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The US Food and Drug Administration (FDA) expanded access pathway allows patients with life-threatening or serious conditions to access investigational drugs outside of trials, under certain conditions. The 21st Century Cures Act (“Cures Act”) requires certain drug companies to publicly disclose their expanded access policies. We characterized the proportion of applicable US biopharmaceutical companies, with an oncology related drug, implementing Cures Act requirements for expanded access policies and whether available policies contain the information described in the Act. We found about one-third of applicable biopharmaceutical companies (32%, 140/423) implemented the Cures Act requirement to have a public expanded access policy. Less than one-third of public policies contained all described information (31%, 44/140). Larger companies and those with at least one drug receiving an FDA expedited designation (59% vs. 21%; P < 0.001), or at least one FDA-approved drug (57% vs. 28%; P < 0.001) were more likely to have a public policy. Our results suggest the Cures Act may be having a limited impact on its goals of supporting timely medical decisions and closing informational gaps for patients and doctors around expanded access to investigational oncology therapies, especially for products sponsored by smaller and newer companies.

Self-aware computer systems will be capable of adapting their behavior and resources thousands of times a second to automatically find the best way to accomplish a given goal despite changing environmental conditions and demands. Such a capability benefits a broad spectrum of computer systems from embedded systems to supercomputers and is particularly useful for meeting power, performance, and resource-metering challenges in mobile computing, cloud computing, multicore computing, adaptive and dynamic compilation environments, and parallel operating systems. Some of the challenges in implementing self-aware systems are a) knowing within the system what the goals of applications are and if they are meeting them, b) deciding what actions to take to help applications meet their goals, and c) developing standard techniques that generalize and can be applied to a broad range of self-aware systems. This work presents our vision for self-aware adaptive systems and proposes enabling technologies to address these three challenges. We describe a framework called Application Heartbeats that provides a general, standardized way for applications to monitor their performance and make that information available to external observers. Then, through a study of a self-optimizing synchronization library called Smartlocks, we demonstrate a powerful technique that systems can use to determine which optimization actions to take. We show that Heartbeats can be applied naturally in the context of reinforcement learning optimization strategies as a reward signal and that, using such a strategy, Smartlocks are able to significantly improve performance of applications on an important emerging class of multicore systems called asymmetric multicores.

The effectiveness of a cheap and easy method of household protection against Culex quinquefasciatus Say and other mosquitoes (Diptera: Culicidae) was investigated in Dar es Salaam, Tanzania. Kerosene-burning lamps (korobois) were modified to heat and vaporize transfluthrin, a volatile pyrethroid insecticide. When transfluthrin was added to fuel of the lamp, protection against biting was poor unless a very high concentration of insecticide was used. A modified lamp (= vaporizing koroboi) was designed to overcome this problem by mixing the insecticide with vegetable oil and heating it to 120 degrees C in a tin held just above the flame. The concentration of 0.1% transfluthrin in vegetable oil gave 50-75% reduction in biting, a similar degree of protection to that obtained from burning a mosquito coil containing a synthetic pyrethroid (0.25% d-allethrin) and significantly better protection than a locally bought coil (brand 'White Crane', probably containing DDT). Greater protection (consistently > 90%) was achieved with a higher concentration of transfluthrin (0.5%) in the vegetable oil. This modified lamp is simple, cheap and employs locally available technology. With further development, and due regard to inhalation toxicity of the vaporized materials, it may offer a more cost-effective alternative to a mosquito coil as a means of personal protection, and a useful complement to a net for the early part of the evening before bedtime.