The Hub and Spoke Model: How to Reduce the Burden of Global Regulatory Affairs
By: Peter Lassoff, PharmD | September 09, 2014
Even the largest biopharmaceutical companies today shy away from maintaining massive global infrastructures to manage every single aspect of their operations. The move toward more agile, partner-driven models has enabled them to cut costs, gain efficiencies and reduce their risks by taking advantage of the existing skills and infrastructure of other industry experts.
But there are still avenues to follow that can further add agility and productivity to their processes. The key is identifying tactical operational work that is necessary but does not drive added value or tap into the team’s core skill set.
Many of these tasks fall into the realm of global regulatory affairs. Increased reporting demands from global regulatory bodies, coupled with internal pressures to maintain current staffing levels, is stretching some organizations to the breaking point.
One of the biggest obstacles in this space is that regulatory affairs work often requires localization, which can create a significant financial and human capital burden. Even though harmonization efforts are in place, the regulatory agencies in many target markets still retain a largely regional focus. For some high-level tasks, it is still necessary to have staff present in major markets to liaise with regulatory agencies, e.g., FDA in the US.
One way to ease the pressure — without taking on headcount — is through industry partnerships in which biopharma companies transition tactical regulatory affairs work to partners who can conduct it more efficiently with greater economies of scale and to the same high quality.
At Quintiles, we refer to this as the ‘Hub and Spoke model.’
Rather than establishing permanent resources in every country, merely to have the necessary feet on the ground to occasionally interface with local regulatory bodies, biopharma companies tap into the existing network of their partners, who provide those resources on their behalf.
With the hub and spoke model, instead of having dedicated regulatory personnel in each country, regional hubs are used (e.g., Argentina for Latin America, Singapore for Asia-Pacific). Work on a ‘core dossier’ for each product is largely done in an off-shored site, where basic files are produced and published. It is then made available electronically, using secure portals such as SharePoint or a RIM system, for each hub to tailor for their countries.
These hubs are responsible for tailoring the regulatory dossier/file for regional acceptability in terms of language and content. Actual submission of the filing can be done directly from the regional hub or, where required, from within the country itself as a ‘post-box/mailbox’ service.
This partnership model for global regulatory affairs management potentially eliminates a company’s need for whole layers of in-country personnel who traditionally take core dossiers and tailor them for each country.
This is the next step toward a more agile and flexible biopharma business model. Managing operational regulatory affairs work for marketed products is a necessary process and has far-reaching legal, commercial and patient obligations. In addition to guaranteeing successful business continuity, a cohesive and nimble regulatory strategy can also help companies expand and leverage their global product coverage into new markets while reducing the vitally important time-to-market lag. All of this can be achieved without having to wait for the lead-time of establishing their own infrastructure — which can ultimately accelerate overall sales.