Economics of new oncology drug development.

PURPOSE: Review existing studies and provide new results on the development, regulatory, and market aspects of new oncology drug development. METHODS: We utilized data from the US Food and Drug Administration (FDA), company surveys, and publicly available commercial business intelligence databases on new oncology drugs approved in the United States and on investigational oncology drugs to estimate average development and regulatory approval times, clinical approval success rates, first-in-class status, and global market diffusion. RESULTS: We found that approved new oncology drugs to have a disproportionately high share of FDA priority review ratings, of orphan drug designations at approval, and of drugs that were granted inclusion in at least one of the FDA's expedited access programs. US regulatory approval times were shorter, on average, for oncology drugs (0.5 years), but US clinical development times were longer on average (1.5 years). Clinical approval success rates were similar for oncology and other drugs, but proportionately more of the oncology failures reached expensive late-stage clinical testing before being abandoned. In relation to other drugs, new oncology drug approvals were more often first-in-class and diffused more widely across important international markets. CONCLUSION: The market success of oncology drugs has induced a substantial amount of investment in oncology drug development in the last decade or so. However, given the great need for further progress, the extent to which efforts to develop new oncology drugs will grow depends on future public-sector investment in basic research, developments in translational medicine, and regulatory reforms that advance drug-development science.

The calculator as an instrument of validation of mathematical knowledge: a case study

En este trabajo se describe una experiencia llevada a cabo con profesores de matemáticas en formación, sobre el papel que pueden desarrollar las nuevas tecnologías para llevar a cabo procesos de demostración y prueba en el aula de secundaria.

The calculator as an instrument of validation of mathematical knowledge: a case study (extended version)

En este trabajo se describe detalladamente una experiencia llevada a cabo con profesores de matemáticas en formación, sobre el papel que pueden desarrollar las nuevas tecnologías para llevar a cabo procesos de demostración y prueba en el aula de secundaria.

An investigation of the mathematical elements of the Dai culture south-west Yunnan province, China

Dai ethnic mathematical culture is an important part of Dai ethnic culture. Mathematical elements show in their daily life. Through a research project of the Yunnan Dehong Dai people in southwest China, We collected the first-hand information, tried to do a small investigative study, and collected mathematics teaching resources that is useful to primary and secondary schools students on mathematics learning  in this minority areas. Keyword: Dai ethnic; Mathematical culture; Primary and secondary schools; Teaching resources.

Mathematical notation in formal specification: Too difficult for the masses? [Correspondence]

The phrase “not much mathematics required” can imply a variety of skill levels. When this phrase is applied to computer scientists, software engineers, and clients in the area of formal specification, the word “much” can be widely misinterpreted with disastrous consequences. A small experiment in reading specifications revealed that students already trained in discrete mathematics and the specification notation performed very poorly; much worse than could reasonably be expected if formal methods proponents are to be believed.

Mathematical modelling of the solidification of liquid tin with electromagnetic stirring

It is well known that during alloy solidification, convection currents close to the so-lidification front have an influence on the structure of dendrites, the local solute concentration, the pattern of solid segregation, and eventually the microstructure of the casting and hence its mechanical properties. Controlled stirring of the melt in continuous casting or in ingot solidification is thought to have a beneficial effect. Free convection currents occur naturally due to temperature differences in the melt and for any given configuration, their strength is a function of the degree of superheat present. A more controlled forced convection current can be induced using electro-magnetic stirring. The authors have applied their Control-Volume based MHD method [1, 2] to the problem of tin solidification in an annular crucible with a water-cooled inner wall and a resistance heated outer one, for both free and forced convection situations and for various degrees of superheat. This problem was studied experimentally by Vives and Perry [3] who obtained temperature measurements, front positions and maps of electro-magnetic body force for a range of superheat values. The results of the mathematical model are compared critically against the experimental ones, in order to validate the model and also to demonstrate the usefulness of the coupled solution technique followed, as a predictive tool and a design aid. Figs 6, refs 19.

Using mathematical models to predict the development of aircraft cabin fires

Computer based mathematical models describing aircraft fire have a role to play in the design and development of safer aircraft, in the implementation of safer and more rigorous certification criteria and in post mortuum accident investigation. As the cost involved in performing large-scale fire experiments for the next generation 'Ultra High Capacity Aircraft' (UHCA) are expected to be prohibitively high, the development and use of these modelling tools may become essential if these aircraft are to prove a safe and viable reality. By describing the present capabilities and limitations of aircraft fire models, this paper will examine the future development of these models in the areas of large scale applications through parallel computing, combustion modelling and extinguishment modelling.

Computer Museum, School of Computing and Mathematical Sciences, University of Greenwich

Computer equipment, once viewed as leading edge, is quickly condemned as obsolete and banished to basement store rooms or rubbish bins. The magpie instincts of some of the academics and technicians at the University of Greenwich, London, preserved some such relics in cluttered offices and garages to the dismay of colleagues and partners. When the University moved into its new campus in the historic buildings of the Old Royal Naval College in the center of Greenwich, corridor space in King William Court provided an opportunity to display some of this equipment so that students could see these objects and gain a more vivid appreciation of their subject's history.

Demonstration thermo-electric and MHD mathematical models of a 500 kA A1 electrolysis cell

In the present study, a 3D full cell quarter thermo-electric model of a 500kA demonstration cell has been developed and solved. In parallel, a non-linear wave MHD model of the same 500 kA demonstration cell has been developed and solved. A preliminary study of the impact of the interactions between the cell thermo-electric and MHD models will be presented.

Mathematical modelling: a laser soldering process for an optoelectronics butterfly package

For sensitive optoelectronic components, traditional soldering techniques cannot be used because of their inherent sensitivity to thermal stresses. One such component is the Optoelectronic Butterfly Package which houses a laser diode chip aligned to a fibre-optic cable. Even sub-micron misalignment of the fibre optic and laser diode chip can significantly reduce the performance of the device. The high cost of each unit requires that the number of damaged components, via the laser soldering process, are kept to a minimum. Mathematical modelling is undertaken to better understand the laser soldering process and to optimize operational parameters such as solder paste volume, copper pad dimensions, laser solder times for each joint, laser intensity and absorption coefficient. Validation of the model against experimental data will be completed, and will lead to an optimization of the assembly process, through an iterative modelling cycle. This will ultimately reduce costs, improve the process development time and increase consistency in the laser soldering process.

Mathematical modelling of the behaviour of granular material in a computational fluid dynamics framework using micro-mechanical models

In this paper, a Computational Fluid Dynamics framework is presented for the modelling of key processes which involve granular material (i.e. segregation, degradation, caking). Appropriate physical models and sophisticated algorithms have been developed for the correct representation of the different material components in a granular mixture. The various processes, which arise from the micromechanical properties of the different mixture species can be obtained and parametrised in a DEM / experimental framework, thus enabling the continuum theory to correctly account for the micromechanical properties of a granular system. The present study establishes the link between the micromechanics and continuum theory and demonstrates the model capabilities in simulations of processes which are of great importance to the process engineering industry and involve granular materials in complex geometries.