The Lifespan of Mature Drugs in 2025: Q&A with Kirsten Jacobs

Kirsten Jacobs, PhD
Chief strategy officer
PharmaLex

Strategies for ensuring revenue from mature drugs are much more complex than with newer products, and an uncertain regulatory future means that they may become more complicated in the coming years. Pharmaceutical Executive spoke with Kirsten Jacobs, PhD, chief strategy officer at PharmaLex, about strategies pharma companies can consider.

Pharmaceutical Executive: What strategies do you suggest to optimize and increase revenue from mature drugs?
Kirsten Jacobs: Pharmaceutical companies are operating in an increasingly complex, diverse, and swiftly changing regulatory environment and must find ways to reduce product risk while also working to achieve cost savings. Mature products present strong opportunities to optimize revenue because they offer a revenue stream that can help companies remain profitable in an intensely competitive global market.

In the past, outsourcing has been key to managing mature product portfolios, but the old “lift and shift” approach is no longer enough. Our approach involves creating a new outsourcing paradigm that prioritizes expertise, knowledge and innovation through strategic relationships designed to help companies navigate the complexities of the global market.

The first step for companies looking to modernize their outsourcing practices is to assess their current operating models to identify mature products and see where they could benefit from strategically integrating safety, quality, and regulatory management globally and locally. Then, finding or deepening relationships with trusted third-party partners who can provide expertise, customized support and services is critical.

To enhance operational and cost efficiency, we’ve established several measures in collaboration with our partners:

• Globally streamlining maintenance activities by leveraging standardized processes and advanced technologies;
• Increasing global compliance through effective management of global regulatory requirements, reducing the need for resources and minimizing costs associated with ad hoc fixes; and
• Strategically integrating services at both global and local levels to ensure seamless alignment and maximize value.

PE: How can companies overcome common missteps that impact process success?
Jacobs: The first misstep would be to keep doing things as they’ve always been done and relying on old outsourcing models, which can only respond to–rather than anticipate–challenges and risks.

When assessing their operating systems, companies need to ask themselves the right questions to help shape a strong game plan that will enable them to thrive and grow across regions. Outsourcing should not be seen as just transferring the work of a set or rote process. Instead, it’s an opportunity to partner with service providers who have the experience with other companies facing similar challenges and who can help optimize and modernize processes.

By leveraging the expertise and proven approaches of their outsourcing partners, companies can free up internal resources to focus on strategic business imperatives and capabilities that drive growth.

We recommend identifying what is core versus non-core to the business and considering where internal resources should–and should not–be focused to deliver the greatest value.

Companies should use best practices and proven approaches to identify the most effective models for implementation based on key performance indicators (KPIs) and return on investment (ROI) models to track gains incrementally.

PE: How can pharmaceutical companies ensure ongoing compliance and adapt to evolving global regulations across their product lifecycle?
Jacobs: Reimagining a more holistic outsourcing paradigm that’s more integrated and strategic can unlock new efficiency gains while helping companies remain compliant in a quickly changing and diverse global market. Taking the more synergistic approach that we recommend means companies can rely on their trusted partners to manage the entire product portfolio, rather than just a single activity, as was typically the norm under older, legacy approaches.

As more companies move away from transactional outsourcing relationships to more relationship-based models based on trust, they’ll be better positioned to reap the benefits of their partners’ regulatory and scientific expertise, which can be combined with operational and technological capabilities across the safety, regulatory and quality domains. The result is that all facets of managing a product across its lifecycle in any given region are holistically managed with compliance, performance, and cost savings in mind.