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PROJECT MANAGEMENT


“CMC project managers have the same goal in mind as all individuals in the pharmaceutical industry: to get safe and effective treatments to patients as soon as possible.”


and clearly define predecessors and dependencies. This is paramount to the ability to manage production.


Now that strategies in which success can be maximised for manufacturing and testing have been outlined, let’s turn to raw material supply chain management. Equally important to having a slot available for production is having the materials available with which to produce. One of the most pronounced impacts that COVID-19 has had on industry in general is a vast decline in production of goods. This is due in large part to factory shutdowns and skilled and unskilled labour shortages resulting from government- mandated quarantines. For many, final treatment production processes, lacking even a single raw material can cause a halt to production, so how can organisations safeguard themselves against this? Some helpful strategies include: • Identification of redundant suppliers. Finding second suppliers of raw materials is critical to ensure seamless production. In many cases, biotechs may find that they are tied to a single supplier for materials such as cell growth media. Every effort should be made to qualify alternatives, regardless of how labour-intensive that process might be.


• Extension of stability profiles. Many materials have short shelf lives (especially when supporting biological processing). Every effort should be made to extend these to the greatest level possible via methods such as freezing. Manufacturers of these compounds have a vested interest in selling as much material as possible, so they don’t always work to maximise shelf life. This opens the door for sponsor companies using the products to conduct freeze-thaw studies and test viability to assess comparability to material that was not previously frozen.


By extending the shelf life of a product, project managers can protect themselves against potential future COVID-19-related production issues by purchasing material in bulk, freezing and storing for future use. Assuming that you have adequately planned slotting and have all the raw materials needed to produce a final treatment product, the last hurdle to overcome is getting it to the patient. Logistics can be among the most challenging issues to deal with, especially if managing a “fresh” product with a very short shelf life, which in some cases can be less than 24 hours. COVID-19 has limited the flight offerings of many commercial airlines, and those that are available are subject to last-minute cancellations. As if domestic logistics were not difficult enough, shipping internationally is even more complicated (especially if you’re shipping into or out of the UK post Brexit). Remembering the fact that the growing number of biotechs is creating insatiable demand, it should be noted that shipping materials (such as validated refrigerated shippers) are becoming increasingly difficult to source. Some logistics mitigation strategies to address these concerns include: • Utilising direct drive rather than flight. Driving eliminates the risk of last-minute cancellations, missing flights and having packages mishandled. Direct drives ensure that control of material is maximised and is a great option for distances between origin and destination that lend to feasibility.


• Expanding robustness of your product via hold-time studies. The more options you have with regard to storage conditions that can be established via hold-time studies, the less risk there will be that you’ll be unable to secure a vessel for transport.


• Proactively scheduling international shipping and discussing regulatory/customs requirements with local officials. Speaking directly to local authorities to determine current regulations and documentation needed can dramatically expedite customs clearance and overall shipping. CMC project managers have the same goal in mind as all individuals in this industry: to get safe and effective treatments to patients as soon as possible. The strategies listed above can help to do so, not only in the wake of COVID-19, but to mitigate any of the challenges that are associated with new drug and treatment development.


Clinical Trial Supply Handbook | 53


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