APR Nov/Dec 2022 - 11

« INSIDER INSIGHT
biosimilars, as well as cell and gene therapies. Concurrently, we face
the challenges of engaging new strategic and tactical approaches
such as outsourcing a significant percentage of manufacturing to third
parties. These evolving strategies demand a higher level of decisionmaking
acumen and critical thinking skills to ensure the quality of
what the public receives.
The Training and Education Gap
is Growing
All of us working in this industry consider ourselves to be experts; but
how does our preparation compare to other groups of professionals? In
the pharmaceutical industry, training remains focused on developing
the individual's ability to properly execute a discrete task. This focus
is a vestige of 19th century norms and schema. We develop skills
through apprenticeship - work with more experienced experts who
then teach skills in return for the apprentice's labor.
The explosive growth of biopharmaceuticals and advanced therapies
has brought with it the possibility of a world changing future for
personalized medicine and disease treatment. However, this same
mind-blowing opportunity has also created a massive gap between
existing and needed talent. Our industry may face a catastrophic
shortage of workers who possess the skills needed for advanced
therapy manufacturing.
Further compromising the existing training model is that these
rapidly developing technologies result in a lack of skilled or
experienced leaders/mentors to teach new workers. The lack of these
leader/mentors is exacerbated in this space because technicians'
manipulations require not only the physical capability to execute
the process but the ability to make critical decisions when issues are
encountered. Any new learning and development frameworks must
engage the metacognitive, kinesthetic, and academic specifics which
are unique to these novel manufacturing methodologies. We must
devise teaching and learning structures which deal with the short and
long term needs of the industry.
The industry is responding to these needs by creating innovative,
pliable, tech-forward training and education tools which include
immersive simulation based, virtual and augmented reality. The best
of these tools includes both education in the concepts underlying
the process and the ability to practice in a risk-free environment.
This shift is proving effective in training the technicians who execute
the work because of the inherent, learner centered benefits of these
personalized learning platforms
Some early efforts which utilize automation and artificial intelligence
are also focusing on the gap at the worker level. What remains,
however, is a huge gap in the expertise of the leaders and experts who
design and maintain the processes, equipment and facilities needed
to meet complex global regulatory requirements. Those charged with
ensuring that the products produced consistently meet the standards
for safety, purity, and effectiveness.
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APR Nov/Dec 2022

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