Leadership Perspective: Q: What value does a top pharmaceutical contract manufacturer bring to its customers?
With Keith Kentala, Vice President, Commercial Operations
Q: What value does a top pharmaceutical contract manufacturer bring to its customers?
A: There are many important ways that a contract development and manufacturing organization (CDMO) brings value to its pharmaceutical partners. Perhaps most important is being a driver in moving a product forward, not an anchor that weighs the process down or holds it back.
The outsourcing partner must be able to get the product over the finish line – whether that’s clinical trial batches, development work, or commercial manufacture – in line with the sponsor’s expectations. You don’t ever want the CMC – chemistry, manufacturing, and controls – portion of your regulatory filing to hold up approval of the product. So a clean CMC from the work your CDMO provides is of tremendous value in getting patients the drugs they need on time, as well as contributing to the pharmaceutical company’s overall financial goals.
CDMOs are entrusted with protecting their pharmaceutical partner’s brand reputations. That means CDMOs must have solid reputations themselves for consistently high-quality products and processes, great technology, and expertise. This is most reliably learned through word-of-mouth, and also the CDMO’s regulatory filings and products on the market. Even external recognition, like Life Science Leader’s CMO Leadership Awards, can give some insight. To have a reputable and industry-respected CDMO is of tremendous value. It also helps tremendously when regulators look at your filings; they want to know who’s manufacturing product and can be reassured by the manufacturer’s reputation.
CDMOs add value when they have the resources needed by pharma, so pharma doesn’t have to invest its capital. Does the CDMO have the technologies and equipment necessary for the job? For example, biologics facilities are expensive to construct, so you can preserve your capital for clinical development and trials by outsourcing to a well-equipped, cost-efficient, biologics-capable CDMO.
Similar to the more tangible technology and equipment lists, experience and expertise add value of a softer, but no less important, nature. It’s valuable when a CDMO can save you time, not to mention aggravation, because they have overcome challenges that are similar to one you may be having. Or when it contributes scientific, manufacturing, and business/operational expertise that keeps your project on track.
Value is also derived when a CDMO can deliver what you need, and only what you need, when you need it. We have clients who just need us to manufacture clinical trial batches, but also those who aren’t ready for manufacturing and need development work. We also have clients who transition with us from clinical to commercial manufacturing. Meeting their exact need can be critical to helping clients keep their project budgets and regulatory timelines, on track.
An essential value is the relationship between the CDMO and the pharmaceutical sponsor. How do you know you’re important to the CDMO? How are they are going to prioritize your needs? Certainly the contract between the two parties protects interests, but the relationship is the additive that makes the engagement work well. There is tremendous value when you have confidence in the organizational capabilities and commitment of your CDMO to have a “customer first” mentality. The old adage is certainly true, if you don’t take care of your customers, someone else will.