The global biopharma industry and the rise of Indian drug multinationals: implications for Australian generics policy

This article provides a synopsis of the new dynamics of the global biopharma industry. The emergence of global generics companies with capabilities approximating those of 'big pharma' has accelerated the blurring of boundaries between the innovator and generics sectors. Biotechnology-based products form a large and growing segment of prescription drug markets and regulatory pathways for biogenerics are imminent. Indian biopharma multinationals with large-scale efficient manufacturing plants and growing R&D capabilities are now major suppliers of Active Pharmaceutical Ingredients (APIs) and generic drugs across both developed and developing countries. In response to generic competition, innovator companies employ a range of life cycle management techniques, including the launch of 'authorised generics'. The generics segment in Australia will see high growth rates in coming years but the prospect for local manufacturing is bleak. The availability of cheap generics in international markets has put pressure on Pharmaceutical Benefits Scheme (PBS) pricing arrangements, and a new policy direction was announced in November 2006. Lower generics prices will have a negative impact on some incumbent suppliers but industrial renewal policies for the medicines industry in Australia are better focused on higher value R&D activities and niche manufacturing of sophisticated products

Quality, safety and efficiency in practice: Risk assessment and standardisation of anesthesia equipment and supplies in operating theaters of high-volume tertiary-care academic medical center

Background: Operating theatres (OTs) are valuable and costly resources that need to be appropriately designed and stocked for efficient, quality and safe patient care. We assessed the logistic inefficiency including the availability and location layout of necessary supplies across OTs of a high-volume tertiary-care academic medical center. Methods: A blinded observer (anesthesia technologist) was allocated to 10 OTs. For each OT, the availability, quantity and time spent to locate and obtain a set of required items were recorded (baseline values). We then developed an OT mapping plan to determine the specific item/s to be stocked in specific locations, and one OT was standardized to this configuration map. A blinded observer was then allocated to this standardized OT and time spent to obtain the same set of items was again recorded. Six of our regular OTs were then standardized to the same configuration, and the time to obtain the items by a blinded observer were again recorded for each OT. T tests compared the time required to locate items in the standardized OT vs. regular OTs; paired t tests compared the time required in each OT vs. itself before and after standardization. Results: The observer required significantly more time in each of the 10 regular OTs compared to the standardized OT. The time spent by the observer to obtain the required items significantly and considerably decreased in each of 6 OTs after their standardization, compared to the time required before their standardization. Conclusion: This quality improvement project successfully reduced the time required to identify and locate different supplies, which impacts on the efficiency and quality of patient care. For anesthesia staff moving from one anesthetizing location to another within the institution, consistencies in location and number of anesthesia equipment and supplies create higher levels of safety and professionalism.Scopu

Original implementation of low-temperature SPS for bioactive glass used as a bone biomaterial

International audienceAlkali borated bioactive glasses powders with compositions based on the SiO(2)-Na(2)O-CaO-P(2)O(5)-x B(2)O(3) system (0 < x < 20 wt%); have been consolidated at low temperature using Spark Plasma Sintering (SPS). Through SPS technique under 50 MPa, it was possible to achieve fully dense and completely amorphous borated glasses at temperatures as low as 420 °C. By increasing the sintering temperature up to 430 °C, the dense samples crystallized which is mostly achieved at higher temperatures. This study reveals that the mechanical properties of these new borated biomaterials are suitable to be used as a promising candidate for repairing defects in non-load-bearing bones as well as for coating on the metallic surface implants to improve the bioactivity process bone/implant. The pressure had a weak effect on the crystallization and densification of the glass compared to the temperature during the powder consolidation by SPS. Moreover, by increasing the boron content, the compressive strength and the elastic modulus of the elaborated glasses decreased for being close to those of the natural

Detection of Pentatrichomonas hominis DNA in biological specimens by PCR

AIM: To develop a sensitive and specific polymerase chain reaction for the detection of Pentatrichomonas hominis in biological specimens. METHODS: Three primers, associated in two primer pairs, were designed to amplify a sequence from the SSU rRNA gene of P. hominis. The specificity of both primer pairs was established by testing DNA extractions of different Trichomonad species, protozoa, bacteria, yeasts, and human leucocytes. The analytical sensitivity was determined through testing dilutions of P. hominis trophozoites. The clinical specificity and applicability of the assay was evaluated on stool samples and self-administered vaginal swabs. CONCLUSIONS: A highly specific and sensitive PCR assay was developed. Both primer pairs performed equally well. SIGNIFICANCE AND IMPACT OF THE STUDY: The presence of P. hominis in vaginal specimens has not been reported before