FTE models help pharma manage excess workload caused by COVID-19

Since COVID-19 started making headlines – and capturing the collective attention of the world in early 2020, several pharmaceutical companies began working around the clock to develop a vaccine, as scores of others worked overtime to ensure the availability of therapeutics to address the virus’s short- and long-term symptoms.

However, there are only so many hours in any full-time employee’s day – and working around the clock can only be sustained for so long. So, for many biopharma companies, the reality is that time spent on the most mission-critical COVID-19-related projects has often meant that other regulatory approval and compliance initiatives are ending up reprioritized or delayed.   

Savvy drug developers are leveraging dedicated, full-time equivalent (FTE) staffing models to bridge the gap.

For years, FTE staffing models have been used as a more cost-effective, scalable and flexible solution for companies that want to avoid the inefficiencies and overhead costs of hiring full-time staff to manage regulatory filings, compliance, post-approval and other initiatives. Since the beginning of the pandemic in particular, many of the manufacturers that utilize Cardinal Health Regulatory Sciences’ FTE model offering have leveraged this service as a cost-efficient way to ensure they’re able to aggressively pursue COVID-19-related projects; while not neglecting other regulatory priorities.

Cardinal Health Regulatory Sciences brings a team of regulatory consulting and medical writing experts together who work as an extension of a pharmaceutical company’s team. Typically, our experts work to establish regulatory strategy; develop consistent, submission-ready documents; quickly manage unforeseen regulatory challenges; and address all aspects of a product’s post-approval journey. With an FTE model contract in place, our regulatory experts can be quickly redirected to work on projects at a client’s discretion, with no need to renegotiate contracts or project scopes.

Over the past year, pharma companies have been increasingly engaging our FTE models to help them manage the regulatory workload for legacy projects, so their full-time staff can focus exclusively on COVID-19 projects. In other cases, the converse is true: clients are directly focusing our regulatory experts on COVID-19 initiatives – for example, helping ensure that regulatory issues don’t cause avoidable stockouts or limit the availability of existing medications that are in high demand for the treatment of COVID-19 symptoms. Here are three concrete examples of how certain developers are leveraging FTE models to make the most strategic use of their own staff’s time and expertise, during a period of time when the world expects an all-hands-on-deck approach to the pandemic response:

• To handle additional regulatory burdens related to emergency use authorization. Over the past year, hundreds of new COVID-19-related products and devices have been granted emergency use authorization by the FDA, in attempt to address what has become the most significant public health crisis in decades. However, while this designation does indeed speed a product’s time to market in most instances, this designation also comes at a cost. Because it is expressly different from a product approval, the emergency use designation demands an elevated regulatory maintenance burden – one that far exceeds the maintenance requirements to which most developers are accustomed. As just a single example, emergency-use authorization means that manufacturers need to have available regulatory filings for every new lot of product as it’s distributed. Particularly considering the high demand for many of these products, managing regulatory filings for every new lot can take considerable time – at the same time that regulatory staff must simultaneously focus on securing full approval of the product. By engaging an FTE model, developers can focus experts on filing the maintenance requirements, or on securing full regulatory approval. Regardless of which they choose, their own full-time staff doesn’t have to be burdened, or slowed down, by handling both.


• To support the redesign of clinical studies, or the reorganization of manufacturing processes that have been impacted by COVID-19. Because of social distancing, quarantine and other COVID-19-related complications, many pharma companies are also being forced to shift and readjust clinical programs for their legacy development projects. In some cases, clinical studies need to be completely reworked or postponed because of COVID-19- related patient access issues. In other cases, developers are having to reconfigure the manufacturing process for legacy products that are already approved and on the market, because they need to repurpose specialized equipment for the manufacture of COVID-19 vaccines. Our pharma clients are increasingly engaging our FTE experts to help them quickly manage and develop compliant solutions to these complex challenges.


• To expedite regulatory filings, clinical study design and other facets of the development process. Increasing a product’s speed to market is always a top priority for most pharmaceutical companies. However, timelines are even more compressed with the development of most COVID-19-related products. This has led to very short turn- around times for responding to inquiries from the FDA and other agencies. This in turn sometimes means, for example, that a developer needs a team of five regulatory experts to focus on an agency response for eight hours each – instead of waiting for a single full-time employee to complete the same amount of work in a week’s time. In cases like these, our FTE models give clients the flexibility to meet tight deadlines by refocusing their FTE model team to work on emergent priorities as soon as they arise.

While the COVID-19 pandemic has undeniably created an environment of near-constant change, shifting priorities and staffing challenges for the pharma industry, our FTE model is well positioned to support pharmaceutical companies through these challenging times. Contact us today to learn how our FTE models can help you contain costs, maintain compliance, and determine the best strategic use of your staff’s time and expertise. Email specialtysolutions@cardinalhealth.com