Pictured: Dr. Rakesh Bhat, API Director of Lab Science (left) and Dr. Shadab Alam (right) working in the Doschak Lab.
In the drug development industry, building a company with the necessary capacity to bring a drug from innovation to the point where it can attract large-scale investment is challenging. Most innovators who launch a company have subject matter expertise in their discovery, but not necessarily in the myriad of technical challenges along the way. These require a diverse team with specific expertise and capabilities to determine if the innovation is even viable, let alone bring it to market. The solution to these challenges leave innovators to either build an in-house team of expertise or seek outside help from contract research organizations (CROs).
In the early stages of funding, Small to Medium-sized Enterprises (SMEs) are generally forced to turn exclusively to CROs, as they lack the capital for a large in-house team. This model works in areas with a high concentration of such service providers as well as a thriving pool of talent, as companies can closely engage with the outsourcing CRO and recruit local experts as they grow their own team.
However, the Albertan, and to a lesser extent, Canadian landscape, lack both components of this ecosystem, and innovators are forced to seek international CROs to do their early development work and are left without options to grow internal capacity, as the teams that have an understanding of their innovation are in another country. This creates a significant amount of risk as companies outsource overseas with little assurances about their ability to engage in next steps and protect their IP. In the worst cases, companies find significant shortfalls in their outsourced work and are unable to move forward or troubleshoot issues.
For General Intermediates of Canada (GIC) – an Edmonton-based SME pharmaceutical company with a broad expertise in chemical synthesis and a drug development program currently focused on cancer immunotherapy – its experience hiring an out of country CRO fell short.
GIC’s current drug candidates are compounds that work by binding with a specific receptor that triggers a stronger response from the body to prevent the growth of tumours. Based on past research and modeling, GIC synthesized these compounds and hired a European CRO to test their effectiveness in binding with specific receptors in living cells – referred to as a “cell line” – that had been developed by a large multinational life sciences company for testing such compounds. Using the data, GIC would be able to file a patent, attract investment, and move forward with their development. The results that came back from the CRO showed promise, but hinted at potential errors.
“We had results, but it was not clear that the compounds showed the desired activity,” says Glenn Weagle, GIC President and CTO. In most cases, a company would have little recourse other than to hire a different CRO and determine if it could replicate the results, with no guarantee. “What we needed was a local CRO. One where we would have a better opportunity to exchange data and work together.”
At an impasse, GIC received a referral about a newly launched institute creating local expertise for life sciences companies, Applied Pharmaceutical Innovation (API).
“When we first heard about API, we were thrilled,” says Weagle. “We needed to have close communication and discussion with an organization that has the specialized expertise in cell-line assays and future advance testing. API provided both within the same city!”
API built a team for GIC that included trainee post-doctoral fellow, Dr. Shadab Alam; its Director of Laboratory Science, Dr. Rakesh Bhat; and University of Alberta Pharmacy and Pharmaceutical Sciences Professor, Dr. Michael Doschak, to quickly establish and run tests on the GIC compounds using the same commercially developed cell line that the CRO in Europe had used. Within a few weeks, the API team had procured the cell line and began to run the tests, but discovered that it was not performing as advertised, and there were errors in the data produced by the European CRO.
As the project grew quickly in complexity and scope, the API team worked closely with the cell line’s manufacturer, working in the lab seven days a week, continually proving to the manufacturer that its product was not working. Even after the team connected with the manufacturer’s scientist who developed the cells, continued troubleshooting left the manufacturer unable to prove why they were not responding correctly. It became clear that API had discovered a critical flaw in the commercial cell line. However, while working with the failing commercial cell line, API was also exploring the potential to create its own that would produce the needed results for GIC.
Within five months of starting the project, API succeeded in its mission. It developed an in-house custom method to test GIC’s compounds that provided clear and reliable data – including a new indication that its compounds showed a higher degree of specificity than other drugs – giving GIC a strong potential and a local capacity to provide ongoing testing as it continues working down the drug development path.
“This is a perfect example of the value of API,” says Andrew MacIsaac, API CEO. “Not only did we solve an urgent problem for a company here in Alberta, we were able to build a team to produce results that they would have not been able to get elsewhere. We work in a more collaborative model that tackles problems alongside a company and builds capacity along the way. Dr. Alam and our team are still working closely with GIC as they continue to refine their compounds, and we’ve built a local capacity at GIC’s fingertips.”