Therapy commercialization: Navigating the path from innovation to impact

Imagine your team has poured time, expertise, and resources into developing a therapy that has the power to transform lives. Now, what comes next? After all that hard work and dedication, how do you get your product into the hands of the patients who need it most? The answer: a long, complex commercialization process.

From early planning and development to post-launch execution, each small step forward can make all the difference in whether a product thrives or struggles in today’s competitive healthcare landscape. Fortunately, a process that can feel like an overwhelming to-do list becomes much easier with a partner who can help you make thoughtful, strategic decisions along the way.

While every therapy’s journey from innovation to impact is unique, each of the Cencora solutions showcased in the following genuine, multi-year engagement helped one of our customers and their therapy on the road to commercial success. This will give you a glimpse into what it takes to bring a new product to market and how Cencora can provide hands-on support.

• Cencora created a strategic market access plan that encompassed a global systematic literature review (SLR) and financial analysis (FA) for the United States and EU-5 (European Union 5: Germany, France, Spain, Italy, and the UK) markets
• Provided local regulatory launch requirements for Germany and the United Kingdom (UK), as they had been selected as the initial European launch markets
• Provisioned an outsourced EU Qualified Person for Pharmacovigilance (QPPV) and deputy and built out a global pharmacovigilance system
• Supported the client during responses to questions from health authorities 
• Assigned a designated global product launch lead to the project to oversee the launch and the Cencora business units in their coordinated delivery of services
• Fully developed the client’s global quality management system (QMS) to support their role as a Marketing Authorization Holder (MAH)
• Finalized the client’s Pharmacovigilance System Master File (PSMF) and helped them fill the mandatory roles for pharmacovigilance at the local level
• Established the client in the EudraVigilance, a pan-European patient safety monitoring system
• Prepared and submitted the Market Access dossiers for both the UK and Germany and began pricing discussion at the local level

• Commenced local pharmacovigilance services (LPVS) with in-market, outsourced professionals, standard operating procedures creation, and client training
• Created all the MAH quality management and compliance standard operating procedures
• Provisioned an outsourced Information Officer (IO) for Germany
• Registered for serialization at the EU and national levels
• Coordinated with local health authorities to submit documentation and obtain approvals for educational materials
• Provisioned an outsourced field-based formulary team in the UK
• Operationalized  launch readiness
• Onboarded the client with Alloga and World Courier, parts of Cencora, to bring the client’s product from the United States into Europe and distribute it across the continent
• Onboarded the client with EU Qualified Person (QP) batch release services alongside system set-up completion at Alloga
  
   

• Cencora’s global consulting services began making final preparations for the client’s product launch
• Completed launch notifications preparations to local health authorities
• Created and executed the required quality technical agreements (QTA)
• Implemented the QMS
• Developed the Site Master Files for the client
• Prepared the first Periodic Safety Update Report, a statutory requirement of the MAH to report any safety issues to health authorities regularly
• WorldCourier completed the client's Transport Study, ensuring lane validation for the client's product route from the United States to Europe

• Alloga completed all warehousing and process setups to handle the product and ensure order-to-Cash systems were ready with end customers validated
• Provisioned an outsourced field-based medical science liaison (MSL) and key account manager (KAM) teams to support the market launch rollout
• Managed the close-out of market access activities and finalization of pricing approvals 
• Officially launched in Germany and UK
• Verified all launch markets went live in the pharmacovigilance system
• Achieved full implementation of the QMS for MAH responsibilities, including an outsourced resource to assist with quality program reports (QPR)
• Began active distribution of promotional and non-promotional materials to the markets
• The Cencora Commercialization Team provided ongoing hypercare post-launch

• Distribution centers received their first inbound delivery of the client’s new commercial product
• Completed Qualified Person batch release activities and certified the stock as compliant
• Transferred title from the client to Cencora
• Shipped the first commercial stock of the client’s new product to wholesalers and hospitals in the launch markets
• The first patient was treated with the client’s new product