Because clinical trials are required to obtain regulatory approval for a drug, they are one of a biotech company’s highest priorities. However, the challenges of funding these trials are significant, both for Big Pharma and even more so for smaller biotechs that have relatively fewer resources at their disposal. What challenges are specific to these smaller companies?
In Canada, small biotechs can compete for funds from the Canadian Institutes of Health Research (CIHR), Canada’s federal funding agency for health research. Composed of 13 separate “virtual” institutes, CIHR provides leadership and support to more than 13,200 health researchers and trainees across Canada. Each institute is dedicated to a specific area of focus, linking and supporting researchers pursuing common goals. Each institute embraces a range of research from fundamental biomedical and clinical research, to research on health systems, health services, the health of populations, societal and cultural dimensions of health and environmental influences on health. Specific funding opportunities are listed on their website.
Alternatively, small biotechs in Canada can compete for funding from from the National Research Council Canada’s Industrial Research Assistance Program (NRC-IRAP), which is Canada’s premier innovation assistance program for small and medium-sized enterprises. NRC-IRAP oversees a set of programs and collaboration opportunities in areas ranging from biologics to natural health products.
In order to be considered for possible IRAP funding, the basic eligibility criteria are: to be a small and medium-sized enterprise in Canada, incorporated and profit-oriented; have 500 or fewer full-time equivalent employees; and have the objective to grow and generate profits through development and commercialization of innovative, technology-driven new or improved products, services or processes in Canada.
Before entering into a financial commitment with a client, both the firm and the project are evaluated on an individual basis during a consultation with one of NRC-IRAP’s advisors. Specifically, the due diligence process assesses the business and management capabilities of the firm and the company’s potential to achieve the expected results and outcomes associated with the proposed project; the financial capabilities of the firm and its plan to commercialize the developed technologies; and the technical aspects of the project and its potential impact on the firm.
The NRC’s Human Health Therapeutics (HHT) portfolio works hand-in-hand with industry to help small biotech firms achieve success and save costs. As an R&D partner, NRC HHT de risks critical steps in the development of biologics, vaccines and delivery of large molecules to the brain, to help improve the health of patients. The program adds value to collaborators’ products and accelerates their progress to market by overcoming challenges in preclinical and early clinical development, expanding product characterization, optimizing bioprocesses and their scale-up, and developing biomarkers.
For example, the NRC’s vaccines program works with Canadian and international partners to develop novel and improved vaccines and enabling technologies. Through these partnerships, co developed vaccine candidates progress through an expanded value chain that includes biomanufacturing and early clinical trials. As a result, the NRC is able to accelerate development, reduce risk and add value to each vaccine candidate.
The NRC has established best practices to guide the management and commercialization of intellectual property for co developed products and enabling technologies. It observes the rigorous standards set forth by Health Canada’s Biologics and Genetic Therapies Directorate (BGTD), ensuring that all of its co developed products meet their regulatory approval requirements to be sold in Canada and other jurisdictions. Canadian cGMP vaccine manufacturers who benefit from our bioprocessing expertise will be well positioned to supply both domestic and global markets. The NRC’s collaborative research projects span a very broad spectrum of activities and business structure models; access to NRC expertise and equipment provides its collaborators—including small biotechs—with the opportunity to accelerate their commercial development timelines.
The challenges are different in the U.S., where the federal government funds a large portion of clinical research primarily through the National Institutes of Health (NIH). Clinical trial costs can vary widely depending on the number of patients being sought, the number and location of research sites, the complexity of the trial protocol and the reimbursement provided to investigators. Funding can therefore come either from the NIH or from private grants. The congressionally mandated Small Business Innovation Research (SBIR) and Technology Transfer (STTR) programs make up about three percent of the NIH extramural budget—about $700 million a year. However, businesses must be U.S.-owned to apply for funding through these programs.
If a small biotech is developing a product targeting a specific patient population, it might seek to apply for funding from an organization founded to support that group. For example, since its founding in 2000, The Michael J. Fox Foundation for Parkinson’s Research has granted more than $450 million in research. Interested companies are invited to apply to a number of open funding programs in various areas of Parkinson’s research. Because competition for these grants is fierce, a small biotech must submit an application that is sufficiently compelling to the organization judges. A small biotech can maximize its chances of success by offering a well-defined description of the drug it is developing, how it will address an unmet need, and how it compares favorably to other drugs currently on the market or in development either at other small biotechs or at larger companies.
The challenges of funding clinical trials are real and serious. A small biotech that is unable to allocate the necessary funding for clinical trials will be unable to bring its product to market, potentially depriving healthcare providers and their patients with innovation that could alleviate suffering.
About the Author:
Anthony Giovinazzo is President and CEO of Cynapsus Therapeutics, Inc., which is developing the only non-injectable (sublingual) delivery of the only approved drug (apomorphine) to be used as a rescue therapy for “off” motor symptoms of Parkinson’s disease.