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首页> 外文期刊>International journal of production economics >Planning operations before market launch for balancing time-to-market and risks in pharmaceutical supply chains
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Planning operations before market launch for balancing time-to-market and risks in pharmaceutical supply chains

机译：在上市前计划运营，以平衡上市时间和药品供应链中的风险

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Shorter product life cycles and the resulting increase in new product introductions boost the importance of product launch operations. In the pharmaceutical sector, product launch operations are of particular importance, as companies seek to reduce time-to-market to better exploit patent protection. Large volumes of product need to be ready to fill the downstream supply chain immediately at market launch. Building up the required inventory is, however, connected to several risks. In addition to the risk associated with the lack of demand information for a new product, there are several risks unique to the pharmaceutical sector. After approval by central authorities such as the FDA or EMA, a new drug still needs to receive market authorization, which is in most cases granted by some local authorities - in Europe, for example, by more than 30 national and regional bodies. The duration of these different market authorization processes as well as their outcomes (e.g. price and reimbursement levels, requirements of label or leaflet changes) are highly uncertain. We develop a two-stage stochastic model to support market launch preparation decisions. It trades off the costs of accepting these risks, for example by risk packaging before authorization, against the lost revenue caused by risk-averse operations. The model is applied to a case based on an empirical study. Our approach results in significant savings compared to current practices. We hereby provide an example of how quantitative methodology can provide valuable decision support for product launch operations, even when complex regulatory affairs need to be considered.
机译：较短的产品生命周期以及随之而来的新产品推出数量的增加，提高了产品发布操作的重要性。在制药领域，产品发布运营尤其重要，因为公司寻求缩短产品上市时间，以更好地利用专利保护。大量产品需要准备好在市场启动时立即填充下游供应链。但是，建立所需的库存会带来多种风险。除了缺乏新产品需求信息带来的风险外，还有制药行业独有的几种风险。在获得FDA或EMA等中央机构的批准后，新药仍然需要获得市场授权，在大多数情况下，这种授权是由一些地方政府授予的，例如在欧洲，由30多个国家和地区机构授予。这些不同的市场授权流程的持续时间及其结果（例如价格和报销水平，标签或传单更改的要求）高度不确定。我们开发了一个两阶段的随机模型来支持市场启动准备决策。它权衡了接受这些风险的成本（例如，在授权之前通过风险打包）与由规避风险的运营导致的收入损失之间的权衡。该模型适用于基于经验研究的案例。与当前做法相比，我们的方法可节省大量资金。我们在此提供一个示例，说明即使需要考虑复杂的监管事务，定量方法仍可为产品发布运营提供有价值的决策支持。

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