OR WAIT null SECS
Industry experts share their top outsourcing tips from both the perspective of companies offering outsourcing services as well as for companies looking to outsource.
In the modern bio/pharmaceutical industry, countless services are outsourced, including manufacturing, process development, scale-up, regulatory compliance assistance, analytical services, software and cloud services, and much more. But what should companies looking to outsource know prior to selecting vendors and partners? In addition, what should the companies that are outsourcing services be aware of?
Pharmaceutical Technology interviewed David Heiger, associate VP, Agilent CrossLab Group; Nandu Deorkar, vice president of R&D production, Avantor; Sébastien Ribault, vice president and head of end-to-end solutions, Life Science business of Merck KGaA, Darmstadt, Germany; Angelo Filosa, PhD, portfolio director, professional and technology services OneSource, PerkinElmer; and Christoph Zehe, research fellow, advanced cell biology, Sartorius Corporate Research, on what outsourcing partners wish you knew.
PharmTech: What are your top recommendations for companies offering outsourcing services?
Filosa (PerkinElmer): Clearly define what you want to outsource and why. Classify activities as core to your work and non-core and then identify partners that have expertise in the non-core activities that are a strategic aspect to how you run your business so your internal team can focus on the science you are advancing.
Decide whether to insource or outsource. Once you have identified the non-core activities, then you need to decide whether they are outsourced or insourced and what needs to be supported on-site or can be done remotely. Certain activities are non-core but still must be done onsite for various reasons. This process is part of defining your outsourcing strategy and identifying the correct partners.
Determine if a vendor can grow with you. Make sure to properly evaluate vendors and understand their expertise and how they can grow with you as you evolve your outsourcing 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 outsourcing. 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 influenced 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 selecting 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 understands 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 committed 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 product portfolio. It is important to keep the whole drug development process in view. A good partner should not only offer individual isolated services but provide more holistic support … Such complete solutions ensure higher success rates, shorter timelines, and simplified project management and communication.
PharmTech: What are your top recommendations for companies seeking 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 outsourcing 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 manufacturing organization (CDMO). They want more transparency in their molecule’s complex development and manufacturing process. A key element in creating transparency is communication, and excellent partners should also be excellent communicators. 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 scientific 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 customers’ process/product requirements and application needs to deliver the service that would exceed customers’ expectations.
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 customers on a project timeline that can be delivered upon. Since outsourcing 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 manifold 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-effective services and fulfill 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 development, cell-culture media, cell banking, analytical, and biosafety testing services provide big advantages, such as higher success rates, shorter timelines, and simplified project management and communication.
Filosa (PerkinElmer): Know the client’s needs. Understand exactly 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 optimal solutions and long-term, trusted relationships. Part of this can mean saying no sometimes and being flexible 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.
Meg Rivers is a senior editor for Pharmaceutical Technology, Pharmaceutical Technology Europe, and BioPharm International.
Bio/Pharma Outsourcing Innovation 2022: February 2022
When referring to this article, please cite it as M. Rivers, “What Outsourcing Partners Wish You Knew," Bio/Pharma Outsourcing Innovation 2022, Supplement to Pharmaceutical Technology (February 2022).