Benchmarking biopharmaceutical process development and manufacturing cost contributions to R&D.

This study aims to benchmark and analyze the process development and manufacturing costs across the biopharmaceutical drug development cycle and their contribution to overall research and development (R&D) costs. This was achieved with a biopharmaceutical drug development lifecycle cost model that captured the costs, durations, risks and interdependencies of the clinical, process development and manufacturing activities. The budgets needed for process development and manufacturing at each phase of development to ensure a market success each year were estimated. The impact of different clinical success rate profiles on the process development and manufacturing costs at each stage was investigated, with a particular focus on monoclonal antibodies. To ensure a market success each year with an overall clinical success rate (Phase I to approval) of ~12%, the model predicted that a biopharmaceutical company needs to allocate process development and manufacturing budgets in the order of ~$60 M for pre-clinical to Phase II material preparation and ~$70 M for Phase III to regulatory review material preparation. For lower overall clinical success rates of ~4%, which are more indicative of diseases such as Alzheimer's, these values increase to ~$190 M for early-phase and ~$140 Mfor late-phase material preparation; hence, the costs increase 2.5 fold. The costs for process development and manufacturing per market success were predicted to represent 13-17% of the R&D budget from pre-clinical trials to approval. The results of this quantitative structured cost study can be used to aid decision-making during portfolio management and budget planning procedures in biopharmaceutical development.

[Analysis of projects funded by NSFC in field of Chinese material medica resource in recent three years].

The paper reviewed the sponsorship and final reports of projects focus on Science of Chinese materia medica resource in Medical Science Department, National Natural Science Foundation of China. The applicant and supportive organizations were analyzed. The progress and results of some projects were summarized by research fields including formation mechanism of Dao-di herbs, research of plant taxonomy, breeding and cultivation of medical plants, ecological and environmental adaptability of Chinese materia medica resource, quality assessment of Chinese materia medica resource, and biosynthesis and regulation of active compounds. In addition, the potential problems and the most and least focused areas in the application were summarized for reference.

Public funding and private investment for R&D: a survey in China's pharmaceutical industry.

BACKGROUND: In recent years, China has experienced tremendous growth in its pharmaceutical industry. Both the Chinese government and private investors are motivated to invest into pharmaceutical research and development (R&D). However, studies regarding the different behaviors of public and private investment in pharmaceutical R&D are scarce. Therefore, this paper aims to investigate the current situation of public funding and private investment into Chinese pharmaceutical R&D. METHODS: The primary data used in the research were obtained from the China High-tech Industry Statistics Yearbook (2002-2012) and China Statistical Yearbook of Science and Technology (2002-2012). We analyzed public funding and private investment in five aspects: total investment in the industry, funding sources of the whole industry, differences between provinces, difference in subsectors, and private equity/venture capital investment. RESULTS: The vast majority of R&D investment was from private sources. There is a significantly positive correlation between public funding and private investment in different provinces of China. However, public funding was likely to be invested into less developed provinces with abundant natural herbal resources. Compared with the chemical medicine subsector, traditional Chinese medicine and biopharmaceutical subsectors obtained more public funding. Further, the effect of the government was focused on private equity and venture capital investment although private fund is the mainstream of this type of investment. CONCLUSIONS: Public funding and private investment play different but complementary roles in pharmaceutical R&D in China. While being less than private investment, public funding shows its significance in R&D investment. With rapid growth of the industry, the pharmaceutical R&D investment in China is expected to increase steadily from both public and private sources.

[Analysis of projects funded by NSFC in field of pharmacology of traditional Chinese medicine between 2010 to 2013 fiscal years].

Projects which supported by National Natural Science Foundation of China (NSFC) in discipline of pharmacology of Chinese medicine between 2010 to 2013 financial years were reviewed. Based on these research items, new features and problems were summarized in this field.

Reducing attrition in drug development: smart loading preclinical safety assessment.

Entry into the crucial preclinical good laboratory practice (GLP) stage of toxicology testing triggers significant R&D investment yet >20% of AstraZeneca's potential new medicines have been stopped for safety reasons in this GLP phase alone. How could we avoid at least some of these costly failures? An analysis of historical toxicities that caused stopping ('stopping toxicities') showed that >50% were attributable to target organ toxicities emerging within 2 weeks of repeat dosing or to acute cardiovascular risks. By frontloading 2-week repeat-dose toxicity studies and a comprehensive assessment of cardiovascular safety, we anticipate a potential 50% reduction in attrition in the GLP phase. This will reduce animal use overall, save significant R&D costs and improve drug pipeline quality.

Exploring productivity and collaboration in Australian Indigenous health research, 1995-2008.

BACKGROUND: Building research capacity in Indigenous health has been recognised as integral in efforts to reduce the significant health disparities between Indigenous and other Australian populations. The past few decades have seen substantial changes in funding policy for Australian Indigenous health research, including increases in overall expenditure and a greater focus on collaborative and priority-driven research. However, whether these policy shifts have resulted in any change to the structure of the research workforce in this field is unclear. We examine research publications in Australian Indigenous health from 1995-2008 to explore trends in publication output, key themes investigated, and research collaborations. METHODS: A comprehensive literature search was undertaken to identify research publications about Australian Indigenous health from 1995-2008. Abstracts of all publications identified were reviewed by two investigators for relevance. Eligible publications were classified according to key themes. Social network analyses of co-authorship patterns were used to examine collaboration in the periods 1995-1999, 2000-2004 and 2005-2008. RESULTS: Nine hundred and fifty three publications were identified. Over time, the number of publications per year increased, particularly after 2005, and there was a substantial increase in assessment of health service-related issues. Network analyses revealed a highly collaborative core group of authors responsible for the majority of outputs, in addition to a series of smaller separate groups. In the first two periods there was a small increase in the overall network size (from n = 583 to n = 642 authors) due to growth in collaborations around the core. In the last period, the network size increased considerably (n = 1,083), largely due to an increase in the number and size of separate groups. The general size of collaborations also increased in this period. CONCLUSIONS: In the past few decades there has been substantial development of the research workforce in Indigenous health, characterised by an increase in authors and outputs, a greater focus on some identified priority areas and sustained growth in collaborations. This has occurred in conjunction with significant changes to funding policy for Indigenous health research, suggesting that both productivity and collaboration may be sensitive to reform, including the provision of dedicated funding.

Treating depression with antidepressants: drug-placebo efficacy debates limit broader considerations.

The core issue regarding antidepressants for many clinicians is whether they perform significantly better than placebos. However, this article suggests eight additional concerns beyond drug efficacy alone to consider regarding antidepressants including: (1) formulating only a one-dimensional, biological view of depression; (2) defining the client's role as passive in treatment; (3) economic corruption of the research and reporting; (4) false or misleading consumer advertising; (5) conflicting data that confuse practitioners and consumers alike; (6) over- and under-prescription of medications; (7) drug side-effects; and (8) harm to the environment. The enhanced effects of psychotherapy utilizing hypnosis offer a means of avoiding most, if not all, of the problems associated with the use of antidepressants as a primary form of treatment.

Building bridges to the future of medicine: recommendations for boosting development of novel and companion diagnostics.

Evaluating the prospects for 'personalized healthcare' has become topical at the 10-year anniversary of the first results from the Human Genome Project. The coincidence of this milestone with a period of global financial difficulty is unfortunate, but industry has signaled its willingness to invest in this new medical paradigm in order to address the problems of high drug candidate attrition as well as escalating healthcare and R&D costs. For diagnostics manufacturers, justifying the ever-growing costs of development without an appropriate framework to provide reasonable return on investment is extremely challenging. Regulators have made good progress in defining what will satisfy current regulatory mandates, but there is still far to go to create conditions that would stimulate investment. My personal perspective is that personalized healthcare represents a solution rather than a problem and herein I describe the bottlenecks slowing development of novel diagnostics from the perspective of a willing commercial stakeholder.