This article looks at the benefits that submission excellence can bring, examines six areas that companies can focus on to achieve it, and suggests how to get started on optimizing the path to approval. However, it does not take into account the possible impact of other factors, such as the competitive dynamics of launching a product earlier than competitors do. The calculation is conservative, since it is based on the assumption that each day gained in the submission process would yield one more day of peak sales for that product.

The calculation assumes that the asset has peak sales of $500 million, takes five years to reach the peak, and has a discount rate of 10 percent. Value per day that the submission is accelerated, a rough calculation suggests that for an average asset in the final stages of development, every month of acceleration translates into a net present value of $25 million to $40 million, and every day of acceleration creates $1 million in value. Using a simple return-on-investment calculation based on the Accelerating submissions proportionately increases the prepatent loss period for which a drug is on the market. There is a significant gap between pharmaceutical-industry median timelines from last patient, last visit (LPLV) in clinical trials to product submission and best-in-class timelines (as shown in the article’s exhibit). Other pharma companies under pressure to accelerate submission timelines will be looking to those experiences for signals on what has gone well and any pitfalls to avoid. Those companies have demonstrated how effective collaboration with regulators can expedite the approval process and how coordination among internal teams can improve submission quality. Organizations sprinting to develop vaccines and therapeutics have dedicated enormous resources to getting to market as quickly as possible.

The value of being first to market has been thrown into sharp relief by the COVID-19 pandemic (see sidebar, “Estimating the value at stake”). Submission excellence can bring benefits for patients and companies alike: the ability to launch products more quickly can shorten waiting times for life-enhancing therapies, yield more days of peak sales, and simplify and streamline an organization’s ways of working. We define submission excellence as the ability to prepare, in industry-leading time frames, high-quality regulatory submissions that accurately represent relevant data and maximize the likelihood of first-cycle approval with a favorable label for a medical product. This article is a collaborative effort by Gaurav Agrawal, Jennifer Dikan, Michelle Lyons, Rosa Poetes, and Maha Prabhakaran, representing views from McKinsey’s Pharmaceuticals & Medical Products Practice.

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