Pharmaceutical Technology Europe- February 2022

Pharmaceutical Technology Europe February 2022

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10 Pharmaceutical Technology Europe BIO/PHARMA OUTSOURCING INNOVATION eBOOK 2022 P h a r mTe c h . c o m strategy. You might look at one service today, but [you will] likely expand the scope in the future; so, it's important that the provider can grow with you. Ribault (Life Science business of Merck KGaA, Darmstadt, Germany): Determine the end goal and assess the team. It is important for companies looking to outsource to define their end goal and determine their key experts and resources to reach that goal. Develop a step-by-step strategy. By defining a step-by-step strategy early in the development process in alignment with quality and regulatory requirements, companies looking to outsource can foresee potential risks and challenges before they arise and help determine the best course of action to help mitigate these risks. Heiger (Agilent): Think 'core vs. context.' If what you require is absolutely core to your business, be cautious about out- sourcing. But don't build what you can buy. It's important to distinguish between the 'core' and the 'context' from the outset. If something is core to your business, then it might be more cost-effective, efficient, and reliable to think about sourcing this yourself. Part of deciding whether to outsource will be inf luenced by your timeframe—are you looking for a short-, medium-, or long-term solution? This way you can determine whether it's worth making a large investment up front to handle the operation in-house. If it's something that is readily available and other suppliers have years of skill in that area, then outsourcing is the right option. Think through your business objectives to ensure you are select- ing an appropriate partner or vendor for the long term. Take the time to remind yourself of what you are trying to achieve in the first place and how these relate to your core business objectives. Having transparent conversations to ensure your vendor under- stands your objectives can give you a good head start. The last thing you want is to be tied into a contract if it's wrong for your core business objectives. These objectives can be aligned with a broader vision for your business and brand. For example, you may want to partner with a vendor with similar commitments to sustainability to make your business greener. If you are com- mitted to offering your customers highly innovative solutions, you'll need to ensure your vendor is continuing to invest in the latest technologies the market has to offer. Deorkar (Avantor): Companies need to look beyond just unit cost. To provide total value, a service provider's capabilities should be understood. Like choosing a contractor, companies shouldn't make a decision based on the cost alone. They need to make sure that the service provider can meet their needs to complete the project. Expectations should be clearly communicated to the service providers as early as possible. The project requirements change over the progression of the project. Open dialogue with your service provider on any changes sooner than later would help to overcome potential delays. Zehe (Sartorius): Choose a provider with proven performance and expertise … The capabilities and experience should be proven by a track record, which gives insight into the number of successful projects, experiences with different product types (antibodies, complex molecules, etc.), and regulatory acceptance (projects that have reached clinical phases, market approval, etc.). Choose a provider offering a comprehensive service and prod- uct portfolio. It is important to keep the whole drug development process in view. A good partner should not only offer individ- ual isolated services but provide more holistic support … Such complete solutions ensure higher success rates, shorter timelines, and simplified project management and communication. What companies outsourcing should know PTE: What are your top recommendations for companies seek- ing outsourcing partners? Heiger (Agilent): Do what you do best. Stay close to your core competencies and ensure a best-in-case experience for your clients. Consider reviewing where your team is spread too thin and not able to support what is key to your business. Look at out- sourcing as a way of taking care of operations. This is important because business can be a stressful, high-paced environment, and handing over operations to a service provider can really help to focus the team. Ribault (Life Science business of Merck KGaA, Darmstadt, Germany): Be transparent. The customer's molecule is often 'the life of their company'; so, they place a significant amount of trust when handing it off to a contract development and manufac- turing organization (CDMO). They want more transparency in their molecule's complex development and manufacturing process. A key element in creating transparency is communi- cation, and excellent partners should also be excellent com- municators. This includes access to its experts when urgent matters come up, as they will. Become technically excellent. A key element in the outsourcing relationship is relying on your partner to possess distinct scien- tific insight and expertise for your molecule's unique journey. Be flexible. A good partner should be flexible to help meet their customer's needs so that they are successful in achieving their milestones. Having the right capabilities, capacity, and scale to meet the client wherever they are in their molecule's journey, when and where it is needed, is critical. It sounds pretty straightforward, but many CDMOs today don't have enough capacity or capabilities to meet their customers' timelines. Deorkar (Avantor): Listen to customers. Outsourcing companies need to spend more time listening to their customers rather than trying to make sales pitches. It's critical to understand cus- tomers' process/product requirements and application needs to deliver the service that would exceed customers' expectations. Understanding what your company does best, current workload, and manpower should all be considered.

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