Professional Background

Dr. James has over 20 years of experience in the design and development of early-stage health care technologies. He specializes in securing seed funding through the NIH SBIR program and is recognized for his expertise in technology translation. His areas of expertise include a range of medical devices and multifaceted computerized cognitive and behavioral assessment systems for Alzheimer’s disease and central nervous system (CNS) disorders.

Medical Devices: His experience includes the design, development, and clinical evaluation of a range of medical devices, including high-performance electroencephalographs, multichannel bioimpedance for cardiac and brain monitoring, near-infrared intracerebral neuromonitor, and positron emission tomography (PET). Ancillary expertise includes integration of microprocessors, specialized sensors, and wireless communications. In close association, he has extensive experience in associated software design and development.

Neurocognitive and Behavioral Assessment and Management Systems: He designed and directed the development and validation of computerized versions of the Alzheimer’s Disease Cooperative Study (ADCS) assessment battery for research and controlled clinical trials of treatment candidates, including the Alzheimer’s Disease Assessment Scale (ADAS, ADAS-Cog), the “gold standard” primary outcome measure. He has also developed a computerized cognitive and behavioral assessment system for research and clinical trials of drug candidates to treat schizophrenia. He has designed and developed a web-based version of the Illness Management and Recovery (IMR) program for the VA Hospital System.

Funding Success with the NIH SBIR Program: Dr. James has received numerous grant awards from the National Institute on Aging (NIA), the National Institute of Mental Health (NIMH), and the National Institute on Neurological Disorders and Stroke (NINDS), serving as principal investigator on more than 20 grants, totaling more than $16M. His approval rate for NIH SBIR grant applications, including revisions, exceeds 80%.

Experience as an NIH Grant Reviewer: He has served as an NIH grant reviewer across five NIH divisions for over 14 years. He is intimately familiar with the processes that determine the “Overall Impact” score, which determines eligibility for funding. As a deeply experienced reviewer, he is highly skilled at analyzing applications and identifying their strengths and weaknesses.

Services

Multi-stage Grant Creation: Grant writing for SBIR and STTR applications is performed interactively. The first stage is a review and analysis of applicant-provided drafts and associated materials. The second is the creation of the grant application, guided by joint discussion and iterative editing. The third stage is completion, including the Budget Justification section.

Mock Grant Review Prior to Grant Submission: For applications already created, a mock review ensures optimal presentation of the rationale, specific aims, and strength of the methodological approach. Weaknesses are identified and corrected before submission to NIH. Mock review follows the same structure of the formal NIH-CSR processes, including section-by-section comments on strengths and weaknesses, sub-scores, and an overall impact score.

Unfunded Grant Application Revision: This service encompasses analysis and refinement of proposals that were either: 1) not deemed acceptable for formal review (i.e., “ND” – not discussed), or 2) received an Impact score that does not merit funding. Revision consists of first reviewing the SUMMARY STATEMENT of reviewer’s comments and judgments. First-time and inexperienced applicants often find these difficult to interpret, which complicates creating a revision that is optimally responsive to key criticisms.

To work with SBIR Grant Writer Dr. James, please visit our quote page and request him in the description area.