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Associations of iron metabolism genes with blood manganese levels: a population-based study with validation data from animal models

Given mounting evidence for adverse effects from excess manganese exposure, it is critical to understand host factors, such as genetics, that affect manganese metabolism. This research paper by Jonghan Kim Birgit Claus Henn, Marianne Wessling-Resnick, Martha María Téllez-Rojo, Innocent Jayawardene, Adrienne S Ettinger, Mauricio Hernández-Avila, Joel Schwartz, David C Christiani, Howard Hu and Robert O Wright of the Departments of Genetics and Complex Diseases and Environmental Health, Harvard School of Public Health, Boston, Massachusetts, evaluates associations of manganese with functional variants in three candidate iron metabolism genes.
Influence of DMT1 and iron status on inflammatory responses in the lung

Research paper by Jonghan Kim, Ramon M. Molina, Thomas C. Donaghey, Peter D. Buckett,, Joseph D. Brain and Marianne Wessling-Resnick of the Departments of Genetics and Complex Diseases and Environmental Health, Harvard School of Public Health, Boston, Massachusetts
Will New Cellular Models of Parkinson’s Disease Advance Understanding of Disease and Therapy?

To date, a model for Parkinson’s disease (PD) that accurately replicates key features of pathophysiology represents a major bottleneck in the understanding of disease mechanisms, as well as in efficient drug screening. Both cell culture systems and animal models of PD have fundamental limitations in that none of these models faithfully recapitulates all of the clinical and pathological phenotypes that define the disease. Effectively modelling disease progression, with reproduction of pathological hallmarks of the disease, such as Lewy bodies, poses significant challenges to the development of an animal or cellular model of PD. Read more in this report by Birgitt Schüle, Assistant Professor and Clinical Molecular Geneticist of The Parkinson’s Institute and Clinical Center.

Articles

Using Industry Spending Data to Develop Strategic Marketing
For CROs and CMOs to get the highest return on investment of marketing dollars, it is essential to develop marketing strategies that maximize opportunities to connect with potential partners. Knowing which sponsor segments to target, as well as which services respective sponsors are looking to outsource, can give insight into how to develop a marketing strategy that will cultivate opportunities and boost the impact of the financial outlay. Industry spending data can help influence the elements of a strategic marketing campaign, from where to place ads (and what to communicate) to which trade shows to attend and exhibit to make the most impact. When looking at overall spending for 2011 and projected outsourcing spend for 2012, one can determine which customer segments to target based on how the services offered by providers compare to the needs of each segment. Big Pharma showed an increased need for bio-analytical testing, process optimization, stability storage and
Predictive Toxicology becomes More Important as R&D Costs Rise
It costs millions to get a drug from conception to development stages, as well as several years of research. However, a key challenge in the pharmaceutical industry is that scientists can put all this work and money into a compound, only to find it has unacceptable toxicology and they have to return to the drawing board. Indeed, the most recent figures suggest the cost of discovering and developing a drug is hundreds of millions of pounds. Clearly this is an impossible situation, as no business wastes money lightly, especially in the current climate. With an increasing pressure to cut costs and streamline processes, pharmaceutical firms are doing all they can to avoid late stage drug attrition and all the connected expense. This is where predictive toxicology becomes a valuable tool. It is one of the key processes in the battle against mounting costs, providing pharmaceutical firms with the ability to predict the toxicological effect of a drug or compound. This enables organisations
The Need for Predictive Toxicology
With the growing cost of drug discovery and development, organisations involved in the manufacture of pharmaceuticals are keen to do all they can to avoid the huge costs associated with late-stage drug attrition. Current figures suggest that the average cost of bringing a drug through screening, chemistry, pre-clinical development and testing has now reached close to $900 million (£559 million), so pharmaceutical companies will use all the technology available to them to avoid the risk of failure, with predictive toxicology considered to be a major tool at their disposal. Predictive toxicology works by giving research and development teams key insights into the toxicological effect of the drug or pharmaceutical compound in the early stages of development, meaning that companies can work towards improving the issues or identifying the cause, ensuring that no costly surprises take place during the clinical trials. Why is it important? Biopharmaceutical company Gilead Sciences hit
Global ADME – Toxicology Testing Market Update
Issues with toxicity remain one of the key reasons why promising drug candidates fail to make it beyond the lab – at a cost to both the company and ultimately the patient. Introducing toxicology screening earlier in the drug development process appears to be a strong investment when the new drug development costs of $1 billion (£624 million) are taken into account. A number of industry factors are also combining to give companies an added imperative to develop successful drug candidates. The patent cliff is looming ever closer on the horizon as the era of blockbuster drugs come to an end and the costs associated with regulatory compliance are on the rise. By 2017, the global ADME toxicology testing market is expected to exceed $10 billion, with the United States market for In-Vivo Toxicology testing alone expected to hit $1 billion by 2015, according to a report from Global Industry Analysts (GIA). "The increasing number of drug targets and volume of assay
Scale-Up and Manufacturing of Regenerative Medicine
When introducing a regenerative medicine cell based product to a commercial setting, there are a number of things to take into consideration to ensure a commercially viable and safe product for patient use. In this Q&A interview, William Fodor, Director of Translational Sciences, Cell Therapy Group, gives some great insights into the commercial manufacturing scale-up process of cell therapies. Pharma IQ: Can you give some advice on the best way for a company to develop standards for commercialisation to improve safety? W Fodor: Well, with any biological product, you have to do all the appropriate testing and there’s really no standards necessarily to be developed by the company because he regulatory process is pretty well outlined by the FDA and the CBER Division and cell therapy products are regulated by the ofice of Cell Tissue and Gene Therapy Division. So, it’s not that you need to develop standards for commercialisation to improve safety. You just need to follow
The Potential of Stem Cell Models for Safety Testing
Dr. Glyn Stacey, Director of the UK Stem Cell Bank, offers some insights into the Bank’s work to support the development of stem cell models for safety testing. Pharma IQ: First, please can you outline the remit of the UK Stem Cell Bank and its relationship with the industry? G Stacey: To deliver ethically sourced and quality-controlled stocks of human stem cell lines to the research community and for use in translational research and clinical applications. The Bank is expected to operate without key conflicts of interest i.e. not engaging in basic stem cell research or near market product development. This enables the Bank to operate as an independent partner working with many different groups and stakeholders in the area. The Bank is keen to collaborate with industry and has engaged in a number of projects involving industry and training activities. Pharma IQ: Can you give an update on the recent work you have been doing? G Stacey: I am working on a number of initiatives:
Tox21 Phase II: Translating Screening Results to Human Relevance

Q&A interview on National Toxicology Program’s vision for the 21st century, including the collaboration known as Tox21, bridging high throughput screening (HTS) results to human toxicology, and leveraging high throughput gene expression analysis as a high content information source. Features contributions from David Gerhold, PhD, Scientist, Genomic Toxicologist, NIH Chemical Genomics Center, National Institutes of Health, and Raymond Tice, Ph.D., Chief, Biomolecular Screening Branch, Division of the National Toxicology Program, National Institute of Environmental Health Sciences.