George Mason University – Graduate Council
Graduate Course Approval Form
All courses numbered 500 or above must be submitted to the Graduate Council for final approval after approval by the
sponsoring College, School or Institute.
Graduate Council requires submission of this form for a new course or any change to existing courses. For a new course,
please attach a copy of the syllabus and catalog description (with catalog credit format, e.g. 3:2:1). The designated
representative of the College, School or Institute should forward the form along with the syllabus and catalog description,
if required, as an email attachment (in one file) to the secretary of the Graduate Council. A printed copy of the form with
signatures and the attachments should be brought to the Graduate Council meeting. Please complete the Graduate Course
Coordinator Form if the proposed changes will affect other units.
Note: Colleges, Schools or Institutes are responsible for submitting new or modified catalog descriptions (35 words or
less, using catalog format) to Creative Services by deadlines outlined in the yearly Catalog production calendar.
Please indicate: New
Modify X
Department/Unit: Public and International Affairs
Delete
Course Subject/Number: BIOD 766
Submitted by: Gregory Koblentz, Deputy Director
Ext: 3-1266
Email: gkoblent@gmu.edu
Course Title: Development of Vaccines and Therapeutics
Effective Term (New/Modified Courses only): fall 2008
Credit Hours: (Fixed) 3:3:0
(Var.)
to
Repeat Status*(check one): X
within term
NR-Not repeatable
Final Term (deleted courses only):
Grade Type (check one)
Prereq X Coreq
(Check one):
Regular graduate (A, B, C, etc.)
Satisfactory/No Credit only
Special graduate (A, B, C, etc. + IP)
RD-Repeatable within degree
*Note: Used only for special topics, independent study, or internships courses
Schedule Type Code(s): 1. X
IND=Independent Study 2.
X
RT-Repeatable
Total Number of Hours Allowed:
LEC=Lecture SEM=Seminar STU=Studio INT=Internship
LAB=Lab RCT=Recitation (second code used only for courses with Lab or Rct component)
BIOD 604 and BIOD 605; or permission of instructor.
__________________________________________________________________________________________
Note: Modified courses - review prereq or coreq for necessary changes; Deleted courses - review other courses to correct prereqs that list the deleted course.
Description of Modification (for modified courses): Increase credits to 3, change title and catalog description, remove pre-reqs.
Special Instructions (major/college/class code restrictions, if needed): Remove major restriction
Department/Unit Approval Signature:_________________________________________ Date: _____________
College/School Committee Approval Signature:__________________________________ Date:_____________
Graduate Council Approval Date:____________ Provost Office Signature:_________________________________
George Mason University
Graduate Course Coordination Form
Approval from other units:
Please list those units outside of your own who may be affected by this new, modified, or deleted course. Each
of these units must approve this change prior to its being submitted to the Graduate Council for approval.
Unit:
Head of Unit’s Signature:
Date:
Unit:
Head of Unit’s Signature:
Date:
Unit:
Head of Unit’s Signature:
Date:
Unit:
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Date:
Unit:
Head of Units Signature:
Date:
Graduate Council approval: ______________________________________________ Date: ____________
Graduate Council representative: __________________________________________
Date: ____________
Provost Office representative: ____________________________________________
Date: ____________
Dept of Public and International Affairs
Biodefense Graduate Programs
4400 University Dr., MS 3F4, Fairfax, VA 22030
Phone: 703-993-9626; Fax: 703-993-1399
To:
CHSS Curriculum Committee
Cc:
Marylou Holly, Academic Coordinator
From: Dr. Gregory Koblentz, Director, Biodefense program
Email: gkoblent@gmu.edu
Date:
October 23, 2007
Subject: BIOD 766
Change Title: Development of Vaccines and Therapeutics
Increase credits to 3:3:0, change Course Catalog Description
Justification: The requested changes to the course title, description, and credit hours are required to accurately
reflect the updated course content. The course continues to address the development of vaccines and
therapeutics to treat natural and man-made diseases. The focus of the course, however, has shifted from
technical issues involving production of pharmaceuticals to the political, economic, scientific, and regulatory
factors that influence the research, development, production and acquisition of such drugs for biodefense and
public health purposes. Therefore, a laboratory component is unnecessary.
_______________________________________________
Dr. Robert L. Dudley, Chair, Public and International Affairs Dept.
College of Humanities and Social Sciences
COURSE CATALOG COPY FORM
For the revision of catalog copy for new or modified courses
A. Subject code number, course title, and credit hours.
Subject code and number: BIOD 766
Title: Development of Vaccines and Therapeutics
Credit code: 3:3:0
B. Prerequisites needed prior to registration in the course or co-requisites:
Prerequisites:
BIOD 604 and BIOD 605; or permission of instructor
Co-requisites:
N/A
C. Description of the course as it will appear in the catalog
Analyzes the process of developing new medical countermeasures against biological weapons
and emerging infectious diseases such as SARS and pandemic influenza. Special attention
paid to the scientific, technical, political, regulatory and economic obstacles to developing new
vaccines and therapeutics. Examines the causes, and potential solutions, of public and private
sector failures.
Office of the Dean Use Only
Entered By:
Date:
George Mason University
Department of Public and International Affairs
Course Number: BIOD 766
Course Title: Development of Vaccines and Therapeutics
Course Description: Analyzes the process of developing new medical countermeasures against biological
weapons and emerging infectious diseases such as SARS and pandemic influenza. Special attention will be paid
to the scientific, technical, political, regulatory and economic obstacles to developing new vaccines and
therapeutics. The causes, and potential solutions, of public and private sector failures will be examined.
Assessment:
The final grade will be calculated as follows:
Mid-Term Exam
Final Exam
Research Paper
Attendance and Participation
30%
30%
30%
10%
Required Textbooks:
Paul F. Torrence, ed., Antiviral Drug Discovery for Emerging Diseases and Bioterrorism Threats
(Hoboken, NJ: Wiley-Interscience, 1995).
Institute of Medicine, Protecting Our Forces: Improving Vaccine Acquisition and Availability in the
U.S. Military (Washington, D.C.: National Academies Press, 2002).
Institute of Medicine and National Research Council, Giving Full Measure to Countermeasures:
Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare
Agents (Washington, DC: National Academies Press, 2004).
Syllabus
Week 1: Introduction
Institute of Medicine, Biological Threats and Terrorism: Assessing the Science and Response
Capabilities (Washington, DC: National Academies Press, 2002), chapters 3 and chapter 4.
Gilfillan L, Smith BT, Inglesby TV, et al., “Taking the measure of countermeasures: leaders’ views on
the nation’s capacity to develop biodefense countermeasures,” Biosecurity and Bioterrorism Vol. 2, No. 4
(2004), pp. 320–327.
Eric Niiler, “Bioterrorism: Biotechnology to the Rescue?” Nature Biotechnology, Vol. 20 (January
2002), pp. 21-25.
General Accounting Office, New Drug Development: Science, Business, Regulatory, and Intellectual
Property Issues Cited as Hampering Drug Development Efforts, GAO-07-49 (Washington, DC: General
Accounting Office, November 2006).
Center for Arms Control and Non-Proliferation, Federal Funding for Biological Weapons Prevention
and Defense, Fiscal Years 2001-2008 (Washington, D.C.: Center for Arms Control and Non-Proliferation, June
2007).
Week 2: Vaccines
William Edstrom, “The Search for Vaccines,” in Geoffrey Zubay, ed., Agents of Bioterrorism:
Pathogens and Their Weaponization (New York: Columbia University Press, 2005), pp. 309-323.
Kendall Hoyt, “Vaccine Innovation: Lessons From World War II,” Journal of Public Health Policy,
Vol. 27 (2007), pp. 38-57.
Philip K. Russell, “Vaccines in Civilian Defense Against Bioterrorism,” Emerging Infectious Diseases,
Vol. 5, No. 4 (July/August 1999), pp. 531-533.
Jeffrey B Ulmer, Ulrich Valley & Rino Rappuoli, “Vaccine manufacturing: challenges and solutions,”
Nature Biotechnology, Vol. 24, No. 11 (November 2006), pp. 1377-1383.
Week 3: Antibiotics
Infectious Disease Society of America, Bad Bugs, No Drugs: As Antibiotic R&D Stagnates, a Public
Health Crisis Brews (Alexandria, VA: Infectious Disease Society of America, July 2004).
George H. Talbot, John Bradley, John E. Edwards, Jr., David Gilbert, Michael Scheld, and John G.
Bartlett, “Bad Bugs Need Drugs: An Update on the Development Pipeline from the Antimicrobial Availability
Task Force of the Infectious Diseases Society of America,” Clinical Infectious Diseases 2006:42 (1 March), pp.
657-668.
Week 4: Antivirals
Paul F. Torrence, ed., Antiviral Drug Discovery for Emerging Diseases and Bioterrorism Threats
(Hoboken, NJ: Wiley-Interscience, 1995).
Week 5: Antibodies
Arturo Casadevall, “Antibody-Based Therapies for Emerging Infectious Diseases,” Emerging Infectious
Diseases, Vol. 2, No. 3, 200-208, July-September 1996, pp. 200-208.
Arturo Casadevall, “Passive Antibody Administration (Immediate Immunity) as a
Specific Defense against Biological Weapons,” Emerging Infectious Diseases, Vol. 8, No. 8, August 2002, pp.
833-841.
Geoff Hale, “Therapeutic antibodies: Delivering the promise?” Advanced Drug Delivery Reviews 58
(2006) 633–639.
Janice M. Reichert and Matthew C. Dewitz, “Anti-infective monoclonal antibodies: perils and promise
of development,” Nature Reviews Drug Discovery, Vol. 5 (March 2006), pp. 191-195.
Monya Baker, Anti-infective antibodies: finding the path forward,” Nature Biotechnology, Vol. 24, No.
12 (December 2006), pp. 1491-1493.
Week 6: Modern Drug Development and Discovery
Helmut Gierseifen, Alexander Hillisch,and Rolf Hilgenfeld, “Modern Methods of Drug Discovery: An
Introduction,” in Alexander Hillisch and Rolf Hilgenfeld, eds., Modern Methods of Drug Discovery (Basel:
Birkhäuser Verlag, 2003).
Jurgen Drews, “Drug Discovery: A Historical Perspective,” Science, Vol. 287 (March 17, 2000), pp.
1960-1964.
William Edstrom and Geoffrey Zubay, “Drug Discovery and Biodefense,” in Geoffrey Zubay, ed.,
Agents of Bioterrorism: Pathogens and Their Weaponization (New York: Columbia University Press, 2005),
pp. 295-307.
Frank Sams-Dodd, “Target-based drug discovery: is something wrong?” Drug Discovery Today,
Volume 10, Number 2 (January 2005), pp. 139-147.
Week 7: Regulatory and Legal Issues
Food and Drug Administration, From Test Tube to Patient: New Drug Development in the United
States, Second Edition (Rockville, MD: Food and Drug Administration, 1995).
Food and Drug Administration, “New drug and biological drug products; evidence needed to
demonstrate effectiveness of new drugs when human efficacy studies are not ethical or feasible,” Federal
Register, Vol. 67, No. 105 (May 31, 2002) pp. 37988–37998.
Gail H. Javitt “Drugs and Vaccines for the Common Defense: Refining FDA
Regulation to Promote the Availability of Products to Counter Biological
Attacks,” Journal of Contemporary Health Law and Policy, Vol. 19, No. 1,
Winter 2002, pp. 37–116.
Richard A. Rettig, The Food and Drug Administration Confronts Homeland
and National Security (Washington, DC: RAND, 2003).
Wendy H. Schacht and John R. Thomas, Bioterrorism Countermeasure Development: Issues in Patents
and Homeland Security (Washington, DC: Congressional Research Service, November 27, 2006).
Julie Samia Mair and Michael Mair, “Vaccine Liability in the Era of Bioterrorism,” Biosecurity and
Bioterrorism, Volume 1, Number 3, 2003, pp. 169-184.
Week 8: Economic Issues
DiMasi JA, Hansen RW, Grabowski HG., “The price of innovation:
new estimates of drug development costs.” J Health Econ 2003;22(2):151–185.
Ruth Levine, Michael Kremer, Alice Albright, eds, Making Markets for Vaccines (Washington, DC:
Center for Global Development, 2005).
Cormac Sheridan, “The Business of Making Vaccines,” Nature Biotechnology, Vol. 23, No. 11
(November 2005), pp. 1359-1366.
Week 9: Department of Defense and Biodefense Countermeasures
Department of Defense, Report on Biological Warfare Vaccine Research and Development Programs
(Washington, DC: Department of Defense, July 2001).
Institute of Medicine, Protecting Our Forces: Improving Vaccine Acquisition and Availability in the
U.S. Military (Washington, D.C.: National Academies Press, 2002).
Institute of Medicine and National Research Council, Giving Full Measure to Countermeasures:
Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare
Agents (Washington, DC: National Academies Press, 2004).
Richard A. Rettig, Jennifer Brower with Orlie Yaniv, The Acquisition of Drugs and Biologics for
Chemical and Biological Warfare Defense Department of Defense Interactions with the Food and Drug
Administration (Washington, DC: RAND, 2003).
Week 10: Bioshield I
Bradley T. Smith, Thomas V. Inglesby, and Tara O’Toole, “Biodefense R&D: Anticipating Future
Threats, Establishing a Strategic Environment,” Biosecurity and Bioterrorism, Vol. 1, No. 3 (2003), pp. 193202.
Congressional Research Service, Project BioShield (Washington, DC: Congressional Research Service,
September 27, 2006).
Lynn Klotz, Supplying the Strategic National Stockpile: Manufacturing Incentives and Countermeasure
Choices (Washington, DC: Center for Arms Control and Non-Proliferation, March 2006).
Lynn Klotz, BioShield Marketing Incentives to Industry (Washington, DC: Center for Arms Control and
Non-Proliferation, January 2006).
Department of Health and Human Services, Project BioShield: Annual Report to Congress, July 2004
Through July 2006 (Washington, DC: Department of Health and Human Services, July 2006).
Renae Merle, “Bioterror Antidote: Prescription Unfilled,” Washington Post, January 16, 2007, p. D1.
Melanie C Trull, Tracey V du Laney & Mark D Dibner, “Turning biodefense dollars into products,”
Nature Biotechnology, Vol. 25, No. 2 (February 2, 2007), pp. 179-184.
Week 11: Bioshield II
Homeland Security Council, Medical Countermeasures against Weapons of Mass Destruction,
Homeland Security Presidential Directive/HSPD-18 (Washington, D.C.: White House, January 31, 2007).
Biomedical Advanced Research and Development Authority (BARDA), Draft BARDA Strategic Plan
for Medical Countermeasure Research, Development, and Procurement (Washington, D.C.: Department of
Health and Human Services, July 2007).
Gigi Kwik Gronvall, Bradley T. Smith, Jason Matheny, Michael Mair, Allison Chamberlain, Shana
Deitch, Luciana Borio, Thomas V. Inglesby, and Tara O’Toole, “Meeting Report: BARDA Roundtable, March
22, 2007,” Biosecurity and Bioterrorism, 2007;5(2), pp. 174-179.
Week 12: Case Study I: Anthrax and Smallpox Vaccines
A. Scorpio, T. E. Blank, W. A. Day and D. J. Chabot, “Anthrax Vaccines: Pasteur to the Present,”
Cellular and Molecular Life Sciences, 63 (2006) 2237–2248
Luciana L. Borio and Gigi Kwik Gronvall, “Anthrax Countermeasures: Current Status and Future
Needs,” Biosecurity and Bioterrorism, Volume 3, Number 2, 2005, pp. 102-112.
Peter B. Jahrling, Gary M. Zaucha, and John W. Huggins, “Countermeasures to the Reemergence of
Smallpox Virus as an Agent of Bioterrorism,” in W. M. Scheld, W. A. Craig, and J. M. Hughes, eds., Emerging
Infections 4 (Washington, DC: ASM Press, 2000).
Steven R. Rosenthal, Michael Merchlinsky, Cynthia Kleppinger, and
Karen L. Goldenthal, “Developing New Smallpox Vaccines,” Emerging Infectious Diseases, Vol. 7, No. 6,
November-December 2001, pp. 920-926.
Isao Arita, “Smallpox Vaccine and its Stockpile in 2005,” Lancet Infect Dis 2005;
5: 647–52.
Janie Parrino, MD, and Barney S. Graham, MD, PhD, “Smallpox Vaccines: Past, Present, and Future,”
Journal of Allergy and Clinical Immunology, Vol. 118, No. 6 (December 2006), pp. 1320-1326.
Itay Wiser, Ran D. Balicer, and Dani Cohena, “An update on smallpox vaccine candidates and their role
in bioterrorism related vaccination strategies,” Vaccine 25 (2007) 976–984.
Week 13: Case Study II: Pandemic Influenza Vaccines
Kanta Subbarao and Tomy Joseph, “Scientific barriers to developing
vaccines against avian influenza viruses,” Nature Immunology, Vol. 7 (April 2007), pp. 267-278.
David S. Fedson, “Pandemic influenza and the global vaccine supply,” Clinical Infectious Diseases
2003; 35: 1552–61.
Institute of Medicine, The Threat of Pandemic Influenza: Are We Ready? Workshop Summary
(Washington, DC: National Academies Press, 2005).
David S. Fedson, “Preparing for Pandemic Vaccination: An International Policy Agenda for Vaccine
Development,” Journal of Public Health Policy (2005) 26, 4–29.
Gigi Kwik Gronvall and Luciana L. Borio, “Removing Barriers to Global Pandemic Influenza
Vaccination,” Biosecurity and Bioterrorism, Vol. 4, No. 2 (2006), pp. 168-175.
David S. Fedson and Peter Dunhill, “From Scarcity to Abundance: Pandemic Vaccines and Other
Agents for ‘‘Have Not’’ Countries,” Journal of Public Health Policy (2007) 28, 322–340.
Week 14: The Future of Vaccine and Therapeutic Development and Acquisition
Scott Gottlieb, Political Roulette and the Public Health: The Impact of Political Intrusions on Drug
Development and the Consequence for America’s Biodefense, AEI Working Paper 113 (Washington, DC:
American Enterprise Institute, July 2005).
Jason Matheny, Michael Mair, Andrew Mulcahy, and Bradley T. Smith, “Incentives for Biodefense
Countermeasure Development,” Biosecurity and Bioterrorism, Volume 5, Number 3 (2007), pp. 228-238.
Kendall Hoyt and Stephen G. Brooks, “A Double-Edged Sword: Globalization and Biosecurity,”
International Security, Vol. 28, No. 3 (2003/04), pp. 123-148.
Department of Health and Human Services, HHS Public Health Emergency Medical Countermeasures
Enterprise Strategy (Washington, DC: Department of Health and Human Services, March 2007).
Department of Health and Human Services, HHS Public Health Emergency Medical Countermeasures
Enterprise Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats (Washington, DC:
Department of Health and Human Services, April 2007).
Department of Defense, Transformational Medical Technologies Initiative Fiscal Year 2007
(Washington, DC: Department of Defense, 2007).