Sustaining the mature product portfolio through strategic outsourcing
Pharmaceutical companies face a common challenge with their mature portfolios: how do they sustain and maintain those products while shifting their resources and expertise to the development pipeline?
As products lose patent protection, revenue for those mature products drops. At the same time, these products remain important to the overall portfolio and must meet compliance requirements, such as requirements around variations and safety updates/reporting.
These pressures have prompted companies to outsource much of their post-launch regulatory compliance to domain experts who can take on the regulatory maintenance of large parts of the established portfolio at the corporate, regional, and local level.
Understanding outsourcing drivers
One of the main reasons why companies seek to outsource the regulatory maintenance of their mature products is to reduce costs. However, strict regulatory standards have led companies to turn to specialist partners to help them remain compliant. An additional advantage of such partnerships is the feedback experts can provide on regulatory changes and trends, which can help companies stay on top of their global regulatory obligations.
Globalisation and the growth of emerging markets has created new opportunities to expand the reach for the mature portfolio. Nonetheless, each market may have slightly different submission expectations; for example, with regards to CMC (Chemistry, Manufacturing, and Controls) activities such as product stability data.[1]
The global nature of the biopharmaceutical industry necessitates on-the-ground support. Partners with local regulatory expertise can offer additional cost savings by allowing companies to scale support as and where it is needed. By outsourcing their regulatory maintenance, businesses can benefit from flexible regulatory knowledge without the burden of managing internal teams, particularly in smaller markets where they don’t necessarily need a full-time employee to support regulated activities.
Another trend that has prompted companies to seek experienced regulatory outsourcing partners is the management of older portfolios that have been added through mergers and acquisitions. Very often, these products need an upgrade in terms of how they are maintained. Outsourcing them can result in more efficient processes, such as migrating these products into a regulatory information management (RIM) system and making sure dossiers are current and more readily available.
Turning the focus to innovation
One of the perhaps less widely touted benefits of outsourcing is that it frees up internal teams to focus on innovative drug development programmes and strategic imperatives while routine activities can be handled by an external partner.
When considering maintenance of the mature portfolio, there is also an opportunity to adopt a more holistic approach to the gamut of activities required to support a product across its lifecycle. These include management of pharmacovigilance activities, such as ongoing adverse event reporting, handling the annual product quality review reports (APQRs), and all the activities needed to maintain a product’s license.
Strategic outsourcing partners foster process innovation, enabling companies to achieve greater efficiencies throughout their operations. They also create opportunities for implementing digital advancements, including automation, artificial intelligence (AI), and cloud solutions, which enhance global collaboration and information sharing.
The combination of regulatory and scientific expertise with advanced technological capabilities provides significant advantages for cost-effectively managing established products. This approach allows critical functions related to safety, regulatory compliance, and quality to be managed cohesively, rather than as isolated tasks, thereby streamlining operations and promoting economies of scale.
Moreover, an integrated strategy supports ongoing improvement and enhanced quality assurance, better positioning companies for future modernisation – a crucial need as health authorities increasingly embrace digital and data-driven methods. For instance, the European Medicines Agency (EMA) and Heads of Medicines Agency (HMA) have released an AI workplan for 2028 focused on the integration of AI in medicine regulation.[2]
Tackling the challenges outsourcing presents
Despite the cost savings and other benefits outsourcing can bring, it is not without its challenges, particularly if there is any misalignment. To mitigate any issues, it’s important to have trust and clear understanding between the pharmaceutical company and its outsourcing partner.
These issues can be alleviated with careful forethought. First, the outsourcing partner needs a clear understanding of how the company works, what its expectations are, as well as full insight into the mature portfolio. One way this can be addressed is by having the outsourcing partner embed programme management team members into the company’s organisation to develop a comprehensive understanding of products and processes. Ongoing collaboration between both parties is also key, including making sure IT functions work together to resolve issues.
Outsourced management of the product portfolio also requires a well-prepared governance structure to manage the communication flow, define key performance indicators (KPIs), and a point of escalation should issues arise. Having a shared project team with a primary contact at the vendor and one at the pharmaceutical company is key to ensuring the requirements and objectives are met. The operation teams carrying out maintenance activities report to that project team and receive guidance from them.
Having a steering committee, with leadership from both organisations, will be key to ensuring the project delivery goals and KPIs are met, and the highest standards maintained.
A holistic outsourcing goal
Outsourcing that leverages the expertise of specialised partners can help companies to reduce costs while enhancing their capacity to respond to the complexities of global markets. Such partnerships can help companies to adopt process innovation through digital capabilities, such as AI and cloud solutions, while freeing their internal resources to focus on new product innovation.
However, successful outsourcing requires careful planning, clear communication, and a robust governance structure to align processes and expectations between partners. Through strategic planning and collaborative outsourcing partnerships, organisations can more effectively manage their mature product portfolios and drive future innovations in drug development.
Disclaimer
The information provided in this article does not constitute legal advice. PharmaLex and its parent Cencora Inc strongly encourage the audience to review available information related to the topics discussed in this article and to rely on their own experience and expertise in making decisions related thereto.
References
[1] Description of differences in CTD M3 (CMC) for MAAs and / or CMC post-approval changes, IFPMA. https://www.ifpma.org/wp-content/uploads/2022/09/20240308_Template-for-Description-of-Differences-1.pdf
[2] Artificial intelligence workplan to guide use of AI in medicines regulation, EMA, Dec 2023. https://www.ema.europa.eu/en/news/artificial-intelligence-workplan-guide-use-ai-medicines-regulation
About the authors
Stefanie Lietsch-Dallwig is senior director, local affiliate services at PharmaLex, a Cencora company. She is an international regulatory affairs professional, fluent in German, English, and French, and has held several senior regulatory affairs positions in the pharmaceutical industry. Her leadership roles have included director regulatory international and emerging markets, head of regulatory intelligence, and director project management. Lietsch-Dallwig brings a demonstrated track record of registration and launch planning for new applications and variations in EU and non-ICH countries.
Paula King, director of regulatory affairs for PharmaLex, a Cencora company, is an experienced programme manager with 20+ years of regulatory, quality, and compliance experience working in a variety of leadership roles including Pfizer, Celgene, and Parexel. She has extensive knowledge of all GxP areas and the ABPI Code of Compliance combined with extensive appreciation of the EU and UK regulatory environments and is trained as an ISO9001 auditor.
