January 2007

PharmaOutlet

January 2, 2008

Contributed by James Rogers Merging Clinical-Trials Safety and Pharmacovigilance The Winds of change in safety monitoring In November 2003, Mark B. McClellan, M.D., Ph.D., a former commissioner with the Food and Drug Administration, made the comment: “…there is no such thing as a completely safe medicine.” In a speech before the Urban Institute, Dr. McClellan […]

Is EDC the next CDMS?

January 2, 2008

VIEW on Data Management Is EDC the next CDMS? The lines between EDC and CDMS continue to blur as technology catches up with practicality and the need for cleaner data faster. Glen de Vries Glen de Vries, Cofounder and Chief Technology Officer of Medidata Solutions Worldwide, discusses why EDC is not a replacement for CDMS […]

What’s New

January 2, 2008

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, Chairman, and CEO of Mindset Marketing Solutions. Mindset Marketing Solutions To Address Direct-to-Consumer Marketing Automated data mining and predictive analytics […]

On the Calendar

January 2, 2008

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 martin.manik@jacobfleming.com, or visit jacobfleming.com. January 16-18 Pharmaceutical Leaders’ Summit Delray Beach Marriott, Delray Beach, Fla. For more information, contact Nicole Lewis, Cambridge Healthtech Institute, at 617-630-1317, e-mail nlewis@healthtech.com, or visit healthtech.com. January 17-19 The 2nd […]

PharmaTrax

January 2, 2008

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 ratio associated with the study, according to a report, commissioned by Quest Pharmaceutical […]

E-Media

January 2, 2008

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 staff to: analyze clinical data for the purpose of detecting, evaluating, and tracking potential […]

Table of Contents

January 2, 2008

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 Registering safety As the emphasis on drug development shifts toward […]

Talent Pool

January 2, 2008

Pharma POOL Lee Davies Schering-Plough Appoints Director, Global Product Communications and Advocacy Relations Schering-Plough, a global science-based healthcare company, has appointed Lee Davies director, global product communications and advocacy relations. Mr. Davies is responsible for global product communications and advocacy relations programs supporting Schering-Plough’s cardiovascular portfolio. He is based at the company’s headquarters in Kenilworth, […]

Letter from the Editor

January 2, 2008

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, then the discontinuation of clinical trials for one of its […]

Registering Safety

January 2, 2008

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 point among patients, their doctors, regulatory bodies, and pharmaceutical […]

A Commitment to Public Health — Dr. Barbara DeBuono

January 2, 2008

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 Thailand and was on location from February through […]

Counter Measures: Switching from Rx to OTC

January 2, 2008

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 products, which has led to an increase in self-medication. Many of […]

UpFront

January 2, 2008

Top 7 Healthcare Issues This year is expected to be a watershed period for the health industries, according to PricewaterhouseCoopers LLP, as health savings accounts reach a tipping point, states act where the federal government hasn’t, and pressure on pricing amid demand for transparency forces pharma companies, hospitals, and health plans to rethink their strategies. […]

FDA: An Agency in Transition

January 2, 2008

In the past year, the Food and Drug Administration has built some momentum in speeding drug development and addressing product safety. Despite the progress made in improving its internal structure, the agency in the coming year will continue to face obstacles. Robert DeLuccia MacroChem A shifting political environment will change the thrust of what’s going […]

Master The New Standard: HBA Leadership Conference

January 2, 2008

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, distinguished speakers, and networking opportunties. Centered around the theme Master the New Standard of Leadership, […]

For Art’s Sake

January 2, 2008

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. Creating good pharmaceutical advertising and marketing requires agencies to think out of the box […]

Managed Markets: Formularies

January 2, 2008

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 beginning to apply cost-management strategies to high-cost biologic, injectable medications, and specialty drugs. They […]

Raise Your Voice — Letters

January 2, 2008

Changes in Washington: Will it Affect the Pharmaceutical Industry? One way that the U.S. government is making good on its promise to reduce the cost of healthcare is by approving Medicare Part D. — Patricia Santos-Serrao, RAC, Regulatory Advisory, Qumas A shift in command Healthcare has always been stated as a priority with both political […]

Sales & Marketing Compliance: Keeping up with Global and Local Challenges

January 2, 2008

As pharmaceutical manufacturers continue to refine and adjust their compliance policies to meet a slew of regulations enacted over the past five years, they also are looking ahead and preparing for regulatory changes that could create many challenges. Six states have legislation that require pharmaceutical companies to report what they spend on physician sales, but […]

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