Science
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.