1] Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts, USA [2] University of the Pacific, Stockton, California, USA [3] MAPS 4 Biotec, Napa, California, USA.
Tufts Center for the Study of Drug Development, Tufts University School of Medicine, Boston, Massachusetts, USA.
Clin Pharmacol Ther. 2014 May;95(5):528-32. doi: 10.1038/clpt.2014.14. Epub 2014 Jan 21.
The marriage of biotechnology and the pharmaceutical industry (pharma) is predicated on an evolution in technology and product innovation. It has come as a result of advances in both the science and the business practices of the biotechnology sector in the past 30 years. Biotechnology products can be thought of as "intelligent pharmaceuticals," in that they often provide novel mechanisms of action, new approaches to disease control, higher clinical success rates, improved patient care, extended patent protection, and a significant likelihood of reimbursement. Although the first biotechnology product, insulin, was approved just 32 years ago in 1982, today there are more than 200 biotechnology products commercially available. Research has expanded to include more than 900 biotechnology products in clinical trials. Pharma is substantially engaged in both the clinical development of these products and their commercialization.
生物技术与制药业（制药）的结合是基于技术的发展和产品创新。这是过去 30 年来生物技术领域的科学和商业实践进步的结果。生物技术产品可以被认为是“智能药物”，因为它们通常提供新的作用机制、疾病控制的新方法、更高的临床成功率、改善的患者护理、更长的专利保护期，以及有很大的报销可能性。尽管第一款生物技术产品胰岛素于 1982 年刚刚获得批准，距今仅 32 年，但如今已有 200 多种生物技术产品上市。研究已经扩展到包括 900 多种处于临床试验阶段的生物技术产品。制药公司大量参与这些产品的临床开发和商业化。
