PharmaVOICE - 
June 2013
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In Every Issue
Last Word
Global Trade Organization Amplifies Sites’ Voice Christine pierre, President of [...]
By

Christine Pierre, President, RxTrials

Talent Pool
Pharma Pool Dr. Lynn KRAMER Eisai Creates New Chief Clinical [...]
By

Ann Grey

On the Calendar
June 17-18 Gross to Net Accounting Forum for Pharmaceutical Manufacturers [...]
By

Heather Hummel

What’s New
New Healthcare-related Products, Services, and Companies Featured Briefs: GSW Launches [...]
By

Ann Grey

PharmaTrax
Pharma Trax Sales, Marketing, and R&D Trends from Industry Analysts [...]
By

Denise Myshko

Tools of the Trade
Tools of the Trade Collaboration Suite Moves Research Networks to [...]
By

Denise Myshko

Marketing Tips & Techniques
Marketing Tips & Techniques: YouTube YouTube Visitors: 1 Billion Served [...]
By

Robin Robinson

UpFront
INDUSTRY at Large Pfizer and CHOP Team up for Pediatric [...]
By

Denise Myshko

Letter from the Editor
Finding meaning in the dataverse According to IBM, Every day, [...]
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Taren Grom, Editor

On The Cover

Big Data: It’s Not The Volume It’s The Value
Big Data: It’s Not The Volume It’s The Value By Robin Robinson The term big data can refer to large volumes of data, or small, unstructured pieces. Most recently, the term references the enormous flow of information that is suddenly available from the many healthcare technology tools that have become available to and used by [...]
By

Robin Robinson

Features

Take the Express Toward NDA Approval
Pharmaceutical manufacturers spend on average billion developing a product for commercialization. With this tremendous investment, it is a pharmaceutical developer’s nightmare to have its product fail during the New Drug Application (NDA) filing process due to safety concerns or lack of pharmacovigilance systems and process planning. By developing a comprehensive and well-rounded pharmacovigilance plan [...]
By

Michael O'Gorman, CEO, Sentrix

Defining Innovation Differently
Innovation, it seems, is the buzzword in every business strategy plan. It’s what pharmaceutical training has always taught us to aspire to. We all want to stay ahead of the curve. And yet, like most of the words in the dictionary, how many ideas are truly new? How many are truly innovative? Well, many of [...]
By

Mark A. Lanfear, Global Practice Leader for Life Science, Kelly Services

Successful Strategic Partnering
Urgent and competing demands are challenging the clinical development efforts of today’s biopharmaceutical companies. Pressures to enhance innovation, feed pipelines, and improve efficiency and quality, all while lowering costs in an evolving regulatory environment are more acute than ever before. An immediate response to these challenges has been for biopharmaceutical companies to cut costs in [...]
By

Brenda Hoeper, Senior VP, Strategic Resourcing, inVentiv Health Clinical

Maximizing Speed to Market by Empowering the Human Element
Under greater public scrutiny in an increasingly environmentally conscious world, Dow Chemical launched a new advertising campaign in 2008 to demystify the people behind the science of the products it developed. This award-winning campaign, called “the Human Element,” featured stunning photos of people, rather than a detailed narrative of the many features and benefits of [...]
By

Michael R. Waldman, Insigniam, and Jennifer Zimmer, Insigniam

Can We Make Monitoring Better? That’s the $5 Billion Question.
Incredibly, only 6 percent of new pharmaceutical products ever recoup their development costs. Any other industry would simply cease production of such an unprofitable venture. But we don’t have that luxury. We need to change the way we do things and reduce resource-sapping redundancies. And that’s exactly what strategic data monitoring sets out to do. [...]
By

Amy Kissam, Executive Director, Integrated Clinical Processes, INC Research

This Old House: Conducting A Clinical Trial Energy Audit
Our local utility company offers free “energy audits.” An auditor will check the robustness of your heating, ventilation, and air conditioning (HVAC) systems and examine your home’s physical envelope — walls, floors, windows, doors — to assess it for leaks. When you live in New England (cold winters, old houses), an energy audit is a [...]
By

Denise Derenzo Lacey, Principle Consultant, Halloran Consulting Group

Clinical Transformation: More Than A Solution It’s A New Way To Work
To succeed in today’s global competitive market, drug companies need to innovate and pursue efficient ways of conducting clinical trials to shorten cycle times and achieve cost savings. As an answer to these new challenges, companies need an integrated and holistic solution based on process optimization and technology that delivers proactive performance management. A Solution [...]
By

Bhaskar Sambbasivan, VP and Head of Life Sciences, Cognizant and Dawn Anderson, Global Head of Clinical Operations,

Artificial Intelligence Improves Pharma Efficiency
As I consult with clients, I see that technology will ultimately be the driver behind pharmaceutical and biotechnology advancements in the coming decade. I believe that the use of artificial intelligence (AI) is a prime example of innovative efficiencies to come. More than 15 years ago, when I was leading the arthritis therapeutic area at [...]
By

G. Steven Geis, Ph.D., M.D., Co-Founder, ClinGenuity Partner, Geis-Hides Consulting LLC

Monitoring Cardiac Safety: Minimizing Risk For Your Next Clinical Trial
Many drugs used to treat non-cardiac conditions are known to have off-target cardiovascular effects including arrhythmias, hypertension, and reduced ventricular function, which may lead to increased cardiac risk and possibly death. This presents a major challenge not only for clinicians who administer these medications, but also for sponsors who have invested significant time, resources, and [...]
By

Mark Weinstein, President and CEO, BioClinica

Electronic Patient Reported Outcomes and Integrated Systems: Effective Solutions for Enhanced Compliance and High Data Quality
With all the elements that comprise a clinical trial — from design to enrollment to analysis — it is little wonder that success can be impeded by challenges along the way. Use of Electronic Patient Reported Outcome Technologies Low patient compliance and low data quality of Patient Reported Outcomes (PROs), such as patient diaries, can [...]
By

Valarie Higgins, Vp, Operations, Almac Clinical Technologies and Richard Wzorek, Director, Production IT, Almac

SHOWCASE FEATURE: Clinical Trial Solutions: Key Partnerships and Innovation: Keys to R&D Sustainability
A growing emphasis on academic and nonprofit organization partnerships could rescue the pharmaceutical industry from the redundancy of an inefficient R&D model and plug the so-called ?innovation gap, according to a new report from research and consulting firm GlobalData. GlobalData’s new report argues that collaboration in drug development benefits both parties, with academia constantly looking [...]
By

Taren Grom, Editor

C-Suite: Biotechnology
C-Suite: Biotechnology By Taren Grom Innovation and technology remain key assets of the biotechnology industry, which is moving toward value-based healthcare and patient centricity. As the world marks the 60th anniversary of the publication of James Watson and Francis Crick’s landmark work on the structure of DNA, G. Steven Burrill, CEO of Burrill & Company, [...]
By

Taren Grom, Editor

Innovative Israel Creates Pharma Opportunity
The state of Israel is one of the most advanced economies in the southwest Asia region, and is rated 38th out of 185 nations worldwide on the World Bank’s Ease of Doing Business Index. Often described as a start-up nation, Israel hosts more NASDAQ-listed companies per citizen than any other country, according to a Forbes [...]
By

Kim Ribbink

Count Down to the Sunshine Act
Count Down to Sunshine Act The final rule for tracking physician payments under the Sunshine Act has provided needed clarity, but questions remain about data accuracy and the public’s ability to interpret the information. The pharmaceutical industry now has some guidance on how to report payments to physicians under the Physician Payment Sunshine Act. On [...]
By

Denise Myshko

2013 DIA Preview
2013 DIA Preview This year’s theme: Advancing Therapeutic Innovation and Regulatory Science. The Drug Information Association’s 49th Annual Meeting will be held June 23 to 27 at the Boston Convention & Exhibition Center. There will be more than 250 sessions covering 22 tracks on hot topics from key thoughts leaders from the life-sciences industry. Physician, [...]
By

Taren Grom, Editor

Adapting to Adaptive Drug Development
The promise of cost-savings associated with adaptive clinical trials is an attractive one. Many drug companies have already put in place trials that use some type of adaptive designs. But most times, companies implement adaptive trial design experimentally, mitigating risk by applying it only during early-phase trials, according to Cutting Edge Information. An adaptive clinical [...]
By

Denise Myshko

Glocal Marketing: Keeping the Global Core While Adding Local Nuances
The immediacy of the online world can aid in effectively localizing brand messages, but the process is still not without its challenges. Although digital tools are changing the methods of how global and local brand teams can customize campaigns, the struggle between global and local messaging still remains. With the onset of digital media, the [...]
By

Robin Robinson

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