Despite decades of promising research, the role of functional food components (nutraceuticals) and dietary supplements in reducing health risks and managing chronic conditions remains for the most part unfulfilled. This failure can be attributed to barriers that are both institutional (e.g., the legal/regulatory framework), and scientific (e.g., the lack of interdisciplinary integration of information). As the baby boomers retire and costs of health care and insurance continue to escalate, demand for prevention and self-care approaches will intensify. The ability to develop and offer products as a “package” together with the requisite information for appropriate use will be of paramount importance.

Exponent’s unique mix of expertise and experience gives clients the broad array of tools necessary to innovate and succeed in this challenging and growing field. Our expertise includes:

• Toxicology, epidemiology/nutritional epidemiology, clinical medicine, human learning and information processing, health economics, exposure and risk assessment, regulatory affairs
• Interdisciplinary data mining and literature harvesting, to fully understand the value of data and information
• Health-promotion/disease prevention evaluation and decision support tools and programs
• Clinical study design, analysis, and reporting
• Adverse event report (AERs) evaluations
• Health economics models and data analyses, including utility assessment, conjoint analysis (e.g., consumer preferences/cost sensitivities, consumer satisfaction/concerns, treatment success/side effects)
• Quality-of-life assessment, costs/outcomes analysis and decision modeling.
• Decision modeling for risk, economic, and patient-reported outcomes (e.g., utilities, preferences, satisfaction, quality of life).

Exponent’s clients include producers of foods, dietary supplements, pharmaceuticals, additives and ingredients; insurance companies; government agencies; law firms; and trade associations. Examples of our experience include:

• Clinical studies to evaluate performance-enhancing supplements for the military.
• Critical review of the scientific literature, a “gap analysis” of data needs and a strategy for GRAS determination of an ingredient for a processed food company.
• Thorough evaluation of available data and literature, review by outside experts and assessment of the feasibility and timeline for GRAS status of a probiotic ingredient to assist an investor group with its business plan and SEC filing.
• Mining the nutritional epidemiology literature and government survey data for potential associations between a functional food component and selected health status factors to determine optimal design of clinical studies supporting a health claim strategy.
• Design, research, development, and evaluation of health risk appraisal programs, including a screening instrument to identify preventive care needs for the military.
• Design, research and development of consumer oriented health promotion and self-care programs based on the World Wide Web.
• Research and development of consumer information for a dietary supplement product line.
• Design of risk models for support of screening decisions.
• Critical review of proposed methodology for assessing impact of including heart-healthy foods in vending machines & cafeterias.
• Development of cost-effectiveness models looking at the impact of folic acid supplement use and other dietary practices for the CDC.
• Evaluation of adverse event reports (AERs) for a new drug compared to an older one for a major pharmaceutical company.

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