What was the rational for establishment of the academy of translational medicine?
Dr. Dean Regier
The academy of translational medicine (ATM) is a combination of 5 years of engagement with translational medicine researchers within the faculty of medicine that collectively identified several important key challenges in terms of translating new therapies and new health products to patients. Those challenges included:
-) Underdeveloped funding.
-) Insufficient collaboration and by that we mean “Interdisciplinary Collaboration”. So, people from multiple disciplines come together to create an approach moving forward. To translate new health products into medicine.
-) Limited knowledge at UBC in terms of understanding the pathway to getting a new product to the patients. By the pathway we mean starting from the manufacturing to evidence generation pathway, to regulatory pathway, and to reimbursement pathway. They are all indeed linked. SPPH can conceptually fill that role. But the link between different departments within the faculty of medicine is not strong. To that end, there is a limited understanding of regulatory and reimbursement roadblocks.
-) Challenge with respect to our technologies, processes and facilities with respect to data capabilities to what we call it “innovation ecosystem”.
What is the vision?
The vision is big. The idea is “How to reduce the timeline for translational medicine by at least 50% over a 10-year period”. It gets something like 12 to 17 years to get the patients and reducing that to half would have a great impact.
In terms of the focus areas, the focus areas are around integrating UBC departments and schools, research centers and institutes, Health Authorities and industry to all come together and support data platforms, research capabilities, educational programs and content experts.
What are the structure and functions of ATM?
We’re developing 4 councils (as it stands now): 1) Regulatory affairs council. 2) Industry liaison Council. 3) Educational council. 4) Data commons council.
Those councils are governed by an executive council which rolls up into the ATM.
What other schools do you work with apart from school of medicine?
We work both within school of medicine and across UBC. We work with business school (Sauder) and School of biomedical engineering (SBME).
It’s a neural network where we can be a hub for all these really important initiatives and try to bring/ stich people together. We try to come up with a way by which investigators and programs interested in interdisciplinary work can come together and create something special against that backdrop of regulatory affairs, regulatory science, data commons, industry partnership, etc.
What are examples of current research projects conducted?
We don’t have any research projects per se: we’re only 2 years old! We’ve had early success with funding and creating educational platforms, a regulatory science micro credential funded by the Ministry of Advanced Education and Skills Training. We received that last March. That micro-certificate is an overview of key components of regulatory affairs and regulatory science and health economics.
We also have a regulatory affairs council that helps us build out the future of ATM in terms of helping the BC ecosystem navigate regulatory roadblocks and for helping us establish the future of regulatory science education at the faculty of medicine.
For future research collaboration, the ATM wants to enable science and enable scientists to come together to co-create interdisciplinary research that is cutting edge. We aim to focus on what kind of physical space, what kind of environment can be put together that really allows investigators across UBC and faculty of medicine come together.
We have been talking to a whole bunch of research programs (e.g. a group called “mend the Gap”). A recently-funded project which mends spinal cord injury. What we’re doing is that we’re talking to them about with whom we can connect them. People they think can help them with regulatory aspects of both a drug and a medical device, both wrapped up in a medical treatment which is a novel pathway in terms of regulatory approval process.
To your point on “micro-certificate course”, are there any other upcoming courses?
We are talking to SBME about creating new courses. We are thinking about having something more in depth around regulatory affairs and regulatory science related to evidence generation. By that we mean more in depth conversations around adaptive RCT designs and Patients engagement. We know regulations around conducting a good RCT that is important for Health Canada but “How do we innovate on the types of evidence that we generate in a way that allows us to move forward innovations in a safe, efficacious, sustainable manner but also in a timely manner. Do we create another arm of the micro credential? Or do we start to create graduate programs related to evidence generation for innovative technology and other regulatory affairs and regulatory science requirements associated with them?
Can students outside UBC participate as well?
Yes. It is a partnership between the Ministry of Advanced Education and Skills Training and Faculty of Medicine. So, we make sure to offer scholarships. Especially scholarships to people who need them. These courses are expensive. We tried to think about diversity in terms of who deliver the lectures and make sure there was depth in variety of perspectives. We also thought about “how we get more diverse students per learner population be aware of the course”.
How can students get up to date with regards to the news and events held by ATM?
We have a Newsletter. The faculty of medicine amplified it quite a bit. For the micro-certificate we had a whole bunch of different partners, industry partners. We had Pan-Canadian regulatory professional associations that we advertised bit!
We had 29 people in the first course. We put it together in 3 months. And then 20 people in the 2nd course. 49 altogether!
Does the academy give students insights on how to commercialize patents?
In the second course, we talked about Intellectual Property and its role in society. We did have an entrepreneurship course that talked about commercialization, partnered with Sauder School of Business.
How do you think the academy paves the way for a sustainable publicly-funded health care system in the long term?
From an economist perspective, what I’m really interested in is the ATM furthering a sustainable public healthcare system in line with public value. Typically, in conversations around discovery and innovation, it’s really upstream like “here’s the genomic test that can inform treatment”. Or “here’s the new treatment that may or may not improve the health of patients”. It’s really what I call upstream thinking. What the ATM is doing is conceptualizing innovation across the entire life cycle of the health product or technology. We take a broad approach, understanding that we need safe, effective, and cost effective drugs and technologies to improve patient and population health. As an economist, it’s near and dear to my heart that the health products we fund are in line with the values and priorities of all aspects of the public. We stich together these conversations of sustainable, cost-effective healthcare and we have these conversations with people who are making these discoveries. Then, we can plan all relevant scientific query at the beginning, knowing what we want to get out of healthcare in the end. Having these conversations with people upstream, in terms of this is what you need to understand, what is valuable to the healthcare system, why population health is important. These conversations aren’t always happening. This is part of what makes the ATM innovative. Usually, you have statisticians, epidemiologist, economists not really talking to the scientists who are making these discoveries. We want to stop being insular and say let’s work together at the beginning to help navigate that entire pathway.
Does ATM have a venue (logistics)?
We are working towards getting a physical location. We are located across UBC and affiliated sites from a physical perspective. We currently have virtual venues.
Is there any other specific topic you want to mention to be addressed in the newsletter?
What we at the ATM are interested in is accelerating innovation to patients. But those innovations need to be safe, efficacious, and sustainable. In my view, the way to achieve this goal is through marrying regulatory science – broadly the work advancing science around the tools of evidence generation (e.g., real world evidence, adaptive clinical trial design, patient engagement) with priority topics like priority pathogens, personalized medicine, advanced therapeutics, artificial intelligence, etc. So, we see regulatory science as a real way to help sustainable innovations move quicker to patients. Again, part of the conversation is that we need to partner with government and industry in order to move some of those conversations forward.