Simplicity or Specialism? Organizational Options for Global Labeling Functions

Denis Fung
Co-founder and Lead of Labelnet
Navitas Life Sciences

Louise Tan
Pharmacovigilance Subject Matter Expert
Navitas Life Sciences

Labeling is changing. The focus is expanding from a set of compliance-centric activities i.e. ensuring that product labeling complies with local and regional regulations and medical practices, towards a more patient-centric one i.e. ensuring that patients and prescribers receive, through both printed and electronic media, accurate and up-to-date benefit-risk information in a timely manner in order to make informed decisions about their treatment choices. As a result, labeling functions within the Pharma companies need to adapt in order to meet this objective. This article explores organization options both at the function level as well as the corporate level, and the key success factors for industry in their pursuance of labeling excellence.

One of the key challenges for the pharmaceutical industry is the need for accurate and timely communications of benefit-risk information about medicinal products between marketing authorization holders (MAH), regulatory agencies, healthcare professionals (HCP) and ultimately patients. Whilst this is a highly regulated area, it is also mired in complexities due to different and sometimes conflicting local and regional regulatory requirements, as well as variations in medical and business practices globally. Against this backdrop, pharmaceutical labeling, defined as the documentation and communication of approved prescriber and patient information to the end users, be they conducted via printed or electronic channels, is increasingly under the spotlight as one of the key communication and risk mitigation means to ensure the safe, effective and informed use of medicinal products in markets worldwide.

The triple goals for a global labeling function: compliance, operational efficiency, adding patient and strategic value

Navitas Life Sciences, together with labelnet, an industry professional network dedicated to pharmaceutical labeling, pioneered the concept of End-to-End (E2E) labeling over 6 years ago. The underlying principle for E2E Labeling is to approach labeling holistically, "from signal to patient", without being bound by artificial barriers such as functional silos which commonly exist in the Pharma industry, in order to ensure that, overall, pharmaceutical labeling is:

1. Compliant with global regulatory requirements, in terms of process and governance, to deliver accurate and timely product information to the end-users, with the MAH having the ability to maintain oversight across its global network of affiliates and partners, and be inspection-ready in all the jurisdictions it operates

2. Operationally efficient, through deployment of fit-for purpose and scalable technologies to manage complex, cross-functional workflow and data which is generated across the E2E labeling journey. It also involves leveraging sourcing, distribution and other partner organizations as appropriate for efficiency gains and improved scalability

3. Value-adding, to create a more positive and patient-centric experience for the end-users, at the same time create greater strategic value for the corporate organization, be more outcomes-focused and providing timely strategic input particularly in early phases of product development (R&D)







Fig. 1. Business objectives for a labeling organization are expanding: from operational to strategic

How can this be achieved? Since its inception, the labelnet community has been sharing insights and learnings in order to build a set of industry best practices in key topics such as compliant E2E process design, cross-functional teams and governance models to facilitate collaboration, and the use of technologies to manage the plethora of labeling content (e.g. Core Datasheets, Reference Safety Information, Prescriber Information, Patient Information, Artwork, Packaging, education and other non-promotional materials, in both printed and electronic media), manage the complex cross-functional workflow (across Clinical Development, Pharmacovigilance, CMC, Regulatory Affairs, Medical, Commercial, Quality and Supply Chain), and to track and report on labeling change status, compliance metrics and performance indicators. An increasing focus is to ensure that organizational models, both at the labeling department level and at the enterprise level, are fit-for-purpose and designed to support the triple aim of compliance, operational efficiency and adding patient and strategic value as described earlier.

Labeling organizational design – key considerations

What needs to change for a Global Labeling Function? When it comes to organizational design, achieving both elegance of simplicity and sufficient depth of specialism has always been a seemingly impossible balancing act. Finding the optimal structure which is best fit for an individual company requires effort and often some degree of experimentation, as it is influenced by the overall size of the company, its product portfolio, as well as its R&D pipeline, the nature, mix and maturity of its products which could include new chemical entities, new biologics, generics, biosimilars, medical devices, combination products, across both prescription and consumer product categories. Higher level corporate strategies and organizational structure (e.g. centralized vs. decentralized corporate models, geographic spread, and partnership models), company culture (e.g. established large Pharma’s vs. emerging Biotech’s, Headquarter location and culture), and history of M&A (previous organizational models, ways of working from legacy companies) will also have an influence of the relative effectiveness of a given model. In short, there is no "one size fits all" model.

Labeling organizational design – emerging options

Despite the statement above, there are clear trends in the types of design that are suited to certain types of companies, with each design having its own pros and cons. Over the past few years, we have observed 4 common models for a Global Labeling function, with the following high level structures:
1. 'The One-Stop shop'
2. 2 sub-functions: Labeling Strategy and Labeling Operations
3. 3 sub-functions: Labeling Strategy , Labeling Operations and Labeling Compliance
4. 4-subfunctions: : Labeling Strategy , Labeling Operations, Labeling Compliance and Regional Liaison







Fig. 2 - Common organizational models for global labeling functions

The One-Stop shop

This model is one in which the bulk of labeling activities are being performed by a generalist labeling professional role. By deploying generalists which look after the creation and maintenance of labeling content and labeling strategy, as well as other operational labeling activities, this model places emphasis on overall ownership and E2E focus, in both content and process, over pure operational efficiency. As such, this type of model suits smaller organizations with fewer products, or products which require dedicated resource due to their nature or complexity, for example highly innovative molecules with complex profiles (and hence intimate knowledge about the product characteristics) for multiple indications. From an E2E labeling perspective, this model achieves good oversight on a product-by-product basis. As there are often global labeling leads per product, this also provides good visibility across regions and affiliates. However, this model can lead to inconsistencies in approach between different products or across therapy areas. It also places emphasis on individual ownership and to some extent, tacit knowledge of key individuals around the labeling histories of specific products, so it may be less scalable for large organizations, particularly those with a high staff turnover

The Labeling Strategy and Operations Model

This model is characterized by two core sub-functions within Global Labeling, , with separate resources for labeling content-strategy and for labeling operational activities, in order to provide a balance between depth of specialism without too many hand-offs. It is common in mid-sized Pharma companies with a moderate sized product portfolio, and suits products of low to medium labeling complexity. A possible challenge with this model is that it can create a segregation of knowledge and competencies and possibly reduced opportunities for personal development. On the other hand, it might suit individuals with a preference for specialism, as the roles are more focused and less generalist than the one-stop shop model. However, one potential misconception which may need to be guarded is that that contributions of a labeling professional engaged in 'operational' activities are less valued than those of a labeling 'strategist'. This needs to be managed to avoid an impact of overall staff motivation.

The Labeling Strategy, Operations and Compliance Model

The addition of a third sub-function focussed on E2E labeling compliance addresses the emphasis to maintain and demonstrate oversight through E2E tracking of labeling updates, compliance metrics and performance KPIs. The labeling compliance sub-function maintains strong links between internal functions, including Clinical Development, Pharmacovigilance, CMC, Regulatory Affairs, Medical, Commercial, Quality and Supply Chain, with particular emphasis on labeling implementation i.e. implementing up-to-date and accurate labeling information into pack as well as online and other electronic media.

While the original focus for many labeling compliance sub-functions was on E”E labeling process adherence, data governance and inspection readiness, labeling content alignment between regional / local labeling content, artwork and packaging, with the core datasheets (CCDS) and other source documents, is increasingly coming under the spotlight and becoming part of the remit of many labeling compliance sub-functions.

One of the main benefits of this model is having a designated E2E compliance owner, focussing on compliance through clearly defined metrics and KPIs. The model appears to be more common in larger organisations, particularly companies with a highly decentralized global network of LOCs (affiliates, partners, regional hubs), where achieving E2E labeling oversight is typically more challenging than for a centralized organization. In a similar but more exaggerated way to the previous model, the depth of specialism and separation between each sub-function are further increased, and the same potential risks e.g. segregation of competencies, perceived reduction in personal development opportunities, and perceived difference in the relative importance of the different roles, need to be managed for this model to succeed.

The Labeling Strategy, Operations and Compliance, with Regional Liaison

Lastly, this 4 sub-function model with the addition of a sub-function focusing on regional coordination and liaison, pays particular attention to the importance of connecting with LOCs who are responsible for a variety of tasks including: local/regional label creation, update and maintenance, translations, preparation of Health Authority submissions and managing the Health Authority negotiations and relationships. This tends to be the model adopted by larger organisations with a greater need for focussed regional liaison. Getting the balance right between the need to support LOCs in labeling management and providing an appropriate degree of empowerment and freedom to operate with local labeling ownership is challenging but can facilitate better management of local activities, better collaboration, as well as global consistency and oversight.

A trend towards specialism?

Among the Navitas labelnet members, it has been observed that the 3 and 4 sub-function models appear to be the more common choices among the larger sized companies (who typically have higher number of FTEs within their global labeling functions), whereas smaller companies with typically narrower product portfolios tend to favour the simpler models, In other words, as companies grow and expand, their global labeling functions have a tendency to favour more specialism, often driven by the need for efficiency gains (through economies of scale), the need for the business processes to become more scalable in order to deal with higher volumes of workload, and the need for consistency in both process and quality across larger product portfolios.

Roles and responsibilities also tend to be more clearly delineated as the number of FTEs within a labeling function increases. Once companies establish robust processes for compliance and efficiency, focus can then be shifted to the more strategic roles of labeling, which tends to go hand in hand with further specialism and the creation of additional sub-functions within global labeling functions.

Regardless of organizational model, we observe that there is also an increasing need for labeling professionals to possess good leadership capabilities, stakeholder management skills, and project management competencies, as the role becomes less compartmentalized and much more collaborative in nature because of the E2E scope. The profile of an effective and successful labeling professional will evolve with the evolving labeling organizational models of the future

Conclusion

Pharmaceutical companies are under increasing scrutiny from regulatory agencies to demonstrate that their products’ benefits outweigh their risks. In the past, the cascade of information from the identification of a safety signal to informing the patients and prescribers, was relatively disjointed, lengthy and ineffective, with each internal function working to their own procedures and metrics and far less cross-functional coordination or clearly defined end-to-end timelines than we have today. However, with the recognition and embedding of the E2E labeling concept in more and more companies, our industry is changing. The focus is expanding from a set of compliance-centric activities i.e. ensuring that product labeling complies with local and regional regulations and medical practices, towards a more patient-centric objective i.e. ensuring that patients and prescribers receive, through both printed and electronic media, accurate and up-to-date benefit-risk information in a timely manner in order to make informed decisions about their treatment choices. Whilst there is no "one size fits all" organisation model for global labeling functions, investment in time and effort in the design and optimization of the labeling organization model will be a significant contributor for success in delivering E2E labeling in a compliant, efficient and a high value-adding way.







Fig.3 - Effective End-to-End labeling is more than just process: Fit-for-purpose organisation design, as well as robust E2E governance are critical for success

Contact: : jayeeta.chowdhury@2020msl.com