By S. Amanda Ali
As a fifth year PhD student in the Institute of Medical Science at the University of Toronto, thoughts of what-to-do-next are always lurking in the back of my mind. Having ruled out conventional routes for graduate students in biomedical science – postdoctoral fellowships, medical school, other professional schools – I’ve considered a career in business.
With financial support from the Centre for Commercialization of Regenerative Medicine (CCRM), I was given the opportunity to attend the 5th Annual Business Education Course on The Business of Regenerative Medicine: From Stem Cells to the Market Place, held at Case Western Reserve University in Cleveland, Ohio. Attendees spanned a broad range of professions and included business people, government officials, scientists, engineers, and physicians. The meeting focused on key economic and business issues in the field of regenerative medicine.
Topics were all related to regenerative medicine, but ranged from entrepreneurism and leadership, to legal and regulatory hurdles, to financing strategies and business models. This was the perfect setting for a graduate student to gain insight into a wide variety of career paths in business.
One particularly memorable talk came from Dr. Jon Rowley, Innovation Director of Cell Processing Technologies at LonzaWalkersville, Inc. Lonza manufactures billions of cells per day, and offers clients contract manufacturing, process development, and cell production facilities. Rowley identified three key factors required for cell therapy to become a sustainable industry: scale, quality, and cost. He emphasized that product development and process development should occur in parallel, in three categories:
- Cells: identity, potency, purity, safety, etc.
- Product: concentration, shelf life, delivery method, doses/year, etc.
- Cost of Goods: consumables, labour, facility, quality assurance, etc.
An overarching challenge in regenerative medicine generally, and in cell therapy specifically, is scalability. As graduate students working at benches, we seldom stop to consider the logistical challenges that would present themselves should our science be translated to bedsides. Rowley pointed out that each step of a cell culture protocol must be adapted for mass production, and each change has the potential to alter cell phenotype, and ultimately the therapeutic product.
As research efforts into regenerative therapies continue to expand, there is a growing niche for experts who are capable of translating those therapies. The therapeutic application of scientific findings will require collaboration among an array of professionals, an effort that is being tackled through meetings like this, and centres such as CCRM.
With greater awareness of the interconnectedness between business and regenerative medicine, I’m inclined to consider a career in “translation” as an alternative to academia. Whether one approaches translation from a business stance, a medical perspective, a scientific mentality, or any other relevant background, it integrates different fields and promotes innovative thinking.
For students in biomedicine who endeavour to make a global impact, I suggest leaving behind the microcosm of specific knowledge gained during graduate studies, and bringing forward the critical thinking skills that can facilitate the translation of regenerative medicine.
S. Amanda Ali is currently studying the genetics of osteoarthritis under the supervision of Dr. Benjamin Alman. She became interested in the field of Regenerative Medicine after completing and serving as teaching assistant for MSC7000Y, a graduate course focusing on the science, the bio-processes, the technologies, the ethical and regulatory aspects of implementation, and the academic/industry partnerships on which clinical success of regenerative medicine is likely to be based. She is an aspiring writer whose work can be found in the IMS Magazine.