Canada springs to motion, and not just with the weather | 088

  Welcome back to another episode of Biotechnology Focus radio! I am your host – Michelle Currie – here to give you the rundown on the Canadian biotech scene. So, as many of you know, we are coming up to a very busy and exciting time of the year, as BIO is just around the corner! And this isn’t just any regular BIO, this year marks the 25th anniversary in its inaugural location – Boston. It’s four days chalked full of keynotes, receptions and networking opportunities that will leave you trying to catch your breath at the end of the week. But if that doesn’t take your breath away, perhaps the performance by Diana Ross might at the largest BIO event of the year!  But bringing the focus back to Canada, a lot has been going on in the last few weeks that is worth mentioning. Keep listening to find out!  +++++  In a world where artificial intelligence has begun to incorporate itself in everything from life sciences to cars, it should come as no surprise that South Korean tech giant, Samsung, is jumping in with both feet opening AI Centres around the globe, one of which just opened in Canada’s most bustling city – Toronto.  The opening of the Toronto AI Centre comes on the heels of the company’s global announcement of two additional and newly established AI Centres in Cambridge, UK and Moscow, Russia as part of a new venture to tap into and contribute to the booming AI industry. The Toronto Centre will work in partnership with the company’s Silicon Valley team to pioneer AI research and development for the region.  Toronto has a rich history of innovation and discovery and is an ideal location for a vast amount of companies to call home. With access to key talent, Toronto is an idyllic place for research and development for speech recognition, where machine-learning technology was applied many years before it was widely applied to other fields. The vision is that the Samsung AI Centre will now serve a significant role in the advancement of AI with a focus on language understanding and computer vision technologies that will ultimately reduce the friction between the user and the device/service, whether it be mobile phones, TVs, appliances, or cars.  Located in Toronto’s downtown core at MaRS Discovery District, the new Samsung AI Centre is a part of a network of research Centres dedicated to research and development in the field of AI. The Centre is the second Samsung AI Centre to be established in North America, with the other in Mountain View, California. The North America AI Centres are led by senior vice president, Dr. Larry Heck, a renowned expert in machine learning for spoken and text language processing, who also co-leads the expansion of Samsung’s AI Centres around the globe.  The Toronto centre will be led by Dr. Sven Dickinson, newly appointed as the head of the Toronto lab, professor on leave and past chair of the Department of Computer Science at the University of Toronto. Dickinson is an expert in computer vision technologies, especially in the field of object recognition. He will play an integral part in Samsung’s research of core AI technologies that entail language, vision and other multi-modal interactions.  As one of the world’s largest urban innovation hubs, MaRS Discovery district supports promising innovators and ventures tackling key challenges in the sectors of cleantech, finance & commerce, and work & learning. In addition, and importantly, the vast MaRS community fosters cross-disciplinary collaboration which drives breakthrough discoveries and new solution for global audiences.  This announcement compliments earlier 2018 news of plans to launch additional AI centres in North America. Dr. Darin Graham will lead the opening of new labs in Canada as the head of Samsung’s Canadian AI Operations. Graham also helped create the Vector Institute – the renowned Canadian AI research institute, as a member of the founding team. The opening of AI centres in Canada will allow Samsung to expand its outpost for industry collaboration and talent recruitment in the major AI hubs in North America.  To date, Samsung has had remarkable success in leveraging Canada’s unique R&D; talents for global impact. The Company’s Vancouver-based R&D; centre has contributed to many in-market innovations and more than doubled its workforce, since opening with over 100 employees. With the addition of the AI centre in Toronto, the company plans to increase the R&D; in Canada from current 100 to 200 in the near future. Additional developments and talent in Canada have been recognized through Samsung Electronics Canada subsidiaries, AdGear Technologies Inc. in Montreal and SigMast Communications Inc. in Halifax, Nova Scotia.  +++++  When it comes to what drugs get funded, how do provinces and the Canadian health care system decide which drugs to fund and which drugs not to? A team of University of Alberta researchers found that when a jury is made up of a cross-section of society and given proper information and context, people are willing to fund drugs and treatments for costly ultra-rare diseases, even at the expense of treatments for larger populations.  An example would be a rare genetic disorder that robs men of sight by the age of 40. It affects one person in 50,000 and does not yet have a cure. But it does have a very expensive, unproven gene therapy that holds the promise of delaying the inevitable.  Tania Stafinski, a researcher in the University of Alberta’s School of Public Health and director of the Health Technology and Policy Unity says, “The fallacy is that these kinds of decisions are based on the greatest good for the greatest number. It’s partly greatest need, partly what the gain looks like, partly the severity of the disease and partly the population affected. It is an interaction of all these things, but not whether it is utilitarian.”  To better understand the social values around spending on new technologies and commercially undeveloped “orphan drugs, Stafinski convened a pair of citizen juries that roughly matched the sociodemographic profile of people in and around Edmonton.  Just like in a legal setting, Stafinski called witnesses that represented government, health-care providers and patients, and led the juries through different trade-off exercises and scenarios. For the most part, specific drugs and technologies were avoided to rid the study of any bias and allow jurors to focus more on the characteristics of the people and what could be achieved.  The jury was put through seven trade-off exercises focusing on things that might matter to them, such as cost, the condition of the patient, what kind of technology is involved, how much improvement could be expected, and even caregiver burden.  Despite the stakes, uncertainties around whether the technology would be able to fully deliver on its claims didn’t play a significant role in decision-making. Even in cases, such as the gene therapy for vision disorder, where there was a risk the technology would fail, Stafinski found that jurors valued the information and innovation component of the research.  Final decisions on what technologies and drugs to fund are currently made by a provincial review committee, guided by a pan-Canadian evidence review process that leaves it up to the provinces to take into account social and ethical implications.  She says there are examples in the Canadian health-care system where a small gain for hundreds of thousands of people is implicitly sacrificed to give sufficient medical gains to a small group. One example is administering the flu vaccine—inhaled versus injected.  Stafinski explains that although a large segment of society may prefer to have the inhaled version of the flu vaccine, with a few exceptions, policy-makers aren’t spending the extra money for the inhaled vaccination, choosing instead to fund medications such as those that improve the quality of life for the 4,000 Canadians who suffer from cystic fibrosis.  +++++  A new study from The Ottawa Hospital is the first of its kind. The study suggests that treatment for erectile dysfunction coupled with a flu vaccine might be the solution to eradicating cancer cells after surgery. The study, published in OncoImmunology, shows that this unconventional strategy can reduce the spread of cancer by more than 90 percent in a mouse model. It is now being evaluated in a world-first clinical trial.  Senior author Dr. Rebecca Auer, surgical oncologist and head of cancer research at The Ottawa Hospital and associate professor at the University of Ottawa says, “Surgery is very effective in removing solid tumours. However, we’re now realizing that, tragically, surgery can also suppress the immune system in a way that makes it easier for any remaining cancer cells to persist and spread to other organs. Our research suggests that combining erectile dysfunction drugs with the flu vaccine may be able to block this phenomenon and help prevent cancer from coming back after surgery.”  The current study investigated sildenafil (Viagra), tadalafil (Cialis) and an inactivated influenza vaccine (Agriflu) in a mouse model that mimics the spread of cancer (metastasis) after surgery. The researchers evaluated these treatments by counting the number of metastases in mouse lungs. They found an average of:  37 metastases with cancer cells alone  129 metastases with cancer cells and surgery  24 metastases with cancer cells, surgery and one of the erectile dysfunction drugs  11 metastases with cancer cells, surgery, one of the erectile dysfunction drugs and the flu vaccine  Dr. Auer is now leading the first clinical trial in the world of an erectile dysfunction drug (tadalafil) and the flu vaccine in people with cancer. It will involve 24 patients at The Ottawa Hospital undergoing abdominal cancer surgery. This trial is designed to evaluate safety and look for changes in the immune system. If successful, larger trials could look at possible benefits to patients.  The researchers are excited about this research because it suggests that two safe and relatively inexpensive therapies may be able to solve a big problem in cancer. If confirmed in clinical trials, this could become the first therapy to address the immune problems caused by cancer surgery.  Using a variety of mouse and human models, Dr. Auer’s team has also made progress in understanding how erectile dysfunction drugs and the flu vaccine affect cancer after surgery. Normally, immune cells called natural killer (NK) cells play a significant role in killing metastatic cancer cells. But surgery causes another kind of immune cell, called a myeloid derived suppressor cell (MDSC), to block the NK cells. Dr. Auer’s team has found that erectile dysfunction drugs block these MDSCs, which allows the NK cells to do their job fighting cancer. The flu vaccine further stimulates the NK cells.  Dr. Auer stresses that although erectile dysfunction drugs and the flu vaccine are widely available, people with cancer should not self-medicate. Any changes in medication should be discussed with an oncologist.  +++++  Some of the hottest areas in biotech that are emerging and driving growth and investment are in the field of regenerative medicine and cell and gene therapy. There have been several acquisitions over the past year that really got the ball rolling with hopes to advance immunotherapies. Despite the curative potential, these therapies come with a hefty price tag and complex challenges. With the first immunotherapies to win regulatory approval in the United States, CCRM, a leader in developing and commercializing cell and gene therapies and regenerative medicine technologies, hosted a panel to discuss how we can bring these therapies to Canada.  The panel represented a wealth of knowledge covering regulatory and hands on approaches to the subject. It was moderated by Michael May, president and CEO of CCRM, and consisted of Donna Wall, MD, section head, Blood and Marrow Transplant/Cell Therapy Program, The Hospital for Sick Children (SickKids); Justin Shakespeare, executive director, Oncology Business Unit, Amgen; Patrick Bedford, senior manager, Clinical Translation and Regulatory Affairs, CCRM; and Aaron Dulgar-Tulloch, PhD, director of Bridge, GE Healthcare Cell Therapy.  There have been many decades of work in people trying variations of immunotherapy approaches and not getting a clinical signal. It was after researchers figured out T-cell biology and that they needed to bring not only the patients’ T-cells right up against the tumour cell but also that they had to get the T-cell excited and activated to go into cell division.  Donna Wall explains, “The first successful patient was only about six years ago. No question that the treatment can cure, as long as you take six years as to how long to treat a number of patients who otherwise have untreatable leukemia. That’s the first type of patients that we have when we have a new treatment. We take the patients where we have nothing else to offer. A number of patients do not make it to the treatment because it takes a while to engineer the cells; a number of patients may not have a response to the treatment; and a number of them who go into remission may end up relapsing. But for the first time, there are many who are responding positively to treatment and are not showing signs of leukemia.”  This is still in a very early-stage as of yet. It is not a one-and-done type of treatment. In order for this to work, the most common CAR-T product removes the cancer cells as well as the patient’s B-cells lifelong – giving them an immune deficiency. It is complex and comes with its own set of issues that may put up to 40 per cent of patients into intensive care for side effects of the CAR-T treatment. The treatment should not be taken lightly and will not be handed out over the counter.  The cost of the treatment is another factor entirely. Like anything new, cost is initially high but is expected to come down over time. It is a huge cost for a company to invest in and build the infrastructure that needs to be actualised as well as looking at regulatory costs. If the treatment becomes more mainstream, its costs pose another issue, as the health care system has not been designed to handle a large influx of big-ticket cases.  Patrick Bedford, CCRM, states, “There’s value in when you want to pay for something, but can you actually pay for it today is the real question. The number of drugs over $50,000 since a decade ago has gone from two to 20, and the drugs targeting orphan or rare diseases has all skyrocketed. There might not be a lot of people in each of these disease populations, but there are a lot of disease populations. So, the idea of affordability is really important. There are some new discussions right now about how to pay for these, like money back, or paying for performance type things, or rather than paying it all at once, pay three, four years later. There are a lot of ideas right now about how to afford the population if we choose they are worth the value to pay for.”  These are living drugs and therapeutics that have a very complex process on the manufacturing side as well as the rest of the supply chain. Each treatment batch is tailored to the patient. Many treatments start as autologous, but there are groups that are currently working on making this into more of an allogeneic process.  Aaron Dulgar-Tulloch explains, “Everyone wants to go from autologous to an allogeneic model. Every commercial entity would prefer to be in that allogeneic scenario because it is much better realised, there’s simplification in the supply chain, logistics, and the scale of benefits. We’re already starting to see groups trying to turn autologous into an allogeneic process. I think we will see more groups coming in with successful approaches to a more allogeneic or classical model.”  However, the playing field is changing as more treatments are reaching approval on a shorter timeline and with less clinical data. Even though much of that data presented to the regulators have been enormously successful, it is not typically a fast-moving field. This leaves the regulators to navigate through the treatments and do so in a receptive and responsible manner.  Since these therapies are still so new right now, it has put a particular strain, even on a global scale, to find individuals with expertise in scale up and industrial manufacturing coupled with biological cellular experience.  Dulgar-Tulloch explains that Canada in particular is feeling the pain from that, in that they don’t have a lot of the manufacturing infrastructure in Canada to pull from, and what Canada has is still heavily engaged in the bioprocess space.   CCRM has a centre devoted to improving the cell manufacturing process and is attracting international attention from companies who are looking for CCRM and GE’s expertise in process development. This work also feeds into the Good Manufacturing Process (GMP) facility that CCRM is building that provides space for therapeutics companies to run phase I and II clinical trials.  What it all boils down to when it comes to markets like Canada, is that timing is often regulatory-driven and balancing considerations as to where manufacturing is and how to support the local market, with timing as an implication on the pricing perspective. Canada needs to leverage its strengths on the clinical side so that we extract value from manufacturing and ultimately deliver these products to patients for commercialization.  +++++  Well that wraps up another episode of Biotechnology Focus radio! As always, we have all the stories online and in full to fish through at your leisure at biotechnologyfocus.ca. If you have a story idea or wish to make a comment, please email me at [email protected]. But until the next time, enjoy the spring weather and for those attending the BIO International Convention this year, good luck and enjoy! From my desk to yours – this is Michelle Currie.