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Tag: Pharmaceuticals Research & Development

Locally developed drug secures FDA approval

Aurinia becomes one of only nine Canadian companies to secure this approval

Earlier this month, Aurinia Pharmaceuticals Inc. announced that their drug, LUPKYNIS, has been approved by the U.S. Food and Drug Administration to treat patients with active lupus nephritis. Aurinia is one of only nine Canadian companies that have successfully taken a novel drug to market through the FDA.

It’s an exciting announcement with an interesting story that originates in the Edmonton region and is a great example of what’s possible for the pharmaceutical sector here. 

Dr. Robert Fraser first discovered the drug voclosporin in 1993. Today it is valued at $3 billion CAD

LUPKYNIS was originally called voclosporin, a drug that Dr. Robert Foster first discovered 28 years ago, after leaving his position at the University of Alberta to found Isotechnika Pharma Inc.. Dr. Foster believed voclosporin could be an improvement to the drug Cylosporin, the standard of care drug for organ transplantation that had some problems from a safety perspective. Through the course of his work, he discovered that voclosporin also had the capacity to treat autoimmune diseases like arthritis, psoriasis and lupus. 

That’s when Aurinia Pharmaceuticals stepped in and purchased the licencing for the indication of voclosporin for lupus. They rebranded the drug as LUPKYNIS.

During the financial crisis in 2008, Aurinia found themselves struggling to secure financing, so Dr. Foster bought the molecule back in company stock in 2013, merging Aurinia with Isotechnika. He served as the company’s CEO and, later, its Chief Scientific Officer. 

Today, that voclosporin molecule is worth nearly $3 billion CAD and the development of the drug has created hundreds of jobs both here in the Edmonton region and in Victoria where Aurinia is headquartered. This recent announcement will certainly expand the drug’s economic impact. 

But beyond its economic impact, Dr Foster points to the fact that this drug will ultimately save lives. 

“Developing the drug and getting it FDA approved was truly a village effort,” said Dr. Foster.

LUPKYNIS, has been approved by the U.S. Food and Drug Administration to treat patients with active lupus nephritis.

Local non-profit Applied Pharmaceutical Innovation (API), played a part in the effort.  API is a not-for-profit institution hosted by the University of Alberta’s Faculty of Pharmacy and Pharmaceutical Sciences that helps innovators in the pharmaceutical space in the Edmonton region launch their ideas into the real world. They connect industry to the services they need for commercial success, and help accelerate the drug development process. They provide expertise, services, and infrastructure to drug developers and they recently worked with Aurinia on its clinical trial data prior to approval. 

“It’s incredibly exciting,” said API CEO, Andrew MacIsaac, “From our perspective, this approval is as exciting as a Nobel prize. It demonstrates what our pharmaceutical sector is capable of.”

Dr. Foster credits the research capabilities and expertise that exists in the Edmonton region for much of the success that LUPKYNIS is seeing.

“I can say with 100 percent certainty that the education at the Faculty of Pharmacy and Pharmaceutical Sciences at the University of Alberta is world class,” says Dr. Foster. “Everywhere I went around the world in my pre-COVID travels, I bumped into people from the University of Alberta—medical directors, senior executives, global heads of pharmaceutical companies—it’s just top notch people all over the world.”

“People look at me and see I’ve come from this place called Edmonton that they’d never heard of, and ask ‘how do you create a drug from such a place?’ Usually, they expect to hear about Stanford, Yale, Harvard, the Ivy Leagues. But no, not at all. You can easily get an education at the University of Alberta that is second to none. It’s really an absolutely world class school.”

Dr. Foster is currently working as the CEO of another biotechnology company that he founded in 2014 called Hepion Pharmaceuticals. Hepion bought all the early-stage molecules from Aurinia that Dr. Foster and his team originally discovered.

“Today, Hepion is doing the whole process over again, but with the benefit in each one of our cases, almost 30 years of experience,” says Dr. Foster. 

“We’re working closely with Hepion and are very excited to see what they bring forward. Having another blockbuster drug launch from our region in the near future is very likely,” says MacIsaac. “That’s thanks to the expertise of Dr. Foster and the hundreds of folks who started their careers at Isotechnika pursuing ventures across the life sciences, not to mention the thousands of others working from successful ventures and cutting edge research institutions.”

Alberta project validates first synthetic health dataset in province

Project Increases Data Accessibility While Maintaining Patient Privacy

 The health innovation community has one more approach towards increasing the timely and safe utilization of health data thanks to a research project co-sponsored by Health City and the Institute of Health Economics (IHE) in partnership with Alberta Innovates, Replica Analytics, and University of Alberta. Unique in Canada, this project was initiated to provide insight into the value and validity of synthetic (simulated) data in health services research. The promising results have been submitted for publication.

Health City and its partners identified synthetic data generation as one approach to leverage the region’s capacity and partnerships in data, artificial intelligence, and machine learning to fuel health system innovation. Synthetic data accurately simulates patient-derived datasets and, although generated from real world data, is not linked to the individuals from whom the data were derived. Because synthetic data contains no real patient health information, the datasets have the potential to be shared freely among investigators or those in industry without raising patient privacy concerns or contravening the Alberta Health Information Act. The project engaged the Office of the Information and Privacy Commissioner of Alberta to ensure synthetic data can be used in a way that respects the privacy of citizens.

“It was important we demonstrate not only that we protect the data privacy of Alberta,” said Mark Diner, Director at Alberta Innovates, “but that the OIPC understands how the process works as well. Albertans must have confidence in game-changing, data-driven innovation.”

“Alberta has the largest regional health authority in Canada, and the opportunity to use data to drive improved health outcomes is immense. Complex healthcare datasets can support research, policy development, and quality improvement projects across the province, but we need advanced tools like synthetic data to make use of these data sets safely. Due to its complexity, the notion that synthetic data would be able to sufficiently capture and simulate real world data in Alberta was unlikely,” said Dr. Dean Eurich, Professor at University of Alberta. “Remarkably, I was somewhat shocked to observe the research results could be replicated with a fairly high level of precision within synthetic data. These synthetic datasets will be extremely beneficial for researchers to share data across jurisdictions. They will also allow academics and students easier access to health data and support more efficient training of the next generation of health data scientists.”

Demonstrating the viability of synthetic datasets creates further opportunities for innovators to work alongside the health system while preserving patient privacy. Creating further opportunities for health innovation to occur in Alberta is a component to driving economic development for the province.

“Better data analysis techniques lead to better healthcare. Synthetic data provides a safe way for talented data scientists from community, academia, and industry to work alongside the health system to drive improved health and validate novel solutions developed in Alberta for Albertans,” said Reg Joseph, CEO, Health City.

“Alberta has a rich repository of health data that can provide important insights to support improvements in health care and improved use of health care resources,” stated Dr. Chris McCabe, CEO of IHE. “Synthetic data is a promising way to address the challenges of using personal health data directly. We look forward to testing this out and providing lessons on how we can use it for improved health and economic benefit for Alberta.”

About Health City

Health City is a Canadian not-for-profit Corporation that works with clinicians, innovators, philanthropic organizations, and companies to develop new pathways of care that can drive better health outcomes and economic development in the health sector. Our focus is on transforming innovations from our health sector into solutions that have commercial application and global relevance, adopting them for impact locally and scaling them for export to global markets.

For more information, visit www.edmontonhealthcity.ca.

About Institute of Health Economics

Institute of Health Economics (IHE) is a not-for-profit health research organization providing expertise to provincial and national stakeholders from the public and private sectors in evidence production, synthesis and application; economic analysis; and policy engagement. It was founded in 1995 on the belief that the best solutions to healthcare problems are the result of a collaborative approach, with all stakeholders at the table sharing insights and information in support of improved health outcomes and a thriving economy.

For more information, visit www.ihe.ca

New rapid COVID-19 test taking off at EIA

GLC, Edmonton company, testing new technology exclusively at airport 

In partnership with GLC Medical (GLCM) Inc., a subsidiary of Graphene Leaders Canada (GLC) Inc., an Edmonton-based company, EIA will host clinical trials of this new technology that has the potential to have global implications for COVID-19 testing. This test is conducted with a handheld unit that takes a saliva sample from a person and is expected to tell if someone has COVID-19 in under 1-minute, compared to other tests with longer laboratory-based waiting periods for results.  This test promises many advantages from its ease of use to the elimination of the nasal swab to direct virus detection.  This kind of test will help address the need for a 14-day quarantine period in Canada and potentially other international quarantine restrictions. By removing or reducing this barrier, it can help travellers feel safer in returning to travel.  

GLC Medical (GLCM) Inc. is headquartered in the Edmonton Research Park and has garnered international attention for the development of this test, which is still undergoing clinical testing as part of the regulatory approval process with health authorities. As an airport, EIA understands working with governments and within a regulated structure. With secure and safe facilities and a consistent flow of passengers, it’s one reason an airport is an ideal place to start testing the trial phase of this new COVID-19 rapid test.   

“We all want travel to get back to normal and a rapid COVID-19 test will accelerate this return while enhancing passenger confidence in the safety of our industry.  While we have seen some growth in recent months, our passenger numbers during COVID-19 continue to remain low and a test like this is crucial to our future. All airlines, airports and the whole travel and hospitality sector are looking for this solution. If EIA can play a role in bringing new technology and science forward by partnering with experts like GLC that’s exactly what we’re going to do. This is an exciting opportunity for all of us.” 

-Tom Ruth, President and CEO, Edmonton International Airport 

“We are very excited to offer the world a graphene-enhanced rapid solution in COVID-19 virus detection. The opportunity to collaborate with EIA, a world-respected airport authority, to enable travel and to bring families back together is very rewarding for us. This graphene-enhanced rapid test demonstrates the power of graphene innovation to overcome the challenges of COVID-19. GLC is proud to be a part of EIA’s initiative in setting the global standard in safety and reliability for their travellers.” 

-Donna Mandau, President & CEO, Graphene Leaders Canada (GLC) Inc. / GLC Medical (GLCM) Inc. 

Prototype of the rapid COVID-19 testing unit. Credit: GLC Medical

 How the test works 

  • The person being tested provides a saliva sample into the testing unit; 
  • The graphene surface inside the testing unit is designed to bond to the spike protein in the virus; 
  • This binding event changes the electronic characteristics of the graphene, and this measurable change is what is used to determine if a person is infected or not; 
  • The device will show a red or green light in under 1-minute to indicate if a person is virus free or not; 
  • The test is not required to be administered by a medical professional and with training can be administered by anyone, similar to how basic first aid training is done. 

 The next step is to bring this test and GLC to EIA and establish a safe and secure test site. Details about the testing and the process will be shared in the coming weeks. A start date has not been determined, but once it begins, the clinical trial will last several weeks over this fall. This trial phase will help GLC Medical secure regulatory approval and certification for its test from Health Canada and other regulatory bodies, including in the United States and other areas of the world. 

 As a not-for-profit corporation, EIA works to attract investment and jobs to the Edmonton Metro Region and support local innovation. Airports connect global communities and create opportunities for people and business. The partnership with GLC Medical has tremendous opportunities to impact many industries beyond just the travel industry. EIA is focused on safety and security as its number one core value and creating a safe passenger experience at the airport is a priority. The EIA Ready program focuses not only on enhanced cleaning but also seeking out and adopting new innovations and technologies to help passengers feel comfortable in the airport and with travel overall. The recent announcement of EIA being accredited by Airports Council International (ACI) with the airport health certification is yet another example of how EIA is putting safety and security as a top priority in creating a safe airport. Visit flyeia.com/ready for more information.  

About Edmonton International Airport 

Edmonton International Airport is a self-funded, not-for-profit corporation whose mandate is to drive economic prosperity for the Edmonton Region. EIA is Canada’s fifth-busiest airport by passenger traffic and the largest major Canadian airport by land area. EIA offers non-stop connections to destinations across Canada, the US, Mexico, the Caribbean and Europe. EIA is a major economic driver, with an economic output of over $3.2 billion, supporting over 26000 jobs. For more information, please visit: flyeia.com, follow @flyeia on TwitterInstagramLinkedin or Facebook

About GLC  

Graphene Leaders Canada (GLC) Inc. is a Canadian technology company producing high quality, high purity graphene nanomaterials which functions as a platform technology with the ability to add value across numerous applications. Graphene Leaders Canada Inc. is focused to work with industry to develop solutions by integrating the graphene to develop new innovative products.  GLC’s tag line is “Making Great Products Even Greater”.   

GLC Medical (GLCM) Inc. is a subsidiary of GLC Inc. and offers graphene solutions in the medical industry leveraging our material science expertise in working with high quality graphene and developing products and solutions to serve the betterment of People and Planet.    

Newborn blood testing saves life of infant after launch

Dr. Stacey Hume, genetics laboratory head at University of Alberta Hospital, talks about a newborn screening program that includes additional screening. The program has already saved the life of newborn infant.

Hudson Cowie was born on the morning of Sunday, June 23. Like all infants born in Alberta, Hudson was given standard screening tests to check for possible health conditions.

Just over one week later, on July 2, Hudson was diagnosed with severe combined immunodeficiency, or SCID, at the Stollery Children’s Hospital in Edmonton. The condition, sometimes known as the “bubble boy disease,” essentially means that Hudson was born without a functioning immune system.

Hudson was the first child in Alberta diagnosed with SCID through newborn blood spot screening, a process every infant born in Alberta undergoes in order to determine whether the child has any medical conditions that can then be treated.

Alberta Health Services introduced screening for four new conditions, including SCID, on May 31. Hudson was the first child diagnosed with SCID through the new screening, something the boy’s father credits with saving his son’s life.

“Simply put, I think it’s fair to say that this test saved my boy’s life,” Ian Cowie said.

Dr. Stacey Hume, genetics laboratory head at University of Alberta Hospital, looks at some blood samples where a newborn screening program, that includes screening for four more conditions, has been implemented. LARRY WONG/POSTMEDIA LARRY WONG / POSTMEDIA

Battling dementia: UAlberta Neuroscientist leads one arm of national research consortium

Nationally funded strategy promises $46 million for dementia research with a focus on prevention.

New funding from the federal government and partners will bolster research focused on identifying new biomarkers for neurodegenerative diseases, such as Alzheimer’s disease. 

“So far, no disease-altering interventions for Alzheimer’s disease have been successful,” said Roger Dixon, professor in the University of Alberta’s Department of Psychology in the Faculty of Science. “For this reason, we aim to discover the earliest signals of the disease, known as biomarkers, so that prevention protocols can be implemented and we can better understand how neurodegenerative diseases work.”

Age-related cognitive decline and dementia, including Alzheimer’s diseases, currently affects more than 400,000 Canadians, and will impact as many as 1.5 million Canadians by 2031. 

The project, spearheaded by Dixon, is part of the Canadian Consortium on Neurodegeneration in Aging (CCNA). CCNA is a national research program on dementia research now in its second phase with $46 million in funding from the federal government and other partners, and includes 310 researchers from 39 universities across Canada. 

“Projected deliverables include developing the best—most accurate, least expensive, most replicable, most generalizable across populations—combinations of biomarkers for neurodegenerative diseases,” said Dixon, who is a member of UAlberta’s Neuroscience and Mental Health Institute

Identifying biomarkers allows research to precisely detect neurodegenerative diseases and better understand how they progress, allowing for precise and personalized approaches to interventions and therapy. Dixon’s national team will build on a strong foundation of research including non-invasive testing techniques such as saliva tests, and understanding factors for healthy and impaired memory at any age. The team includes more than 30 members from 12 institutes, including Liang Li (chemistry), Peggy McFall (psychology), and David Wishart (biological sciences and computing science) from the Faculty of Science. 

“Contemporary biomarker research benefits greatly from new artificial intelligence technologies,” said Dixon. “Thus, we use machine learning, data mining, interactive or network modeling, and precision analyses and applications. For example, we employ data-driven OMICs platforms such as genomics, metabolomics, and connectomics.”

Scientists develop new method for studying early life in ancient rocks

Research results could also inform the search for life on Mars.

Kurt Konhauser, professor in the University of Alberta’s Department of Earth and Atmospheric Sciences, is co-author of the study, which has developed a new method for studying early life on Earth—and beyond. Photo credit: John Ulan

Scientists have developed a new method for detecting traces of primordial life in ancient rock formations using potassium. 

The method relies on searching for high concentrations of potassium in ancient sedimentary rocks, rather than traditional methods that look for carbon, sulfur, or nitrogen—which can appear in ancient rocks through processes unrelated to ancient life. 

“Our findings show that microbial biofilms trapped potassium from ancient seawater and facilitated its accumulation into clay minerals that were buried on the seafloor,” explained Kurt Konhauser, professor in the University of Alberta’s Department of Earth and Atmospheric Sciences and co-author on the study. “This is critical because there is no abiotic mechanism that can be used to explain the potassium enrichment aside from life itself.”

The study examined clay particles from the Francevillian Formation located in Gabon, on the west coast of central Africa. This 2.1 billion-year-old formation hosts well-preserved microfossils in clay. 

2.1 billion year old sediment from Gabon with ancient microbial mat features and biologically-induced potassium enrichment. Photo courtesy of Abder El Albani

“In our quest to find evidence of early life on Earth, we have been limited to looking for a number of signatures that have all proven ambiguous, because, unfortunately, the signatures can be explained by both bacterial and abiotic processes,” explained Konhauser. “Our results indicate that a different signature—potassium—is potentially a more unique tracer, as it could only have been created through the metabolism of living bacteria.” 

The research was led by Jérémie Aubineau and Abder El Albani from the University of Poitiers, France. The paper, “Microbially induced potassium enrichment in Paleoproterozoic shales and implications for reverse weathering on early Earth,” was published in Nature Communications (doi: 10.1038/s41467-019-10620-3). 

Konhauser was recently named the recipient of the 2019 McCalla Professorship, an award issued by the University of Alberta to support outstanding academics who contribute to educational leadership and the integration of teaching and research.

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