Pharma-IT Review
FDA Eyes RFID to Battle Counterfeit Drugs

Portal Synchronizes International Marketing Efforts

Beyond Risk Management

   Tuesday, Nov 30, 2004 Archives Bio-IT World News Bulletin Subscribe Advertising
 
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FDA Eyes RFID to Battle Counterfeit Drugs

A new FDA initiative announced this month aims to use radio frequency identification (RFID) tags to help combat counterfeiting of some popular drugs.


"In recent years, bogus medications have become a growing public health threat because of counterfeiters' ability to infiltrate our drug distribution system with worthless counterfeits," says Lester Crawford, acting commissioner of the FDA. Crawford's comments came in a telephone interview with the media to announce the new initiative.


Essentially, the FDA gave the nod to RFID tags on labels - basically lifting some labeling restrictions that might have discouraged pharmaceutical companies from trying out the technology. "We are providing guidance today to assure companies that if they do the tagging, they won't be violating our labeling regulations," says William Hubbard, assistant director for policy planning at the FDA.

The first drugs to use RFID technology explicitly to combat counterfeiting will be Pfizer's Viagra, Purdue Pharma's OxyContin, and GlaxoSmithKline's AIDS drugs Combivir and Epivir. Industry experts note that Viagra is one drug that has been targeted by counterfeiters due to its popularity. In the case of OxyContin, the RFID labeling is intended to serve a dual purpose: to combat counterfeiting and to track bottles to prevent theft.

    Read More . . .


Portal Synchronizes International Marketing Efforts

Managing pharmaceutical marketing of drugs is a complicated task. Typically, pharmaceutical companies oversee a mix of print, Web, and TV campaigns aimed at doctors and patients. And often, marketing staffs in different countries work with local ad agencies to develop specific content for their markets.


Last year, Novartis found itself trying to bring some control over these processes for its prescription eczema drug Elidel. Specifically, the company realized it needed some way to ensure that the Elidel branding was applied and enforced uniformly across the numerous countries where the drug was sold.


To address this issue, Novartis tapped the healthcare advertising management consortium CommonHealth, which proposed the creation of a Web-based brand-stewardship portal. The branding portal would combine a repository for digital content and a workflow system to ensure that brand management best practices were carried out throughout the organization.

    Read More . . .

Featured Events

2005 Pharmaceutical Marketing Compliance Congress - January 31 - February 1, Washington, DC

MIT Advanced Study Program, Cambridge, Mass.; Spring 2005 Courses

Domestic Outsourcing for Drug Discovery - January 27 - 28, San Diego, CA

Bio-IT World Conference + Expo - May 17-19, 2005, Boston, MA
 

Would you like to see your conference or event listed here? Contact Shari Redan at shari_redan@bio-itworld.com for more information.



Beyond Risk Management

The problems with Vioxx have focused the industry's attention on tracking a drug's safety after it has been approved.


And while some people and organizations are saying the FDA should not do both the approval and post-approval followup, many in the industry are taking a closer look at their own risk management efforts.


One interesting approach starting to get some attention is to combine normal post-release risk-tracking procedures with more-detailed prescription data. The idea is to leverage the combined information to quickly address any physician risk concerns about using a drug or class of drugs.


For instance, when Vioxx's problems became front-page news, physicians and patients naturally had concerns about similar drugs. And even drugs that were not similar, but treated the same disease, occasionally got called into question. Such concerns can (and in the case of Vioxx did) have a dramatic impact on the sale of a drug.

    Read More . . .


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Featured Events

Upcoming Industry Events

2005 Pharmaceutical Marketing Compliance Congress - January 31 - February 1, Washington, D.C.
The 2005 event reconvenes over 350 high level legal, compliance and regulatory members of the pharmaceutical industry and features tracks on direct-to-consumer advertising, off-label promotion and fraud & abuse.For more information or to register, please contact the Center for Business Intelligence
http://www.marketingcompliance.com , or call toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com

MIT Advanced Study Program, Cambridge, Mass, Spring 2005 Courses
The Massachusetts Institute of Technology Advanced Study Program ( ASP) is now accepting applications for the Spring 2005 term. ASP provides full and part-time certificate programs to working professionals at any stage of their careers. The program includes a flexible curriculum of MIT courses designed around the goals of participants and their sponsors. Please visit our website:
http://web.mit.edu/mitpep/asp/bioit.html

Domestic Outsourcing for Drug Discovery - January 27 - 28, San Diego, CA
Attend CBI's Domestic Outsourcing for Drug Discovery conference in San Diego, CA, January 27 -28, 2005 to learn about the discovery outsourcing options that are available both through vendors, whose business model is purely contract work, and via partnering and licensing options. Join colleagues in learning about the many benefits an outsourcing provider or partner can offer. Special early bird and team discount rates are available.  For more information or to register, please contact the Center for Business Intelligence
http://www.cbinet.com/events/HB513/index.html or toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com

Bio-IT World Conference & Expo - May 17-19, 2005, Boston, MA
Bio-IT World Conference & Expo showcases the latest technology developments and research breakthroughs on the complete spectrum of topics involved in drug discovery through market delivery. Visit our web site at 
http://www.bio-itworldexpo.com




Capgemini Analysis

Utilizing the Right Levers to Make Clinical Trials More Efficient

By Klaus Nagels
Principal, Global Life Sciences Sector

Capgemini


The latest generation of clinical trials data management systems is paving the way for pharma companies to conduct clinical trials in lower-cost countries while improving decision-making and increasing the quality and transparency of the data. However, it will take more than a classical consulting approach to make this work; it requires organized collaboration.


There are clear financial advantages to conducting trials in countries in Eastern Europe, or in India and China, where the skill levels of clinicians and healthcare staff are high and the cost base is low.


Not only that, but moving clinical trials to these countries offers relief from the bottlenecks that are hitting trials in the West, such as the increasing reluctance of patients to participate, or the highly prescriptive requirements introduced by the EU Clinical Trials Directive that came into effect in May 2004.


These bottlenecks are increasing the amount of time it takes to set up trials and recruit patients in what can be thought of as traditional clinical trials venues. All of these factors can have a serious and direct financial impact - to the extent of a pharma company missing a marketing window.


But while India, China, and Eastern Europe offer clear cost incentives, many pharmaceutical companies do not, as yet, have operations there. This raises the issue of how to manage and control clinical trials at a distance and still capitalize on the advantages of these locations.


Clinical trials management systems have now reached the stage of maturity where they have a real impact on trial efficiency, providing management with direct and potent levers with which to oversee the process from end to end.


Such systems can provide the means to manage clinical trials remotely, enabling pharma companies to take advantage of lower-cost environments without the risk of losing control.

    Read More . . .

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