Project Selection
An organized and well-delineated process has been developed to select technologies for development within a university’s AMI. It is the responsibility of the AMI Executive Director to identify innovative and biomedically-related technologies with commercial potential to present to the Board of Directors for commercialization enablement. To identify potential technologies, the Executive Director reviews disclosures provided by the university’s Technology Transfer office1 and also seeks out and regularly meets with university administrators, scientists and inventors to confer about technologies that might benefit from and be appropriate for the university’s AMI development program. University inventors and scientists are encouraged to bring technologies to the attention of the AMI for consideration2. With continual input and support from a developing network of university scientists and inventors and the Technology Transfer office, the Executive Director identifies a small number of technologies, typically 8-10 from 50-100 university technologies per year, that should be advanced to a formal project selection phase.
Once the Executive Director identifies a potential biomedical technology for the project selection phase, the Technology Transfer Office is informed. This initiates a formal due diligence effort to assess the potential for successful commercialization and fit for AMI development. This project selection phase, e.g. a due diligence period of 60 days3, which can be extended for an additional 60 days. This period provides time to conduct a broad due diligence effort regarding intellectual property concerns and/or issues, market potential and issues, competitive landscape, technical, manufacturing and clinical risks and needs, exit/transfer options, etc., which the Board requires in order to make informed decisions. The short review period places limitations on the depth of due diligence, although guidelines for review are set in place to ensure that necessary and comprehensive information is accumulated for Board consideration prior to authorizing an internal technology transfer to the university’s AMI. During this review period, the university issues a temporary exclusive option and ceases seeking external transfer opportunities.. If at the end of the review period, the due diligence supports an AMI development program, the Executive Director can present the technology to the Board of Directors. Only those technologies for which the university supports a transfer to AMI for product development should be brought forward to the Board. It is the responsibility of the Board to select which technologies to fund and develop at the AMI.
When a candidate technology proposed by an inventor is considered not a fit for an AMI as may be determined by the due diligence efforts, and the AMI Board accepts the recommendation of the Executive Director to decline that project, the reports that were generated on the market, clinical data, the technology and/or intellectual property are available without cost to the university for its use as applicable in any alternative paths for the technology. These broad and expensive due diligence efforts provide significant value to assist the AMI Executive Director and Board with project direction, needs and commercialization strategies and/or for providing justification and validation of acquisition to potential suitors (where the technology may not be a fit for the AMI to develop but may be appropriate for others).
It is estimated that of the many possible university technologies that can be preliminarily reviewed, only a select few will be identified for the formal project selection phase. Of those that enter the project selection phase, it is estimated than one or two projects per year will be selected for presentation to the Board of Directors. Those that reach the Board will be proposed for AMI funding. If approved, the AMI Executive Director and the Technology Transfer Office will commence licensing negotiations to bring the technology into the AMI.
Once an inventor’s technology has succeeded through the project selection phase receiving Board approval for Phase 1 development funding, a project team that includes an AMI project manager will be organized to execute through the various phases of an industry standard development process. Minimally, the inventor is a technical expert but can be engaged more extensively depending on project needs. Each project is different, and the extent an inventor wants to be involved in the development process may vary. Therefore, the amount of time and the specific role that the inventor plays in the development process is determined as a part of the project plan. The process, however, is not implemented to fund existing labs and continuation of basic research. Instead the AMIs fund product development teams advancing translational development to produce a commercializable, manufacturable, and market ready product. These products follow specification and design as would be executed in industry with significant customer input and focus to drive market success. This approach for technology development under the university umbrella is intended to significantly increase the value of the technology at the time of transfer to an outside party.
- The universities can exclude disclosure of technologies funded by 3rd parties to the AMI.
- For previously undisclosed technologies brought by inventors to the AMI, the AMI will notify the Tech Transfer office to process the necessary disclosure.
- Universities can extend the due diligence period.