Embracing FSPs: Q&A with Jenny Denney

Jenny Denney
Executive vice president
Head of FSP clinical and
biometrics
Parexel

Jenny Denney, executive vice president and head of FSP clinical and biometrics at Parexel, spoke with Pharmaceutical Executive about the growing use of functional service providers (FSPs) in the pharma industry. While these companies offer plenty of benefits, life sciences companies must also understand what they’re actually capable of to truly benefit from them.

Pharmaceutical Executive: Are FSPs seeing a rise in popularity in the pharmaceutical industry?
Jenny Denney: Yes, we are absolutely seeing an increase in implementation of FSP models among our biopharmaceutical customers, largely driven by the need for agility and efficiency in the face of changing market dynamics and increasing complexity in drug development. Amidst the pressures of expiring patents, rising inflation and the current geopolitical environment as well as the competition brought on by technological advancements, our customers are seeking more flexible and cost-effective approaches to accelerate drug development and get medicines to patients faster.

The FSP model enables biopharmaceutical companies to outsource entire functions—such as site monitoring or data management or biostatistics—to specialized partners who can manage these functions across their portfolio of studies. This model supports not only execution of tasks, but also facilitates long-term strategic partnerships. The FSP model is particularly well-suited to the current environment because it offers the flexibility to adapt to changing demands, which is crucial as the pace of change in the industry accelerates. Additionally, the FSP model aids in retaining critical knowledge and talent within a company, as individuals hired through FSPs can grow and progress in their careers while still aligning with a customer’s long-term goals.

PE: What are the driving forces for adoption of the FSP model?
Denney: The top three forces behind the adoption of the Functional Service Provider (FSP) model include:

1. Macroeconomic industry trends and market pressures: Changes in the labor market and global geopolitical environments as well as regulatory changes and patent expirations are putting pressure on our customers’ revenue streams, necessitating faster drug development and quicker delivery of therapies to patients.
2. Need for agility: The biopharma industry requires more agile service models to adapt to the rapidly changing world. The FSP model offers flexibility, making it suitable for the industry's evolving needs.
3. Increasing complexity and volume of studies: The complexity of clinical studies is increasing, requiring more time from investigative sites. The volume of studies is also expected to grow at a compounded annual growth rate of 6.49% between 2024 and 2030. These factors collectively demand more resources that can be easily scaled up and later down if needed.

PE: When should sponsors consider using an FSP?
Denney: The right timing for implementation of an FSP model depends on whether the goal is to supplement internal resourcing or replace a fully outsourced strategy. Within organizations that are relying in internal staff to execute trials, some situations in which sponsors should first consider using an FSP outsourcing model are when the scale of the sponsors internal resources are constrained, there is a lock of presence in key geographies, or there is limited technical knowledge to optimally support an evolving pipeline. From there, sponsors can decide whether they need FSP or Full Service Outsourcing (FSO) support, or a mix of the two. When seeking alternatives to FSO, it is important for sponsors to consider first establishing the internal systems, processes and technical oversight needed to implement an FSP strategy.

FSPs are best suited for long-term relationships and when a full function or aspect of the work is being outsourced as an extension of the sponsor’s team. It’s also best for when a sponsor may want a dedicated team who are proficient in their own systems and processes or more control and flexibility to shift resources as priorities change. An FSO model may be better suited for when resource demand will fluctuate significantly. This could include a limited pipeline (one or two trials) or therapeutic areas with high variance in site demand (such as vaccine trials).

Even with an FSP model, there are different ways the model can actually be implemented. For sponsors that want a lighter touch of involvement from the CRO, a staff-augmented solution allows support to come in and work within their systems with minimal oversight from the CRO. For a higher-touch approach, the managed staff model means that the support is operating within the sponsor’s processes and procedures, but they are being operationally managed by the CRO. The best option may differ based on the sponsor’s culture, budget and needs.

As sponsors are working to understand what support may be best for them, I encourage them to begin conversations as early as possible with their CRO.

PE: How are FSPs improving agility and flexibility in the clinical research sector?
Denney: FSPs enable biopharmaceutical companies to respond to macroeconomic trends, labor market evolution, geopolitical environments, and regulatory changes in an agile manner. By outsourcing functions, our customers can accelerate drug development and adjust quickly to new demands. Take for example the COVID-19 pandemic—sponsors were able to leverage FSPs to address resource constraints by reallocating resources to new studies and adapting to new priorities.

FSP models offer flexibility in outsourcing various functional roles that may not be needed across the breadth of the sponsor’s studies or may be expensive to hire for internally. This versatility helps companies scale operations up or down as needed based on study demand.

To gain the most agility and flexibility when from an FSP model, I recommend that CROs are brought early on in the process so that they can understand the core goals, culture, and vision of the biopharmaceutical company and work in partnership to build an FSP model best suited to meet their unique needs.