The path to market for a drug (or other product requiring regulatory approval) is complex. Oftentimes, the very tasks that companies developing these products need to undertake – engaging experts, preparing regulatory filings and coordinating clinical trials – serve as logistical barriers. The knowledge and resources needed to progress development can be difficult and expensive to access. This is especially true among industry organizations that need to conduct clinical trials. Taking into the account the vast and varied group of experts that needs to be engaged, it can be a challenging and resource consuming process.
With the goal of connecting industry organizations to the world-class expertise and services required to advance their drug development, Alberta’s Applied Pharmaceutical Innovations (API) is taking this challenge head on. API is committed to helping small– and medium–sized organizations access the same resources often found within large pharmaceutical companies, and offering them in an integrated, cost-effective and commercial-focused manner.
Serving as a hybrid ARO/CRO, API provides unique value to companies that are conducting clinical trials. Through its network, the organization links industry and academic expertise in a manner accessible by industry groups to support phase I, phase II and preclinical studies. The integrated services API provides focus on utilizing this expertise to address key challenges in the trial planning and execution phases.
“One of the biggest challenges for companies developing a product that requires a regulatory pathway is accessing all the expertise needed to move forward” says Andrew MacIsaac, CEO of API. “We can provide all the missing pieces, while employing a commercial approach focused on helping our clients get their product into the hands of those who can benefit from it.”
By integrating academic, industry and commercial resources under one umbrella the organization helps industry partners create efficiencies, increase the pace of their development efforts and access expertise that would have normally been difficult to do.
“We have academic scientists working alongside commercial scientists, within projects managed by industry experts,” says MacIsaac. “This brings all of the required experts to the table and provides our clients with the same toolkit as most large pharmaceutical organizations, so they can viably compete in the marketplace.”
Differing from traditional CROs, API takes a collaborative approach – working as an extension of client teams. This novel framework promotes accessibility, notes MacIsaac. “It reduces the cost required to get started, allowing clients to access the expertise they need when they need it without sacrificing the ability to build in-house capacity in the future. In essence, we provide access to resources while teaching for scalability – this is something our clients truly value.”
The success of the organizations who have partnered with API is a testament to the value the group provides. “In Alberta alone, the companies we have worked with have grown to about a 500 million market cap in the last few years” adds MacIsaac. “In many cases due to their ability to leverage the expertise that we helped connect them to – something we’re very proud of.”
“By tapping into API’s network of experts and their tremendous capabilities in life sciences, we were able to further strengthen the research, development and clinical testing capabilities for some science based- products. Through our combined strengths, we have continued to expand PBG BioPharma’s product manufacturing, testing and commercialization offering with increased cost efficiencies.” – Dr. Jacqueline Shan, President, CEO and CSO, PBG Biopharma Inc.
With a portfolio of clients made up of Canadian, American and European companies, API continues to be in high demand. To meet this demand and help even more clients turn breakthrough discoveries into life-saving treatments, therapies and technologies, the organization has plans to grow in the near-future. Upcoming initiatives include expanding commercial drug manufacturing capabilities and implementing Canada’s first integrated research, commercialization, and manufacturing cluster to promote security of supply of critical medicines (through the CCDI program).
This growth, not just within API but within Alberta’s clinical trial ecosystem, is inspiring to Andrew, who sees the province as a future international hub for early phase clinical trials. “There’s real potential in Alberta to provide an integrated, friendly solution to industry partners,” adds MacIsaac. “The speed and efficiency that we, and our provincial partners, are able to provide are positioning [our province] far above our peers. We’re excited for what the future holds.”
To learn more about API, visit their website: https://appliedpharma.ca/.