OR WAIT null SECS
Agnes Shanley is senior editor of BioPharm International.
Ireland's National Institute of Bioprocessing Research and Training (NIBRT), together with technology providers such as GE Healthcare, and universities in Ireland and around the world, are developing courses that aim to close the gap between theoretical studies and practical workplace needs.
There are few parts of the world in which pharma plays as large a role in the GDP as it does in Ireland, which has seen $10 billion in new biotechnology investment over the past 10 years.
As a result, biotech training in Ireland has become very “hands on,” Nuala Calnan, industry consultant and professor at Technical University Dublin told BioPharm International in a July 2019 interview. “Over 50% of our nation’s GDP is in pharma and life sciences. All of the top 20 companies and 18 of the top 20 medical devices companies are based here. It’s a huge cluster and we have over 50 years of deep knowledge about the industry to draw from,” said Calnan. The school’s graduate programs reflect this knowledge (e.g., Technical University Dublin currently offers a master’s degree program in validation, and is developing an online global validation training program with J&J).
This is different from the typical situation in the United States, where students take general, more theoretical science and engineering courses in college and graduate school, but arrive to their first day on the job with very little applied training or familiarity with equipment, Calnan said. Operating companies have to address the skills gap with onboarding and training programs, she said.
Equipment vendors have been stepping in to help manufacturers and contract development and manufacturing organizations (CDMO) address the gap, with most offering training at centers of excellence around the world.
“In Ireland, we’ve had to be more diligent about ensuring a practical approach to training because our economic survival depends on it,” she said. Exporting this approach to training, the National Institute of Bioprocessing Research and Training (NIBRT) in Dublin has been partnering with biopharmaceutical technology vendors to address the need for more practical training.
“Through collaborative approaches between industry and academia, we get to ensure that we are delivering competency, but also that it is based on relevant and hands on experience using actual equipment,” said Killian O’Driscoll, special projects director for NIBRT in an interview with Pharmaceutical Technology in September 2019. “This is a challenge for most universities.”
The Institute launched a program with GE Healthcare in September 2019 to offer more practical courses in single-use processing, and is also planning to develop training programs with GE in topics such as cell therapy technology, process efficiency strategies, process development, and chromatography. Courses will be offered at GE Fast Trak locations around the world, the NIBRT facility in Dublin, Ireland, and the Jefferson Institute of Bioprocessing in Philadelphia, which started up in 2018, in partnership with Jefferson University to provide corporate staff training as well as courses for university students.
“We have been hearing about the industry’s talent shortages and training issues for a while, not only in the emerging markets (e.g., the Middle East, Africa, and Asia), but also in mature markets. GE has been involved in training and workforce development for 30 years with Fast Trak and through our collaboration with NIBRT, we will be able to address the talent shortage, to make our complementary curricula available on the global basis, said Umay Saplakoglu, general manager of GE Healthcare’s Fast Trak, in an interview with PharmTech in September.
Process development is only one area where there is a need to combine theory and hands on teaching, and it will be one topic of focus, said Saplakoglu. “US companies need new onboarding and training that reflect the new nature of biopharmaceutical manufacturing,” she said.
This particular program builds on a partnership that NIBRT established with GE in 2017, when the two launched a center of excellence for single-use bioprocessing equipment. NIBRT then started up another training program at the Jefferson Institute in Philadelphia in 2018. “Generally, we are broadening our training partnerships,” said O’Driscoll in an interview with PharmTech in September 2019.
Existing workforce development programs face training gaps for biopharmaceutical manufacturing, in particular, a need for more knowledge of advanced automation and quality control methods and technologies, said O’Driscoll. “Across the board, graduates show a shortage of necessary skills, despite fast growth in the biopharmaceutical industry,” he said.
And this skills gap will only intensify in the future, O’Driscoll said, as the types of biotherapies being developed become increasingly complex. “Manufacturing platforms for gene and cell therapies have yet to be standardized, so the training challenge goes far beyond what it has been for traditional cell culture and aseptic manufacturing,” he said.
New hires in biopharma will need to be comfortable with new control systems and data analytics, including the use of big data, he said. But autologous therapies will involve a scaling down and more manual work that can also be challenging. “With cell and gene therapies, you will have smaller batch sizes, less automation, and more manual intervention,” he said.
O’Driscoll notes that 2019 has been a busy year for NIBRT on both the research and training front. The Institute now has a new chief science officer, Liz Pop from Purdue University, and is working on partnerships with other companies. NIBRT has also launched online training programs through its Online Academy, a portfolio of short (i.e., 45-minute to one-hour-long) courses, as well as longer ones. So far, the Institute has brought seven courses online, but will be adding another seven in January and another seven during the second quarter of 2020, O’Driscoll said.
The institute is also working with the Boston Consulting Group to consider how it might best apply emerging technologies such as augmented and virtual reality (AR and VR) to its courses. One course would use virtual reality for column packing training, he said.
“Companies need to look at how tacit knowledge can be transferred between teams and coaches and mentors. It’s no longer effective to transfer ring binders to people….and millennials don’t respond to this approach, either,” said Calnan, noting the potential for AR and VR to allow subject matter experts to link up directly with trainees.
At Tech University Dublin, virtual reality is being used in cleanroom training, she said, to train students in column packing of chromatographic skids. “VR helps refresh their knowledge and walk through the procedure the day before they have to do it,” she said.
NIBRT benefits from government investment in training that was made 10 years ago, said O’ Driscoll, but the Institute also has partnership with the top 20 biopharmaceutical operating and vendor companies, including Thermo Fisher Scientific. The Institute also trains regulatory agency professionals, including some programs for the Pharmaceutical Inspectorate, said O’Driscoll.
Ultimately, the hands on approach will also apply to management training programs, which will need to incorporate both patient focus as well as shareholder value, said Calnan. Dublin Technical University is currently developing an MBA in life sciences degree program designed to ensure full training in both the business aspects (e.g, costs and expenses for a project) as well as the technical side. Current programs at many graduate schools tend to emphasize one aspect or the other, with technical universities focusing on the technology side. This will not be sufficient for the future. “Both business and technical skills are needed,” she said, and patients must come first.