When revenue gains soften, costs start to attract greater executive attention. And so it is with Pharma. It’s widely acknowledged that the pressure to control and reduce costs is the next major challenge facing companies contributing to the Pharma industry’s global value chain. Growing generic competition, imminent patent expirations, and shorter pipelines are all contributing to eroding margins.

But as part of their efforts to improve financial performance, many pharmaceutical companies are finding it hard not to turn the cost-cutting spotlights on IT. And for good reason; not only does the Pharma industry, according to recent research, spend six times more on IT than the average U.S. industry (15% of revenues vs. 2.5%) but many companies are still waiting to chalk up measurable IT-driven business value from this huge and growing investment. It’s little wonder that pharmaceutical executives are asking why IT costs so much and yet seems to deliver so little.

Fail more often and fail faster. Pharmaceutical companies are increasingly realizing that the key to a successful product pipeline is eliminating the inevitable unsuccessful products as quickly as possible. And in the pursuit of failure, the most powerful tool is information. The massive commercial databases that contain terabytes of information — including the entire human genome — ought to make it easier than ever to eliminate dead ends. But there’s just o­ne problem: Every year large pharmaceutical companies spend billions of dollars o­n R&D o­nly to scrap hundreds of products that don’t pan out. The “what if” results that can kill a drug before it reaches clinical trials often show up o­nly after years of development. Until recently, 15 years was not uncommon. So the sooner researchers can see the endgame in their data, the better.

Paper-free clinical trials may not ever happen-but many of its advantages are already available.We are nowhere near the nirvana of a completely paperless office. Yet the value of word processing, spreadsheets, and email is simply indisputable. Similarly, the vision of a completely paperless clinical trial from concept to submission is still o­n the distant horizon. Nevertheless, the industry has begun the steady elimination of paper in the management of clinical data and documents, from patient diaries to eCRFs to fully electronic submissions, and is reaping significant benefits. To understand this, let's look at the paperless office.

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A bioinformatics initiative is creating a biological blueprint from genomic and proteomic data. In the wake of unprecedented sequencing efforts and completed genomes, many scientists would argue that the work of interpreting genomic data has o­nly just begun. But making heads or tails out of reams of sequence data is no mean feat as proteomics software races to keep up with genomes rolling out of the research pipeline. However, o­ne group is doing just that. The Blueprint Initiative (www.blueprint.org) is a proteomic bioinformatics project striving to provide software resources through its extensive protein interactions database.


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A significant bias in parameters, estimated with the proportional odds model using the software NONMEM, has been reported. Typically, this bias occurs with ordered categorical data, when most of the observations are found at o­ne extreme of the possible outcomes. The aim of this study was to assess, through simulations, the performance of the Back-Step Method (BSM), a novel approach for obtaining unbiased estimates when the standard approach provides biased estimates. BSM is an iterative method involving sequential simulation-estimation steps. BSM was compared with the standard approach in the analysis of a 4-category ordered variable using the Laplacian method in NONMEM. The bias in parameter estimates and the accuracy of model predictions were determined for the 2 methods o­n 3 conditions: (1) a nonskewed distribution of the response with low interindividual variability (IIV), (2) a skewed distribution with low IIV, and (3) a skewed distribution with high IIV.

The demand for assays to detect and quantify specific DNA or RNA sequences is growing rapidly. Whether screening blood for pathogens, characterizing gene transcription patterns, or studying the relationship between genotype and phenotype, scientists are continually looking for ways to efficiently scale their investigations and refine their measurements. Generally, these genomic assays require carefully designed oligonucleotide primers and probes that are mixed with genomic samples to detect DNA or RNA targets. As genomic assays become more complex, hybridization software becomes hotter.

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What issues does 21 CFR Part 11 present to the pharmaceutical industry? How will technologies such as enterprise content management, level-4 instrument control and open system technology assist in automating multi-vendor instrument data capture, long-term data archival and record retention processes?


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Not just a quick fix, e-procurement requires a thoughtful and thorough approach to produce the most rewards.

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As discussed in the companion article in last month’s issue of BioPharm, many needs of pharmaceutical development and manufacturing, from excipients to contract laboratory services, increasingly are being purchased through e-procurement processes (1). o­ne such process, the o­nline reverse auction, allows buyers to exchange information with sellers and solicit and accept bids from multiple sellers in a Webbased electronic marketplace.

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For pharmaceutical and biotech drug development sponsors with outsourcing needs, the debate between ‘one-stop shopping’ and ‘a la carte’ specialty outsourcing partners rages o­n. The issue has been explored in this publication for some time. Proponents of o­ne-stop shopping claim that this approach offers convenience, scalability and increased response to the demand for supply-chain efficiencies. However, opponents argue that “vertically integrating” disparate functions does not always make the best scientific or business sense and essentially surrenders the benefits of outsourcing strategic process components.

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Biotech companies are among the most intensive instrumentation users of any FDA-regulated business. Because of the complex nature of these companies' research and manufacturing, they typically have a larger number of instruments per employee.

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The Drug Information Association unveils the first in a series of professional development programs delivered through eLearning technologies to members worldwide.

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