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Pharmaceutical companies’ policies on access to trial data, results, and methods: audit study

From www.bmj.com

Objectives  To identify the policies of major pharmaceutical companies on transparency of trials, to extract structured data detailing each companies’ commitments, and to assess concordance with ethical and professional guidance.

Design  Structured audit.

Setting  Pharmaceutical companies, worldwide.

Participants  42 pharmaceutical companies.

Main outcome measures  Companies’ commitments on sharing summary results, clinical study reports (CSRs), individual patient data (IPD), and trial registration, for prospective and retrospective trials.

Results  Policies were highly variable. Of 23 companies eligible from the top 25 companies by revenue, 21 (91%) committed to register all trials and 22 (96%) committed to share summary results; however, policies commonly lacked timelines for disclosure, and trials on unlicensed medicines and off-label uses were only included in six (26%). 17 companies (74%) committed to share the summary results of past trials. The median start date for this commitment was 2005. 22 companies (96%) had a policy on sharing CSRs, mostly on request: two committed to share only synopses and only two policies included unlicensed treatments. 22 companies (96%) had a policy to share IPD; 14 included phase IV trials (one included trials on unlicensed medicines and off-label uses). Policies in the exploratory group of smaller companies made fewer transparency commitments. Two companies fell short of industry body commitments on registration, three on summary results. Examples of contradictory and ambiguous language were documented and summarised by theme. 23/42 companies (55%) responded to feedback; 7/1806 scored policy elements were revised in light of feedback from companies (0.4%). Several companies committed to changing policy; some made changes immediately.

Conclusions  The commitments made by companies to transparency of trials were highly variable. Other than journal submission for all trials within 12 months, all elements of best practice were met by at least one company, showing that these commitments are realistic targets.
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AstraZeneca lance le dispositif médical connecté Turbu+

From buzz-esante.fr

Le laboratoire AstraZeneca lance un nouveau dispositif médical connecté pour suivre le traitement de l’asthme : Turbu+. Découverte.
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Stop talking digital and start thinking patients

From worldofdtcmarketing.com

KEY TAKEAWAY: Digital marketing is not a bunch of tactics, but rather a way to think about how patients are making healthcare decisions.  
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Pharma and the Connected Patient: A patient’s view - Health Solutions

From blogs.deloitte.co.uk

Last month we published our report ‘Pharma and the connected patient: How digital technology is enabling patient centricity’, which looks at the ways pharma is utilising digital technologies to place the patient at the centre of new business and operating models. To support the report, we commissioned primary research from PatientView, a UK-based research company specialising in obtaining perspectives from patient groups across the world. PatientView surveyed patient groups, on our behalf, on their views regarding the use of health apps, including those produced or developed by pharma companies. A mix of 10 multiple-choice and open-ended questions were asked, to which 190 patient groups, representing 56 therapy areas from 38 countries, responded. This week’s blog, by Amen Sanghera, one of our two analysts here at the Centre, takes a deeper look into the findings from the survey.
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Medicine of the future: New microchip technology could be used to track ‘smart pills’ 

From electroiq.com

Caltech researchers have developed microscale devices that relay their location in the body.
Richard Platt's curator insight, Today, 12:20 AM

Called ATOMS, which is short for addressable transmitters operated as magnetic spins, the new silicon-chip devices borrow from the principles of magnetic resonance imaging (MRI), in which the location of atoms in a patient’s body is determined using magnetic fields. The microdevices would also be located in the body using magnetic fields–but rather than relying on the body’s atoms, the chips contain a set of integrated sensors, resonators, and wireless transmission technology that would allow them to mimic the magnetic resonance properties of atoms.

Hack’Tion : Hackathon en cancérologie par Amgen

From buzz-esante.fr

Pour relever le défi de la communication patients-soignants en cancérologie, le laboratoire Amgen lance son premier Hackathon : Hack’tion contre le Cancer !
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How to achieve successful HCP behaviour change

From www.wearecouch.com

The application of existing and new theories, translating theory into real-world solutions, is key to sustainable HCP behaviour change.
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Web mobile : les erreurs fréquentes à éviter

From www.1and1.fr

Il existe de nombreuses sources d’erreurs potentielles lors de la création d’un site Internet mobile. Voici les erreurs courantes dans le Web mobile.
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MAJ septembre 2017 de mon Mapping des services et sites d’informations pour le grand public et les médecins

From lemondedelaesante.wordpress.com

Via ce blog « Le monde de la e-santé », accédez à mon mapping comportant à ce jour 510 références digitales concernant la e-santé. C’est un outil incontournable pour découvrir les sites web, applications mobiles, serious games, sites communautaires, web TV… réalisés par les divers acteurs de la santé au profit des professionnels de santé…
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Hack'tion contre le cancer : un  #hackathon pour améliorer la prise en charge et le parcours patient en #oncologie par @amgenFrance #hcsmeufr #hacktioncontrelecancer

From hacktion-contre-le-cancer.bemyapp.com

48h pour relever le défi de la communication patients/soignants

 

Développer des outils digitaux pour faire en sorte que les patients atteints de cancer, hospitalisés, en ambulatoire ou pris en charge à domicile, puissent être continuellement accompagnés, rassurés et suivis par le corps médical, sans redondance ni oubli.

Lionel Reichardt / le Pharmageek:

Hack'tion contre le cancer : un  #hackathon pour améliorer la prise en charge et le parcours patient en #oncologie par @amgenFrance #hcsmeufr #hacktioncontrelecancer

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Novartis looks outside pharma for digital transformation - PMLiVE

From www.pmlive.com

Appoints former Sainsbury's Argos executive Bertrand Bodson
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Infographie : les pharmaciens et internet 

From pharmagest.com

Usages, équipements, sites internet, réseaux sociaux, formations en ligne… dans notre ère du tout numérique, où se situe le pharmacien ? Quels sont les avantages pour lui d’être connecté ? Sur quelle partie est-il en retard ? Petit tour d’horizon en chiffres ...

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Médicaments : la Cour des Comptes propose une révision des prix tous les 5 ans

From www.pourquoidocteur.fr

Les Sages de la rue Cambon estiment qu'une meilleure maîtrise des dépenses de santé passe, notamment, par une négociation plus stricte des prix des médicaments. 
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Deep Dive: Future Pharma July 2017

From deep-dive.pharmaphorum.com

It was back in 1993, while I was studying to become a doctor, that I first dreamed of how computer science would transform medicine. At that time, ‘digital’ was in its early days, with the internet only just emerging and the appearance of social media still a decade away, but already I saw the potential for digital to radically disrupt healthcare.

 

Today, over 20 years later, I think we are finally reaching the point of ‘healthcare convergence’, where digital technology and traditional medicine combine in a way that will forever change the way we manage health. This convergence has enormous implications and opportunities for the life sciences industry.

To understand why and how this industry – comprising the major global pharmaceutical, consumer health, medical devices and diagnostics companies – needs to adapt, we first need to explore the stages of digital disruption that have led to this point.

 
 
1. Information democratisation

The first stage of digital disruption, which began in the 1990s with the internet and early health-related websites and forums, was the democratisation of information. As online information and discussion around diseases and medical interventions became widely available, patients were no longer dependent on their doctors to provide the facts, and healthcare providers were no longer dependent on commercial companies and infrequent meetings with their peers for evidence on interventions. Medical information was now in the hands of the masses and it disrupted traditional models of sales, marketing and communication.

 

During this stage, a new wave of health companies sprang up building digital communities for patients, caregivers and medical professionals, such as PatientsLikeMe, Inspire, HealthUnlocked, Sermo and Doximity.

 
 
2. Beyond the pill

The next step on the road to healthcare convergence was the era of ‘beyond the pill’ services. As life sciences companies reacted to information democratisation, they also realised the power of providing direct support in ensuring their interventions delivered value to healthcare systems. This evolution has, of course, also been powered by the concurrent increasing concentration on ‘outcomes’ and ‘cost-effectiveness’ over simple clinical efficacy, safety and quality.

Today, going beyond the pill has seen traditional commercial players focus on websites, apps, social media, chatbots, and so on, as ways of providing information and support to ensure patients understand their conditions and take medicines as prescribed. Alongside this, a whole new sector of digital agencies has been born to support this evolution, alongside specialist ‘out-of-the-box’ communication tools like Videum.

 
 
 
3. Digital epidemiology

Data, data everywhere, but not a drop of insight? This is no longer the case in healthcare as the third wave of digital disruption accompanied the exponential growth in real-world data. A new field of digital epidemiology has emerged, with mobile applications that have the power to tap into real-world, real-time insights into the state of our health and how we are managing medical conditions.

 

We have known for some time that there is a gap between clinical studies, which measure the efficacy and safety of an intervention in a broad, largely homogenous population, and its real-world impact on an individual patient with potentially very different characteristics. Now, we have the tools to track those individual patient characteristics – understanding individual patients to a level previously not possible. At the macro level, this ‘digital epidemiology’ is reshaping our understanding of specific conditions, but at a micro level it is helping us to tailor interventions on a very personal basis.

 

For an example of digital disruption in this space, look no further than diabetes technology company MySugr, which was only recently acquired by Roche Pharmaceuticals. With its real-time tracking of over 1 million diabetes patients it not only delivered immense levels of real-world data, but could also intervene ahead of a dangerous episode for an individual patient due to digital early-warning signs.

 
 
 
4. Digital therapeutics

But digital disruption has not stopped with the real-world, real-time data revolution. Technology is emerging that can go beyond helping to tailor individual traditional interventions, and potentially replace them. Early digital diagnosis, which is possible through digital epidemiology, can avert the need for downstream medicines, at least in the short term, but technology is also now competing with traditional medicines and devices in certain areas.

While this stage of disruption is still the most nascent, for a good example of a digital medicine, consider the ‘treatment’ for tinnitus, Tinnitracks, by German startup Sonormed. By eliminating the specific frequency for an individual patient’s tinnitus from their iPhone music collection, this software-based application controls the condition simply through playing their favourite songs, negating the need for older, device-based interventions.

 
The future of healthcare convergence

So, what does all of this mean for traditional healthcare players – pharma, consumer health, devices and diagnostics companies? Will they go the same way as Blockbuster video or Kodak in the face of this digital revolution?

 

Not if they embrace healthcare convergence and work with this disruption!

 

The technology companies, which are driving this change, need the years of experience, understanding, commercial knowledge and reach of these traditional companies. Likewise, these traditional players need to embrace the innovation brought by new technologies, as they cannot acquire or build this expertise quickly enough internally.

The smart companies are therefore building digital innovation and incubation groups, designed to tap into this new ecosystem of health technology startups – to engage with them, mentor them, invest in them and work in synergy for mutual benefit. Consider the recent work by Bayer with its Grants4Apps programme, or Sandoz with its SandozHACk initiative, as good examples of this evolution.   

 

The age of healthcare convergence is here and it has brought two of my great passions – and two great sectors of industry – together: medicine and technology. Our health will be all the better for it.

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How pharma and patient advocacy groups can become in sync

From www.linkedin.com

At next month’s Patient Summit Europe (19-20 October, London) find out how you can be more than a trusted partner – get yourself on the same side as your patients, and deliver sophisticated advocacy that fights their cause.

Patient advocacy groups and pharma companies have the same ultimate goal – better health outcomes – but managing these relationships needs care on both sides.

To give you an insight into the level of discussion you can expect at the summit, we spoke with:
- Nisith Kumar, Director, Global Patient Affairs, Pfizer
- Ann Kwong, Founder and CEO, TREK Therapeutics
- Lynn Bartnicki, Patient advocate, Living Beyond Breast Cancer

Read the article ‘Dancing to the same tune?’ here: https://goo.gl/hgVVms
Kind regards,
Cintia Hernandez Marco

rob halkes's curator insight, September 13, 8:27 AM

“Some drug companies are really focused on patients, and some don’t have a clue.” Lynn Bartnicki, patient advocate

- a quote from the report of Eyeforpharma.

Good to see some words from pharma and patient advocates published.

Even better to follow and read one of the many publications about the pharma and patient groups' relations: a trying but difficult engagement

You can look at the patient perspective in "pharma corporate reputations",

or overviews of the patient movement. A study about pharma and the connected patient. And above all: check your own credibility as a pharma company in the eyes of patients: your bespoke data on your company, for its different affiliations and therapy areas, based on 6 years of global data on corporate reputation in the perspective of patients and patient groups.

rob halkes's curator insight, September 13, 8:41 AM

“Some drug companies are really focused on patients, and some don’t have a clue.” Lynn Bartnicki, patient advocate

- a quote from the report of Eyeforpharma.

Good to see some words from pharma and patient advocates published.

Even better to follow and read one of the many publications about the pharma and patient groups' relations: a trying but difficult engagement

You can look at the patient perspective in "pharma corporate reputations", or at overviews of the patient movement. 

A study about pharma and the connected patient. And above all: check your own credibility as a pharma company in the eyes of patients: your bespoke data on your company, for its different affiliations and therapy areas, based on 6 years of global data on corporate reputation in the perspective of patients and patient groups.

Big Pharma Can't Figure Out Social Media, and the FDA Isn't Helping

From motherboard.vice.com

Pharmaceutical companies are finding that the best—or at least safest—route to take with social media is to just ignore it. Given the a so-far unadapted FDA regulatory scheme for communication via things like Twitter and YouTube comments, rules for how drug companies can and can't interact with consumers online have remained prohibitively vague.

If a patient posts something online, like "this drug made my face turn into a giant boil," does it count as the sort of adverse event that pharmaceutical companies are required to report to the FDA? Historically, an adverse event is an adverse event, but the word-barf of social media makes this a murky proposition. If that's an adverse event, then what are the responsibilities of the drug manufacturer in tracking those events, which might pop up in any number of places online, from obscure message-boards to an @-tweet to, indeed, a YouTube comment?

It's nice to imagine a system, likely administered by the FDA, for mining comments like that, but in the meantime this is yet another online Wild West. Believe it or not, drug companies are in fact capable of playing it safe, especially when it comes to regulation, and so just about 50 percent of all pharmaceutical companies are choosing to sit social media out. This is according to a report published in Nature Biotechnology outlining a state of confusion that's hampering Big Pharma's marketing efforts, sure, but also repressing information that could prove to be critical in assessing the ongoing safety and efficacy of drugs, from clinical trials to the marketplace.

There are two broad categories of problems. One has to do with trials, which can drag out for extended periods of time in which supposedly blind trial subjects are free to post and read whatever they want online. And they do. In 2014, a trial for a drug designed to treat amyotrophic lateral sclerosis was effectively nuked as subjects described their symptoms on the forums of PatientsLikeMe, revealing who had and who hadn't received the experimental drug. The study was then no longer blind, with 27 percent of trial participants active on the same site.

Health is a hyperactive topic within social media

The second category is what's known as "pharmacovigilance," a guiding force in pharmaceutical research and manufacturing since the 1961 thalidomide disaster. It is what it sounds like: Essentially, it's the science of adverse reactions. Some of this information is provided to drug companies through pharmacovigilance agreements with doctors and patients or "spontaneous" reports, while some comes from research, the media, and regulators themselves. Theoretically, adverse event reporting comes from anywhere, and in most countries, drug companies are required to submit this information to regulators.

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It's a data quandary then. Health is a hyperactive topic within social media, as anyone that's spent much time on illness-related forums can attest, and so it should be a golden age of adverse event reporting. But how to actually do that and when to stop is an ugly science. How are social media comments to be weighed? What sources count as quality data? What's to keep an anti-vaccine brigade from trying to sink a safe, life saving drug?

"With social media, anybody can publicly complain in just 140 characters," the Nature report frets. "It's not yet clear under what circumstances companies are supposed to be monitoring these reports, so many of them are choosing the simplest option: ignore."

But ignorance really shouldn't be an option when it comes to adverse event monitoring, particularly if it's intentional ignorance. So what now? The FDA will be coming out with updated guidelines at some point TBD—it published some "vague and overbearing" preliminary guidance in 2014—but the issue really shouldn't be of what on social media drug companies are allowed to ignore so much as what the FDA can do to net as many possible social media comments about potentially dangerous pharmaceuticals. It could be a golden age, or it could be Big Pharma business as usual.

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Médicament, une filière industrielle que la France n’attire plus

From www.egora.fr

L’industrie du médicament est une filière prometteuse, tant les besoins de santé à l’échelle de la planète restent gigantesque
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Abbott recall signals new era in medical-device cybersecurity

From www.chicagobusiness.com

Visit Crain's Chicago Business for complete business news and analysis including healthcare, real estate, manufacturing, government, sports and more.
Florian Morandeau's curator insight, September 13, 5:30 PM

Cybersecurity issues in medical devices are now a point of concern for devicemakers and the FDA.

The Pharma Digital Health Accelerator Club: Companies Leading the Way Implementing Disruptive Innovations

From www.news.pharma-mkting.com

According to Fard Johnmar, founder and president of Enspektos, pharmaceutical executives are flooded with digital health opportunities and executives and leaders at these firms are having trouble triaging these innovations to determine which ones will meet key organizational, business and health goals.

 

Nevertheless, many drug and device companies are establishing internal innovation groups that are responsible for locating, developing and supporting the integration of digital health technologies into their operations. These companies are form an exclusive "Pharma Digital Health Accelerator Club."

 

This article features several examples of what the pharmaceutical industry is doing to implement disruptive digital innovations that help them manage clinical trials, improve their products, and support healthcare professionals and patients.

 

Contents (partial list):

  • Opportunities & Obstacles for Pharma's Use of IoT
  • Novo Nordisk Develops Remote Digital Glucose Monitoring Tools
  • Top Pharma Companies Establish HCP Technology Standards
  • Apple Tightens Health App Rules
  • JNJ Innovation Aim: Develop Breakthrough Medical Devices
  • Takeda Awards $35K to Digital Startup App for Depression
  • JNJ Expands Membership in Digital Innovation Club
  • Takeda Joins Pharma Digital Innovation Club
  • Important Digital Health Incubators in Europe
  • GSK & MIT Test Flumoji - An App That May Provide RWE
  • Pfizer Shuns "Next Shiny Thing" When Developing mHealth Apps
  • The Potential of Apple's ResearchKit in Clinical Trials
  • Google & GSK Team Up to Launch "Bioelectronics Medicine"

 

Download the PDF here.

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GSK and Novartis lead at PM Society Digital Awards

From www.pmlive.com

GlaxoSmithKline and Novartis made their mark at last night’s 2017 PM Society Digital Awards in London last night, each picking up two golds at the ceremony.

GSK’s My PAH mobile app by the EarthWorks and its ERS meeting by ebee Health were rewarded, as were Novartis’ COPD life is calling by Health Unlimited and the HACk – Healthcare Access Challenge by its Sandoz unit.

Bayer, MSD and Teva all picked up a gold each, for work that included multichannel work in hypogonadism and budget modelling in antifungal prophylaxis.

GSK - alongside partner agency The Earth Works - was also acknowledged for its work on the MyAsthmaApp, which received one of two new Inspiration Awards.

HealthiQ picked up the other Inspiration Award on offer for its ‘ground-breaking’ approach to the diagnosis of children with ultra-orphan metabolic disease MPS I.
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Festival de la Communication Santé 2017 : inscrivez-vous ! - Le Club Digital Santé, partenaire du #Fcsanté

From club-digital-sante.info

La 28ème édition du Festival de la Communication Santé se déroulera les 24 & 25 novembre 2017 à Deauville. Un évènement dont le Club Digital Santé est partenaire. Chaque année depuis 28 ans, le Festival de la Communication Santé récompense les meilleures communications santé. Il a pour mission de mettre en lumière les communications numériques…
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The Global Digital Marketing Gap · Forrester

From go.forrester.com

Husson: Over the past few years, I was lucky enough to travel to many different places: in most European countries, in the US, in Brazil, in the Middle East, in India, in Indonesia or very recently in Japan and Thailand. The digital revolution is happening all over the place and it is fascinating to see how it is changing people’s habits. In particular, mobile is a game changer in most economies and this will only accelerate. (..)

Significant economic, political, and technology trends will strain global digital strategies further by elevating the importance of local relevance. Over the next few years, we expect the following trends:

  • Geopolitical shifts drive global fragmentation..
  • Empowered consumers seek brands who reflect their local values (..)
  • Innovative local competitors emerge (..)
  • Mobile’s primacy forces a re-evaluation of local offline marketing(..)
  • Rise of conversational interfaces reward local knowledge. (...)

 

To close this capability gap, marketers must evolve their cultural mindset, adapt their organization to share more responsibilities with local teams, implement an insights-driven approach to personalize experiences, and upgrade their global technology infrastructure.

rob halkes's curator insight, September 12, 5:57 AM

Unexpected(?) trend in Engaging global brands with local customers/users. Thomas Hudson: ".. counter intuitively, digital complicates global marketing... digital increases customer expectations for relevance, giving local brands the edge. Such competition exposes global brands’ digital marketing gap, forcing them to localize their digital approach." I gathered this before for Pharma companies: Pharma needs to differentiate to local! See https://lnkd.in/gqb86hV - and here: https://lnkd.in/eDMsDdr .

 

B. Braun lance le Hack A Fond' au service des enfants malades

From buzz-esante.fr

Pour la 5ème édition de son Prix, la Fondation d’entreprise B. Braun lance le premier « Hack A Fond’ » au service des enfants malades.
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Bayer Unveils Latest Funding for Digital Health Start-ups

From pharmaphorum.com

The digital health start-ups selected for funding via Bayer’s Grants4Apps Accelerator programme have been revealed.

The Grants4Apps programme has been running since 2014, making it one of pharma’s most well-established digital health funds.

This year the scheme will foster four start-ups focused on medical adherence, endometriosis, atrial fibrillation, deep vein thrombosis, and ultrasound diagnostics by providing mentoring and 50,000 Euros in funding.

Those selected include London-based firm aparito which combines wearable technology, an app and a dashboard for professionals to transform data capture during clinical trials.

Aparito’s tech has been used in rare disease and oncological trials in the past.

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FDA clears Adherium's third inhaler sensor, for AstraZeneca's Symbicort inhaler

From www.mobihealthnews.com

Melbourne, Australia-based Adherium, a digital health company that focuses in improving medication adherence and patient outcomes, has just received FDA clearance for a new inhaler monitoring device for AstraZeneca’s Symbicort aerosol inhaler, dubbed the SmartTouch for Symbicort.  
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