By now, it’s no longer a surprise for anyone that the medical marijuana market in the country is geared for explosive growth. Recently Canada’s national drug development and commercialization centre has partnered with Vancouver’s Aequus Pharmaceuticals Inc., on a research program aimed at establishing pre-clinical safety and efficacy of select cannabinoid-based therapeutics. I had a chance to speak with Gordon McCauley, president and CEO of the  Centre For Drug Research and Development  or CDRD. And he provided Biotechnology Focus with some insights into his organization’s partnership with Aequus. Have a listen to our conversation….  

055 | Interview with Gordon McCauley, President and CEO of the Centre For Drug Research and Development

On the Biotechnology Focus Podcast we bring you the latest news, insights, and interviews from Canada's Biotechnology sector.

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  Q&A; with Rory Francis PEI BioAlliance     099| Riding the biotech current to PEI    Welcome to another episode of Biotechnology Focus Radio. I am your host – Michelle Currie. Today, I am joined with a special guest, the executive director of the PEI BioAlliance, Rory Francis, who will be discussing what is happening in the PEI Cluster and with the PEI BioAlliance organization itself.     First, I think it will be important to state what the PEI BioAlliance is and the aim/vision of the organization. Perhaps giving a little bit of the history of the organization as well, then discuss a little bit about what the PEI Cluster is as well.       What is the scale and scope of the PEI Cluster?    Is there a focus of the PEI Cluster? I know that often animal health companies are recruited to the province. Is this something PEI specialises in? What are the incentives that you offer for companies to relocate? What has defined the success of the cluster thus far?    So, coming back to the PEI BioAlliance, what is your operating model? Do you have any strategic priorities? Who is in your company’s portfolio? Who are the major companies and partnerships that should be highlighted? Can you tell me a little bit about your innovation ecosystem? What would you say is the defining success of the organization?       What challenges and opportunities has the organization seen over the years?     What is your strategy for future growth? Does it vary from that of the cluster’s? Incentives?      What are the government’s initiatives? How do they aim to enhance PEI’s assets?     Have I missed anything that you would like to touch on?   

Q&A with Rory Francis PEI BioAlliance | 099

   Welcome to another episode of Biotechnology Focus radio! I am your host – Michelle Currie – here to give you the Canadian biotech rundown from coast to coast. This week there has been some revolutionary research in HIV, and natural killer cells. FACIT – the fight against cancer innovation trust – has invested in three novel cancer therapeutic discoveries, and Oncolytics Biotech enters a clinical collaboration to combat breast cancer. Keep listening to find out more details!    +++++    Researchers at the BC Centre for Excellence in HIV/AIDS (BC-CfE) and Simon Fraser University (SFU), in partnership with University of British Columbia (UBC) and Western University, develop a way of dating “hibernating” HIV strains, in an advancement for HIV cure research in the province.    Published in the prestigious journal Proceedings of the National Academy of Sciences (PNAS), the BC-CfE’s first major scientific contribution to the area of HIV cure research confirms that dormant HIV strains can persist in the body for decades.    Dormant HIV strains, embed their DNA into the body’s cells, tucking themselves away for years – but can reactivate at any time – and are unreachable by antiretroviral treatments and the immune system. This is the reason why HIV treatment needs to be maintained for life.    Dr. Zabrina Brumme, director, Laboratory with BC Centre for Excellence in HIV/AIDS and lead author on the study says that, “If you can’t identify it, you can’t cure it. This research provides further essential clues in the pursuit of an HIV cure—which will ultimately require the complete eradication of dormant or ‘latent’ HIV strains. Scientists have long known that strains of HIV can remain essentially in hibernation in an individual living with HIV, only to reactivate many years later. Our study confirms that the latent HIV reservoir is genetically diverse and can contain viral strains dating back to transmission.”    Dr. Julio Montaner, director of the BC Centre for Excellence in HIV/AIDS  says that, “The BC Centre for Excellence in HIV/AIDS  has consistently been a national and global leader on research on HIV and on the implementation of its pioneering Treatment as Prevention® strategy. The addition of molecular biologist Dr. Zabrina Brumme as director of the innovative BC Centre for Excellence in HIV/AIDS Laboratory ensures the BC Centre for Excellence in HIV/AIDS  will play a significant role in HIV cure research. Curative strategies will need to address this new study’s key findings. I want to acknowledge the study participants and thank them for helping to increase our knowledge on the origins of the latent HIV reservoir.”    Brad Jones, a Ph.D. student with the University of British Columbia (UBC) at BC Centre for Excellence in HIV/AIDS and the first author on the study says that, “By creating family trees of viruses using a technique called molecular phylogenetics, we can reconstruct the evolutionary history of HIV within a person. In essence, we created a highly calibrated ‘time machine’ that gives us a specific time stamp for when each dormant HIV strain originally appeared in a person.”    Through advances in antiretroviral therapy, an individual living with HIV can now live a longer, healthier life on treatment. Treatment works by stopping HIV from infecting new cells. On sustained treatment, individuals can achieve a level of virus that is undetectable by standard blood tests. An undetectable viral load means improved health and that the virus is not transmittable to others—the concept behind Treatment as Prevention®.    Dr. Jeffrey Joy, research scientist at the BC Centre for Excellence in HIV/AIDS and co-author on the study says that “Previous research had already revealed that the HIV reservoir was genetically complex. With our method, we can now understand that complexity with greater granularity, pinpointing exactly when each unique HIV strain originally appeared in a person.”    Dr. Art Poon, assistant professor at Western University’s Schulich School of Medicine & Dentistry, also a co-author on the study, says that, “In order to eradicate HIV from a person’s body, you first need to know the characteristics of HIV in the latent reservoir. We are providing a method for better measuring the timeline of virus latency and evolution within an individual living with HIV.”    “Dating” dormant HIV strains within the viral reservoir involve comparing them to strains that evolved in an HIV-positive person over their entire history of infection.    The BC Centre for Excellence in HIV/AIDS is one of a handful of institutions worldwide capable of such research, thanks to its maintenance of a historical repository of blood specimens from individuals diagnosed with HIV in BC. These specimens date back to 1996 and were originally collected for viral load and drug resistance testing. The BC Centre for Excellence in HIV/AIDS Laboratory has provided HIV drug resistance genotyping for virtually all Canadian provinces and territories since 1998, as well as for many countries worldwide.    This research was funded by the Canadian Institutes of Health Research (CIHR) in partnership with the Canadian Foundation for AIDS Research (CANFAR) and the International AIDS Society (IAS) through its support of the Canadian HIV Cure Enterprise (CanCURE), as well as the US National Institutes of Health (NIH) through its support of the Martin Delaney BELIEVE Collaboratory.    +++++    Immune checkpoint inhibitors are waging a revolutionary war on cancer, but new research challenges the central dogma of how this drug treatment works. This research, published in the prestigious Journal of Clinical Investigation, shows for the first time that often-overlooked immune cells called Natural Killer (NK) cells play a crucial role in responding to checkpoint inhibitors.    co-senior author Dr. Michele Ardolino, a scientist at The Ottawa Hospital and assistant professor at the University of Ottawa  explains that, “Checkpoint inhibitors work by waking up the body’s own immune system and unleashing an immune attack on cancer cells. For many years, everyone assumed that checkpoint inhibitors targeted immune cells called T-cells. But our research shows that they also target Natural Killer cells and these cells play a key role in the how this treatment works.”    Dr. Arolino led the study together with Dr. David Raulet, a professor at the University of California at Berkeley.    Dr. Raulet says that “In the cancer immunotherapy field there has been a singular focus on mobilizing anti-tumor T-cells. We believe that NK cells have an important place at the table. Checkpoint therapy combined with other NK-directed immunotherapies may enable us to target many types of tumours that are currently non-responsive to available therapies.”    T-cells and Natural Killer cells can both recognize and kill cancer cells, but they do so in very different ways. NK cells recognize patterns of changes on cancer cells and are the immune system’s first line of defense. A T-cell, on the other hand, recognizes a single abnormal molecule on a cancer cell and initiates a more focused attack.    In the current study, Drs. Ardolino, Raulet and their colleagues investigated the effect of checkpoint inhibitors in various mouse models of cancer. They found that checkpoint inhibitors could shrink tumours even in mice with no anti-cancer T-cells, meaning that some other kind of cell must be responding to the checkpoint inhibitors. When the mice were depleted of Natural Killer cells, it greatly reduced or eliminated the anti-cancer effect of the checkpoint inhibitors. They also showed that Natural Killer cells produce the same checkpoint receptor molecules that T cells do, inferring they can respond directly to checkpoint inhibitors.    co-lead author Jonathan Hodgins, a PhD student at The Ottawa Hospital and the University of Ottawa says that, “This research helps solve a mystery that’s been seen in the clinic, where certain cancers are very susceptible to checkpoint inhibitors even though their T-cells don’t seem to be activated. If we’re right, Natural Killer cells are probably being activated in these patients.”    Previously, Dr. Ardolino, worked in Dr. Raulet’s lab in California before he was recruited to The Ottawa Hospital and the University of Ottawa in 2016. Together they are now investigating approaches to further enhance the cancer-killing ability of Natural Killer cells.    Dr. Ardolino says that, “My dream is that when people come to the hospital with cancer, we’ll be able to take a biopsy and determine not only the mutations in their cancer, but also profile how their immune system is interacting with their cancer. Then we would give the patient the immunotherapy treatments that is most likely to work for them.”    +++++    As a gateway to the cancer research pipeline in Ontario, and a bridge between public and private sectors with an expanding portfolio of breakthrough innovations, Fight Against Cancer Innovation Trust (FACIT) is committed to supporting Ontario entrepreneurs through the latest round of its Prospects Oncology Fund to continuously identify and advance breakthroughs in science and technology.    FACIT has carefully chosen three novel cancer therapeutic discoveries to receive early-stage capital – biotechnology start-up Talon Pharmaceuticals, the Drug Discovery team at the Ontario Institute for Cancer Research (OICR) and the Centre for Commercialization of Regenerative Medicine (CCRM).    The Prospects Fund provides entrepreneurial scientists with the capital resources necessary to achieve critical proof-of-principle studies for their cutting-edge breakthroughs aiming to benefit future patients.    Talon Pharmaceuticals, through its Multiphore drug design platform, is focused on the discovery, development, and commercialization of medicines designed to save lives and improve patient quality of life. They are developing a novel series of small molecules with an undisclosed mechanism of action applying decades of experience with central nervous system (CNS) drug discovery.    OICR is a collaborative, not-for-profit research institute accelerating the development of new cancer research discoveries for patients around the world while maximizing the economic benefit of this research for the people of Ontario. OICR’s Drug Discovery team and their collaborators at the National Research Council (NRC) will receive funds towards the development of a potentially superior class of antibody-drug conjugates.    CCRM’s mission is to generate sustainable health and economic benefits through global collaboration in cell and gene therapy, and regenerative medicine. CCRM will receive funds towards the development of a universally compatible source for the next generation of CAR-T therapies.    FACIT’s $35-million in investments over multiple years addresses a critical health care seed-stage gap often experienced by Ontario product developers. De-risking innovation sets up successful projects for either company creation or a larger round of financing by FACIT and its investment partners, with over $340-million in follow-on financings to date. FACIT’s maturing portfolio of technology investments anchors companies and jobs in Ontario and reduces the need for entrepreneurs to look south of the border.    David O’Neill, president of FACIT  says that, “Our team is pleased to invest in and work alongside these entrepreneurial scientists, providing capital, industry networks and commercialization expertise, as they advance their therapies closer to clinical development. Capitalizing on the province’s investment in healthcare and scientific collaboration through our strategic partners at OICR is not only good for creating high-skilled jobs but also ensures research undergoes translation to impact the lives of patients with cancer.”    +++++    Oncolytics Biotech Incorporated enters into a clinical collaboration with SOLTI, an academic research group dedicated to clinical and translational research in breast cancer. This clinical collaboration, being sponsored by Oncolytics and facilitated by SOLTI, is a window of opportunity study in the neoadjuvant setting for breast cancer.    Reolysin, (pel-areo-rep), an intravenously delivered immuno-oncolytic virus turning cold tumours hot is under development by Oncolytics Biotech. Patients will receive the appropriate standard of care for their cancer subtype plus pel-areo-rep (or Reolysin with or without the anti-PD-L1 cancer immunotherapy ate-zoli-zu-mab (also known as Tecentriq)). Patients are biopsied on day one, followed immediately by treatment and a final biopsy after three weeks, on the day of their mastectomy. Data generated from this study is intended to confirm that the virus is acting as a novel immunotherapy and to provide comprehensive biomarker data by breast cancer sub-type, to support Oncolytics’ phase 3 study in metastatic breast cancer and is expected in mid 2019.    Matt Coffey, president and CEO of Oncolytics Biotech says that they are thrilled to enter into this collaboration with SOLTI and sponsor this window of opportunity study.  They expect that this study will provide additional biomarker and immunological data to support our planned phase three study in metastatic breast cancer. This data should confirm the findings of our phase two study and generate a robust biomarker plan designed to potentially enhance our phase three program. Importantly, it will also generate additional data demonstrating how the promotion of a virally induced inflamed phenotype should synergise with checkpoint inhibitors targeting PD-L1 like ate-zoli-zu-mab.”    The study, facilitated by SOLTI, will be coordinated by Dr. Aleix Prat, head of Medical Oncology at the Hospital Clínic of Barcelona, associate professor of the University of Barcelona and the head of the Translational Genomics and Targeted Therapeutics in Solid Tumors Group at August Pi i Sunyer Biomedical Research Institute (IDIBAPS) and member of Oncolytics’ Scientific Advisory Board. SOLTI has a network of more than 300 professionals, mostly medical oncologists, in over 80 hospitals in Spain, Portugal, France, and Italy. Final study design and other details will be announced upon enrollment of the first patient, expected around the end of 2018 or very early 2019.     Dr. Prat says that, “It has been demonstrated that when reovirus infects a tumor, it promotes the release of immuno-stimulatory signals. This, in turn, results in the upregulation of PD-L1 on tumor cells and the recruitment of inflammatory immune cells like Natural Killer-cells and cytotoxic T-cells to the tumor, which are required prerequisites for checkpoint inhibitors to function effectively.  In short, it turns cold tumours hot. They believe pel-areo-rep can demonstrate the necessary inflamed tumour phenotype to prime tumours for PD-L1 blockade, which could potentially represent a promising form of cancer immunotherapy combination with ate-zoli-zu-mab. Results from this study will seek to establish the virus as an important immuno-oncology agent in breast cancer, which could ultimately support the expansion of pel-areo-rep beyond metastatic breast cancer into first-line therapy.”    +++++    Well that wraps up another episode of Biotechnology Focus radio. Thanks for listening! Make sure to check out the articles on the website: biotechnologyfocus.ca. Until the next time, from my desk to yours – this is Michelle Currie. 

Revolutionary research breaks the frontline against HIV and cancer | 097

   Welcome to another episode of Biotechnology focus radio! I am your host – Michelle Currie – here to give you the rundown on what is happening in the life sciences sector from coast to coast. This week brought new collaborations, new cohorts, and new research. Keep listening to find out more!    +++++    As regenerative medicine grows around the world, topping a whopping $36-billion annually and only expected to rise, it comes as no surprise that more and more international collaborations are happening – especially within Canada.    CCRM and the Japanese Society for Regenerative Medicine (JSRM) liaise to advance the field of regenerative medicine (RM) and cell and gene therapies in Canada and Japan, signing a Memorandum of Understanding (MOU) this week at the Annual Meeting of the Tissue Engineering and Regenerative Medicine International Society (TERMIS) in Kyoto, Japan.    Michael May, president and CEO, CCRM says that CCRM’s mission is to generate sustainable health and economic benefits through global collaboration in cell and gene therapy, and regenerative medicine. CCRM is catalyzing a global network of highly integrated commercialization centres working together to enable viable and cost-effective patient access to revolutionary new treatments. The Memorandum of Understanding with Japanese Society for Regenerative Medicine, through its vast research network and industry-enabling activities, is a positive step in that direction.”    The Memorandum of Understanding has been put in place to promote academic and industry partnership in Japan, Canada and internationally to advance the field of regenerative medicine and cell and gene therapies. This will include supporting knowledge translation about technologies, policies (e.g., regulatory and health economics), legal and ethical issues.    Prof. Sawa, president of Japanese Society for Regenerative Medicine.  Says that “There are many obstacles to establish a sustainable business model for regenerative medicine in Japan, as it requires a whole new value chain. Canada’s CCRM has been fostering and promoting a successful commercialization model since its launch. JSRM is proud to announce that we have entered into a partnership with CCRM to develop sound industrialization pathways, learning from CCRM’s excellent model to make regenerative medicine an available treatment worldwide.”    Regenerative medicine – that can be a bit of an umbrella term – includes cell and gene therapy, stem cells, biomaterials, molecules and genetic modification to repair, regenerate or replace diseased cells, tissues and organs. This approach is disrupting the traditional biotechnology and pharmaceutical industries with the promise of revolutionary new cures for devastating and costly conditions such as heart disease, diabetes and cancer.    This sector represents so many potential untapped possibilities. Forecasted to grow to US$49.41-billion by 2021, there were 977 clinical trials in cell, gene and tissue therapy underway worldwide at the close of the second quarter of 2018. The sector achieved the first global approvals and reimbursements for major cellular immunotherapies and gene therapies in 2017, that resulted in record-breaking investment and acquisitions in the sector. This field encapsulates the phrase “the world is truly their oyster”.    +++++    The Centre for Drug Research and Development, Canada’s national life sciences venture, announces the first cohort of the CDRD Academy’s Executive Institute.    Earlier this year, CDRD and Pfizer Canada announced the launch of the Executive Institute under the umbrella of The CDRD Academy. The Institute is a 10-month, focused executive development program open to a limited number of senior-level life sciences professionals annually. It was made possible by a $1M contribution by Pfizer Canada.    After reviewing dozens of applications from across Canada, the Adjudication Committee has selected a cohort of diverse, talented, and forward-thinking individuals that is gender balanced, and represents a variety of personal and professional backgrounds. The following individuals have been accepted into the inaugural 2018-2019 class:    Naveed Aziz, Chief Administrative and Scientific Officer, CGEN – Canada’s Genomic Enterprise, Toronto, ON    Deanna Dryhurst, Chief Scientific Officer, ImmunoPrecise Antibodies Ltd., Victoria, BC    Alexander Graves, Chief Executive Officer, Symvivo Corporation, Vancouver, BC    Allison Gaw, Senior Director, Corporate Development and Intellectual Property, Sierra Oncology, Vancouver, BC    Nataša Jovic, Senior Director, Personal Health, Microbiome Insights, Vancouver, BC    Andrew Knowles, Senior Vice President, Operations, STEMCELL Technologies, Vancouver, BC    Frédéric Leduc, Chief Executive Officer and Co-Founder, Immune Biosolutions, Sherbrooke, QC    Stephanie Michaud, President and Chief Executive Officer, BioCanRx, Ottawa, ON    Carolyn Nalder, Director of Business Operations, Tevosol, Edmonton, AB    Frederic Ors, Chief Executive Officer, IMV, Quebec City, QC    Chris Sinclair, Vice President, Global Commercial Operations, Emergent BioSolutions, Winnipeg, MB    Kimberly Stephens, Chief Financial Officer, Appili Therapeutics Inc., Halifax, NS    Carol Stiff, Senior Director, Sales and Marketing, Santen Canada, Toronto, ON    Jefferson Tea, Vice President, Medical and Scientific Affairs, Takeda Canada Inc., Oakville, ON.    Gordon C. McCauley, president and CEO of CDRD  says that “The core of any business is people and supporting and growing our pool of highly-qualified personnel is critical to drive Canada’s health sciences sector. Through the CDRD Academy’s Post-Graduate and Undergraduate Institutes, we have seen tremendous success over the past 10 years in helping high-potential scientists be more commercially minded. But, with the addition of the Executive Institute to the CDRD Academy, we are now extending our work to also help high-potential business people lead Canada’s science-based businesses of tomorrow; and ensure Canada has the management talent it needs to lead the life sciences world.”    The CDRD Executive Institute program is delivered in collaboration with the not-for-profit Center for Creative Leadership (CCL). The program has been custom-designed and aims to combine researched and proven best practices/principles with targeted industry topics to take participants on a leadership journey. It will blend in-depth assessments, workshops, simulations, challenging assignments and executive coaching.    John Helou, president, Pfizer Canada says that ‘’The CDRD Executive Institute is off to a very strong start. The first cohort of life science executives exemplifies the type of leaders needed for the industry to reach its full potential. We are pleased to help meet the development needs expressed by life sciences industry stakeholders across the country, and to be able to count on the leadership of CDRD to implement concrete measures that will increase the innovative skill level of this vital industry. We are confident that the tailored training and coaching will contribute to the success of many life science organizations in Canada, which is critical for the development of new treatments for unmet medical needs’’.    This course offers a unique opportunity that will further the life sciences community within Canada and potentially bring the sector and consequently, the economy to new heights. The first face-to-face session will happen in Vancouver September 12-13, 2018, with additional workshops to be held in Montreal and Toronto throughout the Winter and Spring 2019.    +++++    Concordia synthetic biology researchers develop a method to fight disease at a genetic level that may revolutionize patient care.    Steve Shih, an assistant professor of electrical and computer engineering in Concordia University’s Faculty of Engineering and Computer Science and with a cross-appointment in biology, is also the founder of the Shih Microfluidics Laboratory.    His team created a system that integrates the automation of complex biology experiments in order to find genes that are related to cancer and kill them before they develop into a potentially fatal disease.    The system is described in a paper published last July by the journal Lab on a Chip.    Shih says that “Finding genes related to cancer is already very difficult. It’s like finding a needle in a haystack, especially with current methods. But hopefully, with this new method, we can expedite the whole process and rapidly find the culprit genes.”    However, finding the genes is one thing. Preventing them from causing cancer is another.    To do that, Shih’s team uses CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) a genetic engineering technique that uses a Cas9 protein (essentially a pair of ‘programmed genetic scissors’) to find a cancer-causing gene and essentially snip it out of the DNA and replace it with a healthier one.    Shih says that “Once both ends of the gene are snipped, it degrades to the point where we won’t have it anymore. Now that gene won’t be able to go through pathways that cause cancer. To be able to do that on a typical platform is very difficult, because we’re dealing with very static, very manual techniques.    “By doing this in an automated way, and by also miniaturizing the scale which we’re working on, we’re able to expedite the whole process. Instead of looking at this process as a matter of weeks, we can look at it in a matter of days.”    The paper’s authors — Hugo Sinha, Angela Quach, Philippe Vo and Shih, all affiliated with Concordia’s Centre for Applied Synthetic Biology — created the first digital microfluidic method that automated arrayed gene editing in mammalian cells.    This involves using tiny amounts of fluid to culture lung cancer cells for up to six days, while at the same time automating gene transfection and knockout procedures.    The whole automation and miniaturization process that they have developed has not only saved them heaps of time, but it has also slightly augmented the efficiency of the knockout procedure itself.    The mission to eradicate cancer has been a personal aspect for Shih, and he believes his work will have direct material benefits for people diagnosed with cancer.    He hopes his project will contribute to the development of personalized platforms for treatment based on their genetic makeup. That platform would be easily transferable and can be set up in any kind of lab or hospital.    In fact, Sinha started a company called DropGenie that will create gene-editing platforms that can bring this idea to realisation.    Despite CRISPR being controversial, Shih believes that only now researchers are reaping its benefits.    He adds that “There still isn’t a killer application for microfluidics, but I think we’ve found it. I think we found that we can use these miniaturized platforms for something that can really save people’s lives down the line. That’s why I say it can be a killer app because hopefully, we’ll be able to eventually kill all cancer cells.”    +++++     Researchers from the Peter Munk Cardiac Centre (PMCC) at UHN suggest that the model used by the Canadian Institute for Health Information (CIHI) significantly underestimates mortality in specialized heart surgery centres. The study’s findings show that CIHI’s model does not encapsulate all the medical problems that patients have when at elevated risk for surgery.    The study, looked at the outcomes of 1,635 cardiac operations performed at the Peter Munk Cardiac Centre between 2013 and 2016. It compared the observed mortality within 30 days of surgery to the predicted mortality rates estimated with either the CIHI administrative data model or the clinical data model used by the Society of Thoracic Surgeons (STS).    Of the 1,635 patients that had heart surgery at the Peter Munk Cardiac Centre, 32 died within 30 days of surgery. These results were in line with the 1.96 per cent mortality predicted by Society of Thoracic Surgeons model – which uses comprehensive data to describe how sick patients are before surgery – for this group of patients. In contrast, the CIHI Cardiac Care Quality Indicator estimated that the mortality rate for these 1,635 patients would be 1.03 per cent.    Peter Munk Cardiac Centre researchers noted that the Society of Thoracic Surgeons model captures seven medical conditions that predict worse outcomes after heart surgery that are not captured in the CIHI model.  These risk factors include whether the patient had heart failure, an abnormal heart rhythm, a recent heart attack, very low blood pressure (shock), needed recent CPR or a mechanical heart pump to live, or had kidney failure. These serious conditions forecast a worse outcome after heart surgery, and are not included in the CIHI database.    Dr. Barry Rubin, medical director of the Peter Munk Cardiac Centre and one of the authors of the study  says that “The predicted mortality of patients undergoing heart surgery based on the Society of Thoracic Surgeons model is similar to what we actually observed,” says. “The failure to include these seven medical conditions causes the CIHI database to underestimate predicted mortality after heart surgery in high risk patients.”    According to Dr. Douglas Lee, senior scientist at the Peter Munk Cardiac Centre and lead author of the study, mortality prediction models – either based on clinical or administrative data – use risk adjustment to account for how sick patients are before surgery at different hospitals. This is necessary as outcomes may vary if leading academic institutions such as the Peter Munk Cardiac Centre operate on sicker patients.    Dr. Lee says that “The CIHI and Society of Thoracic Surgeons models aim to predict outcomes based on the medical complexity and acuity of the patient. In general, academic hospitals take on higher risk cases compared to community hospitals, and good risk adjustment models should factor that in when predicting mortality rates,” explains Dr. Lee.    Incorrect data may lend the impression that there is a higher level of mortality then there should be at the PMCC or other academic centres. This could have the inadvertent effect of causing the highest risk surgery patients to defer potentially-life saving heart surgeries.    CIHI has a legislative mandate to publicly release Cardiac Care Quality Indicator data and has done so since October 2017. Clinicians and researchers have been concerned that the CIHI model may underestimate how sick cardiovascular surgery patients are at Peter Munk Cardiac Centre.    Incorrect data may lend the impression that there is a higher level of mortality then there should be at the Peter Munk Cardiac Centre or other academic centres. This could have the inadvertent effect of causing the highest risk surgery patients to defer potentially-life saving heart surgeries.    The Society of Thoracic Surgeons model considers vital medical conditions to accurately predict how high-risk patients will do after surgery. The CIHI model does not accurately account for complexity of patients, which is recorded in databases specifically designed for the measurement of surgical quality, such as Society of Thoracic Surgeons.    Dr Rubin says that “Clinical data-based models like the Society of Thoracic Surgeons collect much more detailed patient information, but are also more costly to maintain. “Administrative models like CIHI’s continue to play a very important role in assessing quality of care across Canada. We will continue to work in collaboration with CIHI to improve the accuracy of quality report cards that can be used as valid evaluation tools for Canadian hospitals.”    The authors caution that there are limitations to the study, as it was completed in a single centre during a three-year period, observing 1,341 isolated coronary bypass grafts, 143 isolated aortic valve replacements and 151 combined procedures. PMCC researchers declared there were no conflict of interests but would suggest validation of these findings in other academic centres over a longer time interval that would include a larger subset of cardiac operations. This study was supported by the Canadian Institutes of Health Research.    +++++    Well that wraps up another episode of Biotechnology Focus radio. Thanks for listening! If you have any questions or comments, please email us at press@promotivemedia.ca . From my desk to yours – this is Michelle Currie. 

With great growth, comes great responsibility | 096

   Welcome to another episode of Biotechnology Focus radio! I am your host – Michelle Currie – here to give you the rundown on what is happening in biotech across the country from coast to coast. There have been some interesting developments in the last couple weeks that are changing the scope of the life sciences industry. Some of which I get the pleasure to share with you today. As a first for Canada, Concordia University now houses a facility that will change how synthetic biology research will be conducted; Bioasis Technologies’ promising drug development may have found a way to cross the blood-brain barrier; the Centre for Commercialization of Antibodies and Biologics invests in ImmunoBiochem to advance their therapeutic candidate; and the Canadian government, as well as other investors, allocate $8.8 million to three projects in Ontario.     Keep on listening to find out more details!    +++++    A new facility at Concordia is about to change history. It will house robots that will bring a whole new concept of speed and scale to synthetic biology research.    The Genome Foundry is the first Canadian laboratory of its kind, and amongst only a handful at leading institutions around the world. By automating notoriously labour-intensive lab work, it will eliminate bottlenecks in a rapidly evolving field where the design principles of engineering fuse with the tools of biology to create meaningful synthetic biological systems.    Christophe Guy, vice-president of Research and Graduate Studies at Concordia says that the Genome Foundry solidifies Concordia’s position as the Canadian leader in synthetic biology research and will enable their scientists to work at the cutting-edge while facilitating partnerships with other institutions. Given that Concordia researchers are already engaged internationally in defining the future of this field, they are eager to witness how this new facility will support the transformative work being done at the university.    At the moment, much of the lab work done by synthetic biologists involves moving and combining small amounts of liquids and cells. The Genome Foundry’s robotics will allow for speed and absolute precision, thus greatly increasing the variety and number of experiments that can be completed, and the accuracy with which they can be reproduced.    The Genome Foundry was established with funds from the Canada Foundation for Innovation and the government of Quebec and is part of Concordia’s synthetic biology hub along with the Centre for Applied Synthetic Biology (CASB), the SynBioApps NSERC CREATE program and the soon-to-be-inaugurated District 3 Innovation Centre science hub.    Vincent Martin, co-director of the Centre for Applied Synthetic Biology says that they are thrilled to open the doors of our Genome Foundry. That this is a monumental addition to Canada’s synthetic biology ecosystem. It empowers researchers to navigate uncharted waters alongside international colleagues, and to incubate the future leaders of the field.    The Centre for Applied Synthetic Biology aims to develop high-value applications in human health, agriculture, chemicals and environmental technologies. It also provides a broad range of unique opportunities — such as the recently announced NSERC CREATE SynBioApps program — for training leading experts in the field.    Launching this technology platform also marks Canada’s participation in the next generation of synthetic biology, with Concordia now engaged in directing how this infrastructure will be developed and used on a global scale.    This facility will have real world, potential life-saving capabilities that deliver an innovative scientific approach to create genetic blueprints for individuals, bring more knowledge to researchers on a faster scale, and help physicians diagnose, treat and prevent their patients from contracting future diseases.    +++++    With neurological diseases predicted to rise exponentially across the globe, whether resulting from the extension of life expectancy or aging populations, more novel solutions are necessary so that health care can stay ahead of the game.    Neurological diseases, disorders and injuries – such as Alzheimer’s disease, amyotrophic lateral sclerosis, multiple sclerosis, brain tumours, and Parkinson’s disease – are some of the leading causes of disability amongst the Canadian population that take a toll not only on the patient and the Canadian health care system, but also have a significant economic impact.    To date, these neurological diseases and disorders have been largely incurable and tend to worsen over time, typically involving invasive procedures by scientists and researchers as they attempt to penetrate the blood-brain barrier. Remarkable as the blood-brain barrier is to neuroscience, it is extremely fickle and highly selective, restricting the paracellular diffusion of water-soluble substances from the blood to the brain. Despite it being nature’s evolutionary way of protecting humans’ greatest asset, it does not come without its faults. Its defensive properties impede the way for medicinal compounds to penetrate the barrier and deliver the potential life-saving properties to their destination point.    Statistics have shown that 1 in 6 will acquire a neurological disease, totalling about 1.25 billion people worldwide. It is for this reason Canadian company Bioasis Technologies Inc. is determined to deliver effective treatments to patients who suffer from one of these diseases.    Vancouver-founded Bioasis has undertaken this challenge by focusing on a single goal: revolutionizing science by transporting therapeutic payloads across the blood-brain barrier and into the brain. They have developed and are in the process of commercializing their proprietary brain delivery technology, the xB3 platform, to make life-saving drugs brain-penetrant and deliver those therapies at a therapeutically relevant dose.    Inception of the company began back in 2007 when researchers discovered an extremely large peptide that was capable of crossing the blood-brain barrier with a substantial amount of cargo. The team did a couple of experiments with Doxorubicin in mice models with cancer that positively showed higher survival rates and became the first proof of concept. The also acquired Trastuzumab data whereby they transferred Herceptin across the blood-brain barrier in sufficient quantities to reduce the number of tumours.    Although researchers have been speculating about less invasive methods that will penetrate the barrier, Mark Day, the president and chief executive officer of Bioasis, comments that the key thing if you have brain cancer is that the only therapeutic benefit will come from a direct infusion into the brain – like drilling a hole in the head – and while some people are trying to inject into the spine and pump it into the central nervous system, none of it has worked. The brain methods do work, so there is at least some data if you inject it that you can get it approved for efficacy for small groups of patients.    Recently, MedImmune, a wholly-owned subsidiary of AstraZeneca, did an independent validation of Bioasis’ xB3 platform technology that transpired incredible results. The study found that the xB3 fusion protein maintained the systemic pharmacokinetics of its payload and had significantly improved and sustained brain exposure of the payload molecule. It provided evidence that Bioasis’ platform technology was recombinant and chemically conjugated drugs across the blood-brain barrier to increase brain exposure.    These data and validation from MedImmune provide promising results that it will work in a phase 1 study. Bioasis figured out that once they attached Trastuzumab to 12 active amino acids (peptide 12aa), 10 times the amount of the drug passed through the blood-brain barrier. Mark Day adds: “What is really important is that once the drug is in the brain it hits the tumour. Looking at these results you can see that there are significant therapeutic doses in the brain and in controlled regions. This shows us that the drug gets into the brain, it gets to the site of action, and binds to those specifically where there are HER2 positive cells.”    Bioasis has four main programs:    xB3-001: Brain Metastases, which is the most common form of brain cancer in adults and is often fatal due to anti-cancer drugs being unable to pass the blood-brain barrier, and is also the program that will progress first to human trials in 2019;    xB3-002: Glioblastoma, one of the most aggressive cancers that originates within the brain, with 80 per cent of diagnosed primary malignant brain tumours as malignant gliomas. It is considered the deadliest form of brain cancer due to its high infiltration of surrounding brain tissue. This program is being done in collaboration with Minerva in Copenhagen;    xB3-007: Neurodegenerative diseases, which entail a progressive loss of function by the neurons in the brain and in being diagnosed at an alarming rate partly due to an aging population; and    xB3-008: Lysosomal storage diseases, which are inherited metabolic diseases that are characterized by an abnormal build-up of various toxic materials in the body’s cells as a result of enzyme deficiencies.    If the xB3-001 and xB3-002 programs are successful, it would be the first time in human history that medicine for cancer has been properly received into the brain without having to drill into the patient’s head. This will be a breakthrough in science and open the doors to a floodgate of scientific possibilities.    Bioasis’ technology platform has been so efficacious that there simply have not been any competitors that have been able to keep up. The receptor with which they work with is ubiquitous to the blood-brain barrier walls, providing more possible passageways for medicine to penetrate through. This receptor, even in its natural form, is critical in cleaning out harmful tissues in the brain like Alzheimer’s disease for example and is necessary to maintain brain integrity.     Mark Day adds that the other thing that differentiates them is how they develop drugs. They know that if you engage the target and prove that the target engagement drives biologic effect – to schizophrenia that would be a lowering of dopamine – then you have a good sense of patient population. So, for some of these diseases, there is a very strong genetic basis to them and subsequent diseases that gives them the mechanism to recruit the patient who is most likely to benefit from the medicine in the first tranche.    The proof of principal in the first point, get the proof of concept, on the back of a positive proof of concept then you would go earlier into the diseases. That’s what they can do with our last two neurodegeneration products. Basically, they go into a smaller niche indication, get the proof of concept and then expand it into other disease areas. That’s been the strategy.    With recent editions to their scientific advisory board and looking ahead to put them in the best financial position for Nasdaq, the future looks promising for this biotechnology company. Penetrating the blood-brain barrier has been an arduous task, but if Bioasis is successful, their technology will revolutionize the treatment for neurodegenerative diseases and brain tumours, potentially slowing the progression of disease, and maybe someday offer a cure.    +++++    The Centre for the Commercialization of Antibodies and Biologics (or CCAB) provides a new investment to help advance ImmunoBiochem’s novel breast cancer therapeutic candidate one step closer to the clinic. The agreement marks a first for CCAB as part of its new business strategy, which aims to attract investment to create successful life sciences companies in Canada. CCAB will develop ImmunoBiochem’s lead candidate towards regulatory filings, and merge their business acumen with its research and technical expertise to support the co-development of new biological therapeutics.    CCAB CEO Robert Verhagen says that today’s announcement marks the beginning of a very exciting period of growth. The agreement with ImmunoBiochem is a natural extension of an already fruitful partnership and that they are looking forward to helping the company get to the next crucial stage in the development of this promising anti-cancer therapy. As CCAB continues to expand its mission in this space, they plan on establishing similar partnerships with other emerging companies in the near future.    ImmunoBiochem is developing novel potentiated biologics to treat triple-negative breast cancer (TNBC), an aggressive form of breast cancer for which there are currently no targeted biological treatment options. Earlier this quarter, ImmunoBiochem secured an additional private investment to support its pipeline and entered into a license agreement with the University of Toronto for novel therapeutic antibodies.    ImmunoBiochem’s CEO Dr. Anton Neschadim says that ImmunoBiochem’s highest priority is to make new treatment options available for patients with this difficult-to-treat breast cancer. They have made significant progress and have validated their approach in vivo. CCAB has been tremendously supportive of their work and they are excited that this new agreement will help them advance their lead candidate even further.     Breast cancer is the most common cancer among Canadian women and is the second leading cause of death from cancer. In 2017, 26,300 women were diagnosed with breast cancer and 5,000 women died from the disease. Triple-negative breast cancer accounts for up to 20 per cent of breast cancers and is one of the most heterogeneous diseases, comprising multiple breast cancer sub-types. Consequently, even highly promising treatments that are in late stages of the clinical pipeline are likely to only address the needs of a partial number of triple-negative breast cancer patients. ImmunoBiochem has developed therapeutic candidates that aim to close on this gap by overcoming treatment challenges associated with tumor heterogeneity.    Much of biological therapeutics distinguish cancer cells from normal cells based on proteins differentially expressed on their surface. In solid tumours, most such targets are heterogeneously expressed, impeding complete responses and driving resistance and relapses. ImmunoBiochem is focusing instead on selective targets in the tumour microenvironment that are broadly present and interact with all cells in a tumour, including tumour-supporting stroma. ImmunoBiochem has shown that this approach could be more effective and safer than conventional surface-targeted therapeutics.    This agreement between the two companies has the potential to lead to viable therapeutics that are sorely needed, especially for cancers that have a high rate of morbidity and mortality.    +++++    Genome Canada announces federal funding for seven new projects under the Genome Canada’s Genomic Applications Partnership Program (GAPP), three of which hail from Ontario. This will be driving $2.9 million of federal funding into the province and an additional $5.9 million from investments in the industry, government, and funding partners. For a total of $8.8 million, this could heed rewarding results.    The announcement was made by the Minister of Science and Minister of Sport and Persons with Disabilities. The Honourable Kirsty Duncan, at the Vineland Research and Innovation Centre.    Vineland is partnering with a team of University of Toronto researchers to develop genomics-based technologies that will induce broad-spectrum disease resistance in greenhouse vegetables, allowing new varieties of vegetables to thrive and reducing waste. This will give growers across Ontario and Canada a competitive advantage in a national industry that already generates more than $1 billion annually from retail sales and exports.    In another Genomic Applications Partnership Program project, researchers at McMaster University are partnered with Hamilton-based start-up Adapsyn Bioscience Incorporated to use its proprietary technology platform that combines genomic and metabolomic data with artificial intelligence and machine learning to redefine and accelerate drug discovery for novel treatments of a wide spectrum of diseases. This partnership secured significant foreign and domestic investment and is creating new high-tech jobs in Ontario.    The third Ontario-based Genomic Applications Partnership Program project announced brings together researchers at the Sunnybrook Research Institute and the University of Toronto with Canadian start-up Fusion Genomics to further develop novel infectious disease surveillance tools. Their technology is unique in its ability to detect and genetically characterize infectious viral pathogens through bioaerosols to serve as an early warning for disease outbreaks in both humans and agricultural animals. The development of this pre-emergence environmental detection technology will drive a paradigm shift in public health and animal welfare by offering complete genomic data to anticipate outbreaks, inform disease transmission dynamics and enable vaccine design and production.    Genomic Applications Partnership Program is a program that partners researchers with companies and other end-users who will apply their innovations with the goal of increasing and accelerating the positive social and economic impact of Ontario’s and Canada’s genomics R&D; capacity. Since 2013, approximately $86.1 million, including co-funding has been invested in 23 Ontario-based Genomic Applications Partnership Program projects, fuelling innovations, spurring job creation and attracting foreign investment in Ontario’s health, agriculture & agri-food, fisheries, environment and natural resource sectors.    In such an emerging industry, there is nothing better than seeing companies and research succeed. With these recent investments, there is high hope that we will see encouraging results in the future.    +++++    Well that wraps up another episode of Biotechnology Focus radio! Thanks for listening! If you have a story or a story idea, feel free to contact me at press@promotivemedia.ca. Until the next time, from my desk to yours – this is Michelle Currie. 

Even at the forefront of change… what’s next? | 095

On the line, I have Andrew Casey who is the president and CEO of BIOTECanada. He is responsible for the day-to-day operations of the association and is the primary spokesperson for Canada’s biotech industry communicating on the industry’s behalf of government, regulators, international bodies, media and the Canadian public. He joins us today to share his expertise and what we can expect to see this year during Global Biotech Week.   Show Notes: 1. Canada has always been a powerhouse in biotechnology. The life sciences sector has had such an overwhelming impact on the Canadian economy and shows no sign of slowing down; and with a rapidly growing population and a high demand for resources and better health care, novel ideas are necessary to keep the economy on its feet. Is this something Canada foresaw in 2003 when it created Global Biotech Week? What was the reason Canada created Global Biotech Week initially?  2. Since then it has snowballed to several other countries. Do you expect to see it grow traction in more in the upcoming years? Where has it spread to thus far? Do you find that it brings the global economy together? 3. What can we in the industry expect to come out of this year’s BIOTECanada event? A little birdy told me that BIOTECanada will be announcing the Gold Leaf Awards winners – which are very prestigious – that represent the companies and individuals who have made significant contributions to Canada’s biotech ecosystem. Any chance you could give us a sneak peak at some of the nominees?  4. Gauging by how Canada has done so well in the past, but now has more extensive global competition, how can Canada prove that we are at the forefront of this monumental shift to feed, fuel and heal the world? And how do you think the world can conjoin together to face and find cures for some of the world’s most devastating and debilitating diseases? 5. When Budget 2018 was released, Bill Morneau, the Canadian minister of finance, stated that that was the largest investment in fundamental and discovery research in Canadian history. What have you seen come from that so far? What do you think we can expect to see? How does this position Canada as a world leader in biotechnology? What do you predict to see happening in the future? 6. Is there anything else I have missed that you would like to touch on? Well that concludes another episode of Biotechnology Focus radio. I would like to thank our guest again, Andrew Casey for being with us today and thank our listeners for their continued enthusiasm of the life sciences sector in Canada. I hope you all have a wonderful week. From my desk to yours – this is Michelle Currie.

055 | Interview with Gordon McCauley, President and CEO of the Centre For Drug Research and Development

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