Managing Expectations and Deliverables: A CMO Roundtable - Pharmaceutical Technology

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PharmTech

Latest Issue
PharmTech Europe

Managing Expectations and Deliverables: A CMO Roundtable
Leading CMOs share their experiences with regard to client expectations and performance indicators as well as strategies for adapting to the changing contract-manufacturing environment. This article is part of the 2010 Outsourcing Resources special issue.


Pharmaceutical Technology
Volume 34, pp. s46-s55

Planning for evolving partnerships

PharmTech» Looking ahead five years, how do you see the relationship between contract-service providers and sponsor companies evolving? Has quality by design, for example, affected sponsor expectations?

»Jenkins (Abbott): I definitely see more collaborative planning efforts with more integrated systems. Expectations for companies to have strategic, system-based approaches (e.g., project management, new product introductions, and new business development) are going to be even higher. Additionally, I believe service providers will be expected to have the expertise and ability to handle more specifics (e.g., product development, project management, productplanning, and supply-chain logistics) as sponsor companies downsize and rely on the service provider to handle greater responsibility.

»Dixon (Baxter): In an ever-evolving industry where regulations and standards change regularly, we expect that contract-service relationships will continue to evolve. In particular, we have seen a trend toward tighter, more integrated partnership approaches between clients and their partners. As industry focuses more on core competencies, outsourcing continues to grow as a viable, productive option to mitigate risk, produce cost savings, and explore life-cycle management strategies. Some recent examples demonstrate that service providers are beginning to participate in regular interactions and planning meetings previously reserved for internal staff only. This type of integration helps reduce communication errors, improves understanding, and aligns processes more effectively, which can translate into significantly improved long-term outcomes.

Several pharmaceutical customers are undertaking QbD approaches with their internal manufacturing, and we recognize that aligning our own processes accordingly is a smart approach. We believe QbD will improve our offerings because it dramatically changes the way we approach specifications and the way we monitor product quality. In summation, with the help of technologies and an ever-continually increasing attention to the metrics and quality of our work, we can develop ever-improved partnerships that can lead to great solutions for the healthcare industry.

»Kosko (Pfizer): I envision that the working relationship between suppliers and their customers will continue to grow closer. The opportunity to employ QbD principals during development will enhance process knowledge and process understanding. Experiments and risk-management tools can be used to ensure product quality and further enforce a science and risk-based approach to product and process development. Suppliers are likely to more broadly use process analytical technology (PAT) to control key aspects of their manufacturing process.

When a contract manufacturer applies QbD, it's not unrealistic to consider that real-time release testing approval might also be pursued. Such an approach is a great example of a contractor bringing tremendous value to customers.

»Alberstetter (Vetter): There is a trend toward preventive development approaches in the pharmaceutical industry. From our perspective, customers that have fully implemented QbD are still setting the benchmark at the present time. By the same token, we have noticed an ongoing consolidation process around this topic, and this will presumably lead to the industry adapting to QbD.


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