Readings

SES # TOPICS READINGS
1 Introduction: The Pharmaceutical Industry and the Drug Development Process Association of American Medical Colleges [AAMC], Food and Drug Administration [FDA], and University of San Francisco [UCSF] Center for Drug Development Science. "Drug Development Science: Obstacles and Opportunities for Collaboration Among Academia, Industry and Government." Report of an Invitational Conference, Washington, DC, 2005.

Bains, William. "Failure Rates in Drug Discovery and Development – Will We ever Get any better?" Drug Discovery World 5, no. 4 (Fall 2004): 9-20.

Drews, Jurgen. "Stategic Trends in the Drug Industry." Drug Discovery Today 8, no. 9 (May 2003): 411-20.

Food and Drug Administration. "Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products." FDA White Paper, 2004.

Fordham University, Center for Ethics Education. "Clinical Trial Registries and Results Databases." White Paper from Proceedings of the Fordham University Summit on Bio-Pharmaceuticals in the 21st Century: Responsibility, Sustainability, and Public Trust, 2005.

Buy at Amazon Posner, J. "The First Administration of a New Active Substance to Humans." Chapter 4 in A Guide to Clinical Drug Research. Edited by Adam Cohen and John Posner. 2nd ed. New York, NY: Springer, August 15, 2000. ISBN: 9780792361725.

Buy at Amazon Walsh, Gary. "Pharmaceuticals, Biologics, and Biopharmaceuticals," and "The Drug Development Process." Chapter 1, and 2 in Biopharmaceuticals: Biochemistry and Biotechnology. 2nd ed. New York, NY: John Wiley and Sons, September 5, 2003, pp. 1-36, and 38-74. ISBN: 9780470843277.

For Reference

Monane, M., et al. "1,293 Things You Wanted to Know About Biotechnology but were Afraid to Ask: A Working Guide of Everyday Terms for the Investor." Needham and Co., 2004.
2 Basic Science Part I – Discovery Innovation and Emerging Technologies, Basic Business Agranat, Israel, and Hava Caner. "Intellectual Property and Chirality of Drugs." Drug Discovery Today 4, no. 7 (1999): 313-321.

"Fixing the Drugs Pipeline." The Economist 370, no. 8366 (March 13, 2004): 33. (London)

Review Again

Food and Drug Administration. "Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products." FDA White Paper, 2004.
3 Examples of Druggability Issues in the Pharmaceutical Industry

FDA Drug Regulatory Process
Reichert, Janice M., "Trends in Development and Approval Times for New Therapeutics in the United States." Nature Reviews Drug Discovery 2, no. 9 (2003): 695-702.

Livingston, David M., and Ramesh Shivdasani. "Toward Mechanism-Based Cancer Care." Journal of the American Medical Association (JAMA) 285, no. 5 (2001): 588-593.

Moukheiber, Zina. "The Virtual Patient." Forbes, January 8, 2001, 234-236.

Searls, David B. "Using Bioinformatics in Gene and Drug Discovery." Drug Discovery Today 5, no. 4 (2000): 135-143.
4 Basic Science Part II – Molecular Toxicology in Preclinical Studies  
5 Pharmaceutical Manufacturing Part I  
6 Pharmaceutical Manufacturing Part II Schiff, Leora, and Fiona Murray. "Biotechnology Financing Dilemmas and the Role of Special Purpose Entities." Nature Biotechnology 22, no. 3 (2004): 271-277.

Edwards, Mark G., Fiona Murray, and Robert Yu. "Value Creation and Sharing Among Universities, Biotechnology and Pharma." Nature Biotechnology 21, no. 6 (2003): 618-624.
7 Clustering Effects in Biotech Companies, Organization and Management

Speeding up Information Management in Clinical Practice

Influenza
Buy at Amazon Swann, G. M. P., and M. Prevezer. Introduction in The Dynamics of Industrial Clustering: International Comparisons in Computing and Biotechnology. Edited by G. M. P. Swann, M. Prevezer, and D. Stout. New York, NY: Oxford University Press, May 28, 1998. ISBN: 9780198289593.

Buy at Amazon M. Prevezer. "Clustering in Biotechnology in the U.S.A." Chapter 6 in The Dynamics of Industrial Clustering: International Comparisons in Computing and Biotechnology. Edited by G. M. P. Swan, M. Prevezer, and D. Stout. New York, NY: Oxford University Press, May 28, 1998. ISBN: 9780198289593.
8 Valuing Pharmaceutical and Biotech Companies

Policy and Economic Considerations in Drug Development
 
9 Putting it all Together: A System Dynamics Model of the Anti-cholesterol Drugs Market

Analyzing the Human Genome Project
Financial Times Articles

Jack, Andrew. "WHO Considers Centralized Flu Vaccine Orders," October 31, 2005.

Cookson, Clive. "Hatching an Alternative to Eggs," October 31, 2005.

Jack, Andrew. "Offer Shows Fresh Interest in Vaccines," November 1, 2005.

———. "COMMENT and ANALYSIS: Fighting Flu: Fears of a Global Pandemic Prod the Vaccine Makers to Roll up Their Sleeves," October 31, 2005.
10 Development and Impact of Genetic Tests

Supply Chain Management in the Pharmaceutical Industry
"Science and Technolgy: Testing Times." The Economist 357, no. 8193 (October 21, 2000): 93-2.

Pollack, Andrew. "A Special Drug Just for You, at the End of a Long Pipeline," The New York Times, November 8, 2005.

"Regulatory Environment for Genetic Testing." Regulatory Brief by the Genetics and Public Policy Center.

Optional Readings

Gutman, S. "The Role of Food and Drug Administration Regulation of in Vitro Diagnostic Devices-Applications to Genetics Testing." Clinical Chemistry 45, no. 5 (1999): 746-9.

Roses, Allen D. "Genome-Based Pharmacogenomics and the Pharmaceutical Industry." Nature Reviews Drug Discovery 1, no. 7 (2002): 541-549.
11 The Impact of Pedigree on Drug Supply Chains

The Biotech Disruption to Anti-Cancer Drug Development
"Report to the Nation: Improving Public Health Through Human Drugs." Center for Drug Evaluation and Research, 2004.

Engels, D. W. "Review of RFID Technologies." MIT Healthcare Research Initiative Technical Memo MIT-HRI-TM-004, 2005.

Kelly, B. "Securing the Drug Supply from Counterfeiting Protects Brand Profits." 2005.

Pitts, P. J. "Meeting the Counterfeit Drug Challenge." 2005.
12 Global Health and the Pharmaceutical Industry in 3rd World Countries Centers for Disease Control and Prevention. "Achievements in Public Health, 1900-1999: Control of Infectious Diseases." MMWR Morbidity and Mortality Weekly Report 48, no. 29 (1999): 621-629.

Murray, C. J. L., and A. D. Lopez. The Global Burden of Disease: A Comprehensive Assessment of Mortality and Disability from Diseases. Harvard School of Public Health, Cambridge, MA, 1996.

National Center for Health Statistics. "National Center for Health Statistics: U.S. Decennial Life Tables for 1989-91, Some Trends and Comparisons of United States Life Table Data, 1900-91." DHHS-99-1150-3, Hyattsville, MD, 1999.

Omran, A. R. "The Epidemiologic Transition: A Theory of the Epidemiology of Population Change." Milbank Memorial Fund Quarterly 49 (1971): 509.

Olshansky, S. J., and A. B. Ault. "The Fourth Stage of the Epidemiologic Transition: The Age of Delayed Degenerative Diseases." Milbank Quarterly 64 (1886): 355.

Buy at Amazon Pearson, T. A., D. T. Jamison, and H. Trijo-Gutierrez. "Cardiovascular Disease." In Disease Control Priorities in Developing Countries (A World Bank Publication). Edited by W. Henry Mosley, Anthony R. Measham, Jos'e Luis Bobadilla, and Dean T. Jamison. New York, NY: Oxford University Press, November 1, 1993, pp. 577-599. ISBN: 9780195209907.

Pearson, T. A. "Global Perspectives on Cardiovascular Disease." Evidence-based Cardiovascular Medicine 1 (1997): 4.

Sheth, T., C. Nair, M. Nargundkar, et al. "Cardiovascular and Cancer Mortality Among Canadians of European, South Asian and Chinese Origin from 1979 to 1993: An Analysis of 1.2 Million Deaths." Canadian Medical Association Journal (CMAJ) 161 (1999): 132.

"Center for Nutrition Policy: Nutrient Content of the U.S. Food Supply, 1909-1994, A Summary." U.S. Department of Agriculture, Washington, DC, 1998.

World Health Organization. "Reducing Risks, Promoting Healthy Life." World Health Report, 2002.
13 Student Presentations  

Additional References

Vaccines

Health Affairs 4, no. 3 (2005).

In particular, the following articles in this issue of Health Affairs discuss the business of vaccines:

Hinman, A. R. "Addressing The Vaccine Financing Conundrum."

DesRoches, C. M., R. J. Blendon, and J. M. Benson. "Americans' Responses to the 2004 Influenza Vaccine Shortage."

McCluskey, M. M., S. B. Alexander, B. D. Larkin, M. Murgula, and S. Wakefield. "An HIV Vaccine: As We Build It, Will They Come?"

Colgrove, J., and R. Bayer. "Could It Happen Here? Vaccine Risk Controversies And The Specter Of Derailment."

Davis M. M., and K. Fant. "Coverage Of Vaccines In Private Health Plans: What Does The Public Prefer?"

Grabowski, H. "Encouraging The Development Of New Vaccines."

Coleman, M. S., N. Sangrujee, F. Zhou, and S. Chu, "Factors Affecting U.S. Manufacturers' Decision To Produce Vaccines."

Landry, S., and C. Heilman. "Future Directions In Vaccines: The Payoffs Of Basic Research."

Orenstein, W. A., R. G. Douglas, L. E. Rodewald, and A. R. Hinman. "Immunizations In The United States: Success, Structure, And Stress."

Pauly, M. V. "Improving Vaccine Supply And Development: Who Needs What?"

Epstein, R. A. "It Did Happen Here: Fear And Loathing On The Vaccine Trail."

Lieu, T. A., T. G. McGuire, and A. R. Hinman. "Overcoming Economic Barriers To The Optimal Use Of Vaccines."

Martin, A. M., and E. J. Emanuel. "Risky Business."

Stern, A. M., and H. Markel. "The History Of Vaccines And Immunization: Familiar Patterns, New Challenges."

Batson, A. "The Problems And Promise Of Vaccine Markets In Developing Countries."

Danzon, P. M., N. S. Pereira, and S. S. Tejwani. "Vaccine Supply: A Cross-National Perspective."

Berndt, E. R., and J. A. Hurvitz. "Vaccine Advance-Purchase Agreements For Low-Income Countries: Practical Issues."

Offit, P. A. "Why Are Pharmaceutical Companies Gradually Abandoning Vaccines?"

Plotkin, S. A. "Why Certain Vaccines Have Been Delayed Or Not Developed At All?"

Danzon, P., and N. S. Pereira. "Why Sole-Supplier Vaccine Markets May Be Here To Stay."