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June 2012
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In Every Issue
Last Word
The New Business Model: Developing Payer-Friendly ­Drugs Through Partner ­Innovation [...]
By

John Chiminski, President and CEO of Catalent Pharma Solutions

Talent Pool
Pharmaceutical POOL William (Bill) HUMPHRIES Merz Pharma Names CEO of [...]
By

Carolyn Gretton

PharmaTrax
Sales, marketing, And R&D Trends affecting the healthcare industry By [...]
By

Carolyn Gretton

Social Media
Social Media trends, regs, and apps By Robin Robinson Consumers [...]
By

Robin Robinson

Tools of the Trade
New electronic and web-based applications, sites, and technologies Integrated Solution [...]
By

Carolyn Gretton

UpFront
UpFront Awards… Octagon receives PACT award Octagon Research Solutions has [...]
By

Taren Grom, Editor

Letter from the Editor
Letter from the Editor Volume 12 • Number 6 Publisher [...]
By

Taren Grom, Editor

On The Cover

Postapproval Studies: More Critical and Challenging Than Ever
By Robin Robinson Phase IV data are in high demand by more stakeholders. As the need for postapproval data reaches a critical point, the industry explores the multiple options and struggles to determine which methods are best for collecting and analyzing important data. There are as many ways to collect data with today’s real-time technologies [...]
By

Robin Robinson

Features

Structuring an eClinical Training Program To Improve Employee Site Performance
Structuring an eClinical Training Program To Improve Employee Site Performance Clinical trials have the potential to represent the costliest and most time-consuming phase of product development. One study can include hundreds of patients and multiple sites, therefore sponsors, as well as CROs, must consider methods that improve site efficiency and data accuracy. Training employees and [...]
By

Ellen Leinfuss, Senior VP, Life Sciences, UL EduNeering

Solving the Numbers Game – The Three Pillars of Late-Phase Clinical Trials
Solving the Numbers Game – The Three Pillars of Late-Phase Clinical Trials Each phase of a drug trial presents challenges, but peri-approval and post-approval studies present challenges beyond those experienced by researchers conducting earlier-stage trials. Trial sizes are larger and global in scale, the amount of data is greater, and the studies often run much [...]
By

Ramita Tandon, Global Head of Late Phase ­Clinical Trials, PAREXEL

Locating Patients and Investigators for Faster Trials
Locating Patients and Investigators for Faster Trials Where are the patients? Where are the investigators who have access to them? These are early questions in clinical trials, and it is hard to find the answers. Numerous studies show that half of clinical trials run late. Delay starts with the clinical trial protocol, which defines patients [...]
By

Bill Gwinn, Vice President, Clinical Informatics Solutions, OptumInsight

The Growing Role of Disease Registries in Evidence Generation
The Growing Role of Disease Registries in Evidence Generation The current policy environment has broadened the scope of evidence that life-sciences companies must provide to healthcare stakeholders. In the United States, the focus is on comparative effectiveness research (CER), and in many other parts of the world, relative effectiveness/efficacy. Public and private payer organizations require [...]
By

William Crown, Ph.D., President Life Sciences, OptumInsight

Defining the Clinical Cloud
Defining the Clinical Cloud The term “eClinical” was jargon that the pharmaceutical industry used over the last decade, without ever agreeing on its definition. Similarly, the term “cloud” has become the latest must-have descriptor for all kinds of technologies, across virtually every business sector. The scope of capabilities encompassed by each or both of these [...]
By

Glen de Vries, President, Medidata Solutions Worldwide

The Value of Strategic Epidemiology to Inform Product Development and Commercialization
The Value of Strategic Epidemiology to Inform Product Development and Commercialization Challenges and Changes in the Biopharmaceutical Industry Every year, the industry is confronted with an increasingly constrained environment in which to invest in research and development. Established blockbuster drugs are reaching the end of their patent lives, facing competition from an increasingly aggressive and [...]
By

Adrian Levy, Ph.D., Senior Scientific ­Advisor, Oxford Outcomes, and Nigel Gregson, Partner, ­PriceSpective, an ICON plc Company

Don’t Get Stuck In A Clinical Trial Rut: Study Challenges, Practical Solutions, and Three Reasons Why You Need to Change
Don’t Get Stuck In A Clinical Trial Rut: Study Challenges, Practical Solutions, and Three Reasons Why You Need to Change The entire biopharmaceutical industry is focused like never before. We are looking critically at mega-spending of global development operations and doing more with less. In an international environment of shifting regulatory sands, the goal is [...]
By

Laurie Halloran, BSN, MS, President and CEO, Halloran Consulting Group

Making the Leap Toward Strategic Outsourcing
Making the Leap Toward Strategic Outsourcing As a result of the increasing pressure placed upon pharmaceutical companies to move drugs through the pipeline efficiently and cost-effectively, companies are looking at ways to improve productivity. Faced with ever-demanding regulatory hurdles when moving drugs from shelf to market, reliable data collection methods are needed throughout the drug [...]
By

Tom Avery, Vice President, ­Strategic Business Development, ERT

Successful Technology Integration Partnerships: A Coalition of the Willing
Successful Technology Integration Partnerships: A Coalition of the Willing Most eClinical technology users aren’t looking for bells and whistles. They want solutions that work as promised, are easy to use, and let them focus on running the trial. Choosing specialized eClinical products over a one-size-fits-all system lets trial managers use the best possible technology for [...]
By

Garry D. Johnson, Executive Vice President and Chief Technology Officer, BioClinica Inc.

Patient-Centric Clinical Trials: Fad, Trend, or Future?
Patient-Centric Clinical Trials: Fad, Trend, or Future? One of the prominent topics of discussion in biopharmaceutical R&D during the past few years has centered on methods for improving patient management in clinical trials. While clinical trials have always focused on patients, only recently has an entirely new lexicon entered the consciousness of professionals involved in [...]
By

Todd Kole, Vice President, Clinical Project Services, Almac Clinical Technologies

Top 10 Patient Enrollment and Retention Myths
Top 10 Patient Enrollment and Retention Myths Myths can Lead to Misses Today’s trial climate frustrates many clinical study teams. Operations must deliver quality trial data under intense pressures. Larger, longer, and more esoterically designed trials place a strain on patient enrollment and retention. Fact and fiction are blurring in this environment. We’ve developed a [...]
By

Scott H. Connor, Vice President, Marketing, Acurian

Safety Panels: Combining the Conventional and Novel Toxicity Biomarkers
Safety Panels: Combining the Conventional and Novel Toxicity Biomarkers The notion of biomarker is not new. The FDA defines a biomarker as the measurable endpoint that can be used as an indicator of a physiological or pathological process. In particular, toxicity biomarkers are those capable of detecting liver, kidneys, bone marrow, and other target organs [...]
By

Maria-Magdalena Patru, M.D., Ph.D., Scientific ­Affairs Medical Liaison, ACM Global Central Laboratory

SHOWCASE FEATURE: Clinical Trial Solutions
SHOWCASE FEATURE: Clinical Trial Solutions Trials Without Tribulations By Carolyn Gretton As clinical studies become more global and increasingly complex, sponsors are striving to improve ­efficiencies, gain increased access to patients and investigators, and better integrate R&D competencies and solutions. “Wireless technologies that streamline the process of swiftly and accurately identifying the best patients for [...]
By

Carolyn Gretton

2012 DIA Preview
2012 DIA Preview New tools, services, and products to improve drug development from DIA exhibitors. This special Drug Information Association section highlights news as well as new and innovative products being offered by companies exhibiting at the upcoming 2012 DIA, the 48th Annual Meeting, in Philadelphia June ­­­24-28. This year’s theme is Collaborate to Innovate, [...]
By

Taren Grom, Editor

Global Marketing: Consistent Across All Borders
Global Marketing: Consistent Across All Borders By Robin Robinson Of the many challenges in global marketing, ­creating consistency in brand messaging is key. Consistency in brand message is more critical than ever in the global environment and can only be achieved as a result of global, regional, and local brand teams working in partnership. Local [...]
By

Robin Robinson

Insights from the C-Suite: Advertising Agencies
Insights from the C-Suite: Advertising Agencies Insights from the C-Suite: Advertising Agencies The explosion of digital and other multimedia opportunities are expanding the available ­communications channels for brand promotions and communications. As a result, advertising agencies are taking appropriate measures to evolve with technology advances and a changing ­marketplace to meet their clients’ needs. According [...]
By

Taren Grom, Editor

A Fair Environment Australia Advances
A Fair Environment Australia Advances By Kim Ribbink Australia’s small, yet geographically diverse mainly coastal populations, a high standard of living, a government-funded health system, and regulated channels add to the country’s appeal as a pharmaceutical market on the rise. With its stable socio-political environment, strong intellectual property laws, and established links to the Asia-Pacific [...]
By

Kim Ribbink

Healthcare and the Political Landscape
Healthcare and the Political Landscape By Denise Myshko Healthcare reform remains front and center within the political arena. The major reforms contained in the Affordable Care Act are not scheduled to take effect until 2014, but the legislation faces legal and political challenges. In March, the U.S. Supreme Court heard appeals related to the legislation, [...]
By

Denise Myshko

Innovation Through Drug Delivery
Denise Myshko
By
It’s Time for Mobile: Do You Know Where Your Consumers Are?
By Robin Robinson There are several very solid reasons why the industry should be using mobile technology in its marketing efforts, but the one that stands out above all others is quite simple — mobile is where the consumers are. There are more smartphones than personal computers in the United States, and in the developed [...]
By

Robin Robinson

What’s New
New healthcare-related products, services, and companies Campbell Alliance Launches Encuity Research Trend Watch: Campbell’s newly formed market research and analytics subsidiary is aimed at driving accelerated growth in the market research segment. Encuity Research, the market research and analytics subsidiary of management consulting firm Campbell Alliance, provides a range of services to the pharmaceutical and [...]
By

Carolyn Gretton

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