity: A Literature Review. Current Drug Metabolism. 6(2): 111-25, April 2005. (Abstract)

Jensen, Kyle and Murray, Fiona. The Intellectual Property Landscape of the Human Genome. Science, 310(14): 239-240, October 2005. (PDF 300KB)

Schachter, Asher D., Marco F. Ramoni, Gianluca Baio et al. A Bayesian Network Model to Predict Late Phase Success of New Molecular Entities. Submitted for Publication September 2005.

Sivaraman A, Leach JK, Townsend S, et al. A Microscale in vitro Physiological Model of the Liver: Predictive Screens for Drug Metabolism and Enzyme Induction. Current Drug Metabolism, 6(6): 569-591, December 2005. (Abstract)

Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. A Cure for Multiple Sclerosis in Our Lifetime? Pharmaceutical Discovery, 5(6): 40-43, August 2005.

Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. The Consequences of Limiting Stem Cell Research: Health and Economic Considerations. Pharmaceutical Discovery, May 2005.

Crown, William H., Ernst R. Berndt, Onur Baser, et al. Benefit Plan Design and Prescription Drug Utilization Among Asthmatics: Do Patient Copayments Matter? Frontiers in Health Policy: National Bureau of Economic Research Working Papers, 7: 95-127, November 2004.

Finkelstein, Stan N., Anthony J. Sinskey and Scott M. Cooper. Biobanks: Will They Help Promote the Genomics Revolution? PharmaGenomics, November / December 2004.

Finkelstein, Stan N., Anthony J. Sinskey and Scott M. Cooper. Medical Imaging in Drug Discovery, Part II. PharmaGenomics, May 2004.

Finkelstein, Stan N., Anthony J. Sinskey and Scott M. Cooper. The Question of Compliance. PharmaGenomics, January 2004.

Ozminkowski, Ronald J., William D. Marder, Kevin Hawkins, et al. The Use of Disease-Modifying New Drugs for Multiple Sclerosis Treatment in Private-Sector Health Plans. Clinical Therapeutics, 26(8): 1341-1354, August 2004.

Roberts, Jr., Thomas G., Bernardo H.L. Goulart, Lee Squitieri, et al. Trends in the Risks and Benefits to Patients with Cancer Participating in Phase I Clinical Trials. Journal of the American Medical Association, 292: 2130-2140, November 2004.

Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. Biobanks: Will They Help Promote the Genomics Revolution? Pharmaceutical Discovery, 20-24, November 2004.

Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. Medical Imaging in Drug Discovery, Part III. PharmaGenomics, June 2004.

Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. Medical Imaging in Drug Discovery, Part I. PharmaGenomics, March / April 2004.

Stafford, Randall S., Curt D. Furberg, Stan N. Finkelstein, et al. Impact of Clinical Trials Results on National Trends on α-Blocker Prescribing, 1996-2002. Journal of the American Medical Association, 291(1): 54-62, January 2004.

Weilburg, Jeffrey B., Randall S. Stafford, Kathleen M. O’Leary, et al. Costs of Antidepressant Medications Associated with Inadequate Treatment The American Journal of Managed Care, 10(6): 357-365, June 2004.

Berndt, Ernst R., Margaret K. Kyle and Davina C. Y. Ling. The Long Shadow of Patent Expiration: Generic Entry and Rx to OTC Switches. Robert C. Feenstra and Matthew D. Shapiro (eds.), Scanner Data and Price Indexes, NBER Series on the Conference on Research in Income and Wealth, 61(chapter 8): 229-267. Chicago, IL: University of Chicago Press for the National Bureau of Economic Research, 2003.

Finkelstein, Stan N., Anthony J. Sinskey and Scott M. Cooper. Getting Personal with Pain. PharmaGenomics, July / August 2003.

Finkelstein, Stan N., Anthony J. Sinskey and Scott M. Cooper. A Public/Private Partnership for Dual-Use Antibiotics. PharmaGenomics, March / April 2003.

Ma, Jun, Randall S. Stafford, Iain M. Cockburn, et al. A Statistical Analysis of the Magnitude and Composition of Drug Promotion in the United States in 1998. Clinical Therapeutics. 25(5): 1503-1517, May 2003.

Stafford, Randall S., Jun MA, Stan N. Finkelstein, et al. National Trends in Asthma Visits and Asthma Pharmacotherapy, 1978-2002. The Journal of Allergy and Clinical Immunology, 111(4): 729-735, April 2003.

Weilburg, Jeffrey B., Randall S. Stafford, Kathleen M. O’Leary, et al. Reducing Frequency of Short Duration Antidepressant Trials May be the Focus of Quality Improvement and Cost Control Efforts, January 2003.

Berndt, Ernst R., Anupa Bir, Susan H. Busch, et al. The Medical Treatment of Depression, 1991-1996: Productive Inefficiency, Expected Outcome Variations, and Price Indexes. Journal of Health Economics, 21(3): 373-396, May 2002.

Berndt, Ernst R., Ashoke Bhattacharjya, David N. Mishol, et al. An Analysis of the Diffusion of New Antidepressants: Variety, Quality, and Marketing Efforts. Journal of Mental Health Policy and Economics, 5(1): 3-19, March 2002.

Crown, William H., Ernst R. Berndt, Stan N. Finkelstein, et al. The Impact of Treatment-Resistant Depression on Healthcare Utilization and Costs. The Journal of Clinical Psychiatry, 63(11): 963-971, November 2002.

Finkelstein, Stan N., Anthony J. Sinskey and Scott M. Cooper. The Coming Paradigm Shift in Pharmaceuticals. PharmaGenomics, September / October 2002.

Narayanan, VK, Frank Douglas, Brock Guernsey, et al. How Top Management Steers Fast Cycle Teams to Success Strategy & Leadership, 30(3): 19-27, 2002. (PDF 84KB)

Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. Getting to Rational Drug Design – At Last. PharmaGenomics, November / December 2002.

Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. The Promise of Protein Microarrays. PharmaGenomics, July / August 2002.

Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. Integrating the Science and Technology Revolutions. PharmaGenomics, May / June 2002.

Stafford, Randall S., Ellen MacDonald and Stan N. Finkelstein. National Patterns of Medication Treatment for Depression, 1987-2001. The Primary Care Companion to the Journal of Clinical Psychiatry, 3(6): 232-235, 2001 / 02.

Stallings, Sarah C., Robert H. Rubin, Thomas J. Allen, et al. Technological Innovation in Pharmaceuticals Pharmaceutical Discovery and Development. Technology / Industry Overviews, 12-16, 2001 / 02.