Commercialization: Page 100
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PharmaVoice Team/PharmaVoice
UpFront
PDUFA Update FDA Requests $87.4 million increase The FDA has put before Congress its recommendations for reauthorizing the Prescription Drug User Fee program (PDUFA). If adopted, PDUFA IV — the fourth reauthorization since the program began almost 15 years ago — would significantly broaden and up...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
PharmaOutlet
Greg Sarian discusses executive trading rules. Contributed by Greg Sarian In an age when corporate scandals are top of mind and full financial disclosure is a must, executives may find it difficult to trade their company’s stock without raising eyebrows about how their insider knowledge may have ...
By Greg Sarian • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
For Art's Sake
A Creative Review by the Experts Each month, this department pays homage to memorable advertising and marketing campaigns. The highlighted executions have been identified by leading creative executives for their noteworthy use of copy, art, photography, whimsy, uniqueness, etc. — in combination o...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
What's New
New Healthcare-related Products, Services, and Companies inChord Communications Now inVentiv Communications The transition marks the final step in the previously announced corporate rebranding of inVentiv Health Inc. As part of the inVentiv Health family, the range of solutions we can bring to ou...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Stroke: Bats and Snakes May Hold the Answer
By Cynthia Borda A decade ago, the introduction of tPA was a major step forward in stroke treatment, and the hope was that other approaches and additional therapies would soon be available. Unfortunately, the next generation of products has yet to materialize. Every 45 seconds, someone in the Uni...
By Cynthia Borda • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Flying Sky High -- Rajesh C. Shrotriya
With enormous enthusiasm and a joie de vive, Dr. Rajesh Shrotriya, chairman and CEO of Spectrum Pharmaceuticals, is instilling his employees with the same gusto for development of new drugs. Propelled by a joy of work and a commitment to remaining focused on a task until it is accomplished, Rajes...
By Kim Ribbink • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Targeted Media Messaging: Patient Recruitment Marketing
By Kim Ribbink Patient recruitment is widely considered to be the most costly and time-consuming aspect of clinical trials, and the need to improve the process is pressing. One key aspect to achieving this goal is the use of appropriate media as part of a marketing campaign to improve patient enr...
By Kim Ribbink • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
E-Media
Blue Spoon Releases Ecosystem Solution For Pharma Sales Effectiveness Blue Spoon Consulting has released a marketing ecosystem-based solution for pharmaceutical sales effectiveness. The new design links the context, content, and process of the virtual and physical domains of pharmaceutical sales ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Leadership Development: The Next Generation
By Taren Grom Life-sciences organizations operate in a complex and challenging environment that includes tighter funding, reimbursement restrictions, longer and more expensive product development cycles, and more regulatory oversight. Whether future leaders are prepared to manage in this complex ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
The Age of Personalized Medicine
By Denise Myshko The understanding of molecular biology has come a long way. One mark of this progress is Pharmacogenomics, which uses markers in an individual’s genetic code to pinpoint the underlying causes of disease. Experts say the technology has a great deal of promise for allowing research...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Raise Your Voice -- Letters
The Future of eClinical Recently, I had the opportunity to participate in an eClinical conference sponsored by etrials Inc. Clearly, among the participants at the event — both sponsors and trial partners –there was an underlying consensus that we understand the benefits of real-time data, know th...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Table of Contents
On the Cover The age of personalized medicine The study of genomics holds promise for helping to identify better drug targets and guiding companies in designing trials. The hope is that pharmacogenomics will lead to more targeted therapies. Features Patient recruitment marketing Patient recruitme...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Is there anything more personal than healthcare? Whether we are talking about medical records or medicine — personalization is coming into vogue, albeit with a caveat on privacy protection. According to a recent Wall Street Journal Online/Harris Interactive Health-Care poll, when it comes to the ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
PharmaTrax
PharmaTrax Sales, Marketing, and R&D Trends from Industry Analysts Scientific Expertise and Good Value Are Important When Choosing a CRO The primary factors pharmaceutical and biotechnology companies consider when selecting a CRO are the strength of its scientific expertise and the cost/value...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
What's New
New Healthcare-related Products, Services, and Companies The breakthrough use of automated data mining and predictive analytics will ultimately make the costly, inefficient one-size-fits-all ‘shotgun’ mass-media marketing approach to consumers obsolete, says Michael D. Weintraub, Founder, Chairma...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Managed Markets: Formularies
By Denise Myshko MCOs and PBMs are now applying their cost-management strategies to biotech and specialty drugs. Biologics and injectable medications are coming under increased scrutiny by managed care organizations (MCOs). MCOs, pharmacy benefit management companies (PBMs), and other payers are ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
For Art's Sake
Each month, this department pays homage to memorable advertising and marketing campaigns. The highlighted executions have been identified by leading creative executives for their noteworthy use of copy, art, photography, whimsy, uniqueness, etc. — in combination or as single branding elements. Cr...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Master The New Standard: HBA Leadership Conference
HBA Leadership Conference Master The New Standard 4th Annual HBA Leadership Conference Attracts More Than 300 Attendees to Boston The 4th Annual Healthcare Businesswomen’s association’s Leadership conference, held in Boston last November, was a two-day event packed with interactive sessions, dist...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Counter Measures: Switching from Rx to OTC
Switching products from Rx to OTC status can be a viable life-cycle management strategy, one that is expected to be used more frequently. By Cynthia Borda Consumers are increasingly comfortable managing their own healthcare. They want easy access to low-cost, effective, safe, and easy-to-get prod...
By Cynthia Borda • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
A Commitment to Public Health -- Dr. Barbara DeBuono
By Kim Ribbink Dr. Barbara DeBuono, as Senior Consultant to the WHO, was assigned to the organization’s SEARO, Southeast Asia Regional Office in New Delhi, India, to review public-health aspects of the tsunami relief and recovery operations. She worked with the WHO offices in India, Maldives, and...
By Kim Ribbink • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Table of Contents
On the Cover Sales and marketing compliance As pharmaceutical manufacturers continue to refine and adjust their compliance policies to meet a slew of regulations over the past five years, they also are looking ahead and preparing for regulatory changes that could create many challenges. Features ...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Registering Safety
By Kim Ribbink As the emphasis on drug development shifts toward improving risk management, new tools have emerged to evaluate safety both pre- and postapproval. Increasingly, companies are looking at patient registries as an integral part of their safety arsenal. Drug safety has become the focal...
By Kim Ribbink • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
Letter from the Editor
Already 2007 is shaping up to be an interesting time. A new Congress, shifting demographics, regulatory restrictions, and other factors are sure to keep industry leaders on their toes. In early December, Pfizer’s two big announcements made headlines: first, a major reduction in its salesforce, th...
By Taren Grom • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
E-Media
New Electronic and Web-based Applications, Sites, and Technologies Phase Forward Expands Clinical-Trials Signal Detection System Phase Forward has unveiled a new version (2.0) of its clinical trials signal detection system — CTSD. The CTSD system enables clinical safety and medical monitoring sta...
By PharmaVoice Team • Jan. 2, 2008 -
PharmaVoice Team/PharmaVoice
On the Calendar
January 16-17 Pharma Pricing Strategies Radisson SAS, Rome For more information, contact Martin Manik, Jacob Fleming Group, at 42-12-5825-2729, e-mail [email protected], or visit jacobfleming.com. January 16-18 Pharmaceutical Leaders’ Summit Delray Beach Marriott, Delray Beach, Fla. F...
By PharmaVoice Team • Jan. 2, 2008
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