Author Archive

Kevin
Walsh

ePharma Summit Recap

Wednesday, February 17th, 2010

Thanks to all the presenters who braved “Snowmaggedon” to present at this year’s ePharma Summit in Pennsylvania.    

There were a lot of interesting presentations including some highlights from @skypen on his recent FDA interview with DDMAC’s Dr. Jean-Ah Kang. 

Of particular interest to me, since we are actively involved in developing guidelines and training, was the presentation from Mel Halkyard, who discussed the process she manages at Eli Lilly to implement social media guidelines and practices. 

When talking about her learnings from the process, which is almost complete, Mel highlighted several themes:

  • 1. K.I.S.S. (Keep It Simple, Stupid). When talking about personnel guidelines, it is important that everyone understands what is needed and required.
  • 2. It’s important to ensure that your social media guidelines are in sync with the rest of the personnel policies and procedures you already have in place.
  • 3. It s a good idea to assign ownership so that there is a clear decision tree, and decisions can be made when needed. Ideally, a single point of contact, possibly a Social Media Czar, or an Interdisciplinary Social Media Steering Committee. Also needed is the sponsorship of senior leadership; preferably from someone who also sees the value proposition. (more…)

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Kevin
Walsh

Crowdsourcing for a Cause

Tuesday, February 16th, 2010

I just read an excellent article about crowdsourcing health care solutions by Eliot Van Buskirk at Wired.  The article, titled “Harvard-Based Crowdsource Project Seeks New Diabetes Answers,” describes in great detail a new initiative to crowd source diabetes information with an end goal of curing Type I diabetes.  (Almost 2.4 million people in the US suffer from Type I diabetes.) “Using federal stimulus funding from the National Institutes of Health, Harvard Catalyst has teamed up with InnoCentive to explore whether open innovation and crowd-sourcing can spark new directions, collaborations and research in the healthcare community.”

Congratulations to the National Institutes of Health for funding this and to Harvard’s medical research department for developing this crowdsourced medical initiative sure to help those with Type I diabetes.

What’s particularly interesting about the first phase of this project is the goal of ideation. The project’s initial objective is not to identify a specific cure, but to start with the basic premises that there are questions or criteria that may not have been considered before now. (more…)

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Kevin
Walsh

The FDA Spends $72 million to Speed Up Detection of Monitored Product Problems

Thursday, January 21st, 2010

As reported by CQ Healthbeat News, the FDA has awarded a contract to speed up  the detection of product hazards. In a nutshell, the FDA awards $72 million over five years to Harvard Pilgrim Health Care Inc to develop a scaled down version of the Sentinel System.  The system meets the requirements of a 2007 law intended to strengthen FDA drug safety oversight.

Forget for a moment the Orwellian program name “the Sentinel System”, it’s great to see the FDA moving up the timeline in their desire to learn sooner about Adverse Events.  However, I find it surprising that they stopped three quarters of the way and didn’t go right to the source.

With all of the technology available to be on the bleeding edge of potential Adverse Events (AEs) being discussed by e-patients, the FDA has decided to spend $72 million on examining historical data. For the historians among you, my definition of historical is anything that is not a part of today’s conversation.  (more…)

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Kevin
Walsh

Imagine the Power of a Proactive FDA

Thursday, November 5th, 2009

At the most recent Health2.0 conference in San Francisco we heard from Sanjay Koyani who is charged with web design and usability efforts at the FDA.  Prior to joining the FDA Sanjay was in similar roles at both the HHS and the National Cancer Institute.  The FDA has been making a lot of news recently for many things.  Among the most recent newsworthy events involving the FDA, which monitors both food and drug safety issues was a peanut butter recall.  Sanjay’s team did a remarkable job with the dissemination of information to consumers and professionals around the peanut butter recall and the affected products.

Sanjay’s team has become prolific users of Twitter and other social media tools to communicate directly with professionals and the general public.   This has resulted in remarkable results both in terms of the speed with which information is disseminated and that at which the public is educated on an issue.  Equally notable was the effort on the part of many citizens to aid in the dissemination of this information and to “pick up the torch’ on behalf of the FDA in informing and educating citizens.  Social media shows again how it can work at its best for another worthy goal. (more…)

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