Insights from the evaluations of the NIH Centers for Accelerated Innovation and Research Evaluation and Commercialization Hubs programs.

BACKGROUND: The National Institutes of Health launched the NIH Centers for Accelerated Innovation and the Research Evaluation and Commercialization Hubs programs to develop approaches and strategies to promote academic entrepreneurship and translate research discoveries into products and tools to help patients. The two programs collectively funded 11 sites at individual research institutions or consortia of institutions around the United States. Sites provided funding, project management, and coaching to funded investigators and commercialization education programs open to their research communities. METHODS: We implemented an evaluation program that included longitudinal tracking of funded technology development projects and commercialization outcomes; interviews with site teams, funded investigators, and relevant institutional and innovation ecosystem stakeholders and analysis and review of administrative data. RESULTS: As of May 2021, interim results for 366 funded projects show that technologies have received nearly $1.7 billion in follow-on funding to-date. There were 88 start-ups formed, a 40% Small Business Innovation Research/Small Business Technology Transfer application success rate, and 17 licenses with small and large businesses. Twelve technologies are currently in clinical testing and three are on the market. CONCLUSIONS: Best practices used by the sites included leadership teams using milestone-based project management, external advisory boards that evaluated funding applications for commercial merit as well as scientific, sustained engagement with the academic community about commercialization in an effort to shift attitudes about commercialization, application processes synced with education programs, and the provision of project managers with private-sector product development expertise to coach funded investigators.

Economic analysis of opportunities to accelerate Alzheimer's disease research and development.

The development of disease-modifying treatments for Alzheimer's disease (AD) faces a number of barriers. Among these are the lack of surrogate biomarkers, the exceptional size and duration of clinical trials, difficulties in identifying appropriate populations for clinical trials, and the limitations of monotherapies in addressing such a complex multifactorial disease. This study sets out to first estimate the consequent impact on the expected cost of developing disease-modifying treatments for AD and then to estimate the potential benefits of bringing together industry, academic, and government stakeholders to co-invest in, for example, developing better biomarkers and cognitive assessment tools, building out advanced registries and clinical trial-readiness cohorts, and establishing clinical trial platforms to investigate combinations of candidate drugs and biomarkers from the portfolios of multiple companies. Estimates based on interviews with experts on AD research and development suggest that the cost of one new drug is now $5.7 billion (95% confidence interval (CI) $3.7-9.5 billion) and could be reduced to $2.0 billion (95% CI $1.5-2.9 billion). The associated acceleration in the arrival of disease-modifying treatments could reduce the number of case years of dementia by 7.0 million (95% CI 4.4-9.4 million) in the United States from 2025 through 2040.

Prospective cost-benefit analysis of a two-dimensional barcode for vaccine production, clinical documentation, and public health reporting and tracking.

In the United States recording accurate vaccine lot numbers in immunization records is required by the National Childhood Vaccine Injury Act and is necessary for public health surveillance and implementation of vaccine product recalls. However, this information is often missing or inaccurate in records. The Food and Drug Administration (FDA) requires a linear barcode of the National Drug Code (NDC) on vaccine product labels as a medication verification measure, but lot number and expiration date must still be recorded by hand. Beginning in 2011, FDA permitted manufacturers to replace linear barcodes with two-dimensional (2D) barcodes on unit-of-use product labels. A 2D barcode can contain the NDC, expiration date, and lot number in a symbol small enough to fit on a unit-of-use label. All three data elements could be scanned into a patient record. To assess 2D barcodes' potential impacts, a mixed-methods approach of time-motion data analysis, interview and survey data collection, and cost-benefit analysis was employed. Analysis of a time-motion study conducted at 33 practices suggests scanning 2D-barcoded vaccines could reduce immunization documentation time by 36-39 s per dose. Data from an internet survey of primary care providers and local health officials indicate that 60% of pediatric practices, 54% of family medicine practices, and 39% of health departments would use the 2D barcode, with more indicating they would do so if they used electronic health records. Inclusive of manufacturer and immunization provider costs and benefits, we forecast lower-bound net benefits to be $310-334 million between 2011 and 2023 with a benefit-to-cost ratio of 3.1:1-3.2:1. Although we were unable to monetize benefits for expected improved immunization coverage, surveillance, or reduced medication errors, based on our findings, we expect that using 2D barcodes will lower vaccine documentation costs, facilitate data capture, and enhance immunization data quality.

Health plan use of immunization information systems for quality measurement.

OBJECTIVE: To evaluate a health plan's business case for using a state immunization information system (IIS) as the primary data source for members' immunization histories. STUDY DESIGN: Case study of Priority Health, a Michigan managed care organization, to investigate use of IIS data for Healthcare Effectiveness Data and Information Set (HEDIS) compliance, quality measurement, and a provider incentive program. METHODS: Primary data were collected through key informant interviews and group discussions with Priority Health and IIS managers. Priority Health's information systems were populated with claims data and supplemental data, before chart reviews, to simulate immunization and health plan quality measures for 2004 to 2007 in the absence of IIS data. Simulated rates were compared with historical rates that included IIS data. The study included a cost-benefit analysis. RESULTS: For 2007, IIS data increased observed immunization rates from 6.49 to 54.13 percentage points for childhood immunizations and 57.63 to 77.97 percentage points for adolescent immunizations. The HEDIS administrative rate for childhood immunizations doubled from 43.38% in 2003 to 88.08% in 2007. The most significant source of savings was in administration of the health plan's Physician Incentive Program, which saw 18,881 fewer chart reviews from 2004 to 2007 when IIS data were used compared with when they were not used. Total costs of using IIS data were estimated to be $14,318 and net benefits were $107,854 -- corresponding to a benefit-to-cost ratio of 8.06. CONCLUSIONS: Health plans using a state IIS as a single point of data entry may realize cost savings and have improved assurance of immunization coverage.