Development Focus
Al Mann’s philanthropic mission is to expedite the development and commercialization of breakthrough biomedical technologies that will benefit mankind by establishing independent product development institutes at selected universities. Unlike other institutes, Alfred E. Mann Institutes (AMI) are neither a basic research grant funding organization, nor a separate independent university affiliate. An AMI is a product development organization integrated on-campus under the university umbrella. Its purpose is to develop products to a later stage before the transfer occurs from the university umbrella to corporate enterprise. This creates a number of advantages for an inventor, the university and of course, the ultimate beneficiaries, the patients.
The scope of projects at each AMI is based on the core competencies resident within each university and the infrastructure to support the research in areas such as nanobiotechnology, biomedical imaging and optics, orthopedic and rehabilitation engineering, neuroscience engineering and many more. AMIs are focused on the full spectrum of biomedical technologies, and based on the collegial relationships between AMIs, may offer consultative support for research in areas where they posses domain expertise.
The specific point of exit for a particular biomedical or pharmaceutical technology is determined on a project by project basis and may be executed at different points from the clinical trial stage to FDA approval.
The AMIs are focused on biomedical technologies and pharmaceuticals used in the clinical setting with distribution to doctors, hospitals, clinics, pharmacies or patients. The end users of products developed at an AMI have a direct patient application.
Product Development
Product development is conventionally reserved for corporate enterprise. Product development is a fairly defined process of moving from concept and/or laboratory bench models to manufacturable products and commercialization.
Technology Development
The product development process draws from the basic research and/or translational research, and enters a product planning phase where the marketing requirements are fully defined for the clinical and end user setting including all system components required for product use (e.g., surgical tools, adaptors/connectors, etc.). In parallel, the technical risks are identified, also drawn from previous university work, while adding the constraints of cost, manufacturing, reliability, safety, regulatory, reimbursement, and clinical and market needs. While translational research performed at universities begins to remove certain risk factors and establish the potential effectiveness of the target outcomes, the remaining key technical challenges and risks to meet all the requirements for commercialization are identified by the AMI and put through the feasibility phase of the product development cycle, the output of which establishes the product design and structure. From the marketing requirements and product architecture, a project plan is developed and the development phases then begin.
Pharmaceutical Development
The drug development process also draws on basic and/or translational research. Pharmaceuticals selected for development within an AMI may already have a reasonable proof of concept established at the university through conventional means (e.g., NIH grants). Once a proof of concept is firmly established, the AMI determines the pre-clinical and clinical path required for regulatory approval, and evaluates the cost-benefit for the effective exit point to transfer from the AMI to an acquiring entity.