15.136J 新药研发原理与实践运营 (Principles and Practice of Drug Development)

MIT Course 15 · Operations Management · 运营管理 · 课号 15.136J

TL;DR

• 创新药从靶点发现、临床前验证到 I-III 期临床试验的高资本、长周期、高失败率运营管理。
• FDA 药品监管合规流程、适应症选择、临床试验供应链管理及加速审批通道策略。
• 生物医药知识产权布局、药品专利悬崖应对、定价医保准入谈判与商业化估值模型。

课程简介 / Description

This course serves as a description and critical assessment of the major issues and stages of developing a pharmaceutical or biopharmaceutical. Topics covered include drug discovery, preclinical development, clinical investigation, manufacturing and regulatory issues considered for small and large molecules, and economic and financial considerations of the drug development process. A multidisciplinary perspective is provided by the faculty, who represent clinical, life, and management sciences. Various industry guests also participate.

讲义 / Lecture Notes

• 2
  • Brief Economic History of the Pharmaceutical Industry
  • Lecture 2 Evolving Economics (PDF - 1.5MB)
• 3
  • The Pharmaceutical Industry and the Drug Development Process; Basic Science
  • Lecture 3 History of Pharmaceuticals (PDF - 3.0MB)
• 8
  • Regulation
  • Lecture 8 Comparative Effectiveness (PDF)
  • Lecture 8 Drug Regulation (PDF - 1.1MB)
• 12
  • Manufacturing III
  • Lecture 12 Manufacturing (PDF)

本资料整理自 MIT OpenCourseWare，遵循 Creative Commons BY-NC-SA 4.0 许可协议，仅供个人学习使用。