Lisa Banket
Cofounding Partner/Publisher
Taren Grom
Cofounding Partner/Editor-in-Chief
Heather Hummel
Project Coordinator
Dan Limbach
Producer, Webcast Network
Denise Myshko
Managing Editor
Kim Ribbink
Features Editor
Robin Robinson
Senior Editor
Marah Walsh
Cofounding Partner/New Business Development

PharmaVOICE Editors' Blog

Thursday, February 25, 2010

Google Chrome Aims for Your Desktop

Dan Limbach

Microsoft has dominated the desktop software landscape for decades. While they have given up some ground in the server market to Linux, they are still nearly ubiquitous on the desktop. Google would love to change all that.

They have a new browser called Chrome that is much faster than Internet Explorer, at least from my experience. Chrome OS is a logical extension beyond the browser, and takes aim at the Microsoft Windows franchise. And like most offerings from Google, they are free. If computing in the workspace has become mostly about connecting to the Internet, efficient collaboration, and mobile computing, Chrome may be the Next Big Thing.
If the thought of giving up Microsoft Office makes you queasy, Google Docs has apps compatible with Word, Excel, and Powerpoint. Need email? There's a Google app for that. A calendar with a task list? Yessiree.

Does Google provide a perfect solution to all your needs? No. You'll have to get used to working a bit differently. But "Free" overcomes a lot of objections. Do the math. How much does it cost every few years to buy MS Office at $300 - $500 per seat? How much IT support is required to maintain the OS and Office software on an annual basis?

If anyone can put a dent in the Microsoft lock on the desktop, it’s Google. Your next computer just might be a sub-$300 netbook running ChromeOS and accessing Google Docs.

Check out this slick and witty independent video on the Chrome browser and Chrome OS.

Tuesday, February 9, 2010

Web Seminar - Driving Site Performance: The Investigator Perspective

Dan Limbach

Join us on March 25, 2010 at 10am EDT for our next WebLinx Web Seminar. Brought to you by PharmaVOICE and sponsored bt Firecrest Clinical. I will be moderating the web seminar, and I invite you to come ready with questions for our expert panelists.

A combination of innovative training, site performance support, monitoring tools and communications solutions drives:
  • Improved compliance
  • Improved patient recruitment and retention
  • Reduced protocol deviations and data queries
  • Greater adherence to study timelines
What does it mean for pharmaceutical companies who haven’t yet embraced the future of the industry?
More info
Register Now

Key Take Aways
  • Insights into the value of online protocol training versus traditional Investigator Meetings
  • Guidance on how to optimize site performance
  • Key information on facilitating global communication
  • How and why to consolidate study documentation
  • A vision for the future of clinical study management
Who Should Attend
  • International Clinical Trial Managers
  • Clinical Project Leaders
  • Clinical Operations Managers
  • Study Monitoring Managers
  • Clinical Outsourcing Managers
  • Medical Directors
Why You Should Attend
  • To discover innovative means of driving site performance across global studies
  • Develop alternative strategies to traditional investigator meeting model

Prof. Brendan M. Buckley, MD, MSc, DPhil, FRCPI
Founder & Director of Medical Affairs
Firecrest Clinical

Nigel Hughes, BSc (Pharm)
Founder & Director
Firecrest Clinical

More info
Register Now

Monday, February 8, 2010

Putting the "e" in e-medical affairs

Robin Robinson

I recently had an interesting conversation with Dr. Paul Weber, who serves as senior director, medical affairs, at Enzon Pharmaceuticals, about the emerging trend in the industry of putting the “e” in e-medical affairs.
In other words, how the industry can effectively use technology and electronic communications to expand the medical affairs footprint.

“These days, it is absolutely critical for health professionals and the lay public to receive the right information at the right time, and this should be everyone’s No. 1 mission,” Dr. Weber says. “Companies need a customer service adaptation for medical information.” 

Dr. Weber’s Medical Information Group at Enzon, in collaboration with an internal IT team, led the launch of a medical information Web site, which included automating the responses, facilitating the integration of IT functionality, and monitoring the results of the new channel. Enzon also collected feedback from healthcare professionals via an automated survey initiative. After a person registers on the site, they are e-mailed a user survey to evaluate their site experience.

In the manner of most small biopharma companies, Enzon’s medical affairs department initially provided a phone number, a fax number, and a designated e-mail address for handling healthcare professional inquiries about its products. In December 2008, the company launched the automated medical information Web site,

Dr. Weber’s enthusiasm for the two-year in-house project was evident during our conversation, and he says Enzon has been very proactive in applying IT to its various functions, particularly in medical affairs.
With a full year of data to analyze, Dr. Weber could easily identify a dramatic growth in unsolicited inquiries from healthcare professionals. Of all the unsolicited inquiries, 20% were generated from the new Web site.
“This was a big shift, and one that exceeded our expectations,” he says. “Our stretch goal was 15%, but 20% is phenomenal during the first year, especially on an effort that we can’t advertise.” (Overall, the unsolicited inquiries grew by 30% year-on-year.) 

The site not only increases the frequency of inquiries, but also extends the reach of medical information. Mr. Weber says the company has received requests from all over the world as a direct result of the Web site. “We’ve had requests from Pakistan, Canada, and several Middle Eastern nations in just the last week,” he says.

As more and more companies of all sizes plan to launch medical information Web sites, Dr. Weber offers up three best practices from his experience implementing 

1. Don’t lose sight of what is important, and that is treating people respectfully, empathetically, and with a complete understanding of their questions. While having an automatic response system can increase the speed and timeliness of responses, electronic activity can never replace dealing with people on a personal level, he says.
“Listen carefully, and respond back with questions by phone or e-mail to make sure that the information the physician receives truly matches what the intention of the question was,” he says. 

2. Make sure connectivity and integration are possible.
“In the beginning, Enzon outsourced the response function for its inquiries, and the Web site was internally developed,” Dr. Weber says. “We were unable to connect these two areas until eight months into the project. Integration significantly reduces response time turnaround and the process is more efficient when systems can communicate with each other.”

3. Remain fully compliant within the environment, which requires record keeping and compliance systems.
“With the slew of regulations are out there, a company can make itself subject to an FDA audit,” he warns. “Although we have more automations and more IT applications in place, we also ensured that systems are in place for record keeping and compliance.” 

The most important compass for success, however, he says, is getting the information out to the healthcare professionals as soon as they ask for it.
“A person who needs information should get it as fast as they need it,” Dr. Weber says. “There should be no barriers to slow the process. Physicians have lifesaving decisions to make and they need information to help guide them so they can positively affect patients’ lives.”

Thank you to Dr. Weber for his medical affairs insight, which allows us to round out our February coverage of e-patient communications. For more information about creating e-patient connections, visit A 360-Degree View of E-Patient Connections.

Editors note: On January 29, 2010, Enzon Pharmaceuticals completed the sale of its specialty pharmaceutical business to the sigma-tau Group, and Paul Weber, MD, RPh, MBA is currently working in a transition focused capacity at Enzon. He has also held similar medical affairs or medical liaison roles at Schering Plough, Hoffmann-La Roche, and Roche Laboratories.

Wednesday, February 3, 2010

Medical Journal Retracts Study

Denise Myshko

It’s about time. The Lancet on Tuesday retracted its infamous study linking the measles, mumps, and rubella vaccine to autism.

That study, published in 1998, unleashed a decade’s worth of controversy about the risks and benefits of childhood vaccines.

But several studies that looked at vaccine use and changes in autism frequency did not reach the same conclusion. And a 2004 scientific review by the Institute of Medicine (IOM) concluded that there is no link between autism and the MMR vaccine and there is no link between autism and vaccines that contain thimerosal as a preservative.

Still, that hasn’t prevented some parent advocacy groups and high-profile celebrities from using that single study from 1998 to launch a campaign against the use of vaccines, claiming vaccines have injured their children.

Before vaccines, every year, measles would infect 4 million American children and kill 3,000; diphtheria would kill 15,000 people; rubella would cause 20,000 babies to be born blind, deaf, or mentally handicapped; and pertussis would kill 8,000 children, most of whom were less than one year old.

Since the publication of that 1998 study, the percentage of children who were not vaccinated in the United States rose from 0.77% in 1997 to 2.1% in 2000. That may not seem all that much, but consider that although the Centers for Disease Control declared the United States cleared of measles in 2000, there was a outbreak of the disease in 2008. At least 131 cases were reported to the CDC, and 11% of the cases were hospitalized. A handful of children in Britain died from the measles around the time of the U.S. outbreak.

The Lancet’s retraction, however, is unlikely to sway the antivaccine groups. The retraction was based on ethics charges against the lead researcher, Dr. Andrew Wakefield. Dr. Wakefield’s supporters are likely to point to anecdotal cases as proof of his theories and suggest — even with the evidence from the IOM and CDC — that science hasn’t disproved his initial study.

This is not to discount the struggles these parents face raising autistic children. Certainly, their need to find someone to blame is understandable. But the truth is that scientists don’t really know what causes autism, although it’s likely that both genetics and environment play a role.