第一章：绪论 Forewords

1.1\t从《我不是药神》说起 From the movie “Dying to survive”

1.2\t药物的研发推动力 Motivation of pharmaceutical research and development

1.3\t生物医药行业的进展和突破 Advances in bio-pharmaceutical industry

1.4\t国际知名医药企业的成长历程 Development of renowned international pharmaceutical companies

1.5\t怎样成为药神？ How to become a god of healing and medicine

第一章课后练习

第二章：新兴生物技术介绍： Introduction to emerging biotechnology

2.1\t现代生物医药技术 Modern biomedical technology

2.2\t基因工程与蛋白质工程技术 Genetic engineering and protein engineering techniques

2.3\t克隆技术的发展 Development of cloning technology

2.4\t干细胞技术的发展 Developing technology of stem cell

2.5\t生物技术的发展 Progress of biotechnology

第二章课后练习

第三章：新药研发创新的选题和思路-1 Topics and ideas of new drug research and development (R&D)- part 1

3.1\t早期创新药物研发的组织形式 Early R&D organization forms of innovative drugs

3.2\t近年来中国制药行业的变化 Recent changes of Chinese pharmaceutical industry

3.3\t中国在世界新药研发的占比和贡献 China\'s share and contribution to new drug R&D in the world

3.4\t创新药研发的中国优势究竟有哪些？Chinese advantages in R&D of innovative drugs

3.5\t中国创新生物药的研发思路-跟跑和并跑 R&D ideas of Chinese innovative bio-pharmaceuticals—to run after and together

第三章课后练习

第四章：新药研发创新的选题和思路-2 Topics and ideas of new drug research and development (R&D)- part 2

4.1\t中国创新生物药的研发思路-2 ：如何领跑 R&D ideas of Chinese innovative biopharmaceuticals – Part 2：becoming the pace maker

4.2\t研发生物药的理论基础与关键技术 Theoretical basis and Key technologies for the R&D of biopharmaceuticals

4.3\t产品的国际市场与临床需求分析 Product analysis of international market and clinical needs

4.4\t研发产品链条的打造 Creation of R&D pipelines

4.5\t研发产品的特色和疗效 Features and efficacy of R&D products

第四单元课后练习

第五章：生物药物的生产制造平台 Manufacturing platform of Biopharmaceuticals

5.1\t生物药物生产的GMP标准 GMP for the production of biopharmaceuticals

5.2\t生物药物研发中试和放大工艺的设计原则 Design principles for pilot and scale-up processes in biopharmaceutical R&D

5.3\t单克隆抗体的制备工艺 Manufacturing technique of monoclonal antibodies

5.4\t基因工程药物的制备工艺 Manufacturing technique of genetic engineering drugs

5.5\t生物药物的质量检定 Quality control of biologicals

5.6\t生物药物生产的智能化工厂 Smart factory for biopharmaceutical production

第五章课后练习

第六章：生物药品的审评和监管： Review and regulation of biopharmaceuticals

6.1\t生物药品的审评和监管 Review and regulation of biological drugs

6.2\t什么是生物药？ What are biologicals?

6.3\tFDA的工作职责和组织架构 Responsibilities and organization structure of FDA

6.4\tFDA对生物药的审评流程 FDA review process for biopharmaceuticals

6.5\t新药的临床测试 Clinical trials for new drugs

6.6\tNDA/BLA的准备 Preparation of NDA/BLA

6.7\tFDA的评审过程和上市后监管 Review process and post-marketing supervision of FDA

第六章课后练习

第七章：生物医药企业的投、融资，估价和孵化 Investment, fund-raising, evaluation and incubation of biomedical enterprises

7.1\t如何开始创业 How to start a business

7.2\t创新药研发和生命科技的投资概况 Overview of investment in innovative drug R&D and life technology

7.3\t新药创投的资金来源 Funding sources for new drug ventures

7.4\t募集到多少钱才够用？How much funding is sufficient?

7.5\t投资人想要什么？What do the investors want?

7.6\t对外合作和转让的最佳时机 Best time for seeking cooperation and license-transfer

7.7\t创新药企业的退出机制 Capital withdrawal of innovative drug companies

第七章课后练习

第八章：尾声 Epilogue

8.1 生物医药产品的专利保护和布局

8.2 同情用药

8.3 从超个性化药物看生物医药产业的新格局

第八章课后练习