Getting a first drug product approved is an exciting, promising milestone in an emerging biopharma company launching its first product, but you need to successfully get the therapy to patients for real success.
A biopharma company’s supply chain team is often the unsung heroes of commercialization – when everything goes as planned, that is. This means making sure the right quantities are safely and reliably in channel after approval, so the company can operate as a viable commercial entity.
Simple, right? Not at all. The supply chain involves multiple functions that likely have not had to collaborate before on a topic as complex and nuanced as a biopharmaceutical supply chain.
The Product Journey, or path to patient, originates with the raw materials and drug substance that is converted into the drug product and then packaged and labeled as a finished good. We refer to this as the upstream supply chain (see diagram below) which is led by Technical Operations. The manufacturing process is as complex as today’s innovative therapies demand but amplified by extensive reliance on many third parties to manufacture, test, and package the finished goods. The process integration, coordination, and intense amount of problem-solving required can be daunting.
Next, the product enters the downstream supply chain which is led by Commercial’s Trade and Distribution function. It begins with a third-party logistics (3PL) partner who executes the order-to-cash process. From the 3PL, the product enters a myriad of distribution options that need to be configured to address the unique combination of product, prescriber, payer, pharmacy, provider, and patient characteristics that must be resolved to address unmet needs and achieve commercial success.
We’ve found that clients who are contemplating commercialization of their first product want to know emerging best practices, what they may be missing, and how to get in front of challenges. We work with a range of stakeholders. Most often, Chief Commercial Officers who are accountable for commercial performance that depends on product in channel, and Supply Chain leaders who are accountable for successful planning and execution of the processes that deliver product in channel.
Problems can arise in the upstream and downstream supply chain as well as when stakeholders from functional groups need to collaborate. We recognize 3 common themes that are the root cause of supply chain challenges – these are preventable issues that can mean a major interruption in a newly approved product’s path-to-patient.
Learn how we helped this emerging life science company with launch demand and supply planning.
Each of these themes presents challenges and risks to a successful (and what should be exciting!) commercialization journey.
This is the first of a series of posts on this topic that will explore each of these three problems, and the ways we avoid the risks they present using effective solutions. Subscribe on the right-hand side of this page to be notified when we post. We’re happy to share what we know and have learned – contact us if you have a specific question.
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