RD Outcomes

Ronald P. Evens

Public/Patient Outcomes 66

Product Outcomes 70

Research Outcomes 73

Data/Information Outcomes 76

Company/Business Outcomes 79

References 82

When outcomes from R&D are addressed, new products are certainly the first outputs that are thought of as being produced by pharmaceutical and biotechnology companies. New products often are prescribed preferentially by physicians for the mitigation of disease and improvement of patient care because of their novel features over existing treatments. These new products will be the primary driver of innovations in health care, research advances, profitability, and business success for a company. However, many other important outcomes are needed routinely to be delivered by the R&D division and need support from all the rest of the company in order for the company to achieve four goals: demonstrate their scientific and medical prowess and productivity, meet the needs of the public and health care community for the best products used optimally, meet the needs of the shareholders, and sustain the company's research edge against the competition.

Several organizations evaluate the industry and create periodic reports for use by the industry, the medical and research communities, and public consumption as well. They address various industry outcomes, challenges, and improvement opportunities, involving diseases, technologies, products, processes, and business issues. The organizations include the following seven categories, along with examples and references provided: private consulting companies (e.g., Boston Consulting Group [1, 2], Ernst & Young [3, 4], and CenterWatch [5]); government (e.g., Food and Drug Administration [6] and Center for Medicare and Medicaid Services [7, 8]); publications (e.g., Nature Drug Discovery [10, 11] and Nature Biotechnology [9]); trade publications

(e.g., Medical Advertising News [12], Pharmaceutical Executive [13, 14], and R&D Directions [15-17]); trade organizations (e.g., Pharmaceutical Research and Manufacturers Association [18, 19] and Biotechnology Industry Organization [20]); university research centers (e.g., Tufts Center for the Study of Drug Development [21-25]); and clinical research organizations (e.g., Parexel [26]). This chapter summarizes many of the key outcomes provided by these analyses and more.

More than 20 different outcomes related to R&D are expected by various external stakeholders listed above. In this chapter, these outcomes of R&D will be discussed subsequently in five categories of outcomes; that is, public's/patients' expectations, the various products, research outcomes, data/information generation, and several company-related deals.

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