How To Solve a Shortage

Raimar Loebenberg is the director of the Drug Development Innovation Centre at the U of A and he’s pictured here operating a tablet press that researchers use to make pills for Phase 1 clinical trials. The centre works closely with API to commercialize drug manufacture.

Still waiting on that car you ordered months ago? Or maybe you drove across town searching for a particular product or over-the-counter medicine. You’re not alone. In the last few years, Canadians have become versed in ordinary supply chain issues affecting our lives, exacerbated by the pandemic. But a more critical issue has emerged — the lack of availability of urgent medications, some of which are vital for life-saving procedures. This shortage in essential medications is just one of the challenges that the not-for-profit organization Applied Pharmaceutical Innovation (API) is actively working to improve.

If you connect the business side of the pharmaceutical industry with academic research in life sciences, API is the result: an independent not-for-profit that bridges academic research and commercial manufacturing. It has the potential to solve problems in the supply chain, make sure we get the most out of our existing meds, and create a new local industry.

Andrew MacIsaac, CEO of API, explains that the organization was born of conversations with grads and within the Faculty of Pharmacy and Pharmaceutical Sciences. “We see a lot of alumni in fantastic careers around the world in the life sciences,” MacIsaac says, “but the sector in Alberta has never really taken off in the way that it could.” Grads and faculty members involved in those conversations wanted to find creative solutions to improve commercial development in Alberta.

Growing the life sciences sector and supporting startups guide API’s operations. The organization builds teams and capacity for companies who are commercializing the research they started at the university, creating the conditions for them to turn into viable, growing enterprises in Alberta, “from molecule to market” according to the organization’s website. One of API’s initiatives is the Health Innovation Hub, serving as an incubator for companies, innovations and entrepreneurs. The hub offers consulting support, access to space, training resources, coaching, consulting and networking opportunities. It’s an effort to open opportunities in Alberta.

“We train tons of really bright students,” MacIsaac says. New companies often struggle to raise capital and some don’t have the ability to do it locally, so they move to other biotech hubs around the world. “Wouldn’t it be great if they could get jobs in this growing sector that is really meeting folks’ needs?”

API is focused on a few big things. One is bridging the gap between research underway at the U of A and the economic activity that comes with it. Another is unlocking the potential of academic research and turning it into life-saving treatments. The cure for a disease or an illness could already exist, trapped in an academic lab. An organization like API is the connector between an academic seeking to commercialize a medicine to ease the lives of patients and the experts that can help.

To nurture the connections between API and the Faculty of Pharmacy and Pharmaceutical Sciences, the faculty shares its facilities and space with API. Researchers and students work closely with the staff at API and have access to its leading technology and equipment.

Christine Hughes, ’94 BScPharm, dean of the Faculty of Pharmacy and Pharmaceutical Sciences, understands the importance of students gaining practical experience in the industry as they complete their coursework. “That’s been a really beautiful thing about API. It’s provided valuable training opportunities to position them for future careers,” she says.

Students get the chance to rotate through different areas in the life sciences sector to build experience modelling clinical trial data for a drug pursuing FDA approval, working in planning, developing a new formulation for a product, working in regulatory affairs and figuring out how products get to the market. They gain practical insights into the commercialization of life sciences technologies.

But back to that supply chain problem that API’s work is addressing: the shortages of essential medications. In addition to over-the-counter medicine shortages, there were recurring shortages of critical hospital drugs, like propofol, demand for which spiked with COVID-19 hospitalizations. Propofol is used to sedate COVID-19 and other patients who need ventilators to stay alive. And it’s used to sedate patients for surgery, so a shortage directly impacts people awaiting life-altering operations.

“You have cases where drugs are continually running out,” MacIsaac explains. “The more time pharmacists spend doing supply chain management, the less time they’re able to spend providing care patients need.” While API can’t solve the shortage, it can reduce the risk and begin to improve the issue.

One of the reasons for the propofol shortage is that manufacturing it requires specific equipment. The Canadian Critical Drug Initiative was born in response to the propofol (and other) shortages. This initiative is a partnership between API and the U of A’s Li Ka Shing Applied Virology Institute to combine research, development and manufacturing in Alberta. API operates the initiative, funded with $25.6 million from the Government of Alberta, plus $80.5 million from the Government of Canada. Part of the funding will go towards a manufacturing facility that will serve as a secondary supply source for medicines with persistent shortages.

In September 2023, U of A Nobel laureate Michael Houghton, ’23 DSc (Honorary), joined API as chief scientific officer. Houghton says that API is providing essential services to aid Albertan and Canadian academic and corporate labs to develop therapeutic drugs. API is providing expertise in drug synthesis, formulations, pharmacology and pharmacokinetics — and in regulatory matters and business development.

“Academic labs and small companies cannot perform all of the above easily,” Houghton says. “So API is essentially boosting drug development and commercialization activities substantially, while also manufacturing critical drugs for Alberta Health Services.”

Looking ahead, Houghton says that API’s collaboration with the Li Ka Shing Applied Virology Institute and their networks of Albertan, Canadian and international collaborators is contributing to the development of treatments for Alzheimer’s disease, new antivirals for herpes viruses, and preventatives against bacterial and other viral diseases.

“API, set up by Andrew MacIsaac, and the Li Ka Shing Applied Virology Institute, set up in 2013 by Lorne Tyrrell, is greatly catalyzing Canadian drug development and commercialization,” Houghton says. And he has a strong hand in it as scientific director of the institute. “This will result in a number of preventative medicines in coming years along with the much needed expansion of the private pharmaceutical sector in Alberta and Canada.” 

A notable partnership for API is with the pharmacy services team at Alberta Health Services (AHS). Since 2022, the two organizations have worked to understand the stability of various drugs in different solutions and containers.

Tania Mysak of the AHS pharmacy services team explains that all compounded sterile products are given a beyond-use-date (BUD) to know how long they are safe to use. It’s important that the BUD allows time for the entire preparation of the medication — from order and manufacturing to delivery to the nursing unit and administration to the patient. A BUD shorter than two days means that nurses need to prepare these medications at the bedside, an uncontrolled environment presenting risks for the patient.

In order to revise a BUD, evidence-based references are required. Since 2022, API and Alberta Health Services have been working on stability studies and have confirmed prolonged compound stabilities for more than 50 sterile recipes. Compounded morphine syringes, for example, now have a BUD of nine days instead of fewer than three. “The partnership with the API has been instrumental in the ongoing success of the stability studies,” Mysak says.

If terms like “stability studies” seem far removed from care, you have never seen a hospitalized loved one forced to wait for scheduled pain medicine. The studies prove extended life of the compounds, decreasing delays for patients. As this body of knowledge grows, it contributes to safer, more efficient health care.

MacIsaac says API works across the life sciences sector. That includes medical devices, health technology, pharmaceuticals, natural health products and more. And the role of the pharmacists and pharmaceutical scientists touches the whole of the sector.

“There are a lot of people in this area who are entrepreneurs,” MacIsaac says. “It’s a really exciting time to be an alumni of the faculty because we’re just starting to see the value of the profession and of the science.”