June 2013

Take the Express Toward NDA Approval

May 29, 2013

Pharmaceutical manufacturers spend on average $1 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 […]

Defining Innovation Differently

May 29, 2013

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 […]

Successful Strategic Partnering

May 29, 2013

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 […]

Maximizing Speed to Market by Empowering the Human Element

May 29, 2013

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 […]

Can We Make Monitoring Better? That’s the $5 Billion Question.

May 29, 2013

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. […]

This Old House: Conducting A Clinical Trial Energy Audit

May 29, 2013

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 […]

Clinical Transformation: More Than A Solution It’s A New Way To Work

May 29, 2013

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 […]

Artificial Intelligence Improves Pharma Efficiency

May 29, 2013

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 […]

Monitoring Cardiac Safety: Minimizing Risk For Your Next Clinical Trial

May 29, 2013

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 […]

Electronic Patient Reported Outcomes and Integrated Systems: Effective Solutions for Enhanced Compliance and High Data Quality

May 29, 2013

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 […]

SHOWCASE FEATURE: Clinical Trial Solutions: Key Partnerships and Innovation: Keys to R&D Sustainability

May 29, 2013

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 […]

C-Suite: Biotechnology

May 29, 2013

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, […]

Innovative Israel Creates Pharma Opportunity

May 29, 2013

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 […]

Count Down to the Sunshine Act

May 29, 2013

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 […]

2013 DIA Preview

May 29, 2013

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, […]

Adapting to Adaptive Drug Development

May 29, 2013

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 […]

Glocal Marketing: Keeping the Global Core While Adding Local Nuances

May 29, 2013

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 […]

Big Data: It’s Not The Volume It’s The Value

May 29, 2013

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 […]

Last Word

May 29, 2013

Global Trade Organization Amplifies Sites’ Voice Christine pierre, President of RxTrials, takes the helm of the Society for Clinical Research Sites (SCRS) after forming the organization to help sites raise their voice with sponsors, CROs, and other clinical stakeholders. The LAST Word PV: What was the impetus behind founding the Society for Clinical Research Sites? […]

Talent Pool

May 29, 2013

Pharma Pool Dr. Lynn KRAMER Eisai Creates New Chief Clinical Officer Position Eisai, the U.S. pharmaceutical subsidiary of Eisai Co., Ltd., has appointed Lynn Kramer, M.D., to the newly created position of chief clinical officer of Eisai Product Creation Systems. In this role, Dr. Kramer is responsible for the approval of protocol designs of pivotal […]

On the Calendar

May 29, 2013

June 17-18 Gross to Net Accounting Forum for Pharmaceutical Manufacturers Hyatt Harbor Side, Boston Institute for International Research, iirusa.comJune 17-19 Next-Gen Kinase Inhibitors The Revere Hotel, Boston Cambridge Healthtech Institute, healthtech.com/kin/ June 18 5th Annual Cloud Slam 2013 ­ Conference & Expo Network Meeting Center at TechMart, Santa Clara, Calif. PharmaVOICE subscribers receive a 30% […]

What’s New

May 29, 2013

New Healthcare-related Products, Services, and Companies Featured Briefs: GSW Launches Health Experience Project Teva Establishes Global ­Specialty Medicines Group Sidebars: On the Shelves AROUND THE GLOBE New 360 Corporate Compliance Program for the Life-Sciences ­Industry Weber Shandwick Launches ­Element Scientific ­Communications What’s New New healthcare-related products, services, and companies GSW, an inVentiv Health company, has […]

PharmaTrax

May 29, 2013

Pharma Trax Sales, Marketing, and R&D Trends from Industry Analysts Featured Briefs: Strategic Partnerships Provide Value Engaging Digital Patients Can Foster Biopharma Product Development Use of Digital Marketing Channels to Increase Sidebars: Impact of Strategic Partnerships Key Findings in Partnership Study Orphan Drug Trials Often Outsourced Medicines Being Developed for Older Americans Therapeutic Trax… Pharma […]

Tools of the Trade

May 29, 2013

Tools of the Trade Collaboration Suite Moves Research Networks to the Cloud Trending Now: Cloud-based systems can facilitate technology transfer, collaboration, and scientific informatics in externalized life-sciences partner networks. Accelrys has launched a software solution — Externalized Collaboration Suite — designed specifically to address the needs of life-sciences organizations engaged in externalized network research. “Today […]

Marketing Tips & Techniques

May 28, 2013

Marketing Tips & Techniques: YouTube YouTube Visitors: 1 Billion Served Monthly Sidebars: YouTube by the Numbers YouTube Visitors Pharma Companies Using YouTube The Impact of YouTube’s Redesign Best Practices for Using YouTube Effectively Trending Now: YouTube is the perfect channel for patient and physician education. Changes in its design and increasing numbers of viewers should […]

UpFront

May 28, 2013

INDUSTRY at Large Pfizer and CHOP Team up for Pediatric R&D Pharmacy Benefits Survey finds PMI Useful In Memoriam Awards… ePharmaSolutions Wins Life- Sciences Industry ICON Wins Partnership Award INC Named Top CRO Ogilvy CommonHealth Wins DxMA Award Milestones… A Decade in the Making NORD Celebrates 30 Years of Serving Patients and Families West Turns […]

Letter from the Editor

May 28, 2013

Finding meaning in the dataverse According to IBM, Every day, 2.5 quintillion bytes of data are created and 90% of the data in the world today has been created in the last two years alone. For those of us not well-versed in coverting bytes into bite-sized numbers, 2.5 quintillion bytes is 2,500,000,000,000,000,000 (18 zeroes), which […]

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