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Are Labeling Complexities Destroying Your Drug Pipeline?
- Hans van Zoonen, Partner, Kalypso
- Stephen Birtsas, Senior Manager, Kalypso

This article will outline labeling complexities biopharmaceutical companies come across and the steps that can be taken to overcome them, increase labeling productivity, and maintain a strong drug development and commercialisation pipeline.

Biopharmaceutical companies face an increasing number of challenges to create, deliver and maintain a strong product development pipeline, and their package label and insert development process can have significant impact on productivity, profitability and compliance.

The Challenges
As an industry used to working against very detailed specifications in a well-defined highly regulated environment, several trends are emerging that challenge the biopharmaceutical packaging status quo. First, ongoing globalisation puts pressure on companies to harmonise product packaging and labeling information. Second, patent expiry and lengthening product development cycles force companies to continue to develop existing products and expand into new geographical markets, multiplying regulatory complexity and the number of product changes. Third, environmental concern focusing on sustainability drives companies to rethink traditional manufacturing processes and materials, which in turn impact manufacturing cost and productivity.

Central amongst these trends is that most biopharmaceutical packaging operations need to manage an ever increasing amount of data across geographically dispersed sites and competitive pressure forces them to do so in less time. Regulatory pressure and severe penalties for compliance violations encourage companies to take a conservative — and time consuming — approach. In the end, productivity suffers and costs increase at the expense of competitive advantage, as the following examples show:

1. Disparate Data: The biopharmaceutical industry is highly regulated and companies have large amounts of product-related data that serve as the foundation for drug labeling. The data typically reside in unstructured document files or file formats that cannot be easily searched or re-used. In addition, data is stored in multiple locations throughout the organisation, often as duplicated copies that become out of sync. With no single source of the truth, companies have to collect, compile, organise, restructure or re-write the information to be used for product labeling and submission. This process usually involves manual compilation and cross-checking of labeling data which is error-prone and results in inefficiencies at best and drug labeling mistakes at worst.

2. Label Labour: Traditional label development processes are inefficient and prone to costly errors. The unstructured, disparate product data mentioned in the first example makes the drug labeling process a manual and tedious process for labeling departments. Labeling departments must collect product information from multiple sources, re-write labeling copy and re-validate the information before developing labeling artwork files.

3. Regulatory Realities: Structured Product Labeling (SPL) standards require biopharmaceutical companies to provide XML-based submissions via SPL standards. To meet these standards, companies have to answer the question, “where does the truth lie?” Unstructured data, authored by different people and stored in different locations often result in re-writes and copy-and-pasting between disparate systems. The consequence is that regulatory submitters may be working from incorrect or outdated information that later has to be corrected or requires a labeling change to match the submission information.

What to Do?
Start with Product Lifecycle Management to Fix Your Disparate Data: When we look for examples of how companies overcame their disparate data challenges, we find industries such as aerospace, defence, automotive, high tech, medical device, food and beverage, and consumer packaged goods have all solved the issue with Product Lifecycle Management (PLM). PLM provides companies with the ability to define a globally centralised product record that contains all product, package, processing and registration information in a single location. A robust and accurate product record enables global collaboration, visibility to product and registration information with a complete history of changes, and validation and approval history. Implementing PLM is the first step in solving disparate data challenges and the foundation for building efficient and accurate package label and insert development capabilities.

Add Artwork Management to Complement PLM and Solve Label Labour and Regulatory Realities: The biopharmaceutical industry’s complex copy development processes demand that the package artwork, inserts, promotional materials and regulatory submissions stay in sync and meet multiple global market requirements. PLM systems do a great job enabling the product development process and storing the product record from concept to end of life but they have a capability gap when it comes to managing the complex and specialised artwork associated with label and insert development. This gap is often reflected in label and insert development teams that struggle to keep pace with tight product launch and commercialisation timelines. A late market entry can cost a company valuable patent life and lost opportunity costs of over USD 1 million a day, while inaccurate product labeling can rack up compliance fines or product recalls.

Artwork Management (AM) solutions fill PLM’s labeling capability gap with the following functionality and help biopharmaceutical companies develop accurate labeling faster and with fewer errors:

1. Artwork annotation and markup: Having a system that allows multiple designers to collaborate on a labeling project simultaneously greatly reduces artwork review time and eliminates laborious phone and email communications when developing and approving labels and inserts. Artwork annotation and markup systems provide virtual spaces where Labeling Specialists, Brand Owners, R&D, Quality, Regulatory and Legal can all electronically review, mark-up and approve labels and inserts throughout the label development process.

2. Digital asset management (DAM): One of the biggest “time wasters” in label development occurs when a labeling specialist spends time working on a digital asset (eg, design file, production artwork file, image, chart or logo) that is not up to date. Maintaining control of digital assets within a globally centralised DAM eliminates de-synchronisation of digital assets by allowing collaboration and sharing of digital assets from a single location thus minimsing labeling errors and speeding up the label development process.

3. Copy Management and Translation: Copy management and translation functionality is arguably one of the most important features of AM systems. Copy management allows biopharmaceutical companies to create a master label manuscript that contains all approved label and insert copy in a centralised database. Labeling copy stored as data rather than as individual documents allows AM systems to implement a robust change control process for all labeling changes and the stored master version of that labeling copy can then be reused for international market launches and translations. Leading companies even integrate parts of their labeling content into their product record stored in PLM so they can automatically flag the need for a label or insert change when critical product information changes. This tight integration of labeling content stored in AM with the product record stored in PLM provides biopharmaceutical companies with world class labeling practices that eliminate the complexities often associated with labeling changes.

A second advantage to using AM software to centralise labeling content in a database is that it allows companies to syndicate label data to multiple locations such as websites and regulatory submissions via XML. Translation, historically a common cause of delays, is also handled by AM software. Copy management gives package label designers an automated workflow combined with stored common phrases. These tools help reduce copy development time associated with translations.

4. Automatic Artwork Generation: In situations where packaging artwork teams are forced to produce a final product very quickly, they can turn to artwork generation tools that can produce error-free artwork through standardised label and insert design templates that are populated with copy stored in the AM systems copy management module. While automatic artwork generation is not easy to implement or appropriate in all cases, companies can significantly reduce time and costs by eliminating variation seen in a manual label development process.

The Roadmap to a Strong Pipeline Biopharmaceutical companies seeking to thrive in a competitive market must align all stakeholders involved in product development, regulatory and labeling so that their product information is structured and stored within a centralised location, such as PLM, integrated with an AM solution. Once a company is able to maximise the re-use of labeling content, improve labeling efficiency and reduce the likelihood of labeling and submission errors they will be well-positioned to maintain a strong drug development and commercialisation pipeline.