University Technology Transfer in the Era of Value Based Health Care
Dr. Christopher McCabe
The ASSESS Project Chief Scientific Officer
Introduction
University technology transfer is the process by which academic institutions commercialize their research and development (R&D) to bring innovative products, including healthcare technologies, to market. This process helps translate cutting-edge scientific discoveries into practical solutions for real-world problems, leading to advances in healthcare and improved patient outcomes. The process typically consists of five distinct activities:
1. Identification of commercial potential
2. Protection of intellectual property
3. Licensing of technology
4. Commercialization and production development
5. Monitoring and evaluation
Early health technology assessment (eHTA) can enrich the Identification of commercial potential, and also contribute to the Monitoring and evaluation function.
Identification of Commercial Potential
Identification of commercial potential considers whether a particular research result has the potential to be transformed into a commercially viable product or service. For healthcare technologies this is typically evaluated with reference to:
Market demand: Is there a significant need or opportunity for the technology in the healthcare sector?
Novelty and uniqueness: What is the novelty and/or uniqueness of the technology and could it provide a significant advantage over existing solutions in the market?
Technical feasibility: What is the technical feasibility of the technology and is it practical and economically viable to develop and commercialize the technology?
Intellectual property landscape: What is the intellectual property landscape for the technology, including the availability of patents and other forms of legal protection?
Potential partners and investors: Are there potential partners and investors, including companies, venture capitalists, and government agencies, that might be interested in investing in or licensing the technology?
Competition: What, if any potential competitors are in development or on the market? Is the new technology likely to be successful in competing against these technologies?
Regulatory requirements: What are the regulatory requirements for the technology? Is it likely that it will be approved for use by regulatory agencies such as the Food and Drug Administration (FDA), European Medicines Agency and Health Canada.
Identifying Commercial Potential with eHTA
Early health technology assessment (eHTA) expands and deepens the assessment of commercial potential by considering the technology through the lens of the target payers and target users. Specifically, eHTAs:
Identify clinical and non-clinical needs of patients and healthcare professionals, which are of sufficient magnitude to justify reimbursement of a technology that addresses them, and informs the design and de-risking of development and commercialization strategies.
Evaluate the impact of the technology on patient outcomes, healthcare delivery and efficiency, providing information on the benefits and drawbacks of the technology, which will affect the price that the technology could command.
Inform regulatory pathway choices through characterizing the minimum safety and efficacy targets and the type of evidence that will be required to support market access at commercially attractive pricing.
Improve commercial viability by identifying the key clinical and non-clinical impacts, including budget impacts, that will support reimbursement, adoption and diffusion of the technology.
Enhancing public trust that universities are maximizing the impact of public investment in their research through designing the licensing and commercialization process on the foundation of an independent assessment of the technology’s potential value.
Early Health Technology Assessment can support the Monitoring and Evaluation function of technology transfer offices, by updating the assessment of impact, value and commercial viability as the technology moves along the R&D pipeline, taking account of additional technology specific evidence and any changes in the market such as the launch of new competitor technologies and changes in the processes of care for the target indication.
The ASSESS Project provides rapid access to experts in health technology assessment. It facilitates early advice on the technology value proposition, considering how it is likely to be considered by those intended to pay for and use the technology, to inform technology transfer professionals and innovators on:
Technology commercial potential
Evidence requirements, including time and cost to market, given likely regulatory and reimbursement pathways
Assessment of new technology explicitly considers its impact on health system efficiency, a central consideration in reimbursement and procurement decision processes. Eight weeks from project initiation, a technology transfer office receives a written report, providing critical insights into the technology's commercial potential, with recommendations on how to optimize the value proposition for maximum commercial success, supported by an Evidence Roadmap describing the types of evidence required for regulatory approval. reimbursement, and to make technology standard of care in clinical practice.
The project serves to support 2 critical functions for technology transfer offices, due diligence and third party evaluation to facilitate discussions with investors and partners.
