SPLITTING HAIRS

Acorn Science

SPLITTING HAIRS

Acorn Science

August, 2019

When it comes to the development of new health technologies and drug treatments, we have to be patient. In fact, the stakes couldn't be higher because not taking the correct approach, with proper oversight at each step, could have dire consequences, including injury -- or even death. That’s why it can take years, even a decade, for new forms of medicine to be tested for safety and efficacy before they’re approved.


This is exactly why we need to take a science-based approach when it comes to regulating cell therapy treatment, or regenerative medicine, which will play a major role in the future of healthcare. According to the Mayo Clinic, patients who might benefit from these forms of treatment are extremely diverse, including those suffering from Type-1 diabetes, Parkinson’s, Alzheimer’s, burns, cancer and strokes, just to name a few. There is no shortage of excitement from physicians, scientists and patients.


While the benefits of cell therapy are promising, the regulatory and oversight framework in Canada will need to keep pace with advancements made in the sector on a global scale. According to the Alliance for Regenerative Medicine, there are 906 gene and cell therapy companies worldwide, with just over 1,000 clinical trials currently taking place. The industry is also growing rapidly. In 2018, the field raised $13.8 billion internationally, an increase of 73 per cent from the year before.


Recognizing this, Health Canada recently launched consultations with stakeholders to “modernize its regulatory framework to meet the new demands of today’s increasingly complex health technology while still protecting the health and safety of Canadians.” The government should be applauded for reaching out and engaging with industry leaders, since taking a collaborative approach backed by informed expert opinion will ensure we foster innovation while upholding patient safety, which is the top priority.


As the founder of a company that does not administer cell therapy treatment but collects live cells and maintains them through cryopreservation for possible future therapeutic use, we fully support and encourage the development of new clinical trial regulations that can establish Canada as a world leader in regenerative medicine.


But this country isn’t alone when it comes to foreseeing the large-scale impact cell therapy treatment will have and the need to play regulatory catchup with rapidly advancing technology.


Earlier this year, the Food and Drug Administration (FDA) in the United States announced plans to accelerate cell therapy approvals . The FDA expects it will receive some 200 Investigational New Drug Applications, which are requests for authorization to administer an investigational drug to humans.


This increased focus on regenerative medicine has prompted the FDA to hire an additional 50 staffers to expedite the approval process. The fast-track process is not to be confused with final approval for use with the general public. Rather, it’s an “accelerated approval pathway may offer a faster route to approval for new treatments, including potentially curative benefits in significant, unmet medical needs.”


As with any new treatment in medicine, there will always be debate on its future impact for patients. While there are differences of opinion regarding the timelines for regenerative medicine treatments, one thing is clear: The industry is growing on a global scale and the federal government has taken notice. Canadians should feel confident that Health Canada is taking the right steps in consulting with industry to ensure their safety is protected and that our nation remains a world leader in cell therapy innovation.


I believe that our own cells are the next currency in healthcare, opening up regenerative medicine treatments and next-generation analytics, and I am excited about the role Canada is taking in this bright future.


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