• Chinese (Simplified, PRC)

Older, marketed established biopharma products may not be as headline-grabbing and ground-breaking as the latest immuno-oncology therapies or precision diagnostics, but they represent a proven therapeutic solution for many markets and a steadfast income stream in a constantly changing economy. But if biopharma companies don’t manage their marketed products efficiently, it will eat away at their already limited margins and threaten to make the products too expensive for the patients who need them.

As their products age, biopharma companies face constant pressure to shrink costs and manage risks while meeting regulatory compliance in an increasingly complex environment. These pressures include increased demand for risk assessments from regulators, higher expectations for regulatory documentation in emerging markets, new and rapidly changing regulatory reporting requirements and the need to more clearly demonstrate the value of products to obtain and retain adequate pricing. In response, companies need to find ways to lower the time and cost of managing these products in order to maintain and improve profit margins.

Fortunately, there is a lot of ‘white space’ in the way most companies manage marketed products that can be eliminated through a more centralized and technology-enabled approach.

In a traditional environment, regulatory affairs and pharmacovigilance are usually treated as disparate functions, and much of the work is conducted manually and in a decentralized manner by individual employees in each market/region. In these regulated environments, any time there is a label change or a variation needed for a submission, the headquarters function will alert each local affiliate, which is then responsible for hunting down the proper data, finding and manually filling out forms, sending them for review and waiting until everything is approved to make those submissions. It’s an inefficient and opaque process that is often fraught with unnecessary delays and added costs, along with a material risk of error.

But it doesn’t have to be.

When companies embrace existing and proven technology to automate and centralize these steps, they can achieve significant time and cost savings in maintaining established products and potentially bring these products to new markets that were previously too costly to access and maintain.

Workflow automation

In everyday life, people have grown accustomed to having most online forms instantly populated with data the moment they type the first letters into a data field. This well-established workflow automation can bring the same level of efficiency -- and reduction in common data entry errors -- to the management of marketed biopharma products. By integrating automation tools with a Regulatory Information Management System (RIMS), and linking that technology to databases of online forms and product information, biopharma companies can instantly populate most of the common fields necessary to manage regulatory updates for managed products. This cuts the time, cost and risk associated with these regulatory steps, and eliminates the wait time between steps that add cost to the process and eliminating many data entry errors.

With workflow automation, any time an affiliate needs to update a label claim or file a regulatory submission, they can log onto the system, perform user focused queries which will locate the necessary data and the most up-to-date forms. A merge process can autofill fields that require previously entered data or the data can be found using structured data authoring from other related documentation. The regulatory professional will only be required to fill in any new data or country specific information, route the dossier for review, and then send it to regulators – realizing material savings in terms of time and resources. By leveraging the “right person, right task” philosophy, this technology-enabled approach may offer substantial savings over current regulatory service models in use today, particularly when combined with labor arbitrage in cost-effective markets.

Hub and spoke

In conjunction with workflow automated technologies, companies can gain further efficiencies in the way they manage marketed products by centralizing this management process. The Quintiles methodology is part of our hub and spoke model.

The traditional regulatory affairs model uses localization, which requires in-country resources in each market where a product is sold. This is particularly challenging in Europe, where fragmentation of markets means they may need to maintain multiple teams across a relatively small region.

But this inefficiency can be minimized through the use of regional hubs to assemble regulatory dossiers for each country in that zone. The core dossier for each product is compiled in a central hub in a cost-effective region where the basic file is produced in English and made available electronically through the use of the RIM system. The regional hubs then access these dossiers to complete the forms based on regional acceptability in terms of language and content and to submit them to the appropriate regulatory bodies or, where required, to junior personnel in the country concerned for submission as a ‘post-box’ function. For example, instead of having about 20 offices across Latin America, a company can have one regional office in Argentina that manages the dossiers for almost every country in that region.  

This centralized solution can potentially save resources to help biopharma companies refocus existing regulatory headcount to more profit-driving projects that will enhance their product portfolio. It also adds a higher level of transparency, compliance and control over regulatory submissions through the use of a centralized data system and standardized processes, combined with an automated workflow layer on top of a RIM infrastructure.

This time and cost savings that can be achieved with automation and centralization not only improves the value proposition for marketed products in existing markets, it can make it possible to roll these products out to new markets that may previously have been cost-prohibitive, creating new revenue streams for biopharma companies and providing underserved populations with access to life saving treatments. It’s one more way companies can move toward a more agile and flexible biopharma business model that benefits patients, prescribers, regulators and their own bottom line.