In our August issue of Pharmaceutical Executive
FEATURES
Cover Story
Epidemiology Arising: A Pharm Exec Roundtable
William Looney
A panel of experts from industry and academia probe the changing role of the pharmacoepidemiology function as it grapples with the challenges of big data analytics, tightening drug safety requirements, growing post-approval study burdens, and payer expectations around the application of real-world evidence. |
Manufacturing
Manufacturing's True North: The Quality Compass
Ian Wilcox, Conrad J. Heilman, Jr., PhD
Biopharma needs to combine a “culture of quality” with value-added process improvements in manufacturing. Here are key steps and strategies that can make a difference—and deliver bottom-line results. |
Adherence
Activating the Patient
Casey McDonald
Adherence is no longer. The emphasis is now on patient activation, but how significant will this change be? How can drugmakers become more collaborative in engaging and empowering patients? Mobile tech and data ownership will certainly play a key role. |
Regulatory
Hurdles Ahead for “Cures” Legislation, PDUFA Renewal
Jill Wechsler
Despite overwhelming House approval last month of the “21st Century Cures” Act, bipartisan support may fall apart in the coming months as key provisions face opposition in the Senate, negotiations begin on reauthorizing FDA drug user fees, and the presidential campaign shifts the debate to broader health issues. |
Biosimilars
Biosimilars Litigation: The Story So Far
Mindy Ehrenfried, William Raich
The case of Amgen v. Sandoz signals that preliminary injunctions will play a major role in future patent disputes. |
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ALSO IN THIS ISSUE
Greece: More Than Next Week's Drug Supply at Risk
Reflector
The volatility of the nation's debt crisis could pose greater challenges for the industry down the line.
New Payment Models: It's Time to Move
Stacie Heller, Peter Weissberg
Commercial success for pharma brands now demands proactive strategies and interventions.
Alzheimer's Update: What to Make of the Latest Buzz
Casey McDonald
New trial results spark usual range of perspectives, doubts.
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| WEBCASTS |
| New expensive treatments for hepatitis C infection: have US payers reached a tipping point?
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| Establishing Processes and Controls to Ensure an Inspection-ready TMF Every Day |
Engineer Your Business to Win in the Mobile Selling Moment
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