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September 26, 2013 | ISSUE NUMBER 319 VOL 11

Big Data
The Big Promise of Predictive Analytics in Healthcare
At Duke University’s Fifth Annual Technology and Healthcare Conference, Eric Siegel called new predictive analytical tools “inevitable” disruptions to the way physicians make treatment decisions and patients receive care. Ben Comer reports ...Read more

Regulatory
FDA, CDER Weigh Organizational Changes
FDA’s newly formed Program Alignment Group (PAG), announced Sept. 6, 2013, will seek to clarify the roles and responsibilities of product centers and the Office of Regulatory Affairs (ORA) to more effectively align practices, processes and resources.
...Read more

Forecast
Pharma Revenues, Healthcare Expenditure Set to Increase, says CMS
Healthcare spending will rise modestly in the US over the next decade, as economic growth picks up, health reform provides expanded coverage, and the population continues to age, according to an annual analysis from the Centers for Medicare and Medicaid Services (CMS)
...Read more

A New Category of Outsourcing Vendor is Emerging to Meet Unmet Needs
The advent of Scientific Process Organizations (SPOs) is due to the increasing demand for a higher level of scientific expertise and an exclusive focus that is normally not catered by traditional Business Process Organizations (BPOs) or Contract Research Organizations (CROs). SPOs are dedicated to filling the gaps left by these other companies who may focus more on operations than science, or more on science than process, or larger multi-industry organizations for whom life science is one of the many industries being serviced.
Download the SPO whitepaper at www.sciformix.com/spo.

Marketing & Promotion
FTC Concerned about Increase in “Sponsored Content”
The blurring of advertising and editorial content, particularly through publishers’ websites and mobile applications, is in the spotlight at the Federal Trade Commission (FTC) as government regulators struggle to deal with the impact of social media on health-related promotion. Jill Wechsler reports
...Read more

Pharmaceutical Executive editorial staff proudly introduces PharmExec TV, their latest high quality pertinent content in a brand new industry-breaking format.Tune In Now.

Video
How Will CMS Handle Public Access to Pharma Data?
Dr. Shantanu Agrawal, director of data sharing & partnership group and the medical director for the center for program integrity at CMS on the Physician Payment Sunshine Act speaks with PharmExec TV about pharma's data
...View here

Improving Clinical Trial Management with cloud-based eTMF
LIVE WEBINAR: Tuesday 8th October, 2013 10:00 am GMT
Register Free at: www.pharmexec.com/etmf

Clinical Trials
Enhancing Racial Diversity in Clinical Trials
A new FDA report analyzing clinical trial subject demographic subgroups found that racial underrepresentation is prominent: trial participants are predominantly white and minorities, such as African Americans and Asians, are excluded. But diversity in clinical trials is important, writes Moe Alsumidaie
...Read more

New eBook
The Best of the Successful Product Manager's Handbook Volume IV
In the fourth volume of this four-volume set from the pages of Pharmaceutical Executive, you'll arm yourself with information and expert accounts to fortify your marketing plans against both the unexpected and the inevitable
...Read more

//Ethan Knowlden, formerly VP of Business Development and Licensing at Novartis Vaccines and Diagnostics, joined Complete Genomics (Mountain View, CA) as Senior VP, General Counsel.//Tenex Health (Lake Forest, CA) announced that it Chief Financial Officer, Dr Rom Papadopoulos will be resigning as CFO and a member of the Board of Directors as of September 30, 2013. Dr Papadopoulos will be returning to his position as Managing Director of merchant banking firm Intuitus Group.//

October 2–4: How To Increase Patient Compliance, Improve Health Outcomes, & Lower Costs Through The Latest Digital Strategies
New York, NY.


October 14­–16: Healthcare Informatics session, Inaugural Strategic Business Exchange
San Antonio, TX.


November 13–15: 2013 HBA Leadership Conference
Boston, MA.


 
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