Principles and Practice of Drug Development

Readings

SES #	TOPICS	READINGS
1	Introduction From Discovery to Market: An Integrated View	Required Jack, Andrew. “Pharmaceuticals: Back to the Lab,” Financial Times, August 10, 2013. Munos, B. “Lessons from 60 Years of Pharmaceutical Innovation.” Nature Reviews Drug Discovery 8 (2009): 959–68. 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.
2	Brief Economic History of the Pharmaceutical Industry	Required Rang, H. P., ed. Chapters 1–3 in Drug Discovery and Development: Technology in Transition. Churchill Livingstone, 2006, pp. 3–40. ISBN: 9780443064203. Saftlas, Herman. “Healthcare: Pharmaceuticals.” Standard & Poor’s Industry Surveys. June 4, 2009. S&P Net Advantage. 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.
3	The Pharmaceutical Industry and the Drug Development Process; Basic Science	No Readings
4	Business of Biopharmaceuticals	Required Silver, Steven. “Healthcare: Pharmaceuticals.” Standard & Poor’s Industry Surveys. August 13, 2009. S&P Net Advantage. Lawrence, Stacy. “Looking for an Oasis.” BioCentury, The Bernstein Report on Biobusiness 16, no. 3 (2008): A1–A10. Johnson, Avery. “As Drug Industry Struggles, Chemists Face Layoff Wave,” Wall Street Journal, December 11, 2007. Martinez, Barbara. “Big Pharma Faces Grim Prognosis: Industry Fails to Find New Drugs to Replace Wonders Like Lipitor,” Wall Street Journal, December 6, 2007. Silberman, Steve. “Placebos are Getting More Effective. Drugmakers are Desperate to Know Why.” Wired Magazine 17.09, August 2009. Recommended Merck & Schering-Plough Merger Investor Presentation (PDF) March 9, 2009. Merck Schering-Plough. 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.
5	Accelerating Cancer Cures: A Global Frontier	Skloot, Rebecca. “About The Immortal Life of Henrietta Lacks.”
6	Clinical Drug Development	Burton, Thomas M. “By Learning from Failures, Lilly Keeps Drug Pipeline Full,” Wall Street Journal, April 21, 2004.
7	Drug Delivery Systems	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. 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.
8–10	Regulation Emerging Pharmaceutical Science and Technology I Manufacturing I Reimbursement Emerging Pharmaceutical Science and Technology II	Required Rubin, L. “Stem Cells and Drug Discovery: The Beginning of a New Era?” Cell 132 (2008): 549–52. Recommended 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. Rubin, L., and F. J. de Sauvage. “Targeting the Hedgehog Pathway in Cancer.” Nature Reviews Drug Discovery 5, no. 12 (2006): 1026–33. The Burrill Report 3, no. 9 (2013). Jones, Matt. “GenomeWeb Feature: Slow, Steady Decline in NIH Funding Leads Researchers to Fear Future Cuts,” GenomeWeb Daily News, July 18, 2013. Philippidis, Alex. “Researchers Chafe as NIH Budgets Shrivel,” Genetic Engineering & Biotechnology News, September 13, 2013. “As VC Falters, Early-stage Biotechs Look Elsewhere for Cash,” FierceBiotech, October 21, 2013. “Universities Stepping Up Efforts To Discover Drugs,” Forbes, October 21, 2013.
11–13	Manufacturing II Manufacturing III Student Presentations	Required Thayer, A. M. “The New Copycats.” Chemical & Engineering News 91, no. 40 (2013): 15–23. Wechsler, J. “Drug Quality at Center Stage for FDA and Manufacturers.” BioPharm International 26, no. 1 (2013): 10–12. Kozlowski, S., J. Woodcock, et al. “Developing the Nation’s Biosimilars Program.” The New England Journal of Medicine 365, no. 5 (2011): 385–88. Thomas, Katie. “Lapses at Big Drug Factories Add to Shortages and Danger,” New York Times, October 17, 2012. Basu, P., G. Joglekar, et al. “Analysis of Manufacturing Costs in Pharmaceutical Companies.” Journal of Pharmaceutical Innovation 3, no. 1 (2008): 30–40. “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. “Business: Trouble in the Making; Pharmaceuticals.” The Economist 364, no. 8288 (2002). Recommended “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. “Guidance for Industry Q10 Pharmaceutical Quality System.” (PDF) ICH. U.S. Department of Health and Human Services, Food and Drug Administration, April 2009.