The life sciences industry is one of the most exciting places to be a globalization professional these days. By tearing a page from technology giants and top consumer brands, life sciences companies are discovering new ways to gather data and establish two-way conversations with patients and medical professionals about their products and the issues they address — all within the bounds of complex industry regulations.
Without knocking the importance of premarketing clinical trials, the amount of data collected in the research and development phase pales in comparison to the data that is potentially available postmarket release. By improving postmarketing surveillance, life sciences companies are on the cusp of a digital revolution in the quality of information they can share with buyers to support the most beneficial outcomes.
Since drugs and medical devices tend to be marketed globally, globalization is the gate for all postmarketing information flowing both upstream and downstream between the organization and global buyers. Let’s explore some of the factors that are spurring life sciences companies to adapt their global communications.
Since the dawn of the internet, buyers in practically every industry have been researching and sharing information about their purchases online, and nowhere is this truer than life sciences. Indeed, the volume of postmarketing medical information available online is growing exponentially.
In fact, in life sciences, some of the most accessible content about any given product is buyer-generated content — where buyers include patients, medical professionals and institutions such as hospitals and insurers.
More than in other industries, life sciences advertising is highly regulated. When it comes to advertising of prescription drugs, for instance, only two countries may actually allow direct-to-consumer (DTC) advertising: the United States and New Zealand. In most countries, this promotion is not allowed, and advertising of nonprescription drugs is regulated and restricted in various ways.
As a result, postmarketing content is omnipresent online — yet only a fraction is under the producer’s direct control. Here are some of the typical examples of producer-controlled and market-controlled content:
Content for patients and medical professionals
Corporate websites and theme-based microsites
Educational materials, including videos and animations
Instructions for use
User generated content (UGC)
Guides and instructions
Clinical evidence, clinical reports
Adverse effects reports
While other industries may respond to buyer reviews by saturating the airwaves with marketing spin, life sciences companies have a public duty to help buyers understand their products — and also to extract meaningful insight from the vast amount of buyer-generated content.
Life sciences embraces
Slowly but steadily, many life sciences companies are augmenting the required dry, jargon-filled content with marketing and social media tactics that consumer brands commonly use to shape conversations with buyers.
The most successful companies try to communicate in a personal, less formal style and language. They adopt the mindset of media companies. After all, health makes for a compelling story, one that lends itself easily to online and social media. Educational disease awareness campaigns, which are non-promotional in nature, have become an acceptable way to start conversations with consumers in the absence of DTC promotion.
Pfizer is a great example of a company that has established a major presence in social media, and a real leader in building theme-specific websites. Let’s consider the case of its campaign, Getting Old (www.getold.com). Without mentioning any specific products, the site (Figure 1) stays focused on the issue and its associated medical conditions in a very social style, free of jargon, in an appealing, light design. A savvy approach to social media, such as the specific Twitter handle #FOGO, for “fear of getting old,” helps to spread the message further. This shows how life sciences companies can massively grow their fan base outside the corporate messaging and online presence.
Patients and physicians today are more connected, more informed and more empowered than ever. They expect life sciences companies to be as accessible as any other type of provider (Figure 2). They expect to interact any time, on any channel they choose. They look for personalized communication, tailored to their needs, and above all, they expect fast, clear answers.
Accenture has recently conducted interesting research looking at which channels patients prefer for receiving information about medicines or medical devices. It is no surprise that the number one spot is occupied by printed information. People trust printed information, and health care is one area where trust matters.
But modern ways of communication — such as social media, mobile apps or live support — are increasingly important to life sciences given the maturing generations of people who have never known life without the internet.
Here are a few examples of new types of companies and platforms that provide new experiences and content to patients and doctors alike:
BlueStar (www.bluestardiabetes.com) is a digital substitute to the traditional forms of treatment, in this case of diabetes type 2. Approved by the FDA, it provides real-time motivational, behavioral and educational coaching. This is designed to help patients self-manage their diabetes treatment plan. This is significant, since diabetes patients are notorious for not always being diligent with their treatment.
The HelpAround app (helparound.co) offers crowdsourcing of medical care. It allows patients — again with diabetes — to share supplies and advice wherever they are. It includes discussion forums and 24/7 access to nurses via a call center. It provides forums to community members where they can ask questions and seek help, for instance if they run out of supplies when traveling.
HealthTap (www.healthtap.com) is another example of crowdsourcing, this time serving health care professionals. This platform allows diabetes patients and other consumers to submit questions to a pool of some 70,000 doctors. There are free and paid subscription levels. Paying subscribers can text or conduct a video conference with a doctor at any time.
SERMO (www.sermo.com) is a dedicated social network for doctors (Figure 3). It allows peer-to-peer discussions and consultations. Only doctors can join and participate and all SERMO’s current 340,000 members are verified doctors.
KevinMD (www.kevinmd.com) is a very popular platform where doctors and other health care professionals publish content that is hugely popular in the online space. This content often serves as reference for others since, statistically, some two thirds of physicians currently access user-generated content for their professional purposes.
Amid growing volumes of multilingual content about medicines, medical devices and medical conditions, regulators began paying attention. The FDA in the United States was among the first to take some action. Currently, this area is regulated primarily for medical devices class II and III.
In January 2014, the FDA issued two relevant guidance documents. Their draft guidance on “interactive promotional media” applies to prescription drugs, but also serves as a reference for medical devices. This guidance specifies that user-generated content on firm-owned or firm-controlled venues is not considered promotional (labeling) as long as the user has no affiliation with the firm and the firm had no influence on the content (with no submission to FDA needed).
The same applies to third party bloggers or managed communities, if companies have no editorial control or oversight over how that content is used. The bottom line is that content a brand produces inside of a real-time channel does not have to be submitted to the FDA before it is deployed inside of a channel.
The other guidance, for “industry internet/social media platforms with character space limitations,” effectively addresses the use of Twitter or online paid search. It provides some no-nonsense guidelines on how life sciences can and should communicate in these media.
surveillance and vigilance
Postmarketing surveillance (the proactive method) and vigilance (the reactive method) are ways of gathering information about any potential adverse effects medicines and medical devices may have after they are made available on the market.
In the Unites States, the FDA tracks some 100,000 adverse events reports a year. Reports are collected in a publicly searchable database, though with variable content and quality. Interestingly, unlike in some other countries, most of these reports originate from manufacturer representatives rather than health care providers.
The electronic reporting of medical device-related adverse effects to the FDA comes into effect on August 14, 2015. This will be done via single reports submitted using the FDA’s eSubmitter tool. The FDA also has two other new tools in place. MedWatch Plus is the electronic system for adverse event reports and other safety information for all FDA-regulated products. The FDA Adverse Event Reporting System (FAERS) is the new repository of advanced analytical methods designed to make analysis of safety reports and potential threats a lot more effective.
In the European Union (EU), the reporting of adverse effects is done via competent authorities in individual member states, via the National Competent Authority Report (NCAR), which then inform the European Commission and other EU member states of all their actions proposed or taken as a result of the reports. As in the United States, the EU maintains a centralized database, EUDAMED, which, however, is not available to the public.
Major changes to the regulatory framework are currently underway in the EU. While the two new regulations governing medical devices that will replace the current directives are still in the making, when they do come into force, there is a clear move toward strengthening the role of the database, and for the collection of data related to clinical investigations. There will be a new centralized system for notifications and reporting of severe adverse events and the scope of postmarketing clinical follow-ups by manufacturers will be largely extended.
The Universal Device Identification (UDI) is quickly becoming key to the advances in the reporting of adverse effects. A UDI is a unique numeric or alphanumeric code that manufacturers need to include on device labels and packages. Each UDI must be provided in a plain-text version and in a form that uses automatic identification and data capture technology.
The huge benefit of UDIs in the context of postmarketing vigilance is that they allow linking specific devices to clinical information. This, in turn, can enhance the context of adverse event reports. The use of UDIs on medical devices ensures their traceability and effective aggregation of adverse event data, as well as better coordination of recalls.
At the moment, UDIs have been introduced by the FDA and are also included in the new EU regulations that are currently in the works. In the US, manufacturers had to update the labels and packages with UDI-related information by September 2014, for class III medical devices and standalone software. By September 2015, they are obliged to do the same for labels and packages of implantable, life-supporting and life-sustaining devices and standalone software. Class II devices then have to meet the same requirement by September 2016.
Adverse drug reactions (ADRs) are no small thing. They are estimated to cause almost 200,000 deaths per year in the EU. This was one of the reasons behind the new pharmacovigilance directive and regulation that came into force in the European Union in July 2012.
With the directive, ADR reports are now submitted centrally only into the EudraVigilance database. In the past, reports went via individual national competent authorities. Given its application across the whole European Union, it is no surprise that ADRs frequently require translations. This is often unstructured content, which needs to be completed very fast, within the window required by the regulation.
Among other things, the new EU pharmacovigilance legislation laid down provisions in Article 57(2) of Regulation (EC) No 726/2004 for implementation of electronic submission of actual medicinal product information in the EU. Marketing Authorization Holders (MAHs) are required to electronically submit to the EMA information on all medicinal products for human use authorized or registered in the EU.
As with other submissions to the EMA for medicinal products, there is a language element to this, depending on the type of authorization procedure used. For products authorized via the mutual recognition procedure, decentralized procedure or the purely nationally authorized products, information needs to be provided in the national languages of the country of authorization. This applies to the product, product substance (this is also to include translation into English), Printed Product Information (PPI) and Printed Substance Information (PSI) (where used). Structured Substance Information (SSI) remains in English.
and regulatory requirements
Progressive life sciences companies are starting to use the web and social media to support the current regulatory requirements, mostly to enhance the reporting of adverse effects. This is important, since according to some estimates, about 90% of side effects to drugs may not currently be reported. The goal is to gather as many relevant inputs as possible from health care professionals, patients, caregivers, sales representatives, call centers, patient support programs, registries, as well as social media.
Novartis is an example of a company that has built an efficient system for electronic, real-time reporting of spontaneous adverse events, or side effects, globally. To encourage reporting, their online interface is available in multiple languages. Reports — submitted by patients or health care practitioners — are stored in the company’s central database of patient safety information in less than a minute, which allows for a rapid reaction.
The amount of content online and in social media is growing exponentially, and the same applies to content from patients and medical professionals related to medical information. Social media has emerged as one new effective risk management tool for tracking potential adverse drug reactions.
A 2014 study funded by the FDA examined some 6.9 million Twitter posts and found 4,401 tweets that resembled an ADR. When compared with data held by the FDA, the study found a high concordance between the data across multiple organ classes. This shows that user generated content related to adverse drug reactions may closely follow what gets reported as actual ADRs using official channels.
In another social media project that involved Novartis, researchers have analyzed over 250,000 social media posts for 250 medicines in the EU. Among these, they identified some 12,000 posts that could be a possible ADR report. These were then filtered down further, arriving at some 1,500 actual ADR reports.
Today, it is possible to build and customize social listening and social media analytical tools that enable pharmaceutical companies to mine online content and social media for user-generated content and identify possible ADRs. This is a nascent field, and one which follows the recent developments in marketing and social media analytics and management, as well as the growing application of natural language processing in commercial scenarios.
Pharmaceutical companies can trawl social media for potential ADRs, analyze users’ comments in multiple languages, taking into account the many potential variants of keywords, including slang, misspellings and so on, and then provide a short-list of potential ADRs that can be narrowed down to actual adverse reactions.
The European Union is involved in the WEB-RADR project (www.web-radr.eu), launched in September 2014, where RADR stands for recognizing adverse drug reactions. This three-year project is coordinated by MHRA (UK’s Medicines & Healthcare products Regulatory Agency) and its participants include the EMA (European Medicines Agency) as well as “big pharma” companies such as Amgen, AstraZeneca, Bayer, Novartis and Sanofi-Aventis.
The project aims to develop new data-mining techniques for publicly-available social media posts, for the detection and evaluation of suspected ADRs. Its goal is also development of a mobile phone app (Figure 4) for direct and instant reporting of suspected ADRs to EU regulators. This app is also to provide a means for regulators to communicate back the latest pharmacovigilance information.
Are we at the cusp?
Digital health care — comprising everything from electronic health records to fitness-monitoring devices, apps and services — has steadily brought life sciences closer to consumer and IT industries over the past decade, so these new trends revealing further convergence should come as no surprise.
Those who stand to win big in this new era are the successful cross-pollinators: life sciences companies that can maintain their tight control over regulated communications while deploying proven tactics from other industries to establish two-way communication with global markets.
If you’re a globalization professional who understands agile localization, community engagement or other hot trends in consumer and tech industries, dust off your resume. What could be more exciting than the chance to help an industry evolve and improve world heath in one career move?