The accessibility of medications isn't just an issue of supply shortages, says pharmaceutical innovator Morẹ́nikẹ́ Ẹniọlá Ọláòṣebìkan — it also means finding modes of administration that better serve patients.
"I think about access to medication in nuanced ways, because you could have a drug that is just not effective for a lot of people. And to me, that's also an access problem," said Ọláòṣebìkan. "We currently make drugs in mass-produced commercial supply, and there are groups of patients that are left out of that."
Around 22% of people over 65 have difficulty swallowing pills and tablets, Ọláòṣebìkan explained, which is how the majority of oral medications are prescribed. Between the patients who struggle with complicated drug regimens and those who simply can't stand the taste of medicine, up to half of prescribed drugs aren't taken properly. This is a problem for patients as well as pharmacists, and one that Ọláòṣebìkan aims to address with her business-to-business platform KemNet, which supplies reformulations of popular drugs to pharmacies.
As a pharmacist, Ọláòṣebìkan has the ability and authorization to, for example, provide medications in liquid form for people who struggle with pills. She's working on scaling a business around that as a member of the summer 2022 cohort for Y Combinator's startup accelerator program, which will hold its Demo Day for about 1,500 investors and media on Sept. 7 and 8.
"I wish that more people knew that there were options available for them. And that they could ask their physicians for options that might be available for them," Ọláòṣebìkan said.
Not every drug can be easily reformulated, and there are legal, ethical, and pharmacokinetic considerations when preparing patient-specific alternatives to off-the-shelf prescriptions. But understanding a patient and finding prescription regimens that work for them is a key part of the pharmacist's job, said Jody Shkrobot, clinical assistant professor with the University of Alberta's faculty of pharmacy and pharmaceutical science.
"Compounding formulations is something that pharmacists have been doing since the origin of the profession, so to speak," said Shkrobot, though he added it is a bit less common in an age of mass-produced medications.
Drug manufacturing is regulated at a federal level, whereas the reformulations of compounds supplied by KemNet fall under provincial control, and involve a more direct patient-provider relationship.
"Typically, the biggest aspect of determining if compounding is occurring as opposed to manufacturing is that usually a pharmacist will not be involved with compounding unless a commercially available product that has an identification number and is regulated by Health Canada is not available. And at that point in time, then the pharmacy can certainly enter into a compounding arrangement to provide the product for their patient if it's appropriate to do so," Shkrobot said.
KemNet currently has three compounders that supply 30 pharmacies in Alberta and has plans to scale the company across North America, a goal that led to Ọláòṣebìkan to apply to Y Combinator. The platform is also being used to provide equivalents for children's pain medications such as Tylenol and Advil to help parents work around the current nationwide supply shortage.
"This is a really unique way to pull together compounding pharmacies in a way that supports a critical service to patients. And we're very happy with that type of work happening within the context of community pharmacy," said Andrew MacIsaac, CEO of Applied Pharmaceutical Innovation.
"With drug shortages being the challenge they are here, we have to take a lot of tools out of the toolbox if we're going to ensure that people have the drugs they need when they need them," he said. "And using compounding pharmacies in a way that better networks them and combines their capacity is another phenomenal tool to have in the toolbox when it comes to supporting people's needs for access to critical medicines."
Ọláòṣebìkan founded Kemet Advanced Manufacturing in 2016 with the aim of addressing global drug shortages by developing modular, portable drug-manufacturing facilities. Kemet is still in the works, Ọláòṣebìkan said; the pivot to the on-demand drug supply model of KemNet reflects a change in her thinking about drug accessibility.
"I start out thinking we're going to build factories — they're going to be transportable factories are going to fix this issue. And then somewhere in there, I realized a way to actually test out some of my ideas is to bring compounders together with pharmacies to produce drugs that are formulated to be inclusive," she said. "So I actually looked at how do we empathize with patients, and how do we collaborate for patients' benefit."
KemNet is one of about 250 startups accepted into Y Combinator's summer 2022 batch, which was significantly smaller than the previous cohort of more than 400 companies as the accelerator adjusts to changing economic conditions resulting in a tightening of the venture capital market. Other Edmonton-based Y Combinator alumni include Future Fields and Wyvern.