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November 29, 2012 | ISSUE NUMBER 278 VOL 8

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Pharmaceutical Executive Staff

Healthcare Reform
Pharma to Gain from New Health Insurance Proposals
A key change in rules to implement the Affordable Care Act (ACA) is regarded as a big win for pharma, as some 20 million Americans are expected to enroll in plans sold through exchanges, greatly expanding the market for prescription drugs. Jill Wechsler reports ...Read more

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Measurement of case quality in pharmacovigilance is a relatively new development. Until pharmaceutical companies began outsourcing their case processing operations, the only measure of effectiveness of their internal operations was compliance with regulatory reporting timelines. Now that these operations are performed by vendors, over the last two years vendor management organizations within pharmaceutical companies and Health Authorities have come up with a way to measure the “quality” of Adverse Event (AE) cases. This paper captures our experience and learning in defining and using Case Quality Metrics while working with large and small pharmaceutical companies.
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Pipeline
Pharm Exec's 2013 Pipeline Report: An End to the Gloom?
Is the "lost decade" of declining pipeline productivity finally over? Our annual survey of analyst assessments of the state of drug development suggests so, with subtle shards of sunlight beginning to penetrate the gloom cast by the historic loss of exclusivity on more than $80 billion of blockbuster medicines since 2009...Read More

Funding
PCORI Opens its Pocketbook
The Patient-Centered Outcomes Research Institute (PCORI) has proposed grants totaling $12 million for up to 14 contracts for studies aimed at improving upon existing research methodologies to demonstrate clinical effectiveness
...Read more

Drug Launch
Why Do So Many New Drugs End Up as Launch Failures?
Pharm Exec's new iPad edition eBook, Global Launch in a Post-blockbuster Era, is available for download now
...Read more

// Sanofi appointed Dr Gary Nabel, Senior VP, Chief Scientific Officer and Deputy to the President for Global R&D. Dr Nabel will be based in Cambridge, MA. // NovaMedica appointed Fabrice Egros as its Chief Operating Officer. The company was formed in 2011 as part of a $760m collaboration between the Russian technology investment fund Rusnano and US healthcare venture fund Domain Associates. // Dr Eugene Washington was appointed to the Board of directors at Johnson & Johnson.// Ampio Pharmaceuticals, Inc. (Greewood Village, CO) announced the appointment of Josh Disbrow as Chief Operating Officer, effective December 15.

December 7: New York Pharma Forum 23rd Annual General Assembly
New York, NY.


December 11–12: 2012 Life Sciences CRM Forum
Philadelphia, PA.


January 24–25, 2013: 3rd Developing CAPAs in the GCP Environment Conference
Arlington, VA.


January 24–25, 2013: 5th Risk Evaluation and Mitigation Strategies Summit
Arlington, VA.


 
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