Developing Competency in the Advanced Therapy Medicinal Products (ATMP) sector - Part 1

Authors: Robert Hanna (Learning & Development Expert, GreenAscot Technologies), Craig Hasilo (Chief Scientific Officer - CellCAN)

Part 1 of 4 - Insights into the evolution of training as a source of competitive advantage.

Groundbreaking advances in the ATMP sector are revolutionizing treatment options for old ailments and rare diseases almost daily. Operators and technicians are in short supply and need to master current competencies and develop new ones regularly to keep up with the evolving field.

Yet, the methods employed to develop competency in this rapidly evolving sector are lagging and risk limiting the productivity and growth potential of the whole sector. Organisations manufacturing ATMP must incorporate new learning methods and technology to advance and remain competitive.

Competency has the potential to multiply the effects of both good and bad practices among production team members whether the process is designed with a machine as the nexus or a human.

Competency is a measure of the consistency with which a person can successfully execute a task. That execution draws on the knowledge, experience, abilities, and skills of the individual, and it is their combination around a process that delivers superior performance.

Indeed, many of the technologies and processes employed in current production lines are designed to mitigate the inconsistency of their human operators, and simultaneously reduce the qualifications necessary for scale-up production. So why not automate production 100%? Interestingly, it is because only a human can intervene and render the decisions that ensure quality and consistency at crucial moments in the process.

Fundamental challenges

The ATMP sector must continually balance the needs of innovation and consistency. While innovation can make variable progress in the laboratory from the moment a discovery is made, it takes a substantial effort to complete a technology transfer to the production environment and commercialise the product. Starting with clinical trials and required studies, a substantial amount of time and an available pool of Highly Qualified Personnel (HQP) is required to execute properly. It is in the technology transfer and commercial production processes that competency development starts to have a major impact on the project’s viability.

There are several challenges to address in the transition from product R&D to production process, whether for clinical trial or commercial distribution. Organisational culture and objectives in R&D labs are very different from production environment, as are the qualification levels of staff, the equipment used, and crucially, the process; indeed, the process is the product. R&D labs often do not follow Good Laboratory Practices (GLP), and even fewer so Good Manufacturing Practices (GMP)¹.

Adapting to the rigour of GMP standards is one of the first hurdles a product faces on to the road to commercialisation. Along with modifications to the production process, the effects of the differences in the final expected outcomes between discovery and scale-up production cannot be understated. Technology transfer creates its own set of requirements. Those who created the product and have the deep knowledge of its development requirements are now challenged with translating this into manufacturing steps².

This is an environment with which they do not have daily familiarity; for example, room design, work and airflow, qualified reagents, quality management systems (QMS), and the need for HQPs in terms of both competency and team ability³. Where R&D is unconstrained and welcomes serendipity, GMP production is rigorously controlled and documented, and does not allow for surprises.

Current practice

Performance-driven organisations use many tools to train their people, encourage knowledge sharing, and allow them to develop understanding that can be applied to their work. Traditional approaches and technologies are unlikely to go out of fashion as they are intuitive, and the purpose of using them is often as much for learning as for team building. The opportunity to supplement them presents itself.

In the recent decades, we have seen an explosion of e-learning in many sectors with variable results as organisations were enticed by the promise of lower costs and the scheduling flexibility they can offer. In the ATMP sector, e-learning modules have been used for general and basic training. Routine qualifications and re-certifications are currently executed with hands-on methods, most likely in-house by the employer’s own staff.

Given the hands-on and highly regulated nature of GMP environments, conservative training practices prevail in ATMP manufacturing. When employees join a company, the foundation of their training is often rushed in meeting settings with the occasional laboratory walk-through, minimised to respect GMP regulations.

Ideally, an increased proportion of their learning could be done through on-the-job coaching on the local processes and methods. The GMP requirement for documented qualification testing renders this approach inefficient for basic tasks like handwashing and gowning; it is nonetheless the bridge between theory/instructional training and on-the-job training. Indeed, if the most important practical training could be delivered during live production runs, this would give the new learner a completely immersive learning experience. GMP rules limit this, so it is the learning team’s job to emulate this most closely, guiding learning rather than training, acting as a resource in self-directed learning, and importantly providing them with the opportunity for hands-on practice in mock settings.

There are justifications for traditional approaches in ATMPs:

• Production lines are unique in terms of people and equipment, complicating standardisation, and driving up the cost of both validation and training costs.
• De-risking training outcomes is a main concern. Organisations struggle to get their people enough hands-on training to move into production environments with confidence.
• Training ability is not central to the role ATMP employees on the production floor were hired for. They are often not equipped with the competencies or tools to effectively train colleagues; therefore, they rely on the tools they are familiar with yet bring new practices in other areas into their work regularly.
• Selection bias also plays a role in defining which training methods are employed. The methods that worked for and are understood by the current generation must be adapted for the next.
• Change control entails the (re-)training of the impacted staff members when the production process is adjusted. This favours simpler training media such as PowerPoint that can be quickly updated to ensure alignment with the QMS. GMP requirements make the timely alignment of training to production practices essential.⁴

On-the-job training in a GMP environment has several benefits – the training demonstrates actual practice rather than presenting theories and analogous practice alone: It also requires the trainer be a demonstrated expert and further satisfies regulatory requirements for GMP training. But does on-the-job training remain the most effective way of dealing with these concerns?

Addressing risk

The complexity of ATMP production and the need for consistency and precision makes training an essential part of any operation. Furthermore, since many procedures on a production line may be relatively new, the pool of experienced HQPs is often small at the start.

To de-risk operations, it is essential to offload as much learning as possible from the actual production line employees.

Due the uniqueness of production lines, their intellectual property, and the investment required to build a GMP production line, much of the current training is also done during actual production via a colleague, deliberately or not. This introduces many risks:

• the trainer may be distracted from their work by the demands of training a colleague and put a batch at risk
• the trainer may not have the pedagogical competencies to teach effectively
• the learner may make an irreparable mistake, resulting in a patient not receiving their treatment
• It may be difficult to separate production deviances due to training from other causes

A precise and efficient approach to training requires a deep understanding of the competency to be exercised. It is important to understand the relationship between procedures and their related competencies, allowing pedagogy to be defined and access authenticated as the organisation must secure the significant value that HQPs represent to the organisation. The competency model and job role determine who needs to be able to do what, and a Learning Management System (LMS) can control access and track the associate’s progress.

An LMS plays a few important roles in organising the execution of training. It houses the competency model, allows curriculum to be mapped to it, and therefore also training and assessment results. Therefore, the LMS allows for many learning activities to be automated (such as completion of e-learnings, survey and quiz results), and also acts as a repository for training content, improving accessibility to employees. Importantly for management, it also automates reporting and can be integrated into Human Resource Management Systems to keep employee files up to date, facilitating stackable credentials and bringing transparency to the career ladder.

To de-risk operations, it is essential to offload as much learning as possible from the actual production line employees. Indeed, the only learning activities that should be done on the line itself should be practical ones where the learner has already been deeply trained on the relevant processes and procedures.

The responsibility of training and learning in ATMP companies falls with the Quality Assurance (QA) team but is often unclear and ends up circulating between QA, HR and Operations. As technical training activities are staunch GMP requirements, but not the exclusive expertise of any of these departments, qualified external training solutions are often sought after. Training material sourced this way must be audited, which can be time-consuming but beneficial in the long run. But what do you audit?⁵

Competency defined

When selecting or auditing training materials, the pre-eminent concern is to satisfy regulatory requirements. The bulk of the focus is then placed on the ‘what’ rather than the ‘how’ of training, and like all GMP processes, the work is irrelevant without a record. The boxes that get checked then satisfy regulatory demands, but without a competence model, human operators are effectively treated as extensions of the machines they operate.

A clearly defined competency model which includes descriptions of proficiency levels needed by role allows the organisation to not only address regulatory needs, but also delivers transparency and sets the employee’s expectations. Finally, the model also acts as a career planning guide, allowing employees to know which skills to develop to get where they want to go.

We'll look at the benefits and implications of competency models in the ATMP sector in part 2 of this four part series.

Technology creates new paths

Learning technology has been evolving rapidly in recent years and has most significantly made possible entirely new ways delivering training and testing for understanding. The pendulum has found a new center, in which the role of technology is blended with traditional methods to improve effectiveness and efficiency. Its role has added significance in crisis situations, adding resilience to ongoing operations. A robust online presence allows for a greater reach, whether across a country, continent, or overseas. It allows the organisation to address unique challenges, such as social distancing, and increased costs and difficulty of travel.

We'll share some insights into how to make the best use of new learning technology in part 3 of this four part series.

Part 4 will discuss the training return on investment. Stay tuned! 

References: 

1 European Medicines Agency, (2 February 2017), Issues identified by stakeholders: follow-up from EMA’s ATMP workshop.

2 Ahmed Elsanhoury, RalfSanzenbacher, PetraReinke, Mohamed Abou-El-Enein, (22 September 2017), Accelerating Patients’ Access to Advanced Therapies in the EU.

3 Robert Dream, (1 November 2018) Impact of ATMP Manufacturing on Process Equipment and Facility Design.

4 European Medicines Agency, (2 February 2017), Issues identified by stakeholders: follow-up from EMA’s ATMP workshop.

5 Advanced Development & Manufacturing Pharmaceutical Technology (October 2019), Pharmtech.com, How to Avoid GMP Audit Citations Caused by Documentation Issues, Pg 3.