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

The FDA wants to hear from patients directly during clinical trials. Their “Voice of the Patient” initiative gives the FDA a broader perspective on outcomes across many treatment areas. Technology is more important than ever for collecting valuable, accurate, timely information from patients.

In this article, you’ll learn about:

• The scientific realities of patient reporting
• Misconceptions about paper-based survey tools
• 8 keys to implementing electronic tools successfully
• The eCOA landscape
• How to choose the best solution

 Read this article now at http://bit.ly/almac-showcase

Risk or Reward? Collaboration and Social Media in the pharmaceutical Industry - white paper

Drug makers are just beginning to realize how collaboration and communication networks can improve business processes. But what seems like a spoon full of sugar is often a tough pill to swallow when you consider regulatory requirements from agencies like the FDA for use of these networks. This white paper provides an understanding of many of the regulatory and legal issues related to electronic communications and social media in the pharmaceutical industry.

Read this paper to gain an understanding of:
• What the regulatory landscape of the pharmaceuticals industry looks like
 • What concerns you should be aware of from a legal perspective

Download this free white paper now - Click Here

Provided by: Actiance

Webinar: The True Impact of Cost-Sharing on Your Brand

Reserve your spot now.

As patients face increasing cost-sharing, nearly every healthcare decision has a cost component. How are these factors affecting your brand? Join us for an insightful session on how cost-sharing is impacting your brand.

Zitter Health Insights has developed a unique mobile research platform that continuously tracks thousands of consumer healthcare decisions at key moments: at the doctor’s office, at the pharmacy, and at home during research and self-treatment. Combined with a database of more than five hundred co-pay programs, ZHI’s analysis provides new insights into how a patient’s perceived net out-of-pocket cost influences prescribing, uptake, and adherence. The session will present information on healthcare journeys involving specialty as well as non-specialty categories.

The presenters will address the following topics:

• When and how is cost discussed in the physician’s office?
• How does cost affect willingness to try a new therapy?
• How do co-pay programs influence uptake for cost-sensitive patients?
• How aware are patients of co-pay coupons?
• How does patient cost influence adherence?
• How does income affect cost-sensitivity?
• What is the average walk-away out-of-pocket cost for different conditions?

Who Should Attend:

• Brand Marketing
• Marketing Management
• Marketing Research
• Marketing Communication Agencies
• Payer Marketing
• Payer Market Research
• Co-pay Program Managers
• Co-pay Program Vendors

Reserve your spot now.

Data Driven Innovation through a Clinical Data Repository - Download White Paper

“Data” is the life sciences’ industry most valuable asset. To date, systems that support clinical trials have focused on collecting, cleaning, tracking, and analyzing data from individual clinical trials. Sponsors want to rely on clinical trial data to support critical decisions. This requires data from multiple trials be aggregated and delivered in a concise easily understood manner so that decisions can be made and appropriate actions taken.

In this white paper, you’ll learn about:

• How a CDR provides advanced analytics for actionable insights
• The critical role a CDR plays in a successful risk-based monitoring approach
• The opportunity to easily share data with partners and external collaborators
• How a CDR supports efficient reporting to regulatory authorities
• Best practices for implementing a CDR
• A pharma case study on implementing a CDR

Download this free white paper now at http://bit.ly/ecswhitepapers

Featured White Paper - Anticipating Success: Meeting the Inherent Challenges of Complex Drug Substances

Throughout May, we are featuring an informative white paper provided by Vetter. The paper discusses the scientific and technical challenges that can crop up from the discovery phase to the commercial launch of a complex substance.

These challenges may be overcome with a systematic approach, which is consistent and repeatable.

You’ll learn about:
• The rise of injectables
• Patient-friendly delivery systems
• Optimizing yields
• Reducing overfilling
• Life cycle management
• 8 important questions that help avoid roadblocks

Download this free white paper now at http://bit.ly/0414vetterwp

April Feature Article - C-Suite: CROs: Opportunities and Barriers to Clinical Innovation

We asked c-suite executives throughout the CRO arena to provide their insights on what the biggest opportunities and barriers for innovation are for improving the drug development process, as well as identify a recent innovation that is improving the process.

Insights from John Potthoff Ph.D., President and CEO, Theorem Clinical Research.

Read more at http://viewer.zmags.com/publication/b1f9917d#/b1f9917d/38

Opportunities: Clinical trials today generate vast quantities of data that must be understood before they can be acted upon. The greatest opportunity for innovation in clinical development of biopharmaceuticals and medical devices lies in advanced software tools and techniques that allow real-time visualization of information in ways that speed understanding. In an era of risk-based monitoring and continual fine-tuning of trial design, connecting data streams with data visualization techniques provides a way for scientists to “see” multiple levels of data as they are generated, revealing new insights that can lead to better choices and decisions. As more and more data sources become available, this ability to visualize data will lead to an even deeper understanding of patients, products, and processes.

Read full article at http://bit.ly/pvdig38

GSK Supports Runner Training for Toughest Footrace on Earth

The Toughest Footrace on Earth

By Heather Hummel

Most of us our inclined to help others.  Some of us donate time to volunteer  for charities, and others of us donate money or items that charities also need to keep moving forward.  But how many of us would take on the challenge of running through the desert for 6 days to help raise money and awareness for a charity? Probably not too many of us.

Kate Eversole, Founder; Head of Partnerships, PatientsCreate, has accepted the challenge. Next month she will be running the Marathon des Sables (MdS), ranked by the Discovery Channel as the toughest footrace on earth.  The MdS is a multi-day ‘ultra-marathon’ or ‘ultra’ run in six days over a course of between 150 and 156 miles (254km).  Through the Sahara desert.  Where the temperature can exceed 120 degrees (50 degrees C).  And runners are required to be self-sufficient, carrying all their food, water and equipment.

After running the London Marathon in 2012, Kate entered MdS and got a space.  Looking back, she now thinks she must have been in a post race high after the marathon.  But she's preparing to take on the challenge and has been able to work out a rigorous training schedule, which has had to fit around her 50 - 60 hour work week.

Kate in Training

Luckily, to help with her training, she's spent the last few months being a lab rat for GlaxoSmithKline’s Human Performance Lab, a world class science facility focused on applied and discovery research, combining GSK science expertise, external advisors and cutting edge technology to deepen understanding of human performance.

Working in partnership with people and organizations committed to elite performance, the GSK Human Performance Lab aims to better understand how the body and brain function. This in turn can be used to develop improved training, recovery, nutrition and competition programs for its partners, enabling them to break through the limits of human performance.

Kate and her running team have been working with the GSK Human Performance Lab to better understand how to enhance their marathon performance. Their research has focused on a number of areas including environmental adaptation, hydration and nutrition so that they are ready to compete in the 155 mile, multi-stage Marathon des Sables race across the Sahara desert. Not only that, but the team is being advised on optimum recovery strategies to ensure that they can push themselves on a repeated basis.

To see how the important work MENCAP does to impact lives, please visit http://www.mencap.org.uk
To learn more about the Marathon des Sables, please visit http://www.marathondessables.co.uk

To sponsor Kate on her journey to challenge herself and raise money for MENCAP, please visit http://www.justgiving.com/Kate-Eversole2

120-degrees f? Carry your food & water ? No problem.

Is 2014 the Year of Telemedicine?

Image by Mayo Clinic

By Dan Limbach

Sometimes a great concept is ahead of the infrastructure it requires to become fully adopted by society. Telemedicine is no exception. Once relegated to expensive gadgets and proprietary networks, telemedicine has recently benefited from the explosion of smartphones, tablets, and other mobile devices. In 2013, over one billion smartphones were shipped, a high water mark for the devices. According to IDC, this growth rate may have peaked, underscoring the maturity of the market.

Data transmission is the other necessary component for a telemedicine infrastructure. With Wi-Fi and cellular networks blanketing the first world, it’s safe to say few people in these areas cannot have access to telemedicine.

Now that these two essential components are in place, the road is clear for an explosion in telemedicine expansion.

Obviously, there are endless issues that must be understood by companies providing telemedicine solutions. Medicare and the Affordable Care Act are two major forces in play. Millions of people are enrolling in the new plan as you read this.

Fortunately, the American Telemedicine Association has been building a community since 1993. ATA is a pioneer in promoting the use of telemedicine, and continues to lead the industry in covering the key issues and educating industry professionals. They are a one-stop shop for news and information. This is their vision for telemedicine.

Telemedicine will be fully integrated into healthcare systems to improve quality, access, equity and affordability of healthcare throughout the world.

One of the best ways to engage with the state of the industry, is to immerse yourself in the community at a major conference. ATA 2014 is the premier telemedicine for professionals. Their annual conference will occur from May 17 – 20, 2014, in Baltimore, MD.

It’s packed with inspirational keynotes, informative sessions, certification courses, networking opportunities, and much more. Please visit the website and register today.

Innovation in Biotech R&D

By Taren Grom

The pharmaceutical industry has dramatically shifted its R&D focus from its historical concentration on small molecule drugs to include a rapidly increasing number of biotechnology products, according to a recent analysis from the Tufts Center for the Study of Drug Development.

Biotech products, which accounted for only 7% of revenue generated by the 10 top selling pharmaceutical-biotech products worldwide in 2001, accounted for 71% of the 10 top selling products in 2012. The transformation of big pharma has been driven as much by new technologies that have enabled development of new products that improve disease outcomes and command high prices, as by the expiring patents on many top-selling small molecule drugs, according to Tufts CSDD Director Kenneth Kaitin.
Biotech products and pipelines, which are extremely attractive pharma companies, are helping to drive the innovation evolution. Novel technology platforms have been developed over the last 30 or so years, some of which according to Tufts has spurred an extensive pipeline of products across a wide range of therapeutic areas. For example, in 1989, only 13 biotechnology products were commercially available. By 2012, that number had grown to 210.

I asked several C-suite biotech executives to identify the biotech innovations that they believe have had the biggest impact, not surprisingly rooted in complex science.

Lloyd Everson, M.D., CEO of MolecularHealth, says Dr. Janet Rowley’s identification of the causal –chromosome rearrangement in chronic myelogenous leukemia (CML) is the poster child for what the whole panomic/genomic movement is all about. Dr. Rowley’s discovery eventually led to the development of Gleevec, the first molecular biomarker targeted therapy for leukemia.

“This paints a tremendous picture of the potential medicine can, and should, evolve into,” Dr. Everson says. “We’re at the beginning of a revolution in medicine; how we understand disease, how we diagnose it, and how the fingerprint of a particular disease paired with the DNA of an individual can accurately spell therapeutic options. There is no greater or more pressing example of this than in cancer care. We are just now beginning to unravel the heterogeneity of cancer and how it behaves in a human being.”

Gary Rabin, CEO and Chairman of Advanced Cell Technology, notes that even with all the fanfare around the Nobel Prize winning technology of induced pluripotent stem cells (iPSC), the overall progression of iPSC technology into the clinic has been hampered by reports that iPSC lines may have epigenetic memory and replicative capacity issues, perhaps as a consequence to incomplete dedifferentiation using current iPS techniques.

“Jacob Hanna and his colleagues at the Weizmann Institute of Science have recently developed a method for generating human iPS cells in a true naïve ground state and maintaining them in that form,” Mr. Rabin says. “If this method has in fact solved the stability issue for iPSC lines, than it opens up the opportunities for utilizing this important technology in regenerative medicine therapies.”

Szilard Voros, M.D., CEO and Co-Founder of Global Genomics Group (G3), is focusing his attention on the large systems-biology-based studies that are currently ongoing.

He believes breakthroughs will come from trials such as the GLOBAL study, which involves the integration of data from up to 10,000 patients who will undergo coronary computed tomographic (CT) angiography (an advanced imaging technology for precisephenotyping) with pan-omicanalyses to identify diagnostic biomarkers and disease pathways for cardiovascular diseases.

For more information about biotechnolgy innovation,  read the complete article in the PharmaVOICE Digital Edition.

The Uninsured in America - podcast and white paper

Podcast: Who are the Uninsured in America?

In this podcast episode, Patricia Ensor discusses the characteristics and behaviors of the uninsured, how they relate to the Affordable Care Act (ACA), and what it means for Pharma.

Play podcast

White Paper: The Uninsured in America - What do characteristics and behaviors tell us about likely participation in the healthcare exchange marketplace?

Based on simulations and projections conducted by multiple groups to date, it is still uncertain who and how many uninsured will, in fact, obtain insurance. Kantar Health undertook an analysis to increase the body of knowledge about the currently uninsured patients. The results are contained in this white paper.

Download white paper