What are FSPs? First, let’s deconstruct the term Functional Service Providers (FSPs) in the industry. A Functional Service Provider allows for partnership support on critical activities sponsors have in their various asset pipelines. Oftentimes historically, these activities had been outsourced wholesale to contract research organizations (CROs), who could provide value to the sponsors across various domains of expertise for their clinical trials.

This type of relationship helps offload volumes of work outside of the sponsor, where they may not have the in-house experience or talent to manage the various functions which require continuous attention throughout the lifecycle from preclinical through all the requisite clinical trial phases leading up to a product launch (and sometimes afterward).

By contrast, an FSP is engageable for routine and non-routine activities where the sponsor again may not have the interest or expertise to sufficiently manage required activities. But FSP relationships tend to be much more flexible, and targeted in their approach, so sponsors can avail themselves of FSP partners’ experience on certain activities, without necessarily engaging in more bulky or long-term commitments.

Greater agility, lower cost

In the FSP approach, flexibility is key, and engaging an FSP model can provide optimum value, speed, and flexibility, often with lower costs compared with traditional outsourcing relationships. The FSP model is gaining traction across the industry specifically for its ability to target areas of need, while leaving unnecessary activities alone.

When FSPs started out, some of the risks were that greater oversight was still required by the sponsor to ensure other ancillary activities weren’t missed; But the model has evolved dramatically recently, to where reputable FSP suppliers also help keep an eye on material activities adjacent to their purview, and feed this information back to sponsor clients, often as a series of recommendations, to ensure nothing is missed.

Take what you need, leave what you don’t

Respondents who use FSPs often report that one of the significant value drivers they see is that activities which need attention by particular expertise are addressed, while not incurring overhead for activities that the sponsor is reasonably equipped to handle on their own. In this way, FSPs provide an augmentive effect—applying talent where it’s needed, and none where it isn’t. No need to over-optimize areas which don’t require administrative overhead.

FSP suppliers will qualify the need with the sponsor to ensure both parties are on the same page, and that resources are focused only on those areas of need. The increased agility of this approach can also lead to faster turnaround times of activities than are otherwise realized, either with legacy partnership models or a completely in-house approach.

De-risking your pipeline

As with other engagement relationships, FSP approaches offer the benefit of offloading and sharing some of the clinical risks associated with product development. Strong FSP partners understand the regulatory landscape, and the requirements therein, and can help de-risk many of the activities that Pareto analysis shows are commonly associated with issues uncovered in clinical stages during inspections (e.g., BiMO inspections, etc.).

For example, if the sponsor has a need for Data Management oversight and execution, or preparation and management of the eTMF, or Pharmacovigilance support, those individual entities can be handled by the FSP, while the rest of the surrounding and feeding (input) activities can still occur in-house. This moves the sponsor’s programs ahead much more rapidly, without layering additional bureaucracy and offerings that may conflict with the sponsor’s in-house capabilities.

Types of FSP engagement activities

Here is just a short list (not exhaustive) of activities that can be handled by reputable FSPs, to increase pipeline velocity and reduce risk:

• Pharmacometrics (ADME, PK/PD)
• Clinical Study Design
• Clinical Study Management
• TMF/eTMF support
• Site Qualification/Initiation/Closeout
• Study/Medical Monitoring
• Data Management, Statistical Programming
• Biostatistics
• Pharmacovigilance
• Medical Writing (CSRs, IBs, ICFs, etc.)
• Medical Science Liaisons (MSLs)

One of the best management strategies is to recognize what one is good at and seek help on the others. As Jeff Bezos put it, “Only do what makes your beer taste better.” What he meant by that is that Outsourcing continues to be an industry-leading way to handle all the activities that aren’t core competencies for the sponsor organization. Just because you “can” build something in-house, doesn’t mean that you “should.” Stay focused on your core business. The biggest companies with the greatest success know this, and they outsource ferociously.

Conclusion

With a litany of different strategic offerings available, our industry has more freedom than ever before to take advantage of partnerships which make them stronger, without having to add to their internal overhead and branch out in directions that aren’t optimal. We’ve seen the evolution of CMOs, CDMOs, CROs, and other CxO offerings. These partners continue to offer strong value to the industry, allowing companies to achieve goals faster and with higher quality than ever before.

FSPs are now part of this ecosystem and are differentiating themselves by providing targeted value to their clients. Many companies polled have said that they’d continue to use FSPs for future assets because they’ve seen the value in their current programs. The FSP model allows the industry to continue to evolve in a future-looking direction and provide high quality advanced therapies to more patients in need than ever before. But the takeaway is clear: The industry is a complex network, and there is expertise available to support those who need it. One need not try to do it alone.

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Ben Locwin is a pharmaceutical industry executive who has worked as a global head of quality and regulatory functions, as well as working with QMS developers to provide input into the future of system designs. He has been featured in The Wall Street Journal, USA Today, Forbes, The Associated Press, NPR, Axios, and other top-tier media.