A Multifaceted Perspective of Pharmaceutical Innovation: A Consideration of the Regulatory Role
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ORIGINAL RESEARCH
A Multifaceted Perspective of Pharmaceutical Innovation: A Consideration of the Regulatory Role Mark Robberson, MBEE1 · Christopher D. Breder, MD, PhD1 Received: 26 March 2020 / Accepted: 19 August 2020 © The Drug Information Association, Inc 2020
Abstract Background The pace of innovation, the creative engine of the pharmaceutical industry, has been variably described as stagnant, stable, or accelerating depending on the metric used for assessment or the quality of evidence. If the predominant perception holds that the speed of innovation is sluggish, pressure for changes in the regulatory environment intensifies. Methods A systematic evaluation of the course of innovation in this industry was performed by applying a formula derived from economic market share theory to estimate the innovative contribution of each new molecular entity approved since 1938. The total and average innovation scores per year are described based on the therapeutic class, mechanism, and drug target. These data are compared to the number and percent of first-in-class drugs per year. Results The average annual score based on therapeutic class novelty has been declining; however, the therapeutic class total innovation score has been stable since the mid-1970s with occasional significant peaks of activity. While the average score based on mechanism or target experienced a decline beginning in the 1950s and 1960s, it has begun to rise since the early 1990s. Notably, the total innovation score has steadily increased since the 1970s. These variations closely parallel the number of first-in-class drugs approved on an annual basis. Conclusions While the reasons underlying these activities are likely complex, there is a temporal association between regulatory efforts to expedite drug development and approval. These findings should be considered when considering future incentivizing regulations and policies. Keywords Innovation · Business cycle · Drug development · Pharmaceutical · Biotechnology
Introduction The most commonly accepted definition of innovation is derived from the Organization of Economic Cooperation and Development’s Oslo Manual Guidelines for Collecting and Interpreting Innovation Data [1]. The fundamental concept in product innovation is that a new product is produced. An innovation is the implementation of a new or significantly improved product (good or service), or process, a new marketing method, or a new organizational method in business practices, workplace organization, or external relations. * Christopher D. Breder [email protected] 1
Advanced Academic Programs, Regulatory Science Program, Krieger School of Arts and Sciences, Johns Hopkins University, Washington, DC 20036, USA
The minimum requirement for an innovation is that the product, process, marketing method, or organizational method must be new (or significantly improved) to the firm. The state of innovation in the pharmaceutical industry in recent literature, as well as the popular news, varies greatly with descriptions range from comp
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