Economic return of clinical trials performed under the pediatric exclusivity program.

CONTEXT: In 1997, Congress authorized the US Food and Drug Administration (FDA) to grant 6-month extensions of marketing rights through the Pediatric Exclusivity Program if industry sponsors complete FDA-requested pediatric trials. The program has been praised for creating incentives for studies in children and has been criticized as a "windfall" to the innovator drug industry. This critique has been a substantial part of congressional debate on the program, which is due to expire in 2007. OBJECTIVE: To quantify the economic return to industry for completing pediatric exclusivity trials. DESIGN AND SETTING: A cohort study of programs conducted for pediatric exclusivity. Nine drugs that were granted pediatric exclusivity were selected. From the final study reports submitted to the FDA (2002-2004), key elements of the clinical trial design and study operations were obtained, and the cost of performing each study was estimated and converted into estimates of after-tax cash outflows. Three-year market sales were obtained and converted into estimates of after-tax cash inflows based on 6 months of additional market protection. Net economic return (cash inflows minus outflows) and net return-to-costs ratio (net economic return divided by cash outflows) for each product were then calculated. MAIN OUTCOME MEASURES: Net economic return and net return-to-cost ratio. RESULTS: The indications studied reflect a broad representation of the program: asthma, tumors, attention-deficit/hyperactivity disorder, hypertension, depression/generalized anxiety disorder, diabetes mellitus, gastroesophageal reflux, bacterial infection, and bone mineralization. The distribution of net economic return for 6 months of exclusivity varied substantially among products (net economic return ranged from -$8.9 million to $507.9 million and net return-to-cost ratio ranged from -0.68 to 73.63). CONCLUSIONS: The economic return for pediatric exclusivity is variable. As an incentive to complete much-needed clinical trials in children, pediatric exclusivity can generate lucrative returns or produce more modest returns on investment.

Developing drugs for developing countries.

Infectious and parasitic diseases create enormous health burdens, but because most of the people suffering from these diseases are poor, little is invested in developing treatments. We propose that developers of treatments for neglected diseases receive a "priority review voucher." The voucher could save an average of one year of U.S. Food and Drug Administration (FDA) review and be sold by the developer to the manufacturer of a blockbuster drug. In a well-functioning market, the voucher would speed access to highly valued treatments. Thus, the voucher could benefit consumers in both developing and developed countries at relatively low cost to the taxpayer.

Broadband electromagnetic cloaking with smart metamaterials.

The ability to render objects invisible with a cloak that fits all objects and sizes is a long-standing goal for optical devices. Invisibility devices demonstrated so far typically comprise a rigid structure wrapped around an object to which it is fitted. Here we demonstrate smart metamaterial cloaking, wherein the metamaterial device not only transforms electromagnetic fields to make an object invisible, but also acquires its properties automatically from its own elastic deformation. The demonstrated device is a ground-plane microwave cloak composed of an elastic metamaterial with a broad operational band (10-12 GHz) and nearly lossless electromagnetic properties. The metamaterial is uniform, or perfectly periodic, in its undeformed state and acquires the necessary gradient-index profile, mimicking a quasi-conformal transformation, naturally from a boundary load. This easy-to-fabricate hybrid elasto-electromagnetic metamaterial opens the door to implementations of a variety of transformation optics devices based on quasi-conformal maps.

Multi-program benchmark definition

© 2015 IEEE.Although definition of single-program benchmarks is relatively straight-forward-a benchmark is a program plus a specific input-definition of multi-program benchmarks is more complex. Each program may have a different runtime and they may have different interactions depending on how they align with each other. While prior work has focused on sampling multiprogram benchmarks, little attention has been paid to defining the benchmarks in their entirety. In this work, we propose a four-tuple that formally defines multi-program benchmarks in a well-defined way. We then examine how four different classes of benchmarks created by varying the elements of this tuple align with real-world use-cases. We evaluate the impact of these variations on real hardware, and see drastic variations in results between different benchmarks constructed from the same programs. Notable differences include significant speedups versus slowdowns (e.g., +57% vs -5% or +26% vs -18%), and large differences in magnitude even when the results are in the same direction (e.g., 67% versus 11%).

A Pharmacology-Based Enrichment Program for Undergraduates Promotes Interest in Science.

There is a strong need to increase the number of undergraduate students who pursue careers in science to provide the "fuel" that will power a science and technology-driven U.S. economy. Prior research suggests that both evidence-based teaching methods and early undergraduate research experiences may help to increase retention rates in the sciences. In this study, we examined the effect of a program that included 1) a Summer enrichment 2-wk minicourse and 2) an authentic Fall research course, both of which were designed specifically to support students' science motivation. Undergraduates who participated in the pharmacology-based enrichment program significantly improved their knowledge of basic biology and chemistry concepts; reported high levels of science motivation; and were likely to major in a biological, chemical, or biomedical field. Additionally, program participants who decided to major in biology or chemistry were significantly more likely to choose a pharmacology concentration than those majoring in biology or chemistry who did not participate in the enrichment program. Thus, by supporting students' science motivation, we can increase the number of students who are interested in science and science careers.