Planning for evolving partnerships
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?
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.
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.
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
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.
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.