The Future of Pharma: Adjusting the Pharma R&D Model
By Mark P. Mathieu
The pharmaceutical industry has enjoyed a protracted winning streak in which it has scored a decade of tremendous growth and profits on the back of novel and important medicines. But where will the victories come from in the next ten years?
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June 26, 2009 | Just as the electronic common technical document (eCTD) is gaining traction as the required format for electronic regulatory submissions, the FDA is changing the game. more June 22, 2009 | The Archimedes Model is a mathematical model that simulates human physiology (and the surrounding health care system) by creating virtual trial populations. more June 15, 2009 | Genentech's relationship with investigative sites—from initial protocol and feasibility surveys to study training, site activation, patient referral tracking, and safety letter distribution—is being wholly managed through a single-sign-on Clinical Trial Portal (CTP). more June 9, 2009 | Wall Street Journal | Merge Healthcare has agreed to a $20 million acquisition of etrials Worldwide. more June 8, 2009 | Financial Times | The Centre for Studies in Ethics and Rights in India has found that GlaxoSmithKline, AstraZeneca, and Johnson & Johnson have violated the guidelines of the Indian Council of Medical Research. more June 5, 2009 | Wyeth Research brought home this year’s Bio-IT World Best Practices Award in the Clinical Trial Design category for developing trial simulation software to streamline the process of designing and running adaptive clinical trials (ACTs). more June 1, 2009 | Even the most progressive, tech-savvy investigative sites are aggravated by many of the e-clinical systems being embraced by study sponsors. Virtually no type of clinical trial technology escapes criticism, but EDC systems seem to be the biggest offenders. more June 1, 2009 | “Clinical clouds” may be the only sensible way to access needed software and information as life sciences companies engage in more collaborations, alliances, and partnerships to weather the “perfect storm of unprecedented challenges” bearing down on their collective bottom line, says Paul Papas, IBM Global Business Services. more May 26, 2009 | Common wisdom holds that drug makers should stay out of the business of developing information technology (IT) software and instead buy off-the-shelf solutions. But that’s not necessarily the best and cheapest way to collect data or manage clinical trials. more
 | Biomarkers: An Indispensible Addition to the Drug Development Toolkit Examining the Potential of Biomarkers Biomarkers are becoming an essential part of clinical development. In this white paper, Thomson Reuters provides insight from experts in industry and academia, and explores the role of biomarkers as evaluative tools in improving clinical research and the challenges this presents. Discover the potential of biomarkers to: - Improve decision making
- Accelerate drug development
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|  | Scientific Data Lifecycle Management: Preparing for Storage in an Uncertain Future Managing vast and overwhelming streams of gene sequencing data today requires ultra-high performance systems and processes. With continued rapid advancement and improvements in gene sequencing, expect tomorrow’s instruments to output quantities of genomic information that will dwarf current levels. Help your organization maintain data control and prepare for the future of sequencing through this informative paper that discusses: - The information technology challenges of gene sequencing
- “Intelligent” methods for data management and customization
- System survival tips... Deciding what data to keep or delete
- New tools to keep scientists ahead of impending data torrents
|  | Managed Innovation, Assured Compliance Developing, executing and managing the transformation, analysis and submission of clinical research data with SAS® Drug Development Get better products to market faster. Download this white paper to discover the top ten challenges facing life science executives and how to overcome them. See how SAS Drug Development transforms clinical data into true innovation.
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Presented by Trade Commission of Spain
Spain Biotech: An Engine for Economic Change
 Discover how Spain is focusing on biotechnology to be an engine for economic change through gradual internationalization, development and technology transfer.
Regional governments are actively investing in public and private biology research and promoting the creation of knowledge-based companies. Spain’s human capital combined with aggressive investment in biotech research and infrastructure has led to the creation of bio-clusters.
Today, there are nearly 700 Spanish companies engaged in biotechnology, with almost 50 percent growth in funding devoted to research. In fact, spending on internal R & D in biotechnology has grown 46 percent and is close to 300 million Euros.
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Profile your company by placing a special advertorial in the Company Watch section. Four key questions are answered by a company executive and posted in this section with the company’s logo and link back to the website.
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Bio-IT Weekly Update
eCliniqua
Predictive Biomedicine
Approaches to Reducing Phase II Attrition
Strategies for reducing clinical attrition rates
Author: Allan B. Haberman, Ph.D.
 Pharmaceutical companies have been responding to a combination of major challenges that many commentators call a “perfect storm.” The high rate of attrition in the drug development process is severely limiting the numbers of high-quality novel drug candidates, especially for innovative drugs that address unmet medical needs. In order to overcome this limitation, the industry must develop strategies that can reduce attrition during Phase II, where most attrition occurs, especially as it continues to drive up the cost of R&D to unsustainable levels. Read More
MANAGER, SCIENTIFIC COMPUTING & PROGRAMMING (Bioinformatics Manager)
SAIC-Frederick, Inc has an exciting opportunity for a Manager, Scientific Computing & Programming - Core Genoytyping Facility in Gaithersburg, Maryland. In this role, you will lead the Bioinformatics & Analysis Group.
Master’s or equivalent required. PhD preferred. Six years experience in development of scientific programs in high-performance computing environment including five years supporting scientific research in computational chemistry, biology, or genetics, & two years supervisory experience. View complete job posting & apply: www.saic-frederick.com. Position #146945.
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