People Power: Training Canada’s Next-Gen HQP in Regenerative Medicine
CellCAN and partners set sights on ramping up national capacity in cell and gene product manufacturing
An explosion of research and clinical trials over the past several years has ushered in the the age of market-authorized gene and cell therapies. How prepared is Canada when it comes to having enough highly qualified professionals (HQP) to support a competitive, home-grown industry?
OIRM sat down with Craig Hasilo, Chief Scientific Officer for CellCAN, to discuss what the future holds for HQP development in Canada. CellCAN is a national network that aims to improve the quality, safety and feasibility of cell and gene therapy in Canada through optimal manufacturing practices. The network has recently launched an innovative new education platform designed to make Canada a global leader in manufacturing expertise.
Q: What’s the current state of training for HQP in Canada, and where does CellCAN fit into the landscape?
A: We’ve always been about focusing on the cell and gene therapy manufacturing niche, breaking down silos between the many organizations working in this space to increase collaboration and leverage strengths in Canadian know-how and best practices. That has really come full circle into addressing the need for very job-specific training and on-the-floor skills related to the manufacturing of these therapies. The dearth of qualified talent is growing here in Canada and around the globe, and we foresee a significant labour shortage if we don’t start training now.
Canada has had a lot of great players working in this sector for a long time, launching clinical trials and maturing products through scale-up. That means there are simply more products in need of being produced, and so there is continually more HQP required to work on these therapeutics and produce them according to stringent regulations. The regulations further require that all HQP who are manufacturing products for patients must have their qualifications maintained through routine training and testing. We call this the “training continuum.”
Never before have we seen such high demand for qualified manufacturing talent than for therapeutics production in response to the COVID pandemic. COVID-19 has shed light on our sector in an unforeseen way, and the federal and provincial governments are investing massively in order to increase our domestic capacity to reach autonomy.
Q: What’s the biggest challenge with developing the capacity to train enough HQP properly?
A: The biggest issue is not that organizations are unable to train their HQP. Over the years, it’s become apparent to us that most groups have at least a minimal capacity to train their HQP. The key issue is that traditional training methods are very inefficient and amount to a huge drain on an organization’s resources. For example, employees working on the production floor have to take time away from their duties to onboard new HQP, even if the HQP have relevant training in a different therapeutic manufacturing space. New HQP need an overview of processes and training in standard operating procedures (SOPs), then they need to observe how the process works day to day. They must attain the required level of skill, competency and comfort before the tasks are turned over to them for autonomous work. Of course, this process must be well documented.
Often this on-the-job training leaves little time for extensive foundational knowledge of overall GMP concepts and regulatory comprehension, and will vary from group to group without national training standards in place.
Depending on the manufacturing process in question, it can take anywhere from eight to 16 months for HQP to reach an acceptable level of autonomy – that’s a very significant amount of time in any business, let alone one as competitive as regenerative medicine.
Q: What are CellCAN’s plans to cut through the HQP training log jam?
A: In order to ramp up the workforce Canada requires, we have to become far more efficient, and that is really our new modus operandi – to serve as an advanced training institute that reduces organizations’ training and onboarding burden. We have developed a phased, multi-pronged plan that ultimately includes the development of in-person training facilities across the country, which we are planning as we speak. These will provide access to training on several manufacturing processes for different therapeutics.
Generally, our focus is on providing a combination of in-person and virtual training with computer-assisted learning, using core adult learning techniques and ensuring that knowledge is delivered in an efficient manner, and that it’s retained.
Late last year, we launched two new virtual learning paths. The GMP Virtual Hands-On Workshop is a 15-20 hour, interactive course designed to provide end-users with a grounding in good manufacturing practices (GMP), clean room requirements, quality management systems and SOPs, and more. The course is recognized by the NGen AmpUp program, which covers 50% of training costs for employees of NGen member companies.
We also launched a 60-minute online module covering the essentials of cell and gene therapy GMP manufacturing, which is a high-level overview of what it takes to translate process development into GMP production. We also have over 20 “a-la-carte” courses online and several additional courses are coming online soon, including one focusing on clinical trial applications and others that are more specific to onboarding HQP.
Q: What is CellCAN’s long-term goal for HQP training?
A: Ideally, we want to make sure that all HQP are working under the common best practices that have been developed across the sector, wherever they are working. We want to standardize skills and job requirements so that employers can compare apples to apples, in the same way that Canada’s Red Seal program has created standards for skilled trades. Part of this includes implementing our industry-first competency framework that links job roles to a specific training curriculum. This will allow participants to have a dedicated learning pathway to develop the required expertise and facilitate stackable credentials for career progression.
The time is right now for us to make sure that Canada’s ecosystem thrives, which is why we are making a concerted effort to actively build this infrastructure. Until now, Canada has not had the capacity to develop a robust training program for these HQP – and that’s where CellCAN and our partners can play a key role.