PharmExec Blog

European Regulator’s Last Ditch Attempt at Transparency

By Peter O’ Donnell.

The European Medicines Agency is determined to minimize opposition to its next moves on releasing clinical trial data. It announced last week yet another consultation on its plans to publish the results of trials — a policy it initially aimed at introducing from the beginning of this year.

The latest twist in this long-running saga is that the agency will, at the beginning of May, launch “a final round of targeted consultations with key stakeholders on its draft policy on proactive publication of and access to clinical trial data.” Read More »

Posted in Europe, Global, Op-Ed, Regulatory | Tagged , , , , | Leave a comment

Are Drug Ads in Print Journals Still Effective?

If the American public could shed girth as quickly as many medical journals have in recent years, we’d all be a lot healthier.

Collectively, medical journals dropped over 4,200 pages in 2013, as reported by MM&M last month, a direct result of fewer ad buys in the category. Professional marketers have steadily shifted resources into digital channels and other outside-the-book physician engagement activities.

But marketers should think twice about cutting off print journal plays, at least for some physician audiences, according Jaime Hodges, EVP, healthcare, at Phoenix Marketing International. The company has developed an assessment tool that attempts to quantify the “stopping power” of a journal ad, among other things, that can influence a physician’s behavior.

Read More »

Posted in Advertising, Agency Insight, Marketing, Sales, Technology | Tagged , , , | Leave a comment

Stop Paying Lip Service to Patient-Centricity

by Michael Edwards

Pharma has operated the same way for 100 years, but the US healthcare model has changed completely in the last 30 years, for payers, pharmacists, hospitals, and even at the clinician level. These changes necessitate pharma – a traditionally stagnant partner – to change now or further risk having its stubbornness result in a fate that will be dictated by those who have figured out how to reinvent themselves to compete in today’s market. Read More »

Posted in Corporate Responsibility, Guest Blog, leadership, Patient Communication, patient compliance, patient education, People, Strategy | Tagged , , , | Leave a comment

Medicare Payment Data Raises Questions About Drug Costs

Even though the just-released Medicare data on payments to individual doctors doesn’t provide specifics on prescription drug outlays, it opens the door to sharp scrutiny of Medicare reimbursement for medicines delivered in physician offices.

The Centers for Medicare and Medicaid Services (CMS) has released data on payments to some 880,000 health care providers who collectively received $77 billion in Medical Part B fee-for-service payments in 2012. It’s part of the government’s “transparency” campaign to better inform the public and health care entities about spending and costs in the delivery system. The American Medical Association blasted this “data dump” as likely to confuse the public and “destroy careers,” which may be valid complaints as journalists, analysts and plaintiffs’ attorneys begin to troll the data set.

Read More »

Posted in healthcare, Legal, pricing, Regulatory | Tagged , , , | Leave a comment

After Delays, Project DataSphere Rolls Out

An industry and academic data-sharing project went live on Tuesday, nearly a year after the platform was expected to launch. Visitors to the site – no credentials needed – can register and access de-identified clinical data from the comparator arms of nine oncology trials, with more to come.

Screen Shot 2014-04-09 at 3.48.31 PM

Click this image to watch a video about Project DataSphere

Project DataSphere, the newest data transparency and collaboration project with buy-in from several top pharmas and academic medical institutions, is now open for research. The launch delay was attributed to a need to expand the analytical tools available on the website.

The project’s goal is not to reassess clinical data on currently available treatments or failed compounds. Instead, participating organizations are deepening the pool of de-identified cancer patient information, which they hope will lead to more efficient clinical trial protocols, epidemiological studies and ultimately the emergence of new cancer therapies (background here).

Read More »

Posted in Biotech, Corporate Responsibility, Europe, FDA, Global, IP, leadership, Legal, R&D, Strategy, Technology | Tagged , , , , , , , , , | Leave a comment
  • Categories

  • Meta