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The incomparable Mark Senak, author of the EyeonFDA blog and social media enthusiast, offers a gift this holiday season to those of you track social media use by life sciences companies. Mark has assiduously compiled a list of the life sciences companies that use social media and their platforms of choice.

It is a comprehensive list and must have for all of you pharma social media junkies out there!

Happy Holidays!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!!!!

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Over the past five years or so there has been a proliferation of blogs that cover the life sciences industry. While I visit some of them frequently, e.g., Pharmalot, EyeonFDA and PharmaLive,.

I am sure that there are others out there that may be useful. To that end, I came across a blog post on the Health and Life website that listed the top 10 essential pharma news blogs. 

#1 Pharmalot

How can we describe the value Pharmalot provides?

Visiting Pharmalot is something we do daily – we can give no blog or resource a higher compliment.  Ed Silverman has the experience to cut through the news and provide readers with the most important tidbits along with pertinent thoughts.

And for those interested in Pharma, the daily email can be quite valuable.

#2 PharmaGossip

Pharmagossip is recognized for horribly accurate, sharp and incisive analysis.  You can feel the author’s passion and concern for upholding ethical standards in almost any post.

Just don’t read before going to sleep or before discussions on whether man is inherently good or bad.

Pharmagossip is a blog that can change how you think about things while keeping up with important pharma news.

#3 In the Pipeline

What’s wrong with dioxygen difluoride and how accurate are HER2 receptor tests?

Derek Lowe does an excellent job of analyzing drugs, especially those that are in the pipeline and being developed.  He’s the kind of guy who points out flaws in a medication a month before clinical trials reveal it’s a dud.

You can wait for the news to be public knowledge.  Or you can read his blog.

#4 The IN VIVO Blog

When the FDA asks ten nephrologists to review a medication and they all decline, the In Vivo Blog catches it.  This blog is well known for accuracy, quality and overall being an extremely useful read for those trying to keep up with the fast-moving pharmaceutical industry.

Best of all, they have a good sense of humor.

#5 Pharma Marketing Blog

Pharma Marketing blog gives you the expert analysis of John Mack, a man who knows a lot about the marketing tactics Pharma companies use – and constantly learns new things and shares his insight with readers.

Is Pfizer running a bait and switch with its Facebook fan page?  Is Allegran running an inappropriate advertising campaign for Botox?

Find out about these and other issues in marketing related to pharmaceuticals by reading what John Mack has to say.

#6 Drug Discovery Opinion

For people who care about pharmaceuticals, the Drug Discovery Opinion is gold waiting to be discovered.

This blog provides analysis of the technical issues that have tremendous implications for drug discovery, efficacy and marketability.  It explains the fundamental science that drives pharmacology.

Its authors have almost unmatchable credentials. Great read and quite useful.

#7 Pharma Strategy Blog

Which Tyrosine Kinase inhibitor shows the most promise?  What’s going on with Avastin and ovarian cancer?

To get the answer to these, and other important questions, Pharma Strategy Blog is excellently informative.  To get a sense of the value of its posts consider this.

Sally Church, the blog’s author, was responsible for helping launch Gleevec. 

Her expertise and talent shows clearly in her posts.  Pharma Strategy blog is top notch and it gives readers insider knowledge.

#8 The MacGuffin

Not a blog for the light of heart, The MacGuffin is infamous for no-holds barred criticism and analysis.

They see things other people don’t.  And they deliver their thoughts in a combination of colloquial and scientific talk. They might deliver a knock-out analysis of a medication and follow up with an inappropriate photo of a celebrity.

Cocky and clever.  Make sure to check out their analysis of schizophrenia.

#9 Pharma Conduct

This blog keeps an eye on the conduct of pharmaceuticals and the healthcare business.  It is mainly written by Eric Milgram, Ph.D. who has more than 10 years of pharmaceutical experience.

It is an investigative blog that is unafraid to expose corruption.  The formal, analytical training Eric underwent to learn chemical analysis shows through in the high caliber of his posts.

#10 The Science Business

Well written, useful and insightful.  Not as willing to take risks and focus on emerging issues as some others on this list, this blog makes the list because it provides extremely high quality writing on health care issues.

Sadly, BioJobBlog did not make the list. I guess I just have to work a little harder.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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Mark Senak, author of the highly informative and well written Eye on FDA blog, reported today that a recent article that appeared on the American Medical News website suggests that the US Food and Drug Administration (FDA) may be considering regulating mobile apps that contain medical or clinical components. While the agency has yet to officially publish guidance on the use of social media in the life sciences industry, it now appears that FDA may be turning its attention on the development of mobile apps; one of the fastest growing segments of the social media movement.

The reason why FDA is taking notice of mobile apps is because a handful of app developers have sought and received FDA clearance for their mobile apps that—because of clinical components —are considered to be “medical devices.” As many of you may know, medical devices which include band-aids, surgical instruments, heart monitors, cardiovascular stents and diagnostic kits, all must receive marketing approval by the agency before they can be sold in the US. Although the agency yet to craft any guidance for clinical/medical app development, it makes sense that FDA ought to evaluate and regulate these products to insure that they are medically-effective and safe. 

According to the American Medical News article, the first app developer to receive FDA market clearance was AirStrip Technologies in San Antonio, for its AirStrip OB application. The app, which was approved in 2009, allows physicians to monitor mother and newborn remotely during delivery. In February, the FDA granted clearance to MobiUS, an app developed by Mobisante, a medical device company in Redmond, Wash. The app permits viewing of medical images for diagnostic purposes. Mobile MIM, a remote diagnostic imaging tool developed by Cleveland-based MIM Software, was also granted market clearance that month. A number of pharmaceutical companies, most notably Pfizer, have been extremely active in the mobile clinical app development space.

The reason why it makes sense for FDA to regulate certain clinical/medical apps is because physicians will rely on them to make medical decisions. For example, the AirStrip OB mentioned above will ostensibly allow physicians to remotely monitor a mother and neonate during delivery. Consequently, the app, aka device, must be evaluated by the agency to determine whether or not it can be used safely and effectively by physicians during childbirth. In this case, the app is similar to a heart monitor that is used during childbirth. And, like all other medical devices, the heart monitor required FDA clearance to determine its safety and effectiveness, before it could be used in real-life childbirth situations. To that end, the agency has hinted that it will be much more proactive in monitoring this new class of devices.

I have no doubt that many pharmaceutical companies and medical devices manufacturers will not be pleased when they learn that the agency is going to “stick its nose” into mobile app development. Nevertheless, in my opinion, if a mobile app is going to be used in possible “life or death” situation, then it ought to be regulated by FDA—the agency that is legally responsible for regulating these types of products. That said, Eye on FDA’s Mark Senak raises a number of valid and insightful points about FDA and its possible role in mobile app development.

“Related to a possible guidance for apps, there are a lot of questions that need to be answered when considering its development – when is an app a medical app?  When does it require regulation?  Who will pay for the oversight – will there be App Developers User Fee Act (ADUFA?) and if so, what will that do to the price and to access.  Will insurance companies have to cover apps?  And what will the process for approval be – something like a 510(k)?”

Finally, I think that the app developers who proactively approached FDA for guidance abut the clinical apps that they were developing “got it right.” This will get the agency “thinking” about clinical/mobile apps and how they ought to be approved and regulated in the future. In turn, this will provide future app developers with a clear regulatory framework that will guide the development of cost effective, safe and efficacious mobile clinical apps.

Until next time...

Good Luck and Good Job Hunting!!!!!!!

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The life sciences industry is all a-Twitter (sorry) about social media and its implications for future business opportunities. Nevertheless, despite the obvious “upside” of social media, as is always the case in the pharmaceutical industry, most companies don’t want to be the first to do anything innovative or novel (go figure).  

Obviously, there are many risks associated with being first in anything. But, the aversion to being first in the industry to “rock the boat” is more pronounced in the pharmaceutical industry than in most others. That said, companies like Novo Nordisk (the first successful promotional product Twitter campaign), Johnson and Johnson ( the first company to blog) and Boehringer Ingelheim (using Twitter for conversational purposes not just a corporate news feed) at various times, dared to go where no company has gone before with the social media experiment. And, despite the apprehension and almost palpable trepidation exhibited by these companies, no overt consequences have resulted from the bold moves made by these social media pioneers. It now appears that there is another new benchmark for companies involved in the pharmaceutical social media experiment; the first ever sponsored pharma Twitter Chat held by @AstraZenecaUS.

This event was first reported (as far as I can tell) by Mark Senak, the author of the informative EyeonFDA blog and one of the leading pharmaceutical social media watchdogs. The Twitter Chat (under the hash tag #rxsave) was held by @AstraZeneca to discuss with its followers ways in which patients can save money on prescription drugs. While I didn’t participate in this somewhat paradoxical chat —a prescription drug companies discussing ways in which patients may save money on their expensive prescription drugs? —it does demonstrate willingness on AstraZeneca’s part to interact with prospective customers in a meaningful way to help them overcome financial barriers to access to potentially life- altering or-saving prescription drugs!

Although there are still no regulatory guidelines governing the use of social media by life sciences companies, the willingness of @AstraZenecaUS to put itself on the line is very refreshing. In my opinion, it is an important first step to help to “humanize” pharmaceutical companies. Also, it demonstrates a willingness by a pharmaceutical company to provide help to persons who perhaps cannot afford or are struggling to gain access to the prescription drugs that they need!

Hat tip and kudos to @AstraZenecaUS!

Until next time...

Good Luck and Good Job Hunting!!!!!!!!

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Mark Senak, social media enthusiast and author of the EyeonFDA blog, raised the question on his blog today as to whether or not the US Food and Drug Administration (FDA) ought to have a fan page on Facebook: the ever expanding, ubiquitous social media platform. He aptly points out that FDA has already created a channel on YouTube and has a twitter account. So, why not a fan page on Facebook, he asked.

While Mark and I agree on most things, I am not convinced that having an FDA fan page on Facebook would make a difference in the way in which FDA communicates with the American public. FDA is already behind on the social media curve and, as the FDA public hearings held late last year suggest, the agency is struggling with formulating regulatory guidelines for its use by drug and devices manufacturers. Might not creating a FDA fan page on Facebook be the proverbial straw that broke the camel’s (agency) back? 

Perhaps I am overreacting to the whole Facebook phenomenon and grossly under estimating the agency’s capabilities. But I simply don’t get Facebook!  At best, it is overwhelming, difficult to navigate and seemingly cluttered mindless chatter and people engaging in Mafia wars. There is no question that a fan page would increase FDA’s exposure and its “hipness quotient” but to what end? The agency already has trouble maintaining and managing its existing web assets (have you ever tried finding information at FDA.gov?). Adding a new website would simply mean more work for overworked and underpaid government employee who seemingly play by different rules than the outside world.

Don’t get me wrong. I am an avid social media enthusiast who believes that persons who engage in social media must be “all in” to be effective. Having said that, I believe that the agency would be better served if it works to improve the navigability and accessibility to information on its existing web assets. There is no question that building an agency fan page on Facebook may convince Americans that FDA gets “the whole social media thing.” But if the fan page doesn’t provide Americans with relevant and useful scientific, medical and regulatory information, then adding a FDA fan page to Facebook will do little more than increasing the heft of an already bloated social media platform whose utility and effectiveness is already beginning to wane.

In my experience, building a website or fan page is the easy part; continuing to populate the pages and sites with useful, meaningful and temporally-relevant content is the difficult part!

Hat tip to Mark for starting the conversation!

Until next time...

Good Luck and Good Job Hunting!!!!!

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For the past several weeks, the EyeonFDA blog has been reporting on the possible regulatory impact of Google’s Sidewiki on life sciences companies. For those of you who may not be familiar with Sidewiki  (released in late September) it is a new feature of the Google toolbar which can turn a static web 1.0 website into an interactive web 2.0 experience by allowing website visitors to leave comments behind.

When you use side-wiki, you have the ability to leave your comments and associate them with a website whether or not the website owner has enabled commenting.  Since the comments are maintained by Google, there is no direct relationship with the website.  Basically, anybody who visits a website that has Sidewiki enabled can say or comment on whatever they like and immortalize it (until Google removes it) for the entire world to see. Apparently, this doesn’t sit well with many website owners and Google purportedly recently release code to disable Sidewiki at websites that don’t want to support it. However, it isn’t clear how robust the anti-sidewiki code is!

While I haven’t formulated an opinion on Side Wiki yet (mostly because it isn’t that interesting to me), it does represent a regulatory dilemma for life sciences companies with marketed drugs and devices. According to today’s EyeonFDA post “If someone writes of an adverse event on a Sidewiki, or promotes an off-label use, it is now on the company's home page.  Is the company under a duty to monitor and correct such misinformation or if they do, do they incur liability for doing so?  It is a conundrum - and there is no insight apparent from the FDA on the matter.” Further, most life sciences companies have yet to craft a legal or regulatory policy for Sidewiki usage. 

EyeonFDA has been assiduously monitoring life sciences company websites for the appearance of Sidewiki. To date EyeonFDA has found it on the following company websites:

1. Abbott
2. Amgen
3. AstraZeneca
4. Bayer
5. Baxter
6. Bristol-Myers Squibb
7. GSK
8. Johnson & Johnson
9. Lilly
10. Novartis
11. Novo Nordisk
12. Pfizer
13. Roche
14. Sanofi-Aventis
15. Takeda

While Google would like everyone to believe that Sidewiki is taking the Internet by storm and spreading like the H1N1 virus, a show of hands at yesterdays e-Patient Connections 2009 meeting in Philly, which was attended by many computer geeks and social media enthusiasts, revealed that about4 out of about 150 had heard of it! Nevertheless, it is out there and life sciences companies would be well advised to formulate internal legal and regulatory guidelines despite the fact that FDA hasn’t issued any guidance on its use.

P.S. Shortly after I posted this, @pharmaguy alerted me to an article that appeared on the today's online PharmaExec.com entitled "SideWiki: What's Pharma To Do"?

Until next time...

Good Luck and Good Commenting

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