Institute for Technology Entrepreneurship and Commercialization, Boston University School of Management, Boston, MA 02215, USA.
N Engl J Med. 2011 Feb 10;364(6):535-41. doi: 10.1056/NEJMsa1008268.
Historically, public-sector researchers have performed the upstream, basic research that elucidated the underlying mechanisms of disease and identified promising points of intervention, whereas corporate researchers have performed the downstream, applied research resulting in the discovery of drugs for the treatment of diseases and have carried out development activities to bring them to market. However, the boundaries between the roles of the public and private sectors have shifted substantially since the dawn of the biotechnology era, and the public sector now has a much more direct role in the applied-research phase of drug discovery.
We identified new drugs and vaccines approved by the Food and Drug Administration (FDA) that were discovered by public-sector research institutions (PSRIs) and classified them according to their therapeutic category and potential therapeutic effect.
We found that during the past 40 years, 153 new FDA-approved drugs, vaccines, or new indications for existing drugs were discovered through research carried out in PSRIs. These drugs included 93 small-molecule drugs, 36 biologic agents, 15 vaccines, 8 in vivo diagnostic materials, and 1 over-the-counter drug. More than half of these drugs have been used in the treatment or prevention of cancer or infectious diseases. PSRI-discovered drugs are expected to have a disproportionately large therapeutic effect.
Public-sector research has had a more immediate effect on improving public health than was previously realized.
历史上，公共部门的研究人员从事基础研究，阐明疾病的潜在机制并确定有希望的干预点，而企业研究人员从事应用研究，从而发现治疗疾病的药物，并开展开发活动将其推向市场。然而，自生物技术时代开始以来，公共部门和私营部门的角色界限已经发生了重大变化，公共部门现在在药物发现的应用研究阶段发挥着更直接的作用。
我们确定了由公共部门研究机构（PSRIs）发现并由食品和药物管理局（FDA）批准的新药和疫苗，并根据其治疗类别和潜在治疗效果对其进行分类。
我们发现，在过去的 40 年中，通过 PSRIs 进行的研究发现了 153 种新的 FDA 批准的药物、疫苗或现有药物的新适应症。这些药物包括 93 种小分子药物、36 种生物制剂、15 种疫苗、8 种体内诊断材料和 1 种非处方药。其中一半以上用于治疗或预防癌症或传染病。预计 PSRI 发现的药物会产生不成比例的大治疗效果。
公共部门的研究对改善公共卫生的影响比之前意识到的更为直接。
