Vetter’s tried-and-true methodology for successful commercial preparedness.
Pharmaceutical companies often face obstacles as they approach their drug product launch. As a result, many choose to engage a Contract Development and Manufacturing Organization (CDMO) as a strategic partner to adequately prepare their unique molecule’s path to market. Though drug customers partner with us at all points in the process, from Phase I through commercialization, market readiness is the time when our support is very valuable. With potential hurdles including supply chain bottlenecks, infrastructure requirements, and knowledge of the marketplace, biotech startups and pharma giants alike rely on the capabilities that Vetter brings.
We bring a proven process that combines our extensive experience with an in-depth product knowledge. By joining forces, the drug developer and Vetter can work together to hone our unique launch management process to meet the individualized needs of the molecule. Driven by a predetermined launch date, supply chain availability and market need, the two teams work as one to achieve commercialization.
Though many drug customers have likely already been working with a CDMO partner like Vetter to get the product to the point of launch readiness, others may choose to begin their partnership at this point. Either way, it is our job as the CDMO to create an iteration of our step-by-step process to bring the drug product to commercialization. Since this is the first chance for the drug developer to turn a profit on their product, it is of the utmost importance that we closely adhere to the predetermined timeline.
First, we must define the launch process and timeline.
Both Vetter and the drug developer will discuss and establish an efficient launch plan that is aligned with the customer’s goals and our capabilities. Since so many departments across the customer and Vetter will be involved throughout the process, it is vital that this timeline created is based on realistic considerations of internal and external factors.
Once a timeline is established, we officially kick off the launch.
At this time, the product is passed off to the commercial team to move it into the launch management process. Several meetings between internal and external stakeholders take place to allow for the utmost transparency. All three of the launch management leads – the project manager, launch manager and customer – must agree on key milestones and goals, and share an understanding of potential risk factors. Now, kick off can be considered complete.
As soon as the kickoff is done, we establish a commercial setup.
A fill and finish partner like Vetter will work with customers to identify the best way for all parties to work together. As progress is made, Vetter and customer will remain in constant communication. As the required infrastructure is set up, we will identify the necessary clean room requirements for the specific molecule.
Then, we manufacture the first commercial batch.
This point in the process shows whether the first commercial fill is successful. It can be assumed that the other necessary steps to reach this milestone have been completed and packaging materials and shipping plans are ready and in place.
The launch management process is now complete.
Once the product has been successfully filled and commercially produced, it can be considered launched, and the project closes. This opens the floor for heightened two-way communication to allow both the customer and Vetter to learn and grow from this process. We help our customers learn how to better get their future drug products to the market, and our customers help us strengthen our launch management processes. Once the project is closed, the commercial team continues with the production of the drug product.
As one of the globally leading CDMOs, this launch management process has succeeded in bringing drug products to commercial readiness time after time. Whether a customer partners with us during Phase I or Phase III, and whether the customer is a biotech or pharma giant or a small startup, this process is equipped to effectively propel new injectables to commercial readiness to support patients around the world.