Ronald P. Evens
Health Care Issues 5
Industry Statistics (The Pharma and Biotech Industries) 11
Research Activities and Costs 14
R&D Productivity 16
Organization of a Pharmaceutical Company 19
R&D Challenges and Issues 24
Summary of Research and Development Approaches 29
Drug and biological product development is a global, massive, complex enterprise that entails health care systems, disease knowledge, drug knowledge, research experiences (basic and clinical research with many disciplines, technologies, and processes), personnel/professional affairs, business and marketing practices, public relations, legal and regulatory issues, and global business, cultural, and medical factors. This chapter is intended to provide some background context for product development regarding applicable general health care issues, a description of the industry and key statistics, the organization of a pharmaceutical company, and drug and biological product development challenges. Thus, a framework is provided for the following 11 chapters that will discuss all the people, processes, systems, and outcomes for drug and biological development applicable in the United States and in Europe as well.
The four areas covered in this chapter include (1) health care issues (spending, changes over time, utilization, causes of disability, improvements with drugs) that serve as a broad context for new product development; (2) industry statistics regarding drug sales, drug costs, research and development (R&D) costs, research activity, Investigational New Drug applications (INDs), New Drug Approvals (NDAs), new molecular entities (NMEs), time frames and speed to market; (3) the organization of a typical company in the industry (FIPCO; fully integrated pharmaceutical company), especially describing seven divisions (research, clinical development, marketing, sales, medical, manufacturing, and global operations); and (4) research and development (R&D) issues that are challenges to drug development by the industry (e.g., complex milleau of phases and content of R&D, major disease, business and clinical challenges, technology issues, blockbuster discussion, collaborations, and culture).
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