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In today’s high-pressure, cost-focused economy, biopharma companies are constantly looking for ways to optimize spending so they can focus their time, resources and expertise on projects that generate the greatest return on investment. One area where companies can find such opportunities is in managing their portfolios of mature products.  Companies invest a huge amount of time and money every year into maintaining the safety data, regulatory affairs and benefit-risk management for established products. These are all vital management functions, but in most cases they could be managed much more effectively.

As products age, companies face pressures to shrink maintenance costs and to grow or maintain revenue, all while still ensuring regulatory compliance and reducing risk. Companies that fail to meet these growth goals and compliance steps face potential market losses, regulatory penalties, and revenue impact. However, complying with these maintenance steps is taking an increasingly larger amount of time and resources, drawing assets away from new development projects that may have greater long-term potential. These dynamics present unique challenges for managing established products, and require innovative and cost-effective approaches that help ensure patient safety and compliance while continuing to meet ever-increasing regulatory demands.

But achieving efficiencies in this area can be challenging. Most companies struggle to even understand the time and cost they spend managing all of their portfolio management tasks, because they lack a global view of their processes. Departmental silos and isolated compliance teams dispersed across multiple regions and treatment categories make it difficult to share information or create the transparency needed to improve processes. This results in duplication of tasks, lack of knowledge sharing, and companies spending more time and money than may be necessary to achieve compliance. 

And things are only going to get worse. Regulators’ heightened focus on data means companies will have to deliver more information and go to greater lengths to validate the consistency of that data and the continued value proposition of these products to meet their portfolio maintenance goals. As regulatory and safety requirements for mature products become more complex and development budgets and timelines continue to shrink, it will become increasingly difficult for biopharma companies to achieve their regulatory obligations within allotted cost constraints.

A partnering approach

To meet these challenges, some companies are partnering with outside experts to take over the management of these tasks on their behalf. Through such strategic pairings, these biopharma companies are able to leverage economies of scale and leading edge technology that their partners bring to the process, which enables them to maximize the commercial value of their established products, cut the time, cost and risk, and gain greater clarity over the entire regulatory and pharmacovigilance process.

Quintiles has been a leader in this trend, creating the Marketed Product Maintenance (MPM) solution to help deliver more efficient portfolio management. By leveraging state-of-the-art technology, and deep expertise in safety, regulatory, and benefit-risk management research, we’ve been able to help our partners reduce the time, cost and risk of product maintenance.

While this is still a new trend, it is clear that most biopharmaceutical companies can benefit from more integration of their regulatory, safety maintenance and benefit-risk management functions if they desire to streamline regulatory tasks, while freeing resources to focus on new product development. It is a better and more cost-effective approach that we believe will soon become a mainstay to portfolio management.


For more information on Marketed Product Maintenance, please read our recent white paper, Value Vigilance.

Topics in this blog post: Biopharma, Risk, Regulatory Environment