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Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 11 Capabilities and limitations should be laid out early in the project discussion. This would help avoid any promises that cannot be delivered. Decide on a timeline. Companies should work with custom- ers on a project timeline that can be delivered upon. Since out- sourcing buffer management is a part of complex biopharma processes, it is essential that all outsourced services meet the customers' critical timeline. If the project timeline cannot be met, always communicate early to find alternative solutions or paths. Zehe (Sartorius): Be flexible and customer focused. In addition to good technologies, service providers also require a high level of flexibility and customer focus to overcome the mani- fold challenges related to biologics development. This includes tailor-made development approaches, short lead and response times, the possibility to stop or change work packages (also on short notice), clear and efficient communication (ideally single point of contact), and flexible business models. Establish and apply platform technologies. Well-developed and efficient technologies are the basis to provide cost-effec- tive services and fulfil the steadily increasing demands with respect to timelines, yields, scalability, and product quality. Furthermore, good platforms ensure regulatory compliance and a high project success rate. Provide complete solutions. Single-vendor/one-stop-shop approaches comprising the full spectrum of cell-line devel- opment, cell-culture media, cell banking, analytical, and bio- safety testing services provide big advantages, such as higher success rates, shorter timelines, and simplified project man- agement and communication. Filosa (PerkinElmer): Know the client's needs. Understand ex- actly what your client's needs are so that you can meet them in the smartest ways. Find solutions for multiple critical needs. Once needs are identified, create a solution that solves multiple critical needs (vs. only one or stove-piped issues). Creating an improved overall workflow will benefit both sides of the collaboration. Think long-term. Good outsourcing is about creating op- timal solutions and long-term, trusted relationships. Part of this can mean saying no sometimes and being f lexible in creating new directions together. This really looks out for a client's best interests. The partnership becomes stronger when you create opportunities for acceleration and improvement of the workflow. PTE What should companies looking to outsource know prior to selecting vendors and partners? Top of mind should be understanding that the partner relationship is long term and so is the horizon for cost savings. Outsourcing does bring efficiency gains, but these can't be realized overnight, and time needs to be allowed for the transition of ownership from the company to the partner. This is a good opportunity to test, learn, and ex- pand on lessons learned. Adopting an integrated product model—incorporating regulatory, quality, safety, and risk management—with a f lexible structure can promote innovation and continual improvement and strengthen quality assurance (Figure 1). Optimal outsourcing in a changing world The next frontier of outsourcing should bring the kinds of benefits that a simple 'lift and shift' would not enable. While it's still about lowering maintenance costs, this is achieved through effective and blended integration of key activities such as regulatory, quality, safety, and risk management through a single programme supported by one trusted part- ner who takes ownership of the entire process rather than having critical tasks exclusively managed offshore. Access to specialist expertise that is unlikely to be found internally and the ability to tap into innovative technol- ogy advances, such as automation, provide long-term value across multiple areas of the business. Process best practices also allow companies to benefit from repeatable capabili- ties, which reduces the time and cost involved in managing regulatory documents. Next-frontier outsourcing models, focused on the maintenance and strategic management of portfolios, are less function and more task oriented, which facilitates collaboration across functions, locations, and regions, enabling companies to respond faster as priorities change and evolve. And while advanced technologies, such as automation, are increasingly a priority to respond to changing reg- ulatory requirements while improving processes, most pharmaceutical systems require appropriate quality man- agement testing and validation, further increasing the administrative burden. A tailored approach to outsourc- ing, one in which the partner brings cross-functional ex- pertise and a commitment to process innovation, helps companies to stay on top of the digital transformation without signif icant investments in infrastructure. Fur- thermore, it lets in-house teams focus on innovation and va lue-added activ ities, a llows companies to avoid t he heav y costs of additiona l staf f ing and technolog y up- grades, and gives the organization access to external per- spectives that offer innovative, efficient ways to support the lifecycle of mature products. References 1. P. Ledesma, "Top Clinical Research Organizations (CROs) in the United States," Sofpromed, Article, 6 Jan. 2020. 2. Congressional Budget Office, Research and Development in the Pharmaceutical Industry, Report (April 2021). PTE Outsourcing Services — Contin. from page 7