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 November 19, 2015 | ISSUE NUMBER 427 VOL 4
Washington Report
Califf Sidesteps Drug Pricing Complaints from Senate
The Senate hearing to weigh the appointment of Robert Califf to be the next commissioner of FDA was a fairly friendly event, with members of the Senate Health, Education, Labor and Pensions (HELP) Committee tossing out mostly softball questions about a range of policies and programs. Jill Wechsler reports
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Compliance
Pressure Mounts for Greater Clinical Trial Data Transparency
A report from the Bioethics International finds that for a group of new drugs approved by FDA in 2012, large pharma companies fell “below legal and ethical standards” for making public information from the relevant clinical trials. Jill Wechsler reports
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Special Feature
Pharm Exec's Pipeline Report 2016
Will a drug pipeline harvest full of treatments founded on strong science, supportive regulation, and unmet medical need offer solace to shareholders and the promise of a reputational rebound? Will presidential politics add to the pressures on drug pricing, with a sour coda to the old refrain, “in the US, the market decides?” Casey McDonald reports
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Regulatory
Hard Times in Washington for Generics
A new report from the Generic Pharmaceutical Association (GPhA) calculates that generic drugs saved $254 billion in 2014, and some $1.68 trillion over the past 10 years. Generics account for 88% of prescriptions, according to analysis by the IMS Institute for Healthcare Informatics, but only 28% of drug spending. Policy makers thus should take steps to promote the development of competitive generic therapies and of biosimilars, says GPhA
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Field medical staffing is changing and ratios of field medical to sales force vary by disease area. Read the article to learn the benchmarks.
R&D
Advances in Clinical Outcome Assessments
Joseph Cappelleri and DIA’s Editor in Chief Stephen Spielberg at the importance of clinical outcome assessments (COAs) to the increased emphasis on patient-centered research
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In this paper, IMS Health describes the next generation of sales, marketing and technology - Orchestrated Customer Engagement (OCE). OCE seamlessly marshals the sequence, context, and purpose of messages to multiple influencing stakeholders. Read more
//Three months after leaving his role as Vice President of Research and Development Biogen, Doug Williams has been named CEO of startup Codiak BioSciences (Cambridge, MA).//MELA Sciences (Horsham, PA) reported that Christina L. Allgeier has been promoted to the post of Chief Financial Officer.//Paragon Bioservices (Baltimore, MD) announced today the appointment of Robert Roche to the company's Board of Directors.//
December 2–3: Publication Planning
Philadelphia, PA.


January 28–29, 2016: 11th Summit on Biosimilars
Alexandria, VA.


February 18–19, 2016: Bio/Pharma Social Media and Digital Platforms
Philadelphia, PA.
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