Coronavirus Pandemic: Is Your Supply Chain Continuity Plan Ready?
Investigational Products North America Team
In April 2010, the Eyjafjallajökull volcano in Iceland erupted for six days, wreaking havoc on air travel and supply chain activities across western and northern Europe for a month. Many companies were caught off guard, resulting in industry-wide recognition of the need to re-evaluate business continuity plans (BCP) to better prepare for threats of this magnitude. Today we are facing a new type of challenge with an undefined period of impact. Many of your companies have already started to engage your BCP and are finding gaps due to the unique level of impact that the virus imposes. As an Industry we are all impacted, and it is a prime time to collaborate and help one another to face this challenge. As such we welcome you to participate in this blog to discuss how you have been working to prepare for this threat.
If you haven’t begun this process here are some things to think about.
Think about where your manufacturing facilities are located, the risks to ongoing manufacturing activities, and impact to the supply chain. Are you prepared for delays? For shortages?
What measures has your company implemented to prevent spread of the virus within the workplace? What is the risk to your supply chain if you were to suffer a sudden loss of workers? Do you have transition plans in place, and good knowledge management practices? Will there be further support to allow workers to work from home either as a preventative measure or if they should be subject to an extended quarantine period? Do you have a pandemic business continuity plan? Have you identified which critical personnel will be needed on campus and who can function off campus? Does your company have the necessary protective materials (e.g., N95 respirators) in place?
How are your distribution plans prepared for disruptions and delays as border crossings become bottlenecks or distribution channels begin to shut down? Do you support direct-to-patient distribution if subjects cannot get to sites? If so, what do you do to ensure quality and integrity of the clinical supply during transit, as well as patient privacy, and patient compliance? How will you support ongoing patient care? Has your company considered Direct-to-Patient so you can be able to supply critical patients with timely investigation products? This is the time to ensure your company and your domestic and international carriers are working closely together to ensure critical IP can be delivered to the most critical patients.
Clinical Trial planning
Will trials still be started as planned? Go to the same countries? Will the trials continue to enroll as planned given high risk to subject participation and willingness to go to clinics? Will the visit schedule be altered to lessen the need to visit a clinic? Will the comparator agent stay the same or need to change due to supply chain disruptions?
What best practices is your company putting into place as you prepare for a potential pandemic?
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