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6 Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 P h a r mTe c h . c o m and optimize processes, the traditional 'lift and shift' model that long prevailed has become unsustainable. Rather, phar- maceutical companies are reconsidering an outsourcing model where partners are more seamlessly integrated into the internal structure so that oversight of the product port- folio is strategically and centrally managed. Not only does this integrated model bring greater efficiency, it also takes advantage of the huge experience outsourcers have gained from 40 years of specializing in their fields. The priority with the new wave of outsourcing is the maintenance and strategic management of por tfolios within the organization to ensure regulatory compliance and reduce risk—while still managing cost constraints. This requires innovative approaches, particularly given the com- plex regulatory demands across markets. By tapping into the expertise, knowledge, and innova- tion acquired over many years, outsourcing organizations can deliver pharma companies new efficiencies through modernized processes, collaborative approaches, a deep- seated knowledge of the changing regulatory environment, and an understanding of how to leverage technology for the best outcomes. Such organizations also bring industry best practices and standards gained from working with many different clients, which in turn leads to greater in- novation and efficiency. Where this integrated, innovative, and strategic outsourc- ing model truly comes to the fore is with supporting mature pharmaceutical products in global markets. This is where a blended approach helps to streamline maintenance oper- ations across all regulated functions, both at a central and local affiliate level. A mature—and valuable—pipeline Innovation is at the heart of pharmaceutical R&D as com- panies seek to develop new therapies for patients in need. At the same time, however, mature products remain essential to companies for both financial and reputational reasons. Mature products are those that are still sold in substantial volumes because of their well-established effectiveness and safety profiles. They are also an important basis for a com- pany's reputation, both with the public and healthcare pro- fessionals. For example, Genentech's reputation as an oncol- ogy leader was established with products such as Herceptin, while AbbVie is a respected leader in rheumatoid arthritis through its blockbuster Humira. Going further back, Bayer established itself as a leader in pain relief and stroke preven- tion with its widely used product Aspirin. As products mature, pressure to sustain revenue while keeping maintenance costs low intensifies. Yet, the activ- ities involved in maintaining mature products are exten- sive—from performing pharmacovigilance activities to maintaining regulator y dossiers and labels to conduct- ing ongoing benefit–risk analyses to maintain licenses. Companies must comply with ever changing regulatory requirements to avoid critical actions from the healthcare authorities and the enormous cost this implies, both finan- cially and to a company's reputation. Making matters more complex, regulatory authorities in various markets and re- gions often have differing expectations, while emerging countries tend to develop their own health authority sys- tems, often implementing new or additional requirements that need to be followed. To meet these complex requirements while minimizing costs, marketing authorization holders (MAHs) need to assess their existing operating models for maintaining ma- ture products and consider how they can benefit from an integrated safety, quality, and regulatory model available through trusted third-party partners that can provide tai- lored services as and where required—locally, from teams of experts in mature markets and by leveraging near- and offshore capabilities, particularly for routine functions. Not only does this approach make sense for safeguard- ing mature products, it also allows companies to focus on new innovations and other strategic business. In addition, companies will also have on-hand access to a large pool of external specialist expertise and knowledge of the industry, which may be limited in-house. To determine the right outsourcing approach, MAHs should first consider their geographic markets and target markets to determine whether they have the necessary re- sources to manage mature products in those regions. Even if there are teams in place in those markets, do they have capacity to manage mature products as well as support new launches or does it make more sense to leverage the local expertise that a partner can provide as part of a tailored outsourcing model? The same question should also be asked on a global level, where companies often have resource constraints so bringing in an external global strategist to oversee maintenance of the mature portfolio allows internal employees to focus their attention on new developments. Companies need to decide where best to focus internal re- sources and whether having internal teams spend their time maintaining mature products makes strategic sense. Mature outsourcing models Managing established products can be even more challeng- ing given the varied organizational structures and limited internal local market resources that many companies are working with. For example, it would not be unusual for large pharmaceutical companies to have 100 or more operating companies or affiliates worldwide. Many of these affiliates will have small offices—some with only one full-time staff member to manage all regulatory activities. Company head- quarters face similar constraints, with limited resources and a need to focus on products under development. To allow these affiliates to focus on core activities—in- cluding helping to launch innovative new products to mar- ket—pharmaceutical companies need to consider tailored models that introduce greater efficiencies to lift the bur- den local affiliates face. They need a f lexible and strategic Outsourcing Services