PROJECT MANAGEMENT
Over the past decade, the biotech industry has grown in leaps and bounds, and this is a trend that is expected to continue. This is clearly illustrated as the number of biotech companies in the US increased by nearly 20% between 2012 and 2016. Meanwhile, the size of the global biotech market is expected to reach $727.1bn by 2025. Hubs are emerging in new and unexpected areas (such as the “Cellicon Valley” in Philadelphia) allowing for cross-pollination knowledge sharing between scientific communities with similar missions but a different focus. While this has created an extraordinary
environment for the discovery of new technology, it has also produced some concerns: with each new company that emerges, new demand is created at a rate that the industry is struggling to deal with. New and emerging sponsor companies may lack the ability to manufacture on their own and so rely on contract manufacturing organisations (CMOs) for production. Many of these CMOs specialise in the production of niche raw materials, such as plasmids, oligonucleotides, and viral vectors, and are working to meet an ever-growing client base. To confound the issue of production bandwidth, many new therapies in development are autologous (meaning that some portion of the raw materials needed to create a final therapeutic product are specific to the individual receiving the treatment), as is the case for many gene and cell therapies. This means that each batch of material created is unique and that scale-up is not possible, so the production suite and clean-room capacity of manufacturers is occupied by the development of a treatment that will only benefit a single person at a time. It should also be noted that production of
therapeutic products is not the end of the process flow of delivery to a patient. The therapy must
“With each new company that emerges, new demand is created at a rate that the industry is struggling to deal with. New and emerging sponsor companies may lack the ability to
manufacture on their own and so rely on CMOs for production.”
52 | Clinical Trial Supply Handbook
still be analysed to meet specifications for final treatment release. A large portion of the industry relies on third-party labs to complete testing, which creates a cog in the drug-development machine that forms another potential point of delay. Thinking about managing all this can quickly become overwhelming – however, this is the opportunity for project managers to shine by ensuring proper planning is facilitated. It should be noted that studies have been conducted showing a high level of correlation between project planning and project success. For instance, Pinto and Prescott (1988) found that a schedule or plan had a correlation of 0.47 with project success, while detailed technical tasks had a correlation of 0.57 and mission definition a correlation of 0.70. Some strategies to ensure project success via high-calibre planning include: • Performing proactive failure mode and effects analysis (FMEA) to identify potential break points and plans to overcome them. Doing this will ensure that slotting availability at CMOs/CTOs is being utilised in an optimum fashion and that the production or testing errors that can lead to time- consuming repeats are minimised.
• Conducting regular cross-functional team meetings in which forecasting of necessary batch production is discussed. This allows the team to align on a path forward, determine resource allocation and brainstorm risks. Doing so will greatly assist in planning slot allocation with CMOs/CTOs.
• Staying in close contact with the CMO/ CTO. Each organisation involved in the development of treatment should be maintaining a dashboard that is shared on a weekly basis to show progress, next steps and risk at a minimum.
• Having a very thorough understanding of patient forecasting from clinical sites. By maintaining an adequate forecast, project managers can ensure that CMOs/CTOs are being utilised appropriately and are not overproducing (which can lead to expiry of material prior to use) or under-producing (which can lead to stockouts, patients missing treatments and drug holidays).
• Development of an integrated project plan. Ensure that all cross-functional activities are captured in a single place
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