Digital Transformation
Sep 17, 2021

How regulatory teams can turn risk into a million-dollar reward

A new approach to mergers, acquisitions, and divestitures in life sciences

The agreement is complete; the ink is dry. But your newly acquired products aren't flowing into the market as they should. Supply has been disrupted. Product recalls are becoming more frequent. Your brand image is taking a beating. And now significant product revenue is at risk. This wasn't part of the original plan.

If you've ever executed mergers and acquisitions (M&A) or divestiture in the life sciences sector, this scenario may sound all too familiar. And with all signs now pointing toward a significant uptick in M&A activity in the life sciences sector, we explore how regulatory affairs leaders are helping their businesses get ahead of the challenge.

A bitter pill to swallow

Over the next year, we expect to see at least one major merger or acquisition among the big-name pharma companies. And at the same time, we expect to see venture capital activity focused not only on creating platforms of new chemical entities around therapeutic areas but also in areas less exposed to patent lifecycles, such as consumer health products.

For regulatory affairs teams, this business ambition means a significant amount of extra work and extra risk. In fact, our experience suggests around 1% of potentially impacted product revenue could be lost if the transition is not managed properly. And for larger acquisitions and divestitures, that could mean 5–10 years of work resulting in millions of dollars lost on rework, discarded stock, and stockouts. Not to mention the potential reputational risks that could follow.

A preventable pain

Moving acquired products through the marketing authorization transfer is tough stuff. It requires new artwork, labeling, and often new suppliers and value chains. And few regulatory affairs teams have professionals dedicated to this work; existing resources will need to stretch, and this means disruption to core activities and distraction from higher-value tasks.

Interestingly, the real challenge isn't a lack of resources or heightened complexity (those are symptoms of a larger issue). It comes down to the way most life sciences companies develop, maintain, and track their marketing authorization transfer plans – with the use of Excel.

It's not easy to integrate processes, data, and systems across regulatory, quality, and supply when all that information is locked into spreadsheets saved in disparate systems. And that leads to siloed working, version control issues, and an overall inability to visualize progress in any measurable way. But it also comes down to an overall lack of enterprise-wide structures and thinking, combined with a lack of systems capable of managing this type of integrated approach.

There is a better way

Now, imagine if it were all digitalized and you had an integrated holistic view across your organization, regulators, and supply chain. All the relevant regulatory, quality, and supply chain data is cleansed and consolidated in a data lake in a secure cloud. Algorithms with built-in business rules and regulatory intelligence comb through the data. And real-time visualizations of marketing applications and supply chains in online dashboards offer a single source of truth. Risks could be predicted and mitigated end to end.

Regulatory affairs teams and their counterparts in quality and supply could quickly and easily spot problems in the approval process and make relevant changes at a component level based on the specific submission type. Everyone would know exactly where each submission is in the process – authoring, manufacturing, quality control, publishing, and dispatch – and have the power to act when changes are necessary. And your regulatory affairs team would have more time to focus on other high-value activities like new product submissions and compliance matters.

About the authors

Claire Colville

Claire Colville

Assistant Vice President, Genpact Pharmalink

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Kyle Fliszar

Kyle Fliszar

Leader, Regulatory Affairs

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