Frequently Asked Questions
- What is the Alfred E. Mann Foundation for Biomedical Engineering and who is the Chief Executive Officer?
- How does the Alfred E. Mann Foundation for Biomedical Engineering relate to all of the institutes and foundations that include Alfred E. Mann in the title?
- Why did Alfred E. Mann establish the Alfred E. Mann Foundation for Biomedical Engineering?
- What is the Alfred E. Mann Foundation for Scientific Research?
- What is an Alfred E. Mann Institute for Biomedical Development?
- Where are the Alfred E. Mann Institutes going to be located?
- What is the organizational structure of an Alfred E. Mann Institute once the Alfred E. Mann Foundation for Biomedical Engineering and the university enter into the Agreement?
- How will the specific projects be selected once an Alfred E. Mann Institute is selected and operational at a university?
- What is the relationship between the university’s Technology Transfer Office and the Alfred E. Mann Institute resident on their campus?
- How is the endowment for an Alfred E. Mann Institute allocated?
- Once endowed, what is the planned duration of an Alfred E. Mann Institute?
- What is the size of the endowment from Alfred E. Mann for each Alfred E. Mann Institute for Biomedical Development?
- How many Alfred E. Mann Institutes will be endowed?
- Who decides what universities will be considered for an Alfred E. Mann Institute on their campus?
- What is the process that is executed to select a recipient of an Alfred E. Mann Institute at their campus?
- Are there specific criteria that determine the selection process?
- What if a university desires to be considered for an Alfred E. Mann Institute on their campus?
- Will the Alfred E. Mann Institutes focus on any specific areas of biomedical research?
- Can an Alfred E. Mann Institute receive additional funding from a government agency, such as NIH funding?
- Can an Alfred E. Mann Institute receive funding from private industry that is interested in sponsoring research?
- What is the intellectual property policy for an Alfred E. Mann Institute?
- Will the Alfred E. Mann Foundation for Biomedical Engineering have a claim on the intellectual property?
- How is the commercialization process structured at an Alfred E. Mann Institute?
- What is the planned exit strategy for products that are developed at an Alfred E. Mann Institute?
- When is a technology sublicensed from an Alfred E. Mann Institute?
- How is technology sublicensed from an Alfred E. Mann Institute?
- If an individual or organization has a technology for which they are seeking funding, could one of the Alfred E. Mann entities be a potential source for funding?
- What are the benefits to the students on a campus with an Alfred E. Mann Institute?
1. What is the Alfred E. Mann Foundation for Biomedical Engineering and who is the Chief Executive Officer?
The Alfred E Mann Foundation for Biomedical Engineering (AEMFBE) is a non-profit foundation responsible for the establishment and oversight of the Alfred E. Mann Institutes for Biomedical Engineering Development (AMIs).
The AEMFBE is led by President and CEO, A. Stephen Dahms, Ph.D., who also serves as chair of the AMIs Site Selection Committee, an advisory committee created by Mr. Mann to assist him with the evaluation and selection of universities as hosts for AMIs.
The AEMFBE provides counsel and support for the AMIs in a variety of specialized activities. These include competitive and market analyses, out-licensing negotiations, regulatory and reimbursement strategy, manufacturability assessment and other processes that support the successful commercialization of biomedical technologies.
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2. How does the Alfred E. Mann Foundation for Biomedical Engineering relate to the institutes and organizations that include Alfred E. Mann in the title?
The AEMFBE is the facilitator of the AMIs located on the campuses of prestigious universities. The Alfred E. Mann Foundation for Scientific Research is an accelerator, focusing upon neuromodulatory medical devices. Both foundations are located in the building pictured above in Valencia, CA. A summary overview of the three different entities is illustrated in below.
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3. Why did Alfred E. Mann establish the Alfred E. Mann Foundation for Biomedical Engineering?
The significant successes of Mr. Mann’s various enterprises have led him to seek ways to use the vast bulk of his acquired wealth for the benefit of mankind. As his priority, Mr. Mann has committed this wealth to the establishment of biomedical product development institutes at selected elite research universities with the goal of accelerating the development and ultimate commercialization of more and needed biomedical technologies.
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4. What is the Alfred E. Mann Foundation for Scientific Research?
The Alfred E. Mann Foundation for Scientific Research began in 1985 with the mission to conduct scientific research to develop innovative technical solutions to improve the quality of life for people suffering from debilitating medical conditions. This Foundation is a California non-profit public benefit foundation led by David Hankin, CEO. David Hankin is an attorney who previously held the positions of General Counsel since 2004 and Chief Financial Officer since 2005, and in 2007 took over the role of CEO.
Dr. Joseph Schulman led the Foundation from its inception as the President and Chief Scientist for 21 years, supporting a breadth of development of technologies. The Alfred E. Mann Foundation for Scientific Research has developed enabling and restorative auditory and visual technologies and supported other neurostimulation prosthetic technologies as well as diabetic devices that have improved the lives of tens of thousands of people worldwide. Dr. Schulman is now the Chief Scientist of the AEMFBE.
The Alfred E. Mann Foundation for Scientific Research is a research organization and is not affiliated with the development of the university-based Alfred E. Mann Institutes.
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5. What is an Alfred E. Mann Institute for Biomedical Development?
Alfred E. Mann Institutes are university-based biomedical technology accelerators designed to expedite the translation of technology towards commercialization and serve as a bridge between the university and private industry. It is anticipated that university intellectual property regarding new medical devices, pharmaceuticals, biologics and other therapies will be moved towards the commercial arena in order to reach patients more rapidly.
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6. Where are the Alfred E. Mann Institutes going to be located?
Each AMI will be located on the campus of a leading research institution, and likely located in close proximity to the Department of Biomedical Engineering or other allied interdisciplinary science centers. Where possible, the Institutes will also be located close to an allied medical school to support clinical research involving the technologies under development.
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7. What is the organizational structure of an Alfred E. Mann Institute once the Alfred Mann Foundation for Biomedical Engineering and the university enter into the Agreement?
Once a university is selected to receive an endowment, three governing entities are established:
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8. How will the specific projects be selected once an Alfred E. Mann Institute is selected and operational at a university?
Members of the university community (faculty, university researchers, and students) may present a biomedical technology under development for consideration to the Executive Director of the Institute for review only after first disclosing the technology to the university Technology Transfer Office. Potential projects are identified and evaluated by the Institute Executive Director and staff and then appropriate potential projects are presented to the Board of Directors for consideration. Professional guidance and assistance in market due diligence for the probability of successful commercialization will be provided by the AEMFBE at the request of the AMI.
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9. What is the relationship between the university’s Technology Transfer Office and the Alfred E. Mann Institute resident on their campus?
The university Technology Transfer Office and the AMIs are closely aligned. Potential Institute projects are selected from the pool of disclosures resident within the university’s Technology Transfer Office. All university technologies must be disclosed to the Technology Transfer Office prior to substantive discussions with the AMI. Operationally 98% of the technologies brought to the AMI are declined within 6 -8 weeks. If a potential mutual interest exists between the Institute, the university, and the developers of a technology, the Institute will have 120 days to conduct an in-depth evaluation. During this time period the AMI can request the AEMFBE to assist in determining the intrinsic value of that particular technology. Further steps involve Board approval and initiation of licensing discussions with the Technology Transfer Office.
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10. How is the endowment for an Alfred E. Mann Institute allocated?
An AMI has an annual operating budget equal to the investment returns on its endowment, minimally 5% of the minimal $100 million endowment. The budget will allow the Institute to support the commercial development of a small number of biomedical projects each year. However, it is anticipated that the university-based Institute-available resources will increase as the revenues from the successful commercialization of intellectual property return to the endowment of the AMI.
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11. Once endowed, what is the planned duration of an Alfred E. Mann Institute?
An AMI and its endowment are designed to operate in perpetuity. The initial renewal term is twenty five years after which, the agreement will be reviewed and may be renewed every ten years.
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12. What is the size of the endowment from Alfred E. Mann for each Alfred E. Mann Institute for Biomedical Development?
Each AMI will be established with a minimal endowment of at least $100 million from Mr. Mann, given through the AEMFBE. The endowment of a particular AMI may be further increased by Mr. Mann. A fraction of the revenues from the successful commercialization of university intellectual property will return to the endowment of the university’s AMI to further increase available capital. Monies and equity will also be returned to the university’s general fund with a small amount returned to the AEMFBE to be used to fund due diligence efforts and provide amplified resources to drive the operation of a consortium of AMIs. The university will distribute revenues and equity to the university inventor(s) as dictated by university policy.
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13. How many Alfred E. Mann Institutes will be endowed?
Currently, three institutes have been endowed: the Alfred E. Mann Institute at USC (which became operational in 2001), the Alfred E. Mann Institute at the Technion, Israel Institute of Technology (Haifa, Israel which became fully operational in 2007) and the Alfred E. Mann Institute at Purdue University became fully operational in 2008.
Mr. Mann’s vision is that 10-12 Alfred E. Mann Institutes will be established initially, the significant majority residing within the United States
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14. Who decides what universities will be considered for an Alfred E. Mann Institute on their campus?
In 2004, Mr. Mann assembled a Site Selection Committee with diverse backgrounds in areas including academia, industry, technology assessment, business development, and in finance to advise and assist him with the robust evaluation and selection process. Several times per year the Site Selection Committee evaluates elite research universities in the U.S. and establishes a recommended list of universities for Mr. Mann to consider and validate.
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15. What is the process used in selection of a recipient of an Alfred E. Mann Institute at a university?
Extensive research is performed on potential universities including the extent and history of sponsored research, patents in a wide range of scientific disciplines, licensing trends, presence and achievements of interdisciplinary science centers and institutes, location of an allied medical school, status of the biomedical engineering faculty,and many more. Based on the above and other collective data, and review and analysis of the Site Selection Committee, the appropriate research institutions are recommended to Mr. Mann for consideration.
Following Mr. Mann’s recommendations, universities are selected and invitations are issued to the Presidents of the respective universities by Mr. Mann. If accepted by the university, several executive visits to the campus are first conducted by the President and CEO of the AEMFBE, Dr. A Stephen Dahms. At this stage the university receives a Summary of Terms between the AEMFBE and the university, the discussions and clarifications of which may require several months to conclude. Subsequently, a select group of the Site Selection Committee visits the campus and evaluates the potential for success of an AMI at the campus. The next stage includes a several day site visit to the campus by the full Site Selection Committee and its consultants, who also analyze the on-campus interdisciplinary science activities and engineering facilities, as well as the overall commitment of the university, its administration, and its faculty to entrepreneurial activities. The Site Selection Committee makes its recommendations to Mr. Mann and once Mr. Mann has approved the Committee’s recommendation, the award is made, leading to discussions to plan the development of an AMI on that campus. It is at this stage that the university receives the full complement of legal documents underpinning the AMIs, including the central Affiliation Agreement.
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16. Are there specific criteria that determine the selection of an Alfred E.Mann Institute?
Yes. The Site Selection Committee is tasked to ensure that the quality and type of research resident at the university and its intellectual property pipeline are likely to generate specific technologies with high probability of commercial success on a continuing basis. The universities are evaluated with a focus on specific areas of expertise including research specialties, sponsored research, volume patent and licensing trends, and licensing volume as well as other in-depth criteria.
The Site Selection Committee conducts its own independent due diligence and evaluates the universities prior to the visitation using the generalized selection criteria shown below.
The AEMFBE provides counsel and support for the AMIs in a variety of specialized activities. These activities include competitive and market analyses, licensing negotiations, regulatory and reimbursement strategy, manufacturability assessment and other activities to support the successful commercialization of biomedical technologies.
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17. What if a university desires to be considered for an Alfred E. Mann Institute on their campus?
Mr. Mann, along with the Site Selection Committee, have established an ongoing list of institutions that meet the majority of the criteria necessary for the potential success of an Institute. The academic institutions on this unpublished list are at any time under various stages of evaluation, having been visited or being scheduled for site visits. Ultimately up to 50 universities will be visited through 2012.
The Site Selection Committee recognizes that a number of other universities may share many of the same characteristics for potential success, and thus it is continually reviewing the pool of select universities. The selection process is confidential and Committee-initiated, which does not include a formal application process.
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18. Will the Alfred E. Mann Institutes focus on any specific areas of biomedical research?
It is anticipated that many of the AMIs may wish to develop specific areas of expertise based on the special intellectual capital that is resident within each university. Mr. Mann desires that the technologies to be included in the portfolio of AMI product enablement be diverse and has requested that the Site Selection Committee not focus on any specific area of biomedical technology research or disease but rather on the quality and potential of the research efforts. Thus the AMIs will not have a focused association with a particular technology or disease states (i.e., nanotechnology, diabetes, colon cancer, etc.) but are intended to explore the broad area of the biomedical sciences and cognate areas for commercial development and to be responsive to technologies and discoveries many years into the future.
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19. Can an AMI receive additional funding from a government agency, such as NIH funding?
Yes. Investigators and staff in an AMI are encouraged to apply for government funding from sources such as the National Institute of Health, the National Science Foundation,, DARPA, etc. The universities with AMIs are strongly encouraged to leverage the AMI in the universities acquisition of additional federal resources for the university, e.g. engineering research centers, shared instrumentation complexes, specialized facilities, etc.
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20. Can an AMI receive funding from private industry that is interested in sponsoring research?
Yes. AMIs can receive private funding from any source, provided that the funding is consistent with the Institute's and the university's interests. In some situations, when a project is being transitioned to industry, there may be a period where the project is jointly funded. Potential conflict of interest issues are carefully monitored.
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21. What is the intellectual property policy for an AMI?
An AMI operates as a non-profit 501(c)(3) private operating foundation on a university’s campus. Under the terms of the Affiliation Agreement between the university and the AEMFBE, the AMI has the right to review and request adoption of specific biomedical intellectual property disclosed to the Technology Transfer Office, unless the biomedical technology is already licensed to another party. The researchers at the partnering universities have the option to negotiate with an alternate outside entity other than their Alfred Mann Institute if preferred. The university owns the intellectual property created by their researchers. The AMI acquires a global, sole, exclusive, royalty-free (on the front-end) license from the university. In the licensing negotiation phase, many aspects are agreed upon between the AEMFBE and the university, such as jointly discovered technologies, licensing a patent portfolio, background intellectual property, milestones, etc.
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22. Will the Alfred E. Mann Foundation for Biomedical Engineering have a claim on the intellectual property?
The AEMFBE does not license or commercialize technologies. The intellectual property remain the property of the university, with the revenue and other benefits derived from the enhancement of university intellectual properties distributed between university, the researcher and the AMI according the terms and conditions set forth in the Affiliation Agreement.
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23. How is the commercialization process structured at an Alfred E. Mann Institute?
The commercialization process at an AMI incorporates three key components, with the direct mission being to expedite commercialization of university intellectual property via processes that increase the probability for success. A quantitative model that incorporates up to twelve business drivers is used to select appropriate biomedical projects that have the greatest potential to deliver the desired return on investment and benefit the patient. Human and fiscal resources are prioritized, expediting selected projects through development using proven, experienced product development staff with appropriate industry experience.
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24. What is the planned exit strategy for products that are developed at an AMI?
The AMIs will advance early stage concepts and ideas that are too early in the development process to attract capital and financing from commercial companies, venture capitalists, or other risk-adverse entities. The Institutes are designed to enable product development by bringing select technologies to a later stage of development than traditionally occurs at a university, overcoming early stage risks that preclude traditional investments from the financial community and barriers that often prevent innovations from reaching the public. The Institute operates to bridge the “Valley of Death” with undiluted capital, thus creating greater value and higher royalty rates for the universities and their inventors. The AMI Executive Director in conjunction with the Board of Directors will determine at which point transfer to a commercial entity is appropriate. The product may be sublicensed, the Institute may partner with an existing commercial entity, or the Institute may collaborate in the creation of a start-up company.
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25. When is a technology sublicensed from an Alfred E. Mann Institute?
Medical devices under development at an AMI are generally developed through product qualification, or, if indicated, through clinical trials. Very rarely sublicensing of medical devices may be pursued at an earlier stage based on specific market dynamics. Although the AMIs are broadly focused on the development of biomedical technologies, selected pharmaceutical or biologic projects may also be considered for development; if one of these latter areas is selected for development within an AMI, due to the high cost and lengthy time requirements for development and clinical trials, it is anticipated that bio/pharmaceuticals will not generally continue beyond completion of Phase 2A.. The AMI Executive Director, in conjunction with the Board of Directors, will determine the point at which commercialization via sublicensing is appropriate.
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26. How is technology sublicensed from an Alfred E. Mann Institute?
Upon satisfactory completion of a product or proto-product, an AMI may elect to partner with an existing company or an adequately financed and managed early stage company, or it may elect to collaborate in the creation of a start-up venture to pursue commercialization. If partnering is the preferred option, the terms and conditions must be deemed acceptable by the Institute and co-governing bodies. Licensing terms may include equity in the venture, in addition to licensing fees, milestone fees and/or royalties. The university, the AMI, the AEMFBE, and the inventor(s) will participate in these proceeds from commercial licensing.
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27. If an individual or organization has a technology for which they are seeking funding, could one of the Alfred Mann entities be a potential source for grant funding?
No. Mr. Mann is committed to the establishment of biomedical product development institutes at selected elite research universities. These will require a significant commitment of both financial and human resources.
Neither the Alfred E. Mann Foundation for Scientific Research nor the AEMFBE are granting organizations: they do not accept applications or requests for funding, nor do they make grants to individuals, organizations nor research entities. The Alfred E. Mann Foundation for Scientific Research is involved in applied research and has cooperative research agreements with selected entities.
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28. What are the benefits to the students on a campus with an Alfred E. Mann Institute?
Undergraduate, graduate and postdoctoral students will benefit from having an AMI on their campus in numerous ways including the potential to gain experience working on a technology being expedited towards commercialization. The AMI team is led by experienced medical device and biotechnology industry professionals who understand the different stages of the financial analysis, clinical assessment, and robust verification and validation. Such experiences will increase student awareness of the multifaceted process involved in commercialization and thus will increase their marketability in the business world.
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