Jen was MITRE’s Project Leader for a novel Innovator Support project for the NIH Office of the Director, Small business Education and Entrepreneurial Development (SEED) office, piloting entrepreneurship coaching and regulatory and reimbursement consulting services for small business and academic innovators.
At the time SEED was created, there were a few NIH centers with sufficient budgets to support a small team of regulatory affairs experts, but no services available to serve all 24 of the Institutes and Centers that have a Small Business Innovative Research (SBIR) program. The team Jen assembled included experts in regulatory affairs, including former FDA review staff; industry experts with experience developing biologics and gene therapies; digital health entrepreneurs; and coding and reimbursement experts including a former CMS team leader.
That team has supported SEED for over five years and has created decision tools for NIH program managers (which are available to ARPA-H program managers through the NIH Intranet) and resources for innovators that are released publicly, including recorded webinars and guides.
Examples of those resources include a guide to selecting a regulatory consultant, background on CPT and other code sets, and a guide to selecting a reimbursement consultant.
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