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Appendix H BACKGROUND PAPERS Case Histories . . The Development of Pneumococcal Vaccine; Summary of Issues Affecting the Development and Utilization of Polyvalent Pneumococcal Vaccine by Robert Austrian, M.D. A Case History: Rubella Vaccine by Louis Z. Cooper, M.D. Issues Issues in the Production and Supply of Vaccines from Domestic Manufacturers and Foreign Sources by Hope E. Hopps, M.S. The Domestic Vaccine Industry: The Economic Framework by Lawrence M. DeBrock, Ph.D. Legal Issues Affecting the Development and Distribution of Vaccines by Richard F. Kingham, J.D. No-Fault Insurance for Vaccine Related Injuries by Jeffrey O'Connell, J.D. Formulating Recommendations on Immunization in the United States by H. Bruce Dull, M.D. Public Sector Perspectives The Interaction of Federal Agencies and Pharmaceutical Companies in Vaccine Development (NIAID) by William S. Jordan, Jr., M.D., and George J. Galasso, Ph.D. The Interaction of FDA and the Regulated Industry with Respect to Vaccine Development (FDA) by Paul D. Parkman, M.D., Hope E. Hopps, M.S., and Harry M. Meyer, Jr., M.D. Vaccine Development and Use: A CDC Perspective (CDC) by Gary R. Noble, M.D. and Alan R. Hinman, M.D. Impediments to the Development and Production of Immunogens of Interest to the Department of Defense (DOD) by David M. Robinson, D.V.M., Ph.D. Role of the Massachusetts Public Health Biologic Laboratories (Massachusetts) by George F. Grady, M.D. 194
195 Vaccine Development Incentives and Disincentives (Michigan) by John R. Mitchell, D.V.M., Dr.P.H. Private Sector Perspectives A Manufacturer's View of the Vaccine Market (Burroughs Wellcome) by Fred A. Coe, Jr. Issues in Vaccine Development from the Perspective of a "New Biotechnology Based Company" (Genentech) by David W. Martin, Jr., M.D. f An Overview of Factors Which May Impede Public-Private Sector Relationships Affecting Vaccine Development and Use (Merieux Institute) by Pinya Cohen, Ph.D. Government Industry Interaction and its Effect on the Biological Business (Lederle) by Francis R. Cano, Ph.D. Vaccine Innovation and the Private Sector (Eli Lilly) by Cornelius W Pettinga, Phi. . - Vaccine Development: An Industrial Point of View (Merck Sharp & Dohme) by Maurice R. Hilleman, Ph.D., D.Sc.