June 2014

C-Suite: Digital Agencies

May 29, 2014

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 […]

New Considerations for the Design and Execution of Immuno-Oncology Drug Trials

May 29, 2014

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 […]

Top 10 Clinical Trial Cost-Cutting Innovations

May 29, 2014

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 […]

How Information Technology is Enhancing Clinical Trials Recruitment and Participation

May 29, 2014

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 […]

Mapping Your Workforce Genome

May 29, 2014

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 […]

Data-Driven Approaches Accelerate Trial Recruitment and Quantify Risk

May 29, 2014

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 […]

Innovating Clinical Trials: Aggregating Clinical Data for Easy Access and Brilliant Insights

May 29, 2014

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 […]

Why Investigators Hold the Cards to Clinical Trial Success

May 29, 2014

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 […]

The New Face of Informed Consent: It’s More Than A Signature

May 29, 2014

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 […]

Move Aside, Paper: Capturing Clinical trial Outcomes in the Digital Age

May 29, 2014

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. […]

SHOWCASE FEATURE: Clinical Trial Solutions: The Upside of Clinical Solutions

May 29, 2014

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 […]

Thailand Makes Great Strides in Healthcare

May 29, 2014

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 […]

New FDA Guidelines Gateway to Social Interaction

May 29, 2014

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 […]

2014 DIA Preview

May 29, 2014

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 […]

Multi-channel Prescriber Marketing New Solutions for a Waiting Market

May 29, 2014

“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 […]

Creating Great Creative

May 29, 2014

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 […]

Personalized Medicine: From Bench To Bedside

May 29, 2014

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 […]

Last Word

May 29, 2014

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. […]

Talent Pool

May 29, 2014

Talent Pool executive appointments and promotions in the healthcare industry Pharma Pool DR. UDIT BATRA EMD Millipore Introduces CEO and President EMD Millipore, the life-sciences division of Merck KGaA, has appointed Udit Batra, Ph.D., as president and CEO, responsible for the organization’s strategic direction to drive growth and product innovation as well as oversight of […]

On the Calendar

May 29, 2014

The Calendar Industry Events and Conferences, including Special Discounts Coming Attractions This year marks the 50th Anniversary of the DIA Annual Meeting, the largest multidisciplinary event that brings together a global network of life-sciences professionals to foster innovation that will lead to the development of safe and effective medical products and therapies to patients. With […]

PharmaTrax

May 29, 2014

Spending on Compounded Medications More Than Doubled in 2013 Cost increases drive higher drug trend for worker’s compensation Significant increases in cost-per prescription drove drug trend for workers’ compensation payers higher in 2013, according to research by Express Scripts. Overall pharmacy spending for workers’ compensation increased 9.5%, according to the Express Scripts Workers’ Compensation Drug […]

Tools of the Trade

May 29, 2014

QualityHealth Develops Opt-In Program to Recruit Patients Trending Now: Clinical Trial Connection deepens patient recruitment insight and improves reach and conversion. QualityHealth has expanded its clinical trial recruitment services to include an advanced opt-in program, the QualityHealth Clinical Trial Connection. This new program offers health consumers the opportunity to educate themselves about the benefits of […]

What’s New

May 29, 2014

Roska Healthcare Advertising Is Now PulseCX TrendIng Now: Customer experience is focus of rebranded agency. Roska Healthcare Advertising has changed its name and brand identity to PulseCX to capture the agency’s focus on the healthcare customer experience, or CX. “The ways in which customers and brands interact has evolved tremendously in the 33 years since […]

Social Buzz

May 29, 2014

FDA’s Thomas Abrams Discusses Social Media’s Impact on the Regulatory Area TRENDING NOW: Social media is changing the regulatory environment. PharmaVOICE asked Thomas Abrams, director of the Office of Prescription Drug Promotion in the FDA’s Center for Drug Evaluation and Research, how social media changed the regulatory environment for the drug and biologic industry. His […]

Innovator’s Corner

May 29, 2014

Make Way for “Electroceuticals” Innovator’s Corner John Rogers, Ph.D., at the University of ­Illinois, is working on a biodegradable ­battery that could eventually lead to a new kind of implantable drug-delivery device. Imagine a programmable drug-delivery system controlled by radio signals that can release medication at the disease site — and then is able to […]

UpFront

May 29, 2014

INDUSTRY at Large Sanofi Pasteur Raising Awareness about Meningitis Sanofi Pasteur Raising Awareness about Meningitis Sanofi Pasteur, the National Association of School Nurses, Voices of Meningitis, a public health initiative, and 12-time Olympic Medalist swimmer Dara Torres are coming together to call attention to ­meningococcal meningitis. Ms. Torres is helping to raise awareness through a […]

Letter from the Editor

May 29, 2014

Making Medicine Personal During the 10th Annual State of Personalized Medicine Luncheon hosted by the Personalized Medicine Coalition (PMC) in March, Edward Abrahams, president of PMC stated: “As our understanding of individual variation continues to develop, personalized medicine products must overcome three challenges before patients can benefit. In the United States, they must pass regulatory […]

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