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Pharma Strategic
helping healthcare stakeholders deliver innovative outcomes
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Pharma Marketing Blog: More Mobile Health App Guidance from FDA for Pharma to Worry About

Pharma Marketing Blog: More Mobile Health App Guidance from FDA for Pharma to Worry About | Pharma Strategic | Scoop.it

The more I dig into FDA regulation of mobile health/medical apps, the more I worry that many pharma health apps aimed at consumers may be in FDA's crosshairs.

At first, I thought that PhRMA and other industry spokespeople were engaging in a bit of fear mongering when they suggested that the FDA "will soon require apps such as medication prescription renewal reminders and blood glucose....

Sven Awege's insight:

Great read for any Pharma marketers thinking about Mobile Apps. If you are, then worth reading this article too:

http://pharmastrategic.com/2012/10/11/to-pharma-app-or-not-to-pharma-app-then-theres-the-it-question/

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Strategy: Why Big Pharmas Do What They Do -- And How Silicon Valley Might Help Them Think Differently - Forbes

Strategy: Why Big Pharmas Do What They Do -- And How Silicon Valley Might Help Them Think Differently - Forbes | Pharma Strategic | Scoop.it

Medical product companies that figure out how to embrace and most effectively apply emerging analytic and digital health technologies, and think creatively about new risk-sharing business models, will be best positioned to deliver.

Pharma’s Underlying Challenge

The fundamental problem the industry is wrestling with is this: car companies know how to make a car, soft drink companies know how to make soda, yet drug companies really have no reliable way of knowing where their next products are going to come from, and in a sense, have to start from scratch each time – at least if they want to make radically new, “first-in-class” products that offer unprecedented, dramatically better benefits to patients.

The problem is, these products are incredibly difficult to come by.  Disease remains very complicated, and it’s exceptionally hard to devise a new molecule that durably interferes with a pathological process yet leaves the rest of the body alone; the technical risk, as it’s called, is ridiculously high.

Not surprisingly, strategies that involve tweaking existing products, or reformulating them in a new way (e.g. liquid Ritalin, as Bruce Booth has discussed), remain popular because they at least reduce the technical risk, and may offer an incrementally – and often meaningfully — better option for patients (see here).  However, an increasingly difficult payor environment is likely to make this approach ever more challenging, materially elevating the commercial risk.  Proving an incrementally better product enhances value can be expensive (because it takes many patients to demonstrate a small difference in an active comparator trial), and of course, risky as well.


Via Dinesh Chindarkar
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Healthcare Social Media Review: Which Tools Work Best For Your Patients?

Healthcare Social Media Review: Which Tools Work Best For Your Patients? | Pharma Strategic | Scoop.it
Welcome to the HealthCare Social Media Review, where you'll find all sorts of articles on the intersection of healthcare and social media.  Over the years, we've found social media to be an excelle...

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Franklin Delano Williams's curator insight, March 30, 2013 12:01 AM

KEY POINT FOR CAH's! "... Lonnie Hirsch (@LonnieHirsch, and on Facebook) writes about the correlation between the number of Facebook “likes” a hospital has, and its patient satisfaction and mortality rates.  Basically, the more popular a hospital is on social media (specifically Facebook), the higher its patient satisfaction scores tend to be.  And hospitals with more likes on Facebook even have lower mortality numbers.  Lonnie points out that about half of the hospitals in the US don’t have a Facebook page yet....."

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FDA 101: A guide to the FDA for digital health entrepreneurs

Given pending mobile medical apps guidance from the FDA, Rock Health has developed a guide for digital health entrepreneurs trying to navigate the FDA process.

Defintely a usefull presentation. Congrats to Rock Health !


Via Olivier Janin
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Pharma gets social: world’s top pharma on Facebook

Pharma gets social: world’s top pharma on Facebook | Pharma Strategic | Scoop.it
This article is about the top global pharma company’s use of the social media channel Facebook.

Via Thibaud Guymard
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Article > PatientsLikeMe goes global with trial matching tool

Article > PatientsLikeMe goes global with trial matching tool | Pharma Strategic | Scoop.it

PatientsLikeMe, the US-based online platform for the exchange of health data, has gone global with the clinical-trial matching tool it launched in the network’s home market last year.

 

The free tool, unveiled by PatientsLikeMe research director Paul Wicks at the UK National Health Service’s Healthcare Innovation Expo 2013 in London, draws on open data to match patients from around the globe with clinical trials based on their condition and location.

Sven Awege's insight:

I wonder how open Pharma eyes are about this. Potentially this type of configuration can completely sideline the controlled and promoted clinical trials run by Pharma (and subsequently promoted through the sales reps). Doctors will be able to tap into real-life data to help make decisions.

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Customer experience for pharma companies - PMLiVE

Customer experience for pharma companies - PMLiVE | Pharma Strategic | Scoop.it

The six pillars of customer experience for pharma

Focus your customer experience strategy on a specific subset of customers in a particular locationInvest in one-to-one qualitative studies, instead of focus groups, quantitative studies, and large sample sizesDesign experiences by making new things, testing them with customers, and revising them until they workMeasure what matters, and not what is easy; that means customer experience quality, and its effect on salesEnsure you have the right qualified people in place to make sure your customer experience efforts are not in vainMake it OK to fail, because even the best ideas can turn into failures, which in time become building blocks for success.
Sven Awege's insight:

Absolutely wonderful article, written with true insights and understanding. A must read right across the different functions and teams in Pharma. These guys will probably be snapped up quite quickly with such understanding ;-)

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HealthKeep Social Network Catalogues Your Medical Records

HealthKeep Social Network Catalogues Your Medical Records | Pharma Strategic | Scoop.it
HealthKeep, a health-based social network, is looking to help people organize their patient history with a timeline of symptoms, medications and conditions.

Via Alex Butler
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Everett Hudson's curator insight, April 2, 2013 7:40 AM

This is very interesting and timely as people are becoming more proactive when it comes to health concerns.

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After FDA’s mobile medical apps final guidance, what’s next?

After FDA’s mobile medical apps final guidance, what’s next? | Pharma Strategic | Scoop.it

FDA testified the guidance should be out by October 1 of this year, but I would guess actually it will probably be out by mid-summer. I’m just basing that on the belief that FDA is now highly motivated to get the darn thing out.

So what happens then? What are the regulatory issues we in the mobile health arena will need to address after FDA’s guidance finally sees the light of day?

Sven Awege's insight:

Great forward thinking article by Bradley Merril Thompson. Excellent read, in preparation of things to come.

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Psoriasis patients flock to social media for practical information

Psoriasis patients flock to social media for practical information | Pharma Strategic | Scoop.it

About eight in 10 psoriasis patients who use health care social networks say they do so primarily to learn how others manage their disease, and get practical tips and advice they couldn’t find elsewhere, according to a survey conducted by the National Psoriasis Foundation, Manhattan Research and Inspire, a company that builds and manages online patient communities.

 

The millions of people with psoriasis, including the one million visitors toTalkPsoriasis in 2012, are not alone in their use of social media for health. A 2011 Pew Research Center study found that one in four Internet users living with a chronic ailment have gone online to find others with similar health concerns.

 

Psoriasis is a chronic, genetic disease of the immune system that causes the skin to crack, itch and bleed, affecting roughly 7.5 million Americans. It is the most common autoimmune disease in the country.

 

 

 


Via Andrew Spong
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Javi T's curator insight, March 21, 2013 3:55 AM

Siempre he dicho que en las comunidades de pacientes, el factor fundamental es el apoyo mutuo, así que dejemos de bombardearles con publicidad y consejos. Apoyemos!!

Ginny Dillon's curator insight, April 24, 2013 1:43 PM

Patients challenged by psoriasis are helping each other online in growing numbers. Now that's progressive!

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A Comprehensive Overview of How Games Help Healthcare in 2013 - GCo

A Comprehensive Overview of How Games Help Healthcare in 2013 - GCo | Pharma Strategic | Scoop.it
People often see games as bad for health but many institutions have been hard at work to make them work for us. Here are 6 ways games can help healthcare

Via Alex Butler
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Birgit Walsh's curator insight, March 22, 2013 4:35 AM
A Comprehensive Overview of How Games Help Healthcare in 2013 #hcsmeu #hcsm
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Samsung previews health app, new trackers with S4 launch | mobihealthnews

Samsung previews health app, new trackers with S4 launch | mobihealthnews | Pharma Strategic | Scoop.it
Sven Awege's insight:

Health is heating up the competition among the top mobile actors. Do you think there will be no impact on Pharma?

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Kentucky primary care provider launches MeVisit after two-year study | mobihealthnews

Kentucky primary care provider launches MeVisit after two-year study | mobihealthnews | Pharma Strategic | Scoop.it

The Glasgow, Kentucky-based primary care doctor discussed how offering his patients online visits and consultations over the phone has helped him mitigate the primary care provider shortage in his area — and how a simple setup like that could help primary care providers meet increasing demands around the country — while cutting costs.

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89% of US physicians would recommend a health app to a patient

89% of US physicians would recommend a health app to a patient | Pharma Strategic | Scoop.it

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Dave Burianek's comment, May 15, 8:45 AM
I think this is interesting.. and as we think about the whole integrated care delivery model, this data and information will play a critical part. Of those practices that Humana will own or be part of in a significant way, I believe we can make this happen. For those docs with small practices, we would need to find the right motivation to have them leverage this info. Do we offer it to them? such as ipads for usage during an office visit? we have to make it simple yet provide the best information so they could provide the best quality of care.
Scott Normandin's comment, May 16, 10:24 PM
the question begs: is/are applications that make access to health care the domain of the younger generation, or as some would content, are applications an additional level of complication to our senior population. Personal experience from the lens of my parents is that "absent" a vetted and universally adopted application that supports a universal view for all, this may by perceived as the "new best new toy" and fade with time. Our seniors; albeit are digital immigrants, working their way into the development of new technologies clumsily, whereas Gen X/Y find the technology adaptable, available and importantly expendable when the next best thing comes available. What defines consumerization: speed of development and release, or the ability to support end users?
Scott Normandin's comment, May 16, 10:24 PM
the question begs: is/are applications that make access to health care the domain of the younger generation, or as some would content, are applications an additional level of complication to our senior population. Personal experience from the lens of my parents is that "absent" a vetted and universally adopted application that supports a universal view for all, this may by perceived as the "new best new toy" and fade with time. Our seniors; albeit are digital immigrants, working their way into the development of new technologies clumsily, whereas Gen X/Y find the technology adaptable, available and importantly expendable when the next best thing comes available. What defines consumerization: speed of development and release, or the ability to support end users?
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Pharma Marketing Blog: DTC Not As Dead As We Thought... But Digital Ad Spending Down One-Third!

Pharma Marketing Blog: DTC Not As Dead As We Thought... But Digital Ad Spending Down One-Third! | Pharma Strategic | Scoop.it

Based on early data from cegedim, it appeared that direct-to-consumer (DTC) ad spending by the pharmaceutical industry declined by 22% in 2012 compared to 2011 (see here). New Neilsen data, however, indicates that the overall decline in DTC spending was only 11-12%.

Sven Awege's insight:

This is a must read to capture the macro dynamics currently hitting our Pharma Marketers. Rich Mayer's comment is spot on - there just isn't the tallent out there doing the hard work of demonstrating value. I'm absolutely convinced the value is there, but if you can't demonstrate it then the old guard will fall back on what they know and love.... expensive TV! 

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Doctors Use Big Data to Improve Cancer Treatments

Doctors Use Big Data to Improve Cancer Treatments | Pharma Strategic | Scoop.it
The American Society of Clinical Oncology is looking to further personalize and improve cancer care by tapping into data from millions of patients around the nation The organization completed the prot...

Via Alex Butler
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The 2013 CMO's Guide To The Social Media Landscape

The 2013 CMO's Guide To The Social Media Landscape | Pharma Strategic | Scoop.it

Our inaugural “CMO’s Guide To The Social Media Landscape,” in 2010, included the top players of the day: Twitter, Facebook, Flickr, LinkedIn, YouTube, Digg, StumbleUpon, Yahoo, Reddit, and Delicious. As the social sphere continued to grow and change, we added a couple more for the 2011 edition: YouTube and Tumblr. Then, with things really heating up, we grew the chart by five for 2012, this time adding Google+, SlideShare, Quora, Instagram, and Pinterest.

So what does 2013’s version look like? Ten, 15, 20, or more entries?

 

Sven Awege's insight:

Great tool for Pharma Marketers - internal lobbying and learning. If you follow this you'll already be asking yourself some of the important questions upstream - bravo to you!

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Rise of the Digital Doctor

Rise of the Digital Doctor | Pharma Strategic | Scoop.it
With the rise of Social Media, we are seeing more and more professionals actively using different paltforms to connect and share. This infographic hig

Via Thibaud Guymard
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A social media manifesto - insights from a former associate commissioner at FDA

Sven Awege's insight:

The Dec. 27, 2011, draft guidance, “Responding to Unsolicited Requests for Off-Label Information About Prescription Drugs and Medical Devices” offers sound counsel but not much in the area of direct guidance. Nevertheless, there are valuable lessons to be learned - if you are willing to read between the numerated lines.

 

The draft guidance doesn’t address many of social media’s (referred to in the document as “emerging electronic media”) regulatory red flags such as adverse events, the question of property owner vs. property user, and a more precise discussion of what “sponsored” means.

 

But the giant regulatory bugaboo, not only of social media but of regulated speech writ large, is off-label communications. So those who are complaining this document isn’t “comprehensive enough” don’t understand what it has to offer. 

...

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Humana and Boehringer Ingelheim Establish Partnership to Promote Population Health

Humana and Boehringer Ingelheim Establish Partnership to Promote Population Health | Pharma Strategic | Scoop.it
LOUISVILLE, Ky.& RIDGEFIELD, Conn.---- Humana Inc., one of the nation’ s leading health and well-being companies, and Boehringer Ingelheim Pharmaceuticals, Inc., a research-based, global pharmaceutical company, today announced a multi-year...
Sven Awege's insight:

Insurance and Pharma working together. Huge potential, I have some reservations though that patients would want to share too much though, with threat of personalized hikes in healthplans! Could be wrong though.

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Design principles for pharma digital strategy | pharmaphorum

Design principles for pharma digital strategy | pharmaphorum | Pharma Strategic | Scoop.it
This article is about parallels between design principles and the strategic challenges for pharma digital strategy.

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David Dellamonica's curator insight, March 27, 2013 4:01 AM

crossroads of technology and liberal arts

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Next: looking beyond the device in digital health

Next: looking beyond the device in digital health | Pharma Strategic | Scoop.it

Observers of the digital health ecosystem seem addicted to the idea that it is accretive when in truth it is commutative.

 

News of the demise of sleep tracker Zeo, theclosure of Google Reader through which many of us have reviewed health news, and the imminent  withdrawal of the best (IMO) version of the best Twitter client through which many health tweet chats have been conducted should hopefully serve to remind us of the transitory nature of digital environments.

 

Personal health data is certainly going to continue to be collected. It will be at the centre of our genome-informed, personalised medical future.

However, we aren’t going to be collecting it via a panoply of trackers, gadgets, wristbands and glasses.

 

We no more want external health peripherals than we do a keyboard for a tablet computer. They are extraneous, inconvenient, and will only be used by health hobbyists.

 

Nor are we ultimately going to want to see that data collected by a smartphone-like device. Mobile devices, whether carried, or viewed via a HUD contact lens, or placed on the back of our hand as a removable skin-like overlay, may be a great way of reviewing data, but in the last instance we don’t want integrated onboard sensors tracking our data for the sole reason that it requires us to remember or desire to continue to collect it, even if the process is passive.

 

This needn’t mean a Matrix-like plug of course, but rather a sensor of whatever sort that merely gathers data.

 

However, not everyone wants to be a cyborg, nor will it be necessary to be one in order to enjoy the long terms health benefits of fully quantifying (and adapting) our health behaviours.

 

Assuming that we don’t all succumb to the beguiling technological singularity, the paradigm will be inverted and the social face of health will be human rather than a mimetic poly-alloy.

 

The future of quantified health will reside in non-invasive sensors that will become as ubiquitous and cheap to use as the bar code, incorporated not only into public spaces but also into products and packaging. Aggregated personal data is Big Data by any other name, and will facilitate the study of health trends and behaviours at a population level.

 

This may sound like science fiction.

 

However, aspects of the transformation of  digital health into a non-invasive sensor-facilitated model are just a few steps down its evolutionary pathway.

 

So let’s look beyond the device-driven quantified self.

 

We’re not still discussing what happened to our Walkman, pocket calculator PDA, diary, Filofax, digital camera, and so on, and nor do we need to talk about how everything that can be integrated into mobile devices will be, because we already know it’s going to happen.

 

There are more interesting questions to ask of the future of digital health, such as....

 


Via Andrew Spong
Sven Awege's insight:

Another mind-challenging post from Andrew. Worth the read.

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Andrew Spong's curator insight, March 16, 2013 3:45 AM

Click on the title link above to read five questions about the future of digital health beyond the device

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Era of mobile health tracking definitively arrives, Samsung Galaxy S4 & accessories focuses on mHealth

Era of mobile health tracking definitively arrives, Samsung Galaxy S4 & accessories focuses on mHealth | Pharma Strategic | Scoop.it
When a company that had over $180 billion in net revenue (more than Apple) for 2012 decides to seriously get into mobile health devices, it's safe to say the age of mobile tracking has definitely arrived.

Via OMP Digital
Sven Awege's insight:

Come on Apple or Microsoft, show us what you've got!

My guess is MS's HealthVault will be packaged into MS solutions within the next year - they have been soft-launching the service again, even in tough markets such as France.

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OMP Digital's curator insight, March 15, 2013 8:02 AM

Samsung’s S Health app is a native app the phone comes with the Samsung Galaxy 4 enabling you to input the calories you consume in a day and a slew of other fitness metrics.

 

As Samsung made over $180 billion in net revenue (more than Apple) for 2012 they have decided to seriously get into mobile health devices, with this it’s safe to say the age of mobile tracking to the consumer has definitely arrived.

Ines Di Loreto's curator insight, March 19, 2013 4:41 AM

The first mobile with built in health applications

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Entreprise numerique panorama 2013 cedhys

Curtain raiser to an association of Pharma & Healthcare CIO's in France on the Digital Enterprise - covers multichannel communications, digital excellence, chan
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Lionel Reichardt / le Pharmageek's curator insight, March 20, 2013 2:46 AM

Intervention de Sven Awege et Lionel Reichardt au Club des Directeurs informatiques de l'industrie pharmaceutique CEDHYS

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Development and Testing of a Multidimensional iPhone Pain Assessment Application for Adolescents with Cancer

Development and Testing of a Multidimensional iPhone Pain Assessment Application for Adolescents with Cancer | Pharma Strategic | Scoop.it
Development and Testing of a Multidimensional iPhone Pain Assessment Application for Adolescents with Cancer
Sven Awege's insight:

Objective: Our (their) objective was to design, develop, and test the usability, feasibility, compliance, and satisfaction of a game-based smartphone pain assessment tool for adolescents with cancer.

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