Building a commercial supply chain to launch a new product is always a high-wire act. Supply Chain leaders must balance preparing the supply network and launch materials with the uncertainties of clinical development and regulatory progress. In addition, they must manage the risks of commercial uptake and demand. These challenges hold true whether you are launching your first commercial product or have launched others in the past.
Just as products, therapeutic areas and distribution channels vary between launches, so do the characteristics of their underlying supply chains. This is especially true with the rise of patient outcomes-focused supply chains. These drive the need for high-touch services and patient logistics down to the last mile.
Life sciences executives discussed four important and pervasive trends in commercial supply chain launch preparation at one of our recent events. These trends are impacting launches throughout the life sciences industry.
#1 – Ultra-Lean Supply Chain Teams
Working with limited resources is fairly standard for emerging life science companies. However, we are seeing more companies push further with ultra-lean launches. They rely on only 1-2 internal employees who are responsible for managing all commercial manufacturing and supply activities.
These situations limit visibility across supply chain, CMC, manufacturing, and QA. Even experienced managers struggle to cover the entire network effectively. Outsourcing parts of the process helps, but it also requires the need for experienced project management. In addition, it introduces challenges for capturing and retaining critical knowledge within the organization.
How to Do It Well
Target your internal resources, so that you can strategically outsource key areas. Ex./ Focus internal resources on existing commercial and clinical supply operations and then use commercial launch-experienced external supply chain support. They can assist with assessing/creating your commercial supply and manufacturing launch strategy and roadmap, as well as execute on commercial buildout activities.
Clearly define and set expectations for what can and will take place before launch. While an ultra-lean team can establish the supply chain to launch, it is often necessary to align the organization on what will be included. Ex./ Additional SKUs, dosage forms, or commercial samples may be brought to market within the first year after launch instead.
#2 – Multiple Launches in Rapid Succession
More companies are planning multiple launches within one year of each other. Converge is seeing this particularly for scenarios where the same or similar molecule is developed for different indications. The intent is typically to first launch the drug in a smaller indication as a “dress rehearsal.” This way you build and test the supply chain in advance of launching the larger indication.
Unfortunately, supply chains often wind up different for each indication. The development and regulatory processes are highly variable, so things rarely go according to companies’ initial, well-laid plans.
How to Do It Well
Contingency planning is critical. Do scenario planning and ask “what ifs” early on as part of your risk management strategy. What factors may cause delay? What contingencies can you plan for? You can always bring in outside consulting support that has this expertise.
Identify signposts with your Commercial and Finance teams. Agree in advance on what conditions will trigger the move to an alternate/contingency plan.
#3 – High-Touch Supply Chains
There is an increasing focus on using the supply chain to improve patient outcomes. Companies are tasking the supply chains leaders with reaching physicians and patients in new ways, including non-traditional treatment settings. These high-touch models require that companies must maintain product integrity all the way to the physician and sometimes to the patient.
Preparing your patient outcomes-focused supply chain may require new and innovative efforts. For example, you may bundle in ancillary materials, information or even services to support patient onboarding and adherence.
How to Do It Well
Adopt a “patient-back” approach to supply chain design. Partner early with your Commercial and Medical teams to understand the requirements for patient treatment and improved outcomes. Exercise your influence to include supply chain requirements and opportunities as decisions are made. As Vin Kosewski, SVP Manufacturing and Supply Chain Management at Kala Pharmaceuticals said at our recent event, “The most successful supply chain leaders are masters of orchestration.”
#4 – Development of Combination Products
Companies are developing more therapeutics with convenience devices or precision-targeting with companion diagnostics as part of the patient outcomes focus. These combinations introduce additional variability and dependencies in development and planning. They affect supply chain buildout. Teams must consider both drug and device/diagnostic development, which are guided under different regulatory frameworks.
How to Do It Well
Deal with device development early. Don’t treat delivery device development as an afterthought. Interdependencies can be managed, and supply chains can stay aligned.
For supply chain leaders in innovative biotech and pharma companies, the days of filling pills into bottles and shipping to wholesalers are fading. You will likely encounter at least one of these more challenging scenarios on an upcoming commercial product launch. They are becoming common for commercial supply chain launch preparation.
When done well, supply chain has the means to help ensure a successful launch. It accelerates topline revenue growth and supports a clear focus on patient outcomes.
To dive deeper on any of these trends, contact me at email@example.com. You can also join Converge’s Supply Chain Working Group to share more best practices and network with your supply chain peers.