How FSP partnerships help drug developers manage dynamic and uncertain market conditions

Explore strategies to optimize drug development in dynamic and uncertain macroenvironments through hybrid FSP/FSO arrangements.

Biopharma and biotech industries currently face significant challenges due to dynamic and uncertain macroenvironments. Specifically, tariffs, most-favored-nation (MFN) pricing models, biotech funding challenges and regulatory changes in clinical research have introduced new layers of complexity and uncertainty in an already competitive and intricate field. According to a recent report, senior executives are now dedicating an average of 13% of their time to managing changes related to tariffs, highlighting the substantial impact these policies are having on the sector.

These disruptions are not only driving up expenses but also causing significant delays in timelines, further complicating the operational landscape. Respondents are reporting increased costs and delays in activities related to supply chains. The Congressional Budget Office (CBO) foresees a potential long-term “reduction in manufacturers’ revenues…[resulting] in lower spending on research and development and thus reduce the introduction of new drugs.”

The ripple effects of these delays are profound, with 23% of respondents anticipating that clinical development timelines will significantly lengthen over the next 12 months, and another 60% expecting moderate extensions. These delays in sponsor activities, such as spending, will cascade through the entire clinical development ecosystem, impacting contract research organizations (CROs) and contract development and manufacturing organizations (CDMOs), and ultimately, patients.

In recent years, and especially in this current landscape, drug developers are relying more and more on functional service provider (FSP) models to effectively manage industry uncertainty as FSP partners provide additional resource flexibility, reliability and continuity to help drug developers create efficiencies and meet their timelines.

Optimizing drug development with hybrid FSP/FSO arrangements

FSP and hybrid FSP/full-service outsourcing (FSO) models offer additional resources and flexibility to help drug developers manage risks to timelines and efficiency. Currently, two-thirds of drug developers leverage FSP or hybrid FSP/FSO arrangements for their clinical development outsourcing. Hybrid models, in particular, are quickly emerging as a preferred option, as they provide drug developers with additional agility and nimbleness in highly dynamic and uncertain market conditions.

In hybrid models, single or multiple FSP offerings are often added to an existing FSO arrangement to optimize clinical trial operations and address unanticipated or changing demands. These bespoke hybrid arrangements are very flexible and are often implemented to help:

• Maintain continuity—including critical staffing continuity—during business disruptions.
• Quickly scale resources or specific capabilities to keep projects on time and on budget in the face of unexpected changes.
• Deliver specific needs that cannot be met by an FSO arrangement alone, such as expansion into new regions, new therapeutic areas and new trial phases.
• Support an existing FSO arrangement with additional expertise or resources to support a specific study function.

An ideal FSP partner will convey the benefits of each approach and work with you to identify the best ways to create a bespoke mixed model solution tailored to your specific needs in a dynamic and rapidly changing market.

Maximizing efficiency through remote-based regional hubs

One highly effective approach to obtaining greater stability and project continuity in uncertain market conditions is the use of remote-based regional hubs. This approach increases flexibility and efficiency by delivering the best-suited and most cost-effective professionals for the job—wherever they are—to ensure projects launch on time and stay on budget.

Remote-based regional hubs offer an alternative to traditional brick-and-mortar office setups typically located in major urban areas. These hubs support a geographically distributed remote workforce that provides greater stability and project continuity in dynamic and uncertain times to help drug developers more effectively manage:

• Rising development costs
• Extended timelines
• Missed deadlines
• Reduced internal capabilities and operational resources
• Disrupted workflows
• Expansion into new regions

In times of increased uncertainty, the right FSP partner leverages remote-based regional hubs to streamline processes, create efficiencies and provide around-the-clock support to help you meet your timelines.

Leveraging technology from FSP partners to enhance the medical writing process

Another effective approach to attaining increased flexibility and efficiency is engaging with FSP partners to incorporate the use of artificial intelligence (AI) tools, like large language models (LLMs), in the clinical trial process.

Medical writers are leveraging LLMs to transform medical writing by making complex technical text more accessible for patients. LLMs produce clear and patient-friendly prose, which is invaluable for creating informed consent forms and lay summaries. Additionally, these models efficiently summarize dense documents, such as clinical protocols, aiding in quicker learning and writing processes. LLMs are also adept at extracting information from detailed sources like white papers and assessment schedules, providing writers with essential context swiftly. Further, they free up time for more critical work by handling simple administrative tasks.

The right FSP partner integrates technologies like LLMs and structured content authoring, facilitating AI-driven insights from structured data. As a result, incorporating LLMs enable medical writers to more efficiently translate complex scientific data into clear and compliant scientific statements, delivered through the flexibility of an FSP model.

Navigating regulatory change with FSP partners

Regulatory oversight is critical to ensuring safe and secure development of new drugs and medical devices. It ensures patient protection, data integrity and ethical conduct in studies. Effective pharmacovigilance regulatory intelligence efforts are critical for successful regulatory oversight but often are a huge burden for small/medium biopharma, biotech and medical device companies.

These companies often rely on FSP partners to navigate the challenges and regulatory complexity, due to constantly evolving regional, national, and global regulations. Lack of proper oversight leads to costly delays, brand damage, and severe consequences like production stoppages or product recalls. In moments of instability, teams must be equipped to quickly and proactively monitor, expertly interpret and apply regulatory intelligence to products, making timely and accurate recommendations.

An ideal FSP regulatory affairs partner helps companies navigate regulatory approval and market access amid significant changes and uncertainties. Having a team of cross-functional FSP experts on board helps bridge regulatory affairs knowledge with extensive clinical and commercial expertise, enabling the most efficient pathways to maximize regulatory approvals and accelerate outcomes. This approach also provides the necessary capabilities to effectively monitor and translate data and apply learnings and implement changes to ensure cohesion, mitigate unexpected delays and bring products to market on time and on budget.

Managing unforeseen staffing challenges by rebadging to an FSP partner

Rebadging, “the practice of transferring and rehiring staff from the sponsor to the FSP,” is a vital part of an FSP model in clinical research. Assuring guaranteed employment demonstrates goodwill and creates instant employee engagement. Rebadging also paves the way for business continuity and flexibility, as the rebadged employees are contracted to continue in their same roles in the same key development programs.

Another benefit of rebadging is that it keeps experienced staff working on the same projects, without loss of continuity and with minimal disruption while shifting those employees off internal payroll and cutting human resources, systems, and facilities costs. By converting fixed internal costs for salaries and equipment (i.e., capital expenditures, or CAPEX) into flexible and scalable service fees (i.e., operating expenses, or OPEX), cash flow is improved and forecasting and budgeting simplified.

In today’s uncertain drug development climate, rebadging helps organizations ensure proper utilization across programs. When considering rebadging, the right FSP partner will help you navigate staffing challenges by offering a dedicated staff transfer team focused on change management and business continuity. The ideal staff transfer team:

• Shifts costs from direct to indirect to give more flexibility and allow right-sized workforces.
• Has expertise in acquired rights directive (ARD) laws and regulations with a high average transfer success rate (e.g., greater than 87%).
• Eliminates risks involved in hiring and layoff cycles.
• Condenses vendor contracts to reduce legal, financial and ongoing oversight burden.

Implementing a rebadging solution is complex. Having the right FSP partner with extensive expertise in managing staff transfers compliantly, and a dedicated team focused on change management and business continuity, is critical. Additionally, an FSP partner with substantial growth and diverse business engagements will ensure effective employee integration.

Meet your timelines with PPD FSP solutions

PPD™ Functional Service Partnership (FSP) solutions enable biotech and biopharmaceutical companies to meet their clinical development timelines and maintain efficiency in dynamic and uncertain macroenvironments by delivering the best of the best: hard-to-find, top-tier staff with a proven track record of reliably delivering clinical development and post-marketing services.

Because you can’t always predict—or find and retain—the staff and services you need, our experts provide outstanding therapeutic and functional expertise, uniquely positioning us to deliver the right experience and knowledge to fill immediate resource and capability gaps.

To ensure projects launch on time and stay on budget, we employ dedicated transition and implementation roles and processes for swift deployment of staff and services, transparent communications, and proactive problem-solving.

With more than 30 years of support for clinical and marketed products, we know what it takes to solve your specific challenges. Whether you need to fill small service gaps or outsource multiple functions across a portfolio, we deliver customized solutions tailored to your needs, providing resource flexibility, reliability and continuity.