Les 4 grandes mutations subies par l'industrie pharmaceutique : Evolution de la promotion auprès des prescripteurs : nous passons d'un modèle quantitatif (visite médicale intense) à un modèle plus ciblé, pertinent, ...
New communications technology has the potential to both disrupt and enhance the pharmaceutical industry, but research shows that pharma often needs to up its game when it comes to the adoption of new technologies.
Mobile devices have transformed how we access and consume content, and are poised to make similarly huge changes to the way consider our health (read “The mHealth App Market is at the Saturation Point”; http://sco.lt/5thWGv). mHealth revenue is projected to reach 26 billion by 2017, and the number of health apps has doubled in just the past two years. Social is also likely to have a major impact in the way that pharma communicates in the coming years. 52% of physician’s surveyed by Deloitte in this research expressed interest in communicating with pharma companies via social media.
However, pharma currently lags behind other verticals for using social media. Pharma spending on digital advertising is far below that of other industries, and it still conducts most of it’s communications with physicians via traditional channels. There is big potential for new communications technology to make the pharmaceutical industry more efficient and more engaged with it’s customers. This infographic from Deloitte shows the potential for new digital technology to allow pharma to market itself more effectively.
A growing number of people turn to the Internet for information on healthcare. More and more of them also use social media—like Twitter and Facebook—to share their personal experiences—whether it’s rating their healthcare provider or discussing their medicines.
Understanding the benefits and risks of medicine from a patient’s point of view is important to the evaluation of our medicines.
"We need to hear from patients about their experiences with our medicines,” says Dr. Murray Stewart, Chief Medical Officer for GSK, who is charged with looking out for patient health and safety when it comes to GSK’s medicines. “Social media presents an opportunity to listen in a much more immediate and direct way than we’ve used in the past.”
We set out recently to find new ways to tap into the information patients share about their ‘real-world’ experience with our medicines.Real-time safety data
With the help of digital experts from outside GSK, we began to analyze publicly available internet posts, filtering out unrelated information and anything that would identify individuals to GSK.
In a 2-year period, we found approximately 22 million Twitter and Facebook posts discussing potential adverse events for 1,000 medicines. Compare this figure to the 8.6 million adverse event reports received by the U.S. Food and Drug Administration’s Adverse Event Reporting System (FAERS) since 1968, and the size of the challenge becomes clear.Real-time benefits data
An additional evaluation of 15 medicines showed that 26% of posts also mentioned the benefits of taking the medicine and useful information around how long a medicine took to work, how long the effects last, and how it compared to other treatment options.
Monitoring social media when one of our inhaled allergy medicines became available over the counter was also hugely helpful. The feedback enabled us to understand how well the product worked for patients when their healthcare professionals were no longer involved in choosing the medicine or giving instructions on dosing.Protecting patients through social listening
Social media posts have also helped us to evaluate and characterise abuse of a medicine, for example reports of crushing tablets that were meant to be swallowed and then consuming them in other ways such as by injection or inhalation. Being aware of common misuse of treatments helps us to make decisions on appropriate labeling and further guidance.More opportunities to explore
While we’ve come a long way in our use of social media, there is still a lot of work to do to fully understand the strengths and weaknesses of this data and to establish best practices. For example, we are working to create automated tools that can sort through very large volumes of information and identify urgent issues so they are addressed quickly.
We believe people will continue to use social media to share their experiences with medications. By paying attention to comments -- whether they are about the benefits or about potential drawbacks – social media can help us to understand the full context of patient experiences. We’re excited by the potential of social media to improve our patient care and we can’t wait to see where it may take us next.
Johnson & Johnson Innovation LLC (JJI) today announced the creation of the Center for Device Innovation at Texas Medical Center (CDI @ TMC), a broad, new collaboration between JJI and TMC that aims to accelerate end-to-end development of breakthrough medical devices. This expands on JJI’s collaboration with TMC established earlier this year with the opening of JLABS @ TMC, combining the resources of the world’s largest medical complex with the capabilities of the Johnson & Johnson Medical Devices Companies*, to advance the health and well-being of people around the globe.
The CDI @ TMC will include multiple components that will accelerate the development of new medical technologies from concept through commercialization, including a new medical device engineering studio housed at the TMC Innovation Institute. This state-of-the-art “maker space” will be home to R&D staff of the Johnson & Johnson Medical Devices Companies and will be used to accelerate both select internal projects and strategically aligned ventures of JJI partner companies.
Science 37, which connects willing individuals to researchers so they can participate in trials from their homes, has raised $31 million in Series B funding. Previously, the company raised $6.5 million.The round was led by Redmile Group, with participation from Lux Capital and Sanofi Genzyme BioVentures, the latter of which will also provide Science 37 with technical and strategic guidance. The funding will be used to help the company further develop its technology and continue to expand into new therapeutic areas.
Celgene is planning to use Apple's ResearchKit framework for an observational study into the burden of chronic anaemia in two blood disorders.
Working on the project with biomedical research organisation Sage Bionetworks, Celgene aims to collect difficult-to-quantify data in myelodysplastic syndromes and beta-thalassemia.
The partners' mobile study will also collect neurological assessments of patients using cognitive testing software from BrainBaseline, technology that allows self-assessment of cognitive performance.
Celgene said its app would additionally support patients living with their disease and allow them to understand their physical functioning and other symptoms of anaemia.
Michael Pehl, president of hematology and oncology for Celgene, said: "We stand at a point where technology is unlocking the ability to capture patient reported outcomes.
"Through our collaboration with Sage Bionetworks and the evolving capability of smartphones and wearables as robust data collection devices, we believe we will be able to provide important new insights for patients with MDS and beta-thalassemia."
Myelodysplastic syndromes and beta-thalassemia typically have clinical endpoints outside traditional measures.
The project will see Celgene and Sage work with patient groups the MDS Foundation and Cooleys Anemia Foundation on defining the right elements for the mobile app to capture in order to ensure it is relevant for patients.
The FDA has entered into the federal register a new draft guidance pertaining to "software as a medical device" (SaMD). The guidance is presented as representing the FDA's current thinking on establishing clinical evaluation guidelines for SaMD, but is written by an international organization of device regulators, the International Medical Device Regulators Forum, of which FDA is a member.
The guidance seeks to articulate what's new and different about SaMD (a category which would include mobile medical apps) and provide a stratified guidance on how to regulate different kinds of software and what kind of evidence is needed for each regulatory category. The guidance stratifies devices on two axes: whether the device informs care, drives care, or treats/diagnoses and whether the condition in question is non-serious, serious, or critical. So software that treats or diagnoses a critical condition is in the highest risk category, while software that informs care about a non-serious condition is in the lowest.
The guidelines also call out and address the fact that software development tends to move faster than traditional medical device development and can more easily be influenced by postmarket data.
"SaMD ... is unique in that it operates in a complex highly connected-interactive socio-technical environment in which frequent changes and modifications can be implemented more quickly and efficiently," the guidance says. "Development of SaMD is also heavily influenced by new entrants unfamiliar with medical device regulations and terminology developing a broad spectrum of applications."