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Industry Focus 2007
Industry Focus 2007 / 7 April 2008 /
There has been much interest in the promise of proteomics to deliver biomarkers with utility for disease diagnosis and classification, and for assessing therapeutic efficacy and monitoring disease progression. However recently, particularly in the past year, expressions of concern have started to emerge regarding the paucity of protein biomarkers that have reached the stage of FDA approval or at least that have been sufficiently validated in independent studies. Therefore, a clear understanding of the current situation with respect to biomarkers and proteomics would be useful in assessing whether the field does hold promise and is ready to ‘deliver’ or whether effort should be focused elsewhere. The observations and derived conclusions presented here are intended to assess the current status of the field.
It is clear that there is currently no road map or agreed multi-step process to move biomarkers from discovery to validation analogous to the process of drug development. This situation is not limited to proteomics biomarkers but to the entire field of biomarkers. The process of biomarker clinical trials is not currently established like therapeutic clinical trials. The discovery process leading to those thousands of biomarker publications is often undertaken in an isolated laboratory and is loosely structured in a manner that does not lend itself to a seamless progression from discovery to validation. Furthermore, the discovery process is undertaken using platforms that are customised, as appropriate to address a particular objective. Additional effort that falls outside of the original scope of the research is required to develop the tools necessary to allow further testing of the biomarkers at the necessary scale to demonstrate utility. (more…)
Tagged with: Fred Hutchinson Cancer Research Center, Proteomics, Sam Hanash MD PhD
Industry Focus 2007 / 7 April 2008 /
Laboratory automation development is being increasingly outsourced to the commercial market according to a recent industrial member survey by the Association for Laboratory Automation (ALA). ALA polled 400 of its members in industry with 14 questions and received 72 responses representing 47 different companies in the Pharma, Biotech and Agriculture Science sectors (an exceptionally good response). This article discusses the four questions that pertain to how the practitioners of laboratory automation in industry get their job done.
We can compare some of these answers to historical responses to the same question by past attendees of the ‘Introduction to Laboratory Automation’ short course at the annual ALA LabAutomation. The size and diversity of the respondent pool in those cases was similar. (more…)
Tagged with: Anne-Kopf Sill, Association for Laboratory Automation (ALA), Greg Dummer, Lab Automation, Steve Hamilton
Industry Focus 2007 / 7 April 2008 /
The pharmaceutical industry has, for many years, operated in a special environment with strong regulation and patent protection. Production efficiency and yields have not, as in many other industries, been the major competition parameter and, as a result of this, pharmaceutical manufacturing has a low manufacturing performance compared to other industries. (more…)
Tagged with: Manufacturing, NNE A/S, Per Vase
Industry Focus 2007 / 7 April 2008 /
It is clear that pharmaceutical analysis plays a very important supporting role in drug development. Already during the conception of a candidate drug, for example by chemical synthesis, suitable analytical means are required to determine the identity and purity of the compound. Subsequent studies performed on candidate drugs with the aim of establishing the pharmacological, toxicological and therapeutic characteristics of the candidate drug vastly rely on bioanalysis.
Although there is still an important place for wet chemistry analysis such as, for example, identification tests, limit tests, titrations for assay etc. in the quality control of bulk drugs, the trend is in many cases to shift to separation techniques because the resolution they offer gives enhanced information about the sample. (more…)
Tagged with: A. Van Schepdael, Analytical techniques, J. Hoogmartens, K.U.Leuven
Industry Focus 2007 / 7 April 2008 /
Research within the pharmaceutical industry has tripled in the past 25 years, with the pipelines of the top companies doubling. Stricter regulations, guidelines, price and reimbursement legislation all result in a changing business environment. The growing market in drug development and increase in research and development (R&D) investment, including that of small service companies; coupled with an increase in development costs; the importance of timely development of new products and the aim of reducing time-to-market are all important financial considerations for achieving business growth.
While pharmaceutical and biotech R&D spending is surpassing $36 billion today and blockbuster drug development is levelling off, Contract Research Organisations (CROs) are moving in the direction of becoming either niche specific or large service providers. In the 1980s, the pharmaceutical industry came under a great deal of scrutiny from the FDA, which was closely monitoring the way clinical trials were conducted by pharmaceutical manufacturers. The regulatory atmosphere at that time was putting pressure on the pharmaceutical industry to outsource its processes. Many ‘new’ outsourcers relocated from the pharmaceutical companies and specialised in one particular area, staying regional and focussing on clinical monitoring, data management or project coordination. The last part of the 20th Century witnessed aggressive mergers and acquisitions among pharmaceutical and biotechnology companies as well many other bodies. As many CROs merged and grew larger, they had become full-service global trial managers. The emergence of truly global service companies with strong track records has tremendously matured the outsourcing process. The CRO industry is advancing through global expansion, process improvement and innovative technology. (more…)
Tagged with: Dr. Amarpreet S Dhiman, Frost & Sullivan, Outsourcing, Research & Development (R&D)
Industry Focus 2007 / 7 April 2008 /
In the highly competitive contract manufacturing outsourcing (CMO) market the industry is on the rise with pharmaceutical and biotechnology companies targeting their resources towards marketing, rather than production and drug discovery. Pharmaceutical and biopharmaceutical companies are faced with the need to outsource the manufacture of their products for a variety of reasons.
Some of the main reasons include start-up companies that frequently do not have the facilities or expertise necessary to produce the type or quantities of drugs or biologics that are necessary for performing pre-clinical and clinical studies of investigational new drugs. Furthermore, established companies with FDA-approved drugs or biologics may not have manufacturing facilities that comply with current good manufacturing practices, or they may not have the adequate capacity to fulfil the commercial demands for their products and may desire manufacturing back-ups. Although the technical details that are part of any contract manufacturing agreement will vary depending on the nature of the project, a mutually satisfactory agreement that anticipates issues that are likely to arise is the key to the production of acceptable product and the long-term success of the relationship. The need for the services of CMOs has given rise to a vibrant industry that is likely to grow as that need increases. This shift in focus towards contract manufacturing also includes cost efficiency, lack of in-house expertise with the changing technology and to have advantage of the time-to-market drugs. (more…)
Tagged with: Dr. Amarpreet S Dhiman, Frost & Sullivan, Manufacturing, Outsourcing
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