Elements to consider as the virus continues to spread include: availability of raw materials and alternations in lead times, locations of manufacturing and testing facilities and back-up locations, distribution routes and alternate channels, and most of all, potential impact of a diminished workforce all along the way. It is one thing to have a business continuity plan but another to forecast the demand of supplies in a continually shifting environment. Just within the clinical trial space, trials are exploring to longer terms between clinical visits, use of alternate locations, and virtual patient/doctor interactions. All of which directly impact the supply chain operational plan and forecast.
To support ongoing care, we are beginning to see regulatory collaboration across the different agencies to determine where restrictions might be changed to lower the barriers for import and distribution of medicinal supplies to patients around the world. Now is the time to not only examine your business continuity plan, but also to conduct long term scenario planning based on these variables to better understand what mitigation and action plans you might want to put in place to strengthen your supply chain operations. Now is the time to forecast various scenarios such as longer resupply timelines, limited international distribution channels, and shifts in enrollment or country start-up.
Additionally, you may want to review your risk management plans. One potential mitigation and action is the implementation of Direct to Patient (DTP) logistics. While this is still relatively new within the industry, Direct to Patient logistics has been successfully implemented within the clinical supply chains for years and has been rapidly growing especially with a new focus on virtual trials. The ability to deliver lifesaving medicine directly to a patient is just the patient-centric approach needed at times like today’s current crisis. Direct to Patient allows those with additional health issues to avoid locations where COVID-19 patients may also be present.
Another point to consider, that can often be forgotten, is to ensure your technologies work to support any adaptations of your processes and plans. If implementing changes in distribution channels, temperature profiling or expiry, or virtual trial design, is your ERP and IRT systems setup to adopt these changes? As your workforce moves to becoming remote, are your communication technologies up to par for continued collaboration. As you work with your manufacturing partners do not forget to also partner with your technology providers to help support your adaptive supply chain.
If your company has not yet explored Direct to Patient logistics or lacks the tools or skills needed to develop long term scenario planning, or your workforce is hit by the virus, our communities of practice are here to support you. It’s critical for companies to collaborate and help one another to managing this global crisis together for the sake of our patients and our societies. Especially in these times of changing messages and policies, let’s work together to help collect, verify and make visible the information we all need to know. Feel free to comment here if you are an ISPE member or within the linked-in posting of this blog to ask questions or offer things like what your company is doing to prepare or what you are seeing in different regions of the world. Together, we can help to ensure an uninterrupted supply chain. From our community to yours, please don’t forget selfcare and remember to check in on your colleagues around the world.
Did you catch Part 1, Coronavirus Pandemic: Is Your Supply Chain Continuity Plan Ready?
iSpeak Blog posts provide an opportunity for the dissemination of ideas and opinions on topics impacting the pharmaceutical industry. Ideas and opinions expressed in iSpeak Blog posts are those of the author(s) and publication thereof does not imply endorsement by ISPE.
