Publications

Sorted by Date: Books | Articles |Working Papers | Student Thesis Abstracts

Sorted by Author: Books | Articles |Working Papers | Student Thesis Abstracts

Books

  • Allen, Thomas J. and Rory P. O’Shea. Building Technology Transfer within Research Universities:  An Entrepreneurial Approach. Cambridge University Press: forthcoming 2008
  • Finkelstein, Stan and Peter Temin. Reasonable Rx: Solving the Drug Price Crisis.  FT Press: February 2008. (Amazon.com)

 

Articles

  • 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, Cambridge University Press, 2006. (PDF 330KB).
  • 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. (328KB PDF)
  • Berndt, Ernst R. and John A. Hurvitz, Vaccine Advance-Purchase Agreements for Low-Income Countries: Practical Issues Health Affairs, Vol. 24, No. 3, pp. 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, Vol. 4, No. 7, pp. 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. (69K PDF)
  • Berndt, Ernst R., Margaret K. Kyle and Davina C. Y. Ling. The Long Shadow of Patent Expiration:  Generic Entry and Rx to OTC Switches In Robert C. Feenstra and Matthew D. Shapiro (eds.), Scanner Data and Price Indexes, NBER Series on the Conference on Research in Income and Wealth, Vol. 61, (chapter 8 / pp. 229-267) Chicago: University of Chicago Press for the National Bureau of Economic Research, 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.
  • 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)
  • 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.
  • 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. (Abstract)
  • 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. (Abstract)
  • 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)
  • 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 IIPharmaGenomics, May 2004.
  • Finkelstein, Stan N., Anthony J. Sinskey and Scott M. Cooper. The Question of Compliance PharmaGenomics, January 2004.
  • 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.
  • Finkelstein, Stan N., Anthony J. Sinskey and Scott M. Cooper. The Coming Paradigm Shift in Pharmaceuticals PharmaGenomics, September/October 2002.
  • 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)
  • Jensen, Kyle and Murray, Fiona, The Intellectual Property Landscape of the Human Genome Science, 310(14): 239-240, October 2005. (PDF 300KB)

  • Lee, Harry L. T.,  Paolo Boccazzi, Rajeev J. Ram, et al. Microbioreactor Arrays with Integrated Mixers and Fluid Injectors for High-Throughput Experimentation with pH and Dissolved Oxygen Control Lab Chip, 6: 1229–1235, 2006. (PDF 753KB)

  • Lee, Harry L.T, Paolo Boccazzi, Nathalie Gorret, et al. In Situ Bioprocess Monitoring of Escherichia Coli Bioreactions Using Raman Spectroscopy Vibrational Spectroscopy, 35: 131-137, 2004. (PDF 201KB)

  • 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.

  • 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. (Abstract)
  • 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)
  • 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.
  • 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)
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 IPharmaGenomics, March/April 2004.
  • Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. Getting to Rational Drug Design – At LastPharmaGenomics, November/December 2002.
  • Sinskey, Anthony J., Stan N. Finkelstein and Scott M. Cooper. The Promise of Protein MicroarraysPharmaGenomics, 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., 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.
  • 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.
  • 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., Dan Huse, Stanley N. Finkelstein, et al. A Framework to Evaluate the Economic Impact of Pharmacogenomics Pharmacogenomics, 7(6):853-62, September 2006. (241KB PDF)
  • Stallings, Sarah C., Anthony J. Sinskey, and Stan N. Finkelstein. Considerations in the Economic Assessment of the Value of Molecular Profiling, In M. E. Burczynski & J. C. Rockett (eds.), Surrogate Tissue Analysis, Genomic, Proteomic, and Metabolomic Approaches, (Chapter 16, 263-274), CRC Press, Taylor & Francis Group, Boca Raton, 2006.
  • 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.
  • 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)
  • Trusheim, Mark R., Ernst R Berndt and Douglas, Frank L., Stratified Medicine: Strategic and Economic Implications of Combining Drugs and Clinical Biomarkers Nature Reviews Drug Discovery, 6: 287-293, April 2007. (PDF 300KB)
  • 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.
  • 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.

 

Working Papers

Expanded Working Papers List

To request copy of a specific working paper, contact cbi@mit.edu

  • Allen, Thomas J., Ralph Katz, Frank Basa and Stephen White. Project Management and the Performance of Drug Development Teams, MIT Program on the Pharmaceutical Industry (POPI) Working Paper No. 48-99, 1999.
  • Allen, Thomas J. and Frank Basa. Managing the Drug Development Process: A Preliminary Report on a Study of Project Management in the Pharmaceutical Industry, January 1994.
  • Basa, Frank and Thomas J. Allen. Project Management and the Locus of Decision‑Making in Drug Development, MIT Program on the Pharmaceutical Industry (POPI) Working Paper No. 30-96, February 1996.
  • Crown, William H., Ernst R. Berndt, Onur Baser, Stan N. Finkelstein, Whitney P. Witt, Jonathan Maguire and Kenan Haver. Benefit Plan Design and Prescription Drug Utilization Among Asthmatics:  Do Patient Copayments Matter? Frontiers in Health Policy: National Bureau of Economic Research (NBER) Working Papers, Vol. 7, pp. 95-127, November 2004.
  • Douglas, Frank and Gigi Hirsch. Global Outsourcing: Defining China’s Leading Edge, 2006. (PDF 70KB)
  • Finkelstein, Stan N., Niraj L. Sehgal and Randall S. Stafford. National Trends in Treatment for Diabetes Mellitus, MIT Program on the Pharmaceutical Industry (POPI) Working Paper No. 66-04, 2004.
  • Myers, Stewart C. and Christopher D. Howe. Life-Cycle Financial Model of Pharmaceutical R&D, MIT Program on the Pharmaceutical Industry (POPI) Working Paper No. 41-97, April 1997.
  • Raju, G.K. and Charles L. Cooney. Active Learning from Process Data, MIT Program on the Pharmaceutical Industry (POPI) Working Paper No. 60-01, June 2001.
  • Raju, G.K. and Charles L. Cooney. ‘Benchmarking’ Pharmaceutical Manufacturing Performance, MIT Program on the Pharmaceutical Industry (POPI) Working Paper No. 37-96, 1996.
  • Stallings, Sarah C., Stan N. Finkelstein, Anthony J. Sinskey , et al. An Economic Framework for Evaluating Personalized Medicine, MIT Program on the Pharmaceutical Industry (POPI) Working Paper No. 64-03, revised May 2005.
  • Stallings, Sarah C., Robert H. Rubin, Thomas J. Allen, et al. The Contributions of Science and Technology in Advancing Society's Needs through Drug Development, MIT Program on the Pharmaceutical Industry (POPI) Working Paper No. 58-01, February 2001.

 

Student Thesis Abstracts

To request copy of a specific thesis, contact cbi@mit.edu

Title: Assessing the Economic Case for Stratified Medicine
Author: Amir Goren
Advisors: Professor Ernst Berndt and Dr. Thomas Roberts Jr.
Issue Date: 2007

Title: Assessing Decision Inputs in Drug Development between Small, Early Stage Companies and Big Pharma: Is There a Difference?
Author: Dan Rippy
Advisors: Professor Fiona Murray and Professor Kimberley Thompson
Issue Date: 2007

Title: Enhancing Productivity through Effective Collaborations: The Barriers and Enablers of Collaboration within Geographic Clusters
Author: Rupa Bahri
Advisors: Professor Ernst R. Berndt and Dr. Frank L. Douglas
Issue Date: 2007

Title: Mergers and Acquisitions in the Medical Device Industry
Author: Kevin Lee Ohashi
Advisors: Professor Anthony J. Sinskey and Professor Antoinette Schoar
Issue Date: 2007

Title: The Accelerated Approval Process in Oncology: An Examination of the Conversion Rate of Approved Therapies to Full Approval
Author: Jean Jinsun Kim
Advisors: Professor Ernst R. Berndt and Professor Anthony J. Sinskey
Issue Date: 2006

Title: The Globalization of Clinical Drug Development
Author: Fabio Albuquerque Thiers
Advisors: Professor Ernst R. Berndt and Professor Anthony J. Sinksey
Issue Date: 2006

Title: The Pharmaco-economics of Combination Therapies: A Study of the Effects of Component and Market Factors on Combined Therapy Price
Author: Sundar Subramaniam
Advisors: Professor Ernst R. Berndt and Dr. Frank L. Douglas
Issue Date: 2006