The Role of Public-Sector Research in the Discovery of Drugs and Vaccines

• Published in: The New England journal of medicine Vol. 364; no. 6; pp. 535 - 541
• Main Authors: Stevens, Ashley J, Jensen, Jonathan J, Wyller, Katrine, Kilgore, Patrick C, Chatterjee, Sabarni, Rohrbaugh, Mark L
• Format: Journal Article
• Language: English
• Published: Waltham, MA Massachusetts Medical Society 10.02.2011
• Subjects: Biological and medical sciences; Biomedical Research - history; Biomedical Research - legislation & jurisprudence; Drug Approval - statistics & numerical data; Drug Discovery - history; Drug Discovery - legislation & jurisprudence; Drug Discovery - statistics & numerical data; FDA approval; General aspects; History, 20th Century; History, 21st Century; Intellectual Property; Licenses; Medical research; Medical sciences; Pharmaceutical industry; Prevention and actions; Public health. Hygiene; Public health. Hygiene-occupational medicine; Public Sector - history; Public Sector - legislation & jurisprudence; Teaching hospitals; Technology Transfer; United States; United States Food and Drug Administration; Vaccines; United States; United States > US; Medicine; Drug; Prevention; Immunoprophylaxis; Scientific research; Vaccine; Discoveries; Public sector
• ISSN: 0028-4793; 1533-4406
• DOI: 10.1056/NEJMsa1008268

During the past 30 years, advances in biotechnology and changes in the legal environment have allowed public-sector research to make substantial contributions to the development of new drugs and vaccines. Advances in public-sector research, as represented by FDA-approved medications, are discussed. Historically, there has been a clear distinction between the roles of public-sector research and corporate research in the discovery of new drugs and vaccines to solve unmet medical needs. Public-sector research institutions (PSRIs) have performed the upstream, basic research to elucidate the underlying mechanisms and pathways of disease and identify promising points of intervention, whereas corporate researchers have performed the downstream, applied research to discover drugs that can be used to treat diseases and have then carried out the development activities to bring the drugs to market. The intellectual property that protects the investment in developing these drugs is created . . .