PharmaVOICE - 
June 2014
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In Every Issue
Talent Pool
Talent Pool executive appointments and promotions in the healthcare industry [...]
By

Ann Grey

On the Calendar
The Calendar Industry Events and Conferences, including Special Discounts Coming [...]
By

Heather Hummel

PharmaTrax
Spending on Compounded Medications More Than Doubled in 2013 Cost [...]
By

Denise Myshko

Tools of the Trade
QualityHealth Develops Opt-In Program to Recruit Patients Trending Now: Clinical [...]
By

Denise Myshko

What’s New
Roska Healthcare Advertising Is Now PulseCX TrendIng Now: Customer experience [...]
By

Ann Grey

Social Buzz
FDA’s Thomas Abrams Discusses Social Media’s Impact on the Regulatory [...]
By

Taren Grom, Editor

Innovator’s Corner
Make Way for “Electroceuticals” Innovator’s Corner John Rogers, Ph.D., at [...]
By

John Rogers, Ph.D., University of Illinois

UpFront
INDUSTRY at Large Sanofi Pasteur Raising Awareness about Meningitis Sanofi [...]
By

Denise Myshko

Letter from the Editor
Making Medicine Personal During the 10th Annual State of Personalized [...]
By

Taren Grom, Editor

On The Cover

Personalized Medicine: From Bench To Bedside
Pharmaceutical companies are embracing the concept of personalized medicine from research and development to commercialization. Personalized medicine is the future of medicine. It will become standard in every hospital, clinic, and medical practice, supported by electronic records, decision support systems, and tests that analyze disease for specific genetic markers. Traditionally, the pharmaceutical R&D path has [...]
By

Denise Myshko and Robin Robinson

Features

C-Suite: Digital Agencies
We asked C-suite executives throughout the digital arena to provide their insights on what the biggest opportunities are for innovation, what the biggest barriers are, and identify a recent innovation that is improving the process. Leigh Householder Chief Innovation Officer GSW Opportunities: We’re just on the cusp of really seeing the anticipatory Web come to [...]
By

Taren Grom, Editor

New Considerations for the Design and Execution of Immuno-Oncology Drug Trials
There is much excitement in the field of immuno-oncology drugs with the approval of sipuleucel-T (Provenge), ipilimumab (Yervoy), and the very promising data on other checkpoint modulators, new oncolytic viruses, and therapeutic vaccines on the horizon. There are some important adjustments in treatment response criteria, endpoints, and trial design that need to be made to [...]
By

Jeffrey Weisberg, DO, FACP, Vice President, Medical Affairs, Oncology, Worldwide Clinical Trials

Top 10 Clinical Trial Cost-Cutting Innovations
The challenges associated with conducting and managing today’s clinical trials have never been greater. According to a recent survey, clinical trials today cost 60% more than they did five years ago. Primary cost drivers include trial site startup (i.e., training, systems setup and access, regulatory process and documentation, ethics review); site payments, site monitoring, and [...]
By

Sandra R. Lottes, PharmD, VP, Global Clinical Development, UBC

How Information Technology is Enhancing Clinical Trials Recruitment and Participation
New platforms and technology today are able to help keep the right physicians apprised of the right open trials — communicating information efficiently across multiple locations in a large geographical area. Pharmaceutical companies have long struggled to achieve clinical trial recruitment goals. Half of randomized clinical studies fail to recruit their target populations, and of [...]
By

Jeff Meehan, Chief Commercial Officer, MD On-Line

Mapping Your Workforce Genome
What if you could plan out your workforce needs with the precision that we see in well-crafted R&D protocols and personalized medicine? And what if you could look at your human capital engagements and the available “talent supply chain” in the way science has started to look at sustaining health and patient outcomes? Our modern [...]
By

Mark A. Lanfear, Global Practice Leader, Life Sciences, Kelly Services, Inc. and Kevin D. Duffy, Global Vice President, Life Sciences, Kelly Services, Inc.

Data-Driven Approaches Accelerate Trial Recruitment and Quantify Risk
At one time, biopharmaceutical companies could develop their clinical trial recruitment strategies using nothing more than historical experience, anecdotal knowledge, and gut instinct. They could trust investigators to supply the necessary patients, and as a last resort, bolt on some media coverage. But, that cottage-industry practice no longer works. To find patients and consistently complete [...]
By

Ramita Tandon, Senior VP and General Manager, InVentiv Clinical Trial Recruitment Solutions

Innovating Clinical Trials: Aggregating Clinical Data for Easy Access and Brilliant Insights
There are increasing pressures for life-sciences companies to look aggressively for ways to decrease costs and bring new products to market more quickly. Sponsors want to leverage their clinical data to support critical decisions. To do this clinical data need to be easily accessible and integrated for sponsors to have a complete view of the [...]
By

Raj Indupuri, Executive VP, Principal Partner, eClinical Solutions

Why Investigators Hold the Cards to Clinical Trial Success
Why Investigators Hold the Cards to Clinical Trial Success “Including experienced investigators early in the process of writing a protocol would help prevent common issues that hinder trial enrollment and retention” said a clinical trial investigator from Jacksonville, Fla. Clinical trials demand the active participation of investigators. It’s that simple. And that complicated. The doctor-investigators [...]
By

Dr. Claire Sears, Investigator Engagement, DrugDev

The New Face of Informed Consent: It’s More Than A Signature
Contributed by: Marc Sirockman, Executive Vice President & General Manager Artcraft Health and Lisa Moss Calderwood, MA, Senior Medical Writer, Artcraft Health Informed patients make for compliant participants, compliant participants deliver verifiable data. This equation leads to the delivery of a product ready for market approval and ultimately market launch. Patient-centered care is driving the [...]
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Marc Sirockman, Executive Vice President & General Manager, Artcraft Health and Lisa Moss Calderwood, MA, Senior Medical Writer, Artcraft Health

Move Aside, Paper: Capturing Clinical trial Outcomes in the Digital Age
There has been much discussion throughout the healthcare industry about providing a positive patient experience and encouraging patients to have more of a voice in their treatment options. Stakeholders have come to recognize that patients have valuable information to share about their experiences with diseases and medications, which should influence drug approvals and treatment decisions. [...]
By

Mark Wade, Director, Patient Focused Solutions, Almac

SHOWCASE FEATURE: Clinical Trial Solutions: The Upside of Clinical Solutions
Even as pharmaceutical companies and their development partners continue to grapple with bringing safe products to market on time and on budget, new technologies, models, and analytics are driving improvements to counter the industry’s challenges. According to R&D leaders who recently participated in a roundtable discussion convened by the Tufts Center for the Study of [...]
By

Taren Grom, Editor

Thailand Makes Great Strides in Healthcare
With a growing pharmaceutical market, renowned biotechnology research programs, and strong government support for the industry, Thailand has much to recommend it to the global pharma industry. The Kingdom of Thailand, a country with a population of 70 million people, is regarded as newly industrialized with a GDP economy forecast to grow by 4% in [...]
By

Kim Ribbink

New FDA Guidelines Gateway to Social Interaction
New FDA?Guidelines Gateway to Social Interaction With the final ruling approaching next month, experts outline what has changed and what hasn’t under the new FDA draft guidelines. As the industry settles into a wary comfort zone with the draft guidelines around social media issued in January, we review the changes and look to what lies [...]
By

Robin Robinson

2014 DIA Preview
2014 DIA Preview New tools, services, and products to improve drug development — as well as personnel appointments — from DIA exhibitors. This year marks the 50th Anniversary of the Annual Meeting of the Drug Information Association, the largest multidisciplinary event that brings together a global network of life-sciences professionals to foster innovation. The meeting [...]
By

Taren Grom, Editor

Multi-channel Prescriber Marketing New Solutions for a Waiting Market
“An organization’s ability to learn, and translate that learning into action rapidly, is the ultimate competitive advantage.” — Jack Welch, author and former chairman and CEO of General Electric While the healthcare market has seen dramatic changes, the impact has been especially significant on prescribers, many of whom are now employees of larger delivery networks [...]
By

Taren Grom, Editor

Creating Great Creative
Market forces and patient expectations make coming up with the next big creative idea more challenging than ever. In today’s patient-focused and patient-driven marketplace, it is going to take more than a purple pill, a green moth, or an Italian-accented bumblebee to make a connection with patients. Creative must go beyond entertainment, and provide support [...]
By

Robin Robinson

Last Word
Ben Kramer, M.D., VP of U.S. Medical Affairs, Immunology and Infectious Diseases, at Genentech, talks about patient education and adherence. PV: What do you think makes for a successful patient education program? Kramer: Patients need to be well-informed about their disease, and the information has to be presented in a way that can be understood. [...]
By

Ben Kramer, M.D., VP of U.S. Medical Affairs, Immunology and Infectious Diseases, Genentech

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