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June 2011
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In Every Issue
Last Word
Combating Drug Resistance Roger Pomerantz, M.D., Senior VP and Head [...]
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Talent Pool
Pharmaceutical POOL Dr. Janet HAMMOND Roche Strengthens Translational Medicine Leadership [...]
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OUTLET
This year’s report on the pharmaceutical sector by Ernst & [...]
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Social Media
Patient Communities Improve Adherence TrendWatch: Two recent studies show that [...]
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Tools of the Trade
New Electronic and Web-based Applications, Sites, and Technologies Featured Briefs: [...]
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What’s New
New Healthcare-related Products, Services, and Companies Trend: Healthcare agencies are [...]
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PharmaTrax
Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: [...]
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UpFront
Awards… GSK Medical Officer Honored Merck Scientists ­Recognized by PhRMA [...]
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Letter from the Editor
Ready or Not Here Comes Pharma 3.0 Pharma 2.o was [...]
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Taren Grom, Editor

On The Cover

Pharma 3.0: A Call for Collaboration and Experimentation
Success or failure in Pharma 3.0 — an ecosystem comprised of established industry members, nontraditional companies, and an increasingly informed data-empowered consumer — will be based on life-sciences companies’ ability to develop innovative, outcomes-focused offerings through structured, systematic, and scalable approaches to business model innovation. The two most prevalent elements that will separate the winners [...]
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Robin Robinson

Features

Managing Outsourced Development: Designing a Performing Process
Ronald S. Waife, MPH, President With the rise of mega-CROs, and the widespread willingness of large pharma to outsource clinical development to them, is there anything left for a sponsor’s clinical development group to do? Indeed yes. More than ever, there are hyper-critical functions that sponsors must execute effectively to produce success in clinical development. [...]
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Ronald S. Waife, MPH, President, Waife & Associates Inc.

Industry Experts Challenge the Status Quo on Content Management
For more than two decades, life sciences organizations have purchased, customized, configured, deployed, and maintained a series of ever-expanding and complex content management tools to help them efficiently manage content. The creation of industry-specific applications added to these technologies’ ability to support more specific life sciences needs, such as regulatory submissions and document management. And [...]
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Ian Talmage, John Cogan, Steve Hasler, Pierre Morgon, and Ruedi Blattmann

Clinical Data Gap Analysis ­Uncovering Hidden Opportunities
David Fishman, MBA President Snowfish LLC The practice of medicine relies on clinical evidence. From a product’s conception through approval, launch, and post-launch activities, clinical evidence is the rationale for a product’s overall existence. Clinical data is critical for differentiation and ultimately, market acceptance. A solid grasp of the clinical data for a product and [...]
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David Fishman, MBA President, Snowfish LLC

Metrics for Faster Clinical Trials
Almost half of clinical trials run late, year after year. Why does this happen? The biggest delaying factor is finding enough patients, and the delay starts with the clinical trial protocol. The protocol includes the inclusion and exclusion criteria that define the patients who are eligible for the study. Criteria are growing in complexity, and [...]
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Bill Gwinn, VP, Clinical Informatics Solutions, QualityMetric Inc.

Bringing Process Efficiency to ­Clinical Trial Randomization
Modern business has fully embraced the benefits of process efficiency. From the widespread adoption of process improvement as driven by Michael Hammer, author of “Reengineering the Corporation,” its evolution to the Six Sigma movement, to the more recent “lean sigma” approach, process efficiency has become a business goal for most organizations. The benefits of efficient [...]
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Stan Haavik Director of Product Marketing, Medidata Solutions Worldwide

Partnering with CROs: Achieving Operational Excellence
Our industry is facing a challenge. In 2010, the FDA approved only 21 new drugs, down from 26 in 2009 and 24 in 2008. To counteract this decrease, biopharmaceutical companies are increasingly anxious to launch their products as quickly as possible to benefit from related revenue sooner. One way they’re looking to speed their development [...]
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Jamie Macdonald Senior VP and Chief Operating Officer, Kendle

Effective Use of Health Technology ­Assessment to Maximize Market Access: Start Early and Update Often
We all know that the face of drug discovery and the market for new pharmaceutical products (and medical devices/diagnostic technologies) is changing. The era of the blockbuster appears to be over, the cost of bringing a new product to market has skyrocketed and when a new product is eventually licensed, sceptical payers are increasingly demanding [...]
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Andrew Briggs, Ph.D., Senior Scientific ­Advisor, Oxford Outcomes, an ICON plc ­Company

Understanding the Finer Points of the Electronic Source Documentation Draft Guidance
For those involved with collecting data generated by clinical trials, the recent draft guidance on electronic source documentation released by the FDA deserves your scrutiny. The impact of this guidance for sites is significant and the implications for CRAs, data managers, and technology vendors could be potential show stoppers. Since the draft guidance may not [...]
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Jonathan Andrus VP, Data and Study Operations, BioClinica

SHOWCASE FEATURE: A Changing Rhythm
According to Barbara Wirostko, M.D., chief medical officer for Altheos, the question of whether a product candidate will be reimbursed by government and third-party payers is now surfacing in the earliest stages of discovery. “Because there are now issues around who is going to reimburse and who is going to pay for novel, expensive new [...]
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Carolyn Gretton

Merhaba, Turkey: Opportunity Knocks
As the largest pharmaceutical market in the Middle East and the fastest growing in the Mediterranean region, Turkey presents some exciting opportunities for the pharmaceutical market. Consumption of pharmaceuticals in Turkey totals around billion, with 50% of these drugs being manufactured domestically and about 70% of this manufacturing is done by foreign companies, according [...]
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Kim Ribbink

Changing Oncology Regulations
Developing oncology therapies can be complex. These products often have a tough time making it to the market. In fact, a study released in February by the Biotechnology Industry Organization and BioMedTracker shows that oncology products had the lowest Phase III success rate among seven therapeutic areas, with only 34% of candidates succeeding at this [...]
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Denise Myshko

Educating the Scientists of the Future
High-quality science education is critical for the success of pharmaceutical and biotechnology companies, not only to meet the need for scientists in the future but also to foster scientific ­literacy. Education reform is a hot-button issue for the nation in general and the pharmaceutical industry in particular. Studies show American students are falling behind other [...]
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Denise Myshko

DIA Preview
New Tools, Services, and Products Designed to Improve Drug Development This special Drug Information Association section highlights the new and innovative products being offered by ­companies exhibiting at the upcoming 2011 DIA — 47th Annual Meeting in Chicago. (Note: briefs are listed alphabetically by company and include the booth number for the 2011 DIA exhibitor.) [...]
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R&D’s Technology Evolution
Technology tools are the cornerstones for achieving a drug development process that is faster, cheaper, and easier. Over the last 10 years, there has been increasing use of EDC, ePRO, CTMS, dashboards, and other tools to streamline the drug development process. Now a changing R&D paradigm is leading to systems integration and a convergence of [...]
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Denise Myshko

CSR Gets a Makeover
Corporate social responsibility (CSR) policies have been in place for decades at most companies, but the increased social awareness of today’s consumers has stepped up the visibility of such programs. The state of the world’s economy, the ever-evolving business environment, and an overall growth in social awareness of corporate sustainability is shining a spotlight on [...]
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Robin Robinson

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