How the FSP Model Augments Biotech Sponsors’ Internal Capabilities

Smaller companies requiring additional capabilities, resources or expertise often rely on an FSP partner for support — from strategic direction to fulfillment of any given function.

The biotech industry has been called “a landscape shaped by economic shifts” where industry leaders need to drive their companies forward in an environment ripe with opportunity, navigate a range of complexities, and use capital efficiently as they intelligently leverage technology and scientific insights. Under these conditions, it’s easy to see why biotech companies must be dynamic, flexible and agile to succeed.

Meeting the never-ending challenges of drug development in this active environment — including pressure to identify drug prospects earlier and hire more conservatively — frequently leads biotech companies to outsource some portion of clinical development functions. Our white paper on the topic examines reasons biotech companies use the functional service provider (FSP) model to support their clinical development activities and the value that FSP engagements bring to these organizations.

FSP solutions are widely used in biotech

Biotech companies of any size can benefit from using a contract research organization (CRO) to fulfill trial-related functions and services. These outsourced capabilities are most often delivered through an FSP model, a full-service outsourcing (FSO) model or a hybrid of the two.

• With FSO, all tasks for a clinical trial are outsourced.
• With FSP, some or all of a specific function or functions (clinical operations, pharmacovigilance, regulatory, etc.) are outsourced.
• Both models can be designed to fit the sponsor’s needs and applied narrowly (any given study or single product) or widely (across the entire portfolio).
• Sponsors also may choose bespoke, hybrid FSP/FSO engagements under which one or more FSP elements are added to an existing FSO arrangement, or combined with an FSO deployment from the start, to create a more cost-effective, efficient and streamlined solution.

FSP solutions are great options for biotech companies that lack the ability to complete a function or functions in an efficient and cost-effective manner. Sometimes the gap exists because the sponsor has never developed in-house resources related to one function or another, choosing instead to focus its core workforce on critical internal competencies. Other times, the sponsor may find that rapid growth has overwhelmed personnel and resources, and they now need to quickly ramp up resources as the asset develops. Regardless of the catalyst, a custom FSP solution can be crafted to suit the sponsor’s unique needs and to match the fast pace and agile nature of a biotech company.

A provider of CRO services like the PPD™ clinical research business of Thermo Fisher Scientific has the FSP capabilities and expertise to quickly and efficiently support clinical development functions for a biotech developer. Common functions that biotech companies entrust to an FSP partner as they work to avoid delays and keep projects on track include:

• Study startup and site support
• Pharmacovigilance (PV)
• Documentation/medical writing
• Data management
• Biostatistics and programming
• Regulatory affairs (RA)

Over the years, we’ve built up a pool of talented experts across every facet of the industry, and we have the experience and resources to quickly place these experts in key roles within the sponsor’s organization or support sponsors’ needs using PPD FSP solutions’ systems and processes. No matter the actual function being performed, our FSP solutions drive quality, control costs and enable our experts to act as true collaborators. PPD FSP solutions are also beneficial to sponsors when used for staff augmentation that is unrelated to a specific function but focused on driving quality, cost controls, improved efficiencies and faster delivery.

Biotech companies can take advantage of several common delivery models when engaging an FSP partner to gain access to services they otherwise lack, and a bespoke solution using a combination of models is often the best fit. This flexibility enables the developer to quickly fill gaps with top-tier talent or specific functional expertise and enables high levels of scalability, ensuring the sponsor can easily scale up or down as workloads fluctuate. Delivery options include:

• Fixed price
• Full-time equivalent (FTE)
• Unit-based
• Output- or performance-based
• Time and materials (T&M)

We know that every biotech developer is unique, and our goal is to provide biotech support through our customized solutions and industry-leading capabilities and expertise.

PPD FSP solutions are proven for helping companies deliver on time and within budget

When newer, smaller biotech companies need to achieve successful clinical development with limited capabilities, resources and expertise, they don’t have to build out those capabilities themselves — they can rely on PPD FSP solutions for everything from strategic direction to a wide range of functional expertise. We embrace the biotech mindset and are adept at delivering highly personalized and nimble solutions for our clients. We work closely with our clients to ensure that they remain agile and successful, no matter their size or available resources, and we ensure their needs are reliably met as they continue to evolve.

With more than 25 years of experience across more than 160 countries, PPD FSP solutions deliver hard-to-find, top-tier expertise to meet the unique needs of our biotech clients. PPD FSP solutions enable our customers to achieve success in accelerating drug development with deep expertise and solutions for every step of their journey. Our extensive, proven expertise across a wide range of functional areas — powered by more than 30,000 research professionals worldwide — provides much-needed resource flexibility, reliability and continuity to help you stay agile and flexible to complete your development projects on time and on budget.