By Drs. Peter Zandstra and Michael May
For those of us who have been following and working in the cell and gene therapy (CGT) field for a significant number of years, this is an exciting time.
The current global market for regenerative medicine is US$36B and forecasted to grow to reach US$49.41B by 2021.1 With 977 clinical trials in cell, gene and tissue therapy underway worldwide at the close of the second quarter of 20182, CGT treatments and regenerative medicine-based technologies have reached a level of momentum that industry, investors, the health-care system, regulators and the media are taking very seriously.
A “tipping point” has emerged with the seminal approval of Novartis’ Kymriah in the U.S. and Europe, its USD$475,000 list price by the Centers for Medicare & Medicaid Services, and the growing catalogue of high-value acquisitions in the sector.
To meet the increasing demand for newly-approved and upcoming therapies, there is still a long inventory of challenges to overcome, from manufacturing, supply chain, regulatory, reimbursement, market accessibility and more. To address these challenges, we need smart, talented, experienced engineers, scientists and business leaders. Because the industry is still relatively new, there is a shortage of these people. To maintain momentum, we need to get serious about training.
Canada’s largest biotechnology company, STEMCELL Technologies, says it has average annual growth of 20 per cent and anticipates hiring 4,000 highly skilled people in science and technology and other professions over the next 10 years.
In a 2016 op/ed in the Vancouver Sun, Dr. Allen Eaves, CEO of STEMCELL Technologies, writes: “One of the biggest recruitment challenges for STEMCELL is attracting world-class scientific minds with niche training to move from traditional academic jobs into careers in biotechnology. We are specifically looking for PhD scientists, highly trained in the fields of cell biology, tissue engineering and immunology, to develop new technologies for regenerative medicine and cell-therapy research.”
The issue of talent in CGT has at least three bottlenecks: is there the entrepreneurial talent and seasoned management to allow us to scale sucessfully; will there be the necessary specialized skills (cellular and biological engineering, patent law, cell and gene manufacturing, regulatory, reimbursement, etc.) to support this industry; and, are educational institutions offering the interdisciplinary skills to produce the talent that converges in multiple fields of expertise to lead this field moving forward?
Developing entrepreneurial talent, experienced bioengineers and seasoned management happens organically over time and by putting training programs in place. It also happens by leveraging successive wins and cumulative “lessons learned.” The CDRD Life Sciences Executive Institute, in partnership with Pfizer Canada, is an excellent example of a “bottom-up” program designed to supply Canadian life sciences companies with the executive talent it needs. Rotman School of Management’s Creative Destruction Lab is supporting science-based companies through its mentoring process – we are both advisors – and its new Global Executive MBA for Healthcare and the Life Sciences will give mid- and senior-level executives the business tools and leadership training to help biotech companies to thrive.
The Council of Canadian Academies’ (CCA) 2017 report “Building on Canada’s Strengths in Regenerative Medicine” identified the technical training of highly qualified personnel (HQP) through the Canadian university system as a “strength for regenerative medicine, and more broadly as a strength across many disciplines. […] The recruitment of Canadian HQP with comprehensive technical knowledge by other countries [is] evidence of this strength.” The report points to other reports that support this position, stating that Canada’s “educated and multicultural workforce” is a strength in regenerative medicine.3
While Canada graduates very capable scientists and engineers, we need to make the transition to industry smoother for these deeply educated and talented individals. As the CCA report notes, “relevant applied skills could include those related to entrepreneurship, legal and ethical affairs, translational research, clinical trial implementation, product development, and large-scale manufacturing.” These hybrid skills are already in demand and that will increase as the industry grows.
Biomedical engineering is where engineering design principles and mathematics are applied to medicine and biology, allowing students to make significant contributions to improving human health by finding new diagnostic or therapeutic solutions. This growing discipline is ready-made for CGT.
At the University of Calgary, Professor Michael Kallos is Director of the Biomedical Engineering Graduate Program and Associate Director of the Centre for Bioengineering Research and Education (among other things). He also runs a lab where they are “working on bioprocess development and bioreactor protocols for stem cells, and training bioengineers to design and run them – a critical need!”
Many of these university programs will require partnerships with community colleges to train specialized technicians driven by compliance to strict quality systems. The McMaster Mohawk Bachelor of Technology is an example of a program that will supply highly qualified personnel to this sector.
The 55-year-old Institute of Biomaterials and Biomedical Engineering at the University of Toronto has also been graduating highly-trained students who are primed to make an impact in CGT. This model is being refined and built upon in Vancouver where, in 2017, the University of British Columbia (UBC) launched the School of Biomedical Engineering.
As Canada’s first multi-faculty comprehensive biomedical engineering school, UBC is investing in the future by educating the bioengineering talent with in-depth biology deconstructed with quantitative engineering design principles and contextualized with real world health problems. In September 2018, BME@UBC will welcome its first cohorts of undergraduate students, complementing strong and well-established graduate education programs. UBC undergraduate students will be eligible to participate in industry co-op programs during their education.
Beyond education, hands-on experience provided by industry is essential. CCRM, through its advanced manufacturing centre – the Centre for Advanced Therapeutic Cell Technologies – and its new Good Manufacturing Practices facility – the Centre for Cell and Vector Production – is offering recent graduates and management-level employees the skills to succeed in an industry that will continue to grow and provide good-paying jobs in the future.
CCRM has an exceptionally capable workforce, which we are building through our international networks with academia and industry. Most exciting, we are beginning to seed “CCRM alumni” in companies in the U.S., U.K., Europe and Japan. In fact, in many ways CCRM has been a training ground for industry leaders who launch their careers in our labs.
In Canada and around the world, there are other examples of training programs preparing tomorrow’s CGT leaders, but demand remains high and gaps in expertise are an issue today. Governments, educational institutes and industry need to come together to ensure that the global CGT industry does not stall and sputter because of a workforce that is too inexperienced to lead, commercialize, manufacture and scale new treatments that will revolutionize medicine. Patients are relying on us!
If talent is an issue that our industry comes together to support, we will all benefit in the long run, along with the patients we are striving to help.
CCRM is a Canadian leader in developing and commercializing regenerative medicine technologies and cell and gene therapies. It is a centre of excellence funded by the Government of Canada through the Networks of Centres of Excellence program. Michael May is President and CEO of CCRM.
Peter Zandstra is the Chief Scientific Officer at CCRM and the Founding Director of UBC’s School of Biomedical Engineering. Zandstra and May co-founded CCRM, which launched in June 2011.
Learn more about CCRM at www.ccrm.ca.
1. Regenerative Medicines Market by
Therapy (Cell Therapy, Gene Therapy, Immunotherapy,
Tissue Engineering), Product
(Cell-based, Acellular), Application
(Orthopaedic & Musculoskeletal Spine,
Dermatology, Cardiovascular, Central Nervous
System), Region – Global Forecast to
2021. marketsandmarkets.com. Website,
2. Alliance for Regenerative Medicine Q2
2018 Data Report
3. KPMG. (2014). Following Through: Realizing
the Promise of Stem Cells. Ottawa
(ON): Canadian Stem Cell Foundation