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Principles and Practice of Drug Development

Graduate · Historical course

Fall 2013

Topics

Student Presentations
Final Class

Readings

Jack, Andrew. “ Pharmaceuticals: Back to the Lab ,” Financial Times , August 10, 2013. ↗
Required
Munos, B. “ Lessons from 60 Years of Pharmaceutical Innovation .” Nature Reviews Drug Discovery 8 (2009): 959–68. ↗
Required
U.S. Food and Drug Administration. “FY 2011 Innovative Drug Approvals.” (PDF - 5.0MB) U.S. Department of Health and Human Services, U.S. Food and Drug Administration. ↗
Required
Rang, H. P., ed. Chapters 1–3 in Drug Discovery and Development: Technology in Transition . Churchill Livingstone, 2006, pp. 3–40. ISBN: 9780443064203.
Required
Saftlas, Herman. “Healthcare: Pharmaceuticals.” Standard & Poor’s Industry Surveys . June 4, 2009. S&P Net Advantage .
Required
U.S. Food and Drug Administration. “FY 2011 Innovative Drug Approvals.” (PDF - 5.0MB) U.S. Department of Health and Human Services, U.S. Food and Drug Administration. ↗
Required
Silver, Steven. “Healthcare: Pharmaceuticals.” Standard & Poor’s Industry Surveys . August 13, 2009. S&P Net Advantage .
Required
Lawrence, Stacy. “ Looking for an Oasis .” BioCentury, The Bernstein Report on Biobusiness 16, no. 3 (2008): A1–A10. ↗
Required
Johnson, Avery. “ As Drug Industry Struggles, Chemists Face Layoff Wave ,” Wall Street Journal , December 11, 2007. ↗
Required
Martinez, Barbara. “ Big Pharma Faces Grim Prognosis: Industry Fails to Find New Drugs to Replace Wonders Like Lipitor ,” Wall Street Journal , December 6, 2007. ↗
Required
Silberman, Steve. “ Placebos are Getting More Effective. Drugmakers are Desperate to Know Why .” Wired Magazine 17.09, August 2009. ↗
Required
Merck & Schering-Plough Merger Investor Presentation (PDF) March 9, 2009. Merck Schering-Plough. ↗
Recommended
Schoeberl, B., E. A. Pace, et al. “ Therapeutically Targeting ErbB3: A Key Node in Ligand-Induced Activation of the ErbB Receptor–PI3K Axis .” Science Signaling 77, no. 2 (2009): ra31. ↗
Recommended
5 · Accelerating Cancer Cures: A Global Frontier · Skloot, Rebecca. “ About The Immortal Life of Henrietta Lacks .” ↗
Recommended
6 · Clinical Drug Development · Burton, Thomas M. “ By Learning from Failures, Lilly Keeps Drug Pipeline Full ,” Wall Street Journal , April 21, 2004. ↗
Recommended
Alves, S., E. Régulier, et al. “ Striatal and Nigral Pathology in a Lentiviral Rat Model of Machado-Joseph Disease .” Human Molecular Genetics 17, no. 14 (2008): 2071–83. ↗
Recommended
Moreira, J. N., A. Santos, et al. “ Non-Viral Lipid-Based Nanoparticles for Targeted Cancer Systemic Gene Silencing .” Journal of Nanoscience and Nanotechnology 8, no. 18 (2008): 2187–204. ↗
Recommended
Rubin, L. “ Stem Cells and Drug Discovery: The Beginning of a New Era? ” Cell 132 (2008): 549–52. ↗
Required
Radley, D. C., S. N. Finkelstein, et al. “ Off-label Prescribing Among Office-based Physicians .” Archives of Internal Medicine 166 no. 9 (2006): 1021–26. ↗
Recommended
Rubin, L., and F. J. de Sauvage. “ Targeting the Hedgehog Pathway in Cancer .” Nature Reviews Drug Discovery 5, no. 12 (2006): 1026–33. ↗
Recommended
The Burrill Report 3, no. 9 (2013). ↗
Recommended
Jones, Matt. “GenomeWeb Feature: Slow, Steady Decline in NIH Funding Leads Researchers to Fear Future Cuts,” GenomeWeb Daily News , July 18, 2013.
Recommended
Philippidis, Alex. “ Researchers Chafe as NIH Budgets Shrivel ,” Genetic Engineering & Biotechnology News , September 13, 2013. ↗
Recommended
“ As VC Falters, Early-stage Biotechs Look Elsewhere for Cash ,” FierceBiotech , October 21, 2013. ↗
Recommended
“Universities Stepping Up Efforts To Discover Drugs,” Forbes , October 21, 2013.
Recommended
Thayer, A. M. “ The New Copycats .” Chemical & Engineering News 91, no. 40 (2013): 15–23. ↗
Required
Wechsler, J. “ Drug Quality at Center Stage for FDA and Manufacturers .” BioPharm International 26, no. 1 (2013): 10–12. ↗
Required
Kozlowski, S., J. Woodcock, et al. “ Developing the Nation’s Biosimilars Program .” The New England Journal of Medicine 365, no. 5 (2011): 385–88. ↗
Required
Thomas, Katie. “ Lapses at Big Drug Factories Add to Shortages and Danger ,” New York Times , October 17, 2012. ↗
Required
Basu, P., G. Joglekar, et al. “ Analysis of Manufacturing Costs in Pharmaceutical Companies .” Journal of Pharmaceutical Innovation 3, no. 1 (2008): 30–40. ↗
Required
“Quality Manufacturing: A Blockbuster Opportunity for Pharmaceuticals, An Economist Intelligence Unit White Paper Written in Co-operation with Oracle.” (PDF) Economist Intelligence Unit, The Economist , September 2005. ↗
Required
“ Business: Trouble in the Making; Pharmaceuticals .” The Economist 364, no. 8288 (2002). ↗
Required
“Guidance for Industry Q8(R2) Pharmaceutical Development.” (PDF) ICH Revision 2. U.S. Department of Health and Human Services, Food and Drug Administration, November 2009. ↗
Recommended
“Guidance for Industry Q10 Pharmaceutical Quality System.” (PDF) ICH. U.S. Department of Health and Human Services, Food and Drug Administration, April 2009. ↗
Recommended
There is no single textbook for the class, but a substantial selection of journal articles and news items are listed in the readings section. ↗
Listed reading

Sources

Course catalogue ↗Historical OpenCourseWare
MIT OCW readings ↗
MIT OCW calendar ↗
MIT OCW syllabus ↗
Historical MIT OpenCourseWare offering. Named reading entries and schedule topics are automatically extracted from the linked source pages.