By Timm Pauli, senior director and head of global regulatory informatics and operations at PharmaLex. Dr. Marie-Charlotte von Brevern, associate director of global program management at PharmaLex.
How to improve efficiency and drive innovation with limited resources
Ongoing lifecycle maintenance of medium or large portfolios puts a tremendous resource strain on pharmaceutical companies. These activities are crucial to keeping your products on the market but can stretch teams thin, making it harder for companies to focus on new product development, line extensions and further global roll-out activities.
At the same time, both product maintenance and product development are becoming more complex. Ever-changing regulations across global markets, specific CMC requirements for special product categories, a move toward innovative clinical approaches (such as decentralized clinical trials, adopting Bayesian models for trial designs, and applying digital tools for electronic patient reported outcomes), and increased digitization of many regulatory processes all require specific expertise that might be unavailable in-house.
Outsourcing can provide needed relief for management in numerous ways. In-house teams can regain time to focus on value-added tasks. Leadership can save on the budget by avoiding costly staffing and technical infrastructure upgrades. External expertise and perspectives can support teams in innovative ways, offering new, more efficient approaches and methods to support product lifecycle activities.
Taking a strategic approach
However, if such outsourcing projects are carried out piecemeal, most of your management and oversight activities will still fall to internal resources. Instead, outsourcing programs that adopt a strategic approach are more likely to give internal teams the support and flexibility they need to focus on new projects. Truly transformational outsourcing should combine operational activities for any product portfolio with state-of-the-art program management and coordination, KPI and reporting measures, as well as ad-hoc support for any additional one-off projects, and would also involve the outsourcing partner taking full responsibility, or ownership, of the program.
Typical reasons mid- to large-sized pharma companies choose to outsource:
- Enable internal resources to focus on value-added, strategic activities
- Reduce complexity for in-house teams
- Foster scalable and flexible resource models
- Quickly connect with a large pool of external expertise in flexible and cost-effective ways
- Gain access to the latest technology solutions without having to make changes to existing on-site infrastructure, saving the company time and money
- More seamlessly manage new technical requirements (based on new or changed technical requirements from health authorities)
- Tap into operational excellence across different therapeutic and functional domains as well as process expertise and technology innovation
A primary consideration for companies is how to achieve cost-effective and flexible portfolio maintenance, while not jeopardizing quality and compliance. There are different ways in which a comprehensive portfolio maintenance outsourcing program can benefit pharmaceutical companies.
The first is that outsourcing allows companies to leverage strategic, expert-driven support to streamline maintenance operations across all regulated functions, both at a central and local affiliate level, all backed up with quality measures, KPIs and reporting tools.
Another reason companies seek outsourcing support is if they need more information about regulatory requirements in certain markets, but lack the in-house expertise on the topic or process. Alternatively, sometimes companies have a workload peak and need short-term support to supplement their internal resources.
Other increasingly important considerations today are that technology solutions are becoming ubiquitous throughout the business and must be regularly updated and improved to keep pace with new developments, requirements and specifications. This has become an even greater priority with the move to advanced technologies, such as automation and natural language processing as companies embrace the digital transformation. What makes the process more complex is that most pharmaceutical systems require appropriate quality management testing and validation, further increasing the administrative burden. Outsourcing the pre-configuration, testing and validation to experts helps companies to stay on top of the digital transformation.
Considered partnerships
Regardless of where you seek to leverage support, when choosing to outsource it’s important to select a partner that will take responsibility for your process or portfolio. After all, your marketed product portfolio is your most valuable intellectual property and the basis of your success. At its best, an outsourcing partnership can provide you with a new level of support and insight. This opens the door for a wide range of opportunities, including:
- Switching your focus to innovation. By removing the burden of handling the regulatory maintenance of your company’s mature product portfolio, your internal team of experts can turn their attention to new products and processes.
- Access to an expert pool of external resources, including specific knowledge around product types, technologies and processes that may not be available in-house. These might include:
- Therapeutic areas
- Technology capabilities, including expertise in implementing, validating and maintaining regulatory solutions such as regulatory information management systems; deep knowledge of new data standards such as Identification of Medicinal Products; as well as experience with leveraging innovative technologies to support operational excellence, such as robot process automation (RPA), natural language processing (NLP) and machine learning.)
- Market access and real-world evidence
- Local or regional regulatory intelligence
- Strategic advice during development, initial filing, and lifecycle maintenance
- Having access to local regulatory support for global maintenance of a mature product portfolio to meet ongoing compliance requirements.
- Expanding local presence by partnering with external staff based in markets where you do not have on-site operations.
- Addressing resource gaps when your in-house team is working at maximum capacity.
- Adopting a cost-effective solution rather than investing in additional full-time specialist staff.
- Reducing technical and administrative burden and alleviating the pressure to keep up with the digital transformation pace by shifting system ownership to outside vendors.
Stay current, stay compliant
The pharmaceutical industry is faced with mounting pressures amid ever-changing requirements around pharmaceutical product development and lifecycle maintenance. As a result, companies must stay current to ensure compliance. This can best be achieved by looking to external partners for support, ensuring workload flexibility for your internal teams and the opportunity to focus on value-adding activities without compromising compliance. It’s important that your outsourcing partner is willing and able to take ownership of the programs or projects they manage. Furthermore, with innovation now intrinsically entwined with technology advancements, any outsourcing partner should have demonstrated expertise with supporting the digital transformation, for example, by helping to streamline processes through automation and by leveraging capabilities such as NLP and RPA to support innovation.
Gaining access to specialist expertise, flexible global work forces and innovative state-of-the-art technology solutions provides long-term value for pharma companies across multiple areas of the business. Strategic, well-considered outsourcing ensures you focus on and build upon innovation; it gives you access to the type of dedicated and specific expertise that you are unlikely to have internally; it allows you to expand into new and emerging markets while ensuring you understand and meet local requirements; it allows you to leverage support during peaks; and it ensures you keep pace with the latest digital developments. Importantly, as the article explores, all these opportunities can be gained through outsourcing based on partnership, collaboration, trust and demonstrated expertise.
