Translational Research Partnership Awards Program - Phase II
In 2011, the Foundation launched a second phase of the institutional Translational Research Partnership Program with six additional universities.
Translational Research Program Critical Success Factors
Based on the tools developed and lessons learned from the Translational Research Partnership Program, universities should be able to implement formal Translational Research programs. The key factors that are required to initiate a program and optimize opportunities for success are:
TR Designated Funds
Less-than one million dollars per year is the nominal amount required to run a program. This resource pool provides seed or bridge funding to de-risk a project to its first commercial event and attract professional money and experienced management.
Clearly Defined Fundable Milestones
A fundable milestone is that point in a project’s life where sufficient risk has been eliminated to attract professional funders will to license and commit the resources necessary to advance the project. For the biomedical arena, the fundable milestones require an understanding and plan for the following:
- The strengths and weaknesses of the current clinical standard of care
- Identification of the unmet clinical need that will change medical practice
- Intellectual property unencumbered by prior art, with freedom to operate
- Clear FDA and regulatory strategies
- A successful Killer Experiment as defined by the domain experts
- A clear commercial strategy with understanding of the customer decision cycle
- Defined reimbursement strategy
- Understanding how adoption will proceed from product introduction to routine use
- Funding required to achieve the licensing event
These items are dynamic and change over the life cycle of a project.
Program and Project Champions
Selecting the right project is fundamental to the program’s success. This requires a team with an in-depth understanding of the commercial and technical risks.
- BMEs and clinicians who are passionate about changing medical practice to improve outcomes for their patients.
- A CPD with industry background who understands the issues and can support the research teams in the areas where they may lack the proper competencies.
- An OC that understands the program and is empowered to objectively select only fundable projects independent of the Project Team passions. The OC must be program stewards and project mentors.
- An OTT that is properly resourced by the university and that has objectives consistent with translational research and business creation.
Coulter TR Partner Universities, Phase II
Senior Administration Support
A university’s mission is the creation and dissemination of knowledge delivered via “education, research, and service”. At the beginning of the Foundation’s programs, many academics felt that TR deviated from this mission. Rather, TR has proven it addresses all three! Students looking to the future are educated as they participate in projects. Translational research is the practical application of basic research discoveries. The economic development that results from translating innovations serves the community by creating jobs.
Translating academic innovation requires commitment from the top echelon of the university. Several leaders from the partner universities included translating university innovation as a key strategy in their five-year plans. Many modified their promotion and tenure policies to include translational activities as a consideration. They committed resources and understood that a high performing OTT is a strategic competency that needs to be properly funded and staffed.
As a consequence of the program, the Office of Technology Transfer at several universities, traditionally considered a transaction-oriented cost function, were transformed into vibrant business development and commercialization organizations.
The Team Approach
Translational Research (TR) is a team activity. It requires engineers, clinicians, OTT, project directors, statisticians, data managers, regulatory experts, IP attorneys, thus, a team! It is also highly complex, requires high-levels of persistence, and significant funding. Many of the researchers who participated in the programs, however, have indicated that pursuing TR has changed their approach to basic research. Now, they start their basic research with a purpose in mind, instead of being driven solely by scientific hypotheses.