Principles and Practice of Drug Development

3-0-6 units · Graduate

Description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules. Economic and financial considerations of the drug development process. Multidisciplinary perspective from faculty in clinical; life; and management sciences; as well as industry guests.

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

Prerequisites & course information

Same subject as 10.547[J] , HST.920[J] , IDS.620[J] Prereq: Permission of instructor G (Fall) 3-0-6 units

Sources

Course catalogue ↗2026–2027
MIT OpenCourseWare ↗Fall 2013
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.