FSP Flex Hub Teams Maximize Efficiency Across Lifecycle Maintenance

Lifecycle maintenance of a portfolio of marketed products is an ongoing regulatory affairs (RA) process subject to widely fluctuating workloads, making it the ideal function to outsource to a functional service provider (FSP) partner. Learn how our unique flex hub delivery model provides a cost-effective approach that fosters speed, predictability, value and continuity while maintaining high levels of quality throughout a product’s life cycle.

Companies developing new drugs and inventing new medical devices face a wide range of challenges. Most industries have in common the need to meet strict timelines while also achieving quality and compliance standards and staying within budget. Biotech and biopharma companies, however, must do all of this in the face of wildly fluctuating workloads — particularly during the post-marketing phase.

Maintaining a product’s ongoing availability to consumers requires the developer to comply with safety and quality standards across every region where the product is marketed, for as long as it is marketed. This requires an expert RA team capable of processing large volumes of routine submissions to support any changes to manufacturing, market expansion, or safety and quality reporting — for every drug or device in the company’s portfolio.

Essentially, lifecycle maintenance demands the ability to produce hundreds (or even thousands) of high-quality dossiers in the shortest time possible. However, completing this work is only half the challenge. Drug developers need to staff RA teams that can handle regular lifecycle maintenance ebbs and flows across lifecycle maintenance tasks, and plan for a workload that sometimes requires senior-level expertise, while at other times is much more suited to support staff.

For many companies, the best way to meet fluctuating workloads while maintaining quality and consistency across geographies (and over the time that a product may be marketed to the public) is to outsource RA functions to an FSP partner. Recognizing these challenges, our unique flex hub delivery model provides a cost-effective approach that fosters speed, predictability, value and continuity while maintaining high levels of quality throughout a product’s life cycle.

A unique flex hub model that delivers global solutions at scale

At the PPD™ clinical research business of Thermo Fisher Scientific, a typical FSP RA engagement designates a single team to provide oversight across a client’s many products and throughout all their markets. This approach is great at breaking down information silos, which in turn improves accuracy and efficiency across complex portfolios.

Under other implementations, this single-team approach could become a bottleneck that constrains the rate at which projects are completed and limits effective worktime to just a few time zones and an 8–10 hour workday. PPD Functional Service Partnership (FSP) Regulatory Affairs solutions teams, however, are deployed in a global flex hub model that delivers an efficient, accurate and consistent workforce 20 or more hours per day.

To ensure maximum coverage and effective management of time-sensitive deliverables, our PPD FSP Regulatory Affairs solutions experts designate a centralized submission management team within one of our flex hubs in India, Bulgaria, Mexico or elsewhere. This team oversees workload planning across regions, whether it is day or night in the client’s time zone.

A typical flex hub deployment includes:

• An oversight director responsible for leadership across the client’s portfolio.
• One or more program leads responsible for operational management and working from different geographies to create broader coverage around the clock.
• Any number of regulatory specialists that report up to the program leads. These experts in the compilation of country-specific applications can deliver final, compliant dossiers to regulatory agencies or to local country affiliates for submission. They also ensure that all project systems are kept up to date and information is available in the relevant planning and tracking tools.

Under this model, as one team member wraps up work at the day’s end, they pass the project over to a colleague whose day is just beginning. In this way, we maintain accuracy and consistency across the client’s lifecycle maintenance functions, while completing them quickly and at scale. This combination of quality and speed is the hallmark of the flex hub model.

Our delivery model creates additional efficiencies by having a PPD FSP Regulatory Affairs solutions specialist manage the submissions for all countries. This means that the same program lead will coordinate all submissions and participate in project meetings with the client teams — a level of involvement that reduces costs compared to less consolidated coordinator activities. This approach also streamlines any changes or updates to planning and tracking tools, while ensuring consistency by putting systems access in the hands of a single team. And it enables careful motoring of quality and compliance key performance indicators (KPIs), along with greater opportunity to apply time- and cost-saving process improvements.

How the flex hub model saves one developer time and money

As an example of the value that our flex hub model brings to biotech and pharmaceutical developers, here is a brief look at one long-term partnership in place since 2013. For this large global client, our PPD FSP Regulatory Affairs team manages all aspects of lifecycle maintenance submissions, works through established delivery and operating procedures, carefully tracks and reports KPIs, and even develops training. The deployment, which uses client-validated systems for dossier compilation, publishing and regulatory information management (RIMs), includes:

• One dedicated partnership manager with responsibility for portfolio management.
• Eight dedicated regulatory submission leads to drive continuity and compliance, based in Portugal, France, Bulgaria, Peru and Philippines.
• Two to four RA and publishing resources per lead, located in or near the lead’s time zone.

Having access to these globally dispersed resources provides flexibility, quality and cost-predictability — all of which helps the client fiscally manage fluctuating workloads, streamline processes and ensure those processes are consistently applied to all product/submission types. PPD FSP Regulatory Affairs solutions also deliver leadership and strategic planning as members are actively engaged in recommending process improvements/implementations and focused training.

Early on, we worked with the client to establish meaningful KPIs, which we now carefully monitor and analyze. This helps us quickly identify and address any potential problems, and it helps spotlight successes that may influence future planning.

Among the results tracked to date include:

• More than 54,000 lifecycle maintenance submissions delivered for 54 products in 165 countries. That amounts to 5,000 – 6,000 submissions per year, or just under 500 per month. Without the flex hub model and our ability to work around the clock, that output would have been significantly less.
• An estimated 25% reduction in costs through effective resourcing by way of low-cost hubs.
• Reduced time and cost per unit by up to 60% in the first five years.
• Increased trust with the client, due to our performance. The client now consistently involves the PPD FSP Regulatory Affairs solutions team in brainstorming and strategizing.

With a flex hub model, meet your timelines without having to pay for idle resources

PPD FSP Regulatory Affairs solutions’ capabilities empower lifecycle maintenance solutions that transform growth, de-risk treatments and deliver new products to patients sooner — all while eliminating the hassles and waste associated with in-house RA teams that struggle amidst fluctuating workloads.

Unlike traditional RA solutions that must finance a steady headcount even when workloads are low, our flex hub model ensures that our clients do not pay for unused resources — but they do have ready access to the level of capacity they need at any given time. Additionally, our flex hub model ensures that specialists are available around the clock, trained and equipped to process workloads as a true team — taking on work begun by others and executing tasks in such a way that one’s work can be transferred to a colleague at the end of the day.

With PPD FSP Regulatory Affairs solutions, our clients are assured their lifecycle maintenance projects are completed accurately, consistently, quickly and at scale. This combination of quality and speed is uniquely enabled by a flex hub model that:

• Has stability — but flexibility too: Top management and the project lead provide a stable base and take responsibility for planning and organizing. The specialists that execute submissions are very flexible and able to quickly scale up or down to meet changing workloads.
• Prioritizes knowledge over geography: This innovative model enables us to hire in countries all around the world to capture knowledge and skills that benefit our clients, no matter their location.
• Enables bespoke solutions: With more than 25 years of experience across 250 clients and nearly 100 products, we develop FSP engagements to deliver the functions best fit each client’s unique needs.
• Has a proven record of success: Quality and timeliness are key to everything we do, and the data demonstrates that our model works. At present, we have 99% first-cycle approvals, 100% licenses obtained, 100% dossiers validated and over 99% of submission milestones achieved on behalf of our clients.