B.C. is home to a booming biomedical sector that is turning scientific discoveries into life-saving treatments and preventions. But what if we could bring these new health innovations to patients in half the time?
That’s the ambitious goal of UBC’s Academy of Translational Medicine (ATM), and one that could greatly benefit British Columbians and people around the world.
“We’re usually talking 15 to 20 years before a medical discovery makes it from the lab to patients,” says Dr. Anne Steino, a biochemist and the ATM’s senior manager of operations. “To cut that time in half would give patients access to new treatments sooner and mean tremendous cost savings for the whole ecosystem, including our health care system.”
Bringing a new discovery to market involves many steps, but one common hurdle is the regulatory review process.
“There’s a huge need here. We kept hearing from experts and industry that it can be challenging to navigate complex regulatory systems and how promising new treatments fail to advance through regulatory review for various reasons,” adds Dr. Steino.
To help tackle this challenge, the ATM established a Regulatory Advisory Council with members from regulatory and industry organizations and academic institutions to guide and advise on the regulatory direction of the ATM.
“We brought together people from local and international industry and academia who really understand regulatory affairs and where the regulatory landscape is going in the post-COVID world. It’s an incredible team with a strong vision to become thought-leaders in this area and help drive Canada-wide policy generation.”
Leading the council as its new Chair is Dr. Dean Regier, a senior scientist with BC Cancer and associate professor in the UBC School of Population and Public Health. Dr. Regier currently serves on B.C.’s Drug Benefit Council, which makes evidence-informed recommendations to the Ministry of Health about which drugs to cover under the provincial PharmaCare program.
“The ATM is absolutely delighted to have Dr. Dean Regier take on this critical role for the Academy, given his expertise on the topic, and his passion for regulatory science,” says Dr. Poul Sorensen, director of the ATM and professor in UBC’s department of pathology and laboratory medicine.
Below, Dr. Regier shares his perspective on how the council will help accelerate translational medicine in B.C.
What role does the regulatory system play in bringing new biomedical innovations to patients?
The health regulatory system protects the health of Canadians by overseeing the safety, quality and efficacy of medical products. Before a new drug or medical device is authorized for use in Canada, it must first be reviewed and approved by Health Canada. Then it’s up to the provinces to make decisions on reimbursement, determining which treatments will be made available to patients and covered under public drug plans. These are important steps that any new medical innovation must go through.
What role will the ATM’s Regulatory Advisory Council play?
The ATM is working to reduce the time and cost of bringing life-changing bio-medical innovations to patients. The Regulatory Advisory Council will provide the ATM with a deep understanding of the regulatory landscape, highlighting key challenges for the efficient and timely translation of medical innovations to the clinic. We will propose innovative approaches and policy recommendations to address and navigate these challenges.
How has the pandemic impacted the regulatory landscape?
The speed at which COVID-19 vaccines and treatments have been developed, tested and approved has been remarkable. It shows us what is possible when we generate the right types of evidence to support regulatory and reimbursement decisions. The pandemic spurred a boom in healthy system collaboration, data sharing and the use of real-world evidence, all of which helped deliver safe and effective vaccines and treatments in record time.
What can we learn from the pandemic to bolster biomedical innovation in B.C. and Canada?
Regulatory processes need to be nimble and enable innovation, while at the same time ensure safety and efficacy. In my view, any improvements in regulatory processes should be focused on generating real-world data and clinical trial evidence that allows health regulatory systems to more efficiently deliberate on patient value, safety and cost-effectiveness.
I believe we should focus on building a ‘learning healthcare system’ that embeds research into health care delivery. Every day, health care providers make decisions that impact patients’ quality of life, and there’s a lot of important data and insights that can be captured from that. In a learning healthcare system, we’d be able to leverage this real-world evidence alongside rapid, high-quality clinical trials to improve patient outcomes in real time. This is a key enabler in accelerating scientific discovery of new drugs and treatments.
The challenge is that our current regulatory policies and practices, and our health system as a whole, aren’t well adapted to this approach. It’s something we’re working towards in B.C. and across Canada, but there’s much more to do, from improving data infrastructure and sharing, to updating regulatory policies, to strengthening collaboration across the health sector.
What is your ultimate goal as Chair of the Regulatory Advisory Council?
By enabling pathways for evidence generation, my goal is to advance B.C.’s biomedical innovation ecosystem and give patients timely access to innovative medicines. Key for me is furthering a learning healthcare system that is efficient, affordable and that improves patient health and wellbeing.
What could this mean for patients and Canada’s health care system?
It all comes down to providing patients with the best possible care, based on the latest science, discoveries and new forms of evidence. It means giving patients access to new treatments sooner and ensuring an equitable, cost-effective and sustainable publicly-funded health care system in the long term. Additionally, by creating an innovation ecosystem supported by learning healthcare, we can create jobs and grow the economy through new investment and healthier populations.