QUALIFICATIONS

Government buyers acquire commercial off-the-shelf  (COTS) products through a well-defined acquisition process. But for those novel solutions and pre-commercial products still in early0stage development that have the potential to address unmet medical needs, developmental consistency leading to acquisition is not necessarily well envisioned or practiced. While there are technologies that from a technical perspective qualify for funding through congressionally directed funding programs, e.g., Broad Agency Announcement (BAA) programs, SBIR or NIH, it has been Milestones’ observation that few are evaluated and qualified for commercial potential using business metrics before contract award. Here are examples of recent contracts:

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Milestones was retained by the Modernization Office of the USAF Surgeon General to provide a variety of business strategies, needs assessment and long range planning:

Milestones provided due diligence for 12 technologies including cost-benefit analysis, ROI and business case to support funding activities through the AFSGR road Agency Announcement program (FY2008).

Milestones developed a due diligence process to evaluate the AFSGR's technology portfolio. (FY2007 and FY2008).

Milestones provided business development work for EOS ACTD and AFSGR, including business strategy for the SGR program for technologies funded for 2010 - 2015 and the strategic plan for EOS as a platform technology for personalized medicine. (FY2007)

Milestones provided market, manufacturing and competitive analyses to assess technology solutions for traumatic brain injury.

Milestones provided a comprehensive end users needs assessment among target audiences for a molecular diagnostic platform for clinical and surveillance uses  (FY06)

Milestones designed and implemented a pre-IDE regulatory strategy and pre-IDE submission for a transformational molecular diagnostic that detects upper respiratory infections for military and civilian markets. Activities included writing an informal Investigational Device Exemption (IDE) for the EOS/ACTD (Epidemic Outbreak Surveillance/ Advanced Concept Technology Demonstration) for the RPM™ molecular diagnostic. (November 2004 to June 2005).

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For the Peer Review and Medical Research Program (PRMRP), a subordinate activity to the US Army Medical Research and Materiel Command (MRMC), see next, Milestones worked with senior staff to develop a presentation, "Next: Commercializing your technology," for the April 2004 Military Health Forum. The target audiences were principal investigators who had received development grants from PRMRP and program managers for PRMRP. The presentation led to the formation of the Product Assessment and Commercialization team, see next.

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For the US Army Medical Research and Materiel Command (MRMC),  Milestones invented the Product Assessment and Commercial Team (PACT) methodology to assess commercial potential of 17 of 1,300 technologies funded through congressionally directed appropriations. Following the assessment, three technologies were selected to receive advanced development counsel, which included preparing research teams to meet informally with the US Food and Drug Administration in connection with development of a regulatory strategy; needs assessment for technologies to ensure the technology application meets physician/physician need; and target market focus group to assess clinical utility and relevance.

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Subsequently, MRMC contracted the PACT team to develop a curriculum, "Essential Elements for Commercializing Technologies," to assist government program managers to facilitate commercial development for technologies that received congressional research grants. The curriculum has been adapted for presentation to international bioscience conferences, including BIO, and military health fora.

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For the National Medical Test Bed (NMTB), Lorraine Ruff contributed to review panels of NMTB-funded technologies. Subsequently, Milestones was asked to form a two-person team, including Lorraine Ruff, for business case analysis for technologies that NMTB believed to have high commercial potential. The assignment included business analysis, intellectual property review to ensure that the technologies were novel and could compete; financial review for fundraising purposes, partnerships and product positioning and launch. During the three-year relationship, Milestones worked with a number of emerging growth research institutions and product development-stage companies yielding five commercialized technology application from five companies. ON TO PARTNER BIOS ►