By Zoe Dunn, Principal, Hale Advisors

Glenn Byrd, Senior Director, Promotional Regulatory Affairs, MEDIMMUNE

I spoke with Glenn Byrd, Senior Director, Promotional Regulatory Affairs, Medimmune, the global biologics R&D arm of AstraZeneca. Glenn’s comments are his own and don’t necessarily represent the views of his company.

At Digital Pharma West this year, Glenn will be providing an FDA/regulatory perspective on marketing in a digital world. He’ll be predominantly focused on addressing the issues of activities in social media, such as what considerations are important when looking at each platform.

I asked Glenn, what is the starting place for consideration of a particular platform?

He sees the environment in which companies operate to be important. The existing FDA regulations, guidance documents, and enforcement actions are relevant rules of thumb and should be a guide for communications, irrespective of the platform. We have a framework, as an industry, for those communications that we can use as a “roadmap” – guardrails to keep us from “going over the cliff,” he says.

Then, what is the end goal?

Glenn feels that segregation of information is key – branded and non-branded communications must be clearly distinguished. Several companies have done a good job of building communities around non-branded communications, which is also helping their reputations.

My next question was, does the biopharmaceutical industry have a role in the disease conversation?

We discussed that Biotech/Pharma has some of the best educational information coming from its data and clinical research. It would actually be doing these disease communities a disservice not to share industry knowledge. The industry has a responsibility to communicate its scientific content.

This brought me to ask, is there a valid concern coming from many companies on FDA enforcement actions around social media?

Glenn says there are unknowns from the FDA in this area, but we know what our communications parameters are: balanced perspective, showing the whole picture, and being truthful in what we say. Enforcement, and the objections the FDA raises in those actions, is consistent over the last 20+ years. It’s not a question of the platform, but rather of the behavior.

For more on this and other hot-button issues, come to the 4th Digital Pharma West, June 24-27 in South San Francisco. If you are interested in registering place visit the online registration and mention Priority Code C376BLOG.

By Zoe Dunn, Principal, Hale Advisors

Suzanne Niedrich, Associate Director, Neurology eMarketing, LUNDBECK

I spoke with Sue Niedrich, who leads the Digital Center of Excellence at Lundbeck U.S. in addition to being responsible for digital strategy across three neurology brands. Sue’s comments are her own and don’t necessarily represent the views of her company.

On the first day of the conference, Sue is moderating a panel on Digital Marketing for Pharma 2013: Where Is The Industry Going and What Are We Doing to Ensure Innovation and Improved Customer Experience?  So I asked Sue, in her opinion, where the industry is going.

Traditional marketing has to adapt to the digital world, Sue says. As an industry, the expectation is so much greater now to engage with our customers and listen to what they need. Traditional websites often serve as the hub for our brands, but they only offer one-way communication. There are a host of  other digital and social platforms that we need to consider and include when developing our overall digital strategies.

YouTube is one such platform. Clearly it can serve as an effective way to engage our customers with our brands. However, come June, YouTube will be modifying the way its channel looks/acts, which will again force us to respond more quickly than perhaps we are accustomed to. If we’re unable to adapt and remain compliant, we risk losing what could be a sizable investment in this channel. Marketing teams should be asking themselves “How do we keep abreast of these changes? How do wce adjust nimbly to them? As social media platforms constantly change, how do we plan for the unknown impact on our digital marketing initiatives?”

As an industry, the current state of digital communications requires that we become more patient/consumer-centric, Sue says. We have to take an active role in managing our digital presence. That means having supportive senior management and cross-functional partnerships to help manage that process. Customers are framing the conversation and we need to tap in and be an active participant. We also know that issues can arise, so we need to be able to respond to customers quickly and transparently and also manage expectations of our stakeholders. Delivering content in a multichannel way with digital as the connector is one strategy: it forces various teams to work together and breaks us out of our typical silos. Another important strategy is to make sure we understand what is most important to our customers and truly be “customer-centric” in this digital world we all live in.

Ultimately, this will lead to a major shift in our planning process. We’ll need to identify and align our business goals early and often, clarify how we get there, and adjust if need be along the way. We’ll need better ongoing communication with agency partners, medical/legal/regulatory, PR, and marketing teams, including “crowdsourcing” the best solution from all of them. Collaboration will be a key to leverage everyone’s strengths and ideas. Smaller budgets and teams, essentially doing more with less, will put pressure on this process, so ultimately we need to be realistic about how much we can take on and focus on fewer goals that have the most impact.

Come see Sue and her other panelists at the 4^th Annual Digital Pharma West, June 24-27 in South San Francisco.

There are a number of Responsive Web Design benefits to pharma marketers, but many doubt this new approach can survive the MLR process. While every company has different levels of risk they are willing to assume, I can assure you that RWD websites are being developed by many of the major Pharma companies in the U.S. Even more exciting, Responsive Web Design websites are starting to be seen in the wild!

A really great example was produced for Actemra®, an RA product from Genentech. Not only does the site look great across many platforms, including tablet and desktop, but their mobile view introduces a persistent menu thatenables users access to a vast amount of content with one-click.

Genentech is one of many companies that are either using our 5th Finger Responsive approach, or the traditional Responsive Web Design approach as part of a new redesign engagement. But, like any new technology, the largest hurdle will always be getting it through MLR.

While every process is unique, you may find the two very basic tips below to be helpful:

1. Get your MLR team involved early. Provide real world examples of how the technology works, how it would be translated to your brand, and get their initial feedback and hurdles you may need to overcome. If possible, bring them along to industry conferences to introduce them to new trends and talk to the folks who are creating them.
2. Start with mobile. Not only is a mobile-first approach helpful in the creation process, but by starting with mobile, you will clear the largest hurdle first.

I hope this brief post gives you some hope that Responsive Web Design is not only possible, but it is a reality for Pharma marketers.

- Chris Crichton, VP Mobile Health

Join Chris and the 5th Finger team at the 4th Digital Pharma West conference taking place June 24-27 at the Hyatt Regency San Francisco Airport – Burlingame. Chris will be speaking about Responsive Design: How and When to Take Advantage of the Digital Marketing Trend at the Mobile Day on June 24.

It’s only in the beta testing phase, but a smartphone app called “Small Things” is being tested as a gamification solution to assist families with children with type 1 diabetes to achieve better patient adherence in consistent glucose testing. After downloading, the Small Things app sends an alert to the patient when it is time for a glucose test, and then has the child type in the results to his/her smartphone. The results can then be transmitted to the child’s parents or caregiver, and as a reward, the child receives game currency that can be cashed in for “virtual monster-like creatures”. Afterwards, the child can use more currency to raise and nurture their new creature as sort of a “virtual pet”. The pet then lives in a virtual world on the child’s smartphone and can be customized with many different add-ons. The child’s parents get notified every time currency is earned and are therefore ensured of their child’s adherence to proper glucose testing.

Funding and non-profit affiliation is still largely up in the air and yet to be determined. But pharmaceutical gamification is an idea that has been catching fire in the past year or so. Gamification itself is an industry that has been booming ever since Foursquare began with the idea of awarding mayorships and badges to its users back in 2007. If the pharmaceutical industry can use it to its advantage, and in the process get kids with type 1 diabetes to test their blood more often, then “game on!”

It’s really an idea that makes complete sense. One of the biggest reasons, a child with type 1 diabetes doesn’t want to test their blood is because nothing of any positive consequence can happen from it. If a child is going to go through the social anxiety it takes to separate themselves from a social group, and use proper glucose testing to treat their condition; then it makes sense that some sort of reward system may provide the incentive necessary to get kids to “play along”.

For more insights on gamification and novel strategies for improving patient care and compliance, please do take a few moments to review the agenda for the upcoming 4th Digital Pharma West conference.

The Pharmaceutical industry may just have the social media guardrails it has long been waiting for.

While the Food & Drug Administration (FDA), which regulates the industry, hasn’t yet issued its promised social media guidance, it may just defer to the newly-released Federal Trade Commission’s (FTC) staff guidance document on digital advertising, industry executives are saying.

The FTC’s .com Disclosures guidance, issued March 12, underscored the need for marketers to make their ad claims “clear and conspicuous” and reiterated that the message, not the medium, will continue to define compliant ads. When it comes to disclosures, the same standards of responsibility and consumer protection apply to digital media as they do to print, radio and TV, the FTC stated. “Cyberspace is not without boundaries, and deception is unlawful no matter what the medium,” the agency stated.

The FTC document updates guidance from 2000 that didn’t address such issues as how to include disclosures such as Important Safety Information in tweets, text messages and on YouTube videos. In the past decade, mobile platforms and social media usage has surged, leaving marketers to navigate new media with old guidelines.

Highlights from the FTC’s new guidance:

• “Place the disclosure as close as possible to the triggering claim,” and in the case of “space-constrained ads that require disclosures, place the disclosure in the ad whenever possible”
• Avoid using hyperlinks for disclosures: “required disclosures about serious health and safety issues are unlikely to be effective when accessible only through a hyperlink”
• Avoid “conveying such disclosures through pop-ups, because they are often blocked”
• If a disclosure is necessary to prevent an ad from being deceptive or unfair or otherwise out of compliance, but the disclosure cannot be made “clearly and conspicuously” the ad should not be run
• “If a particular platform does not provide an opportunity to make clear and conspicuous disclosures, then that platform should not be used to disseminate advertisements that require disclosures”

The full text can be found here.

Hale Advisors believes the FTC’s guidance gives marketers clear direction for communicating in the digital space. There is no ambiguity here. The pharmaceutical industry is required to be responsible with its claims and disclosures; this now answers questions on specific practices such as linking.

It’s been 3.5 years since the November 2009 meeting when the FDA said it would issue social media guidelines. The FDA’s bailiwick is safety, not communication. Now we’ve got the top communication agency providing direction and leadership, and it’s now time for the FDA to get onboard to provide direction to marketers and communicators across our industry.  Perhaps, then we can stop waiting on guidance to develop innovation in the digital space and innovate within our clear parameters.

For more insight into social media guidance and its future in the the pharma digital space, join us at the 4th Digital Pharma West conference, where Zoe Dunn will Co-Chair the event with John Vieira, Senior Director, Global Brand Strategy, Edoxaban at Daiichi Sankyo and Bob Allen, Director of Digital Marketing at AstraZeneca.

Yes, we realize that we are in the life sciences industry, an industry that is at its foundation had decisions made moreso as the result of fear, fear of warning letters, fear of fines, fear of a social media channel being opened up that will lead to unhappy patients airing their feedback to the world, fear of potentially pushing the envelope a bit too far internally and having it impact your career trajectory.

Is it best for us as an industry to let these fears stifle our creativity, stifle our innovation?

Perhaps prevent us as digital marketers at organizations that play a huge role in the advancement of life saving and life advancing therapies to sit back and not reach the people that our products impact the most, where they are most likely to see it, read it, and potentially take action on it?

I am thankful that even despite all the fears we face as a result of MLR in our industry, we have seen some really great progress at these conferences from some of the organizations that are driving ahead despite these fears. At this past Digital Pharma East in October, we had entire session dedicated to this topic where Paul Ivans of Evolution Road Consulting led a discussion with senior level participants from leading pharmaceutical companies (including Boehringer-Ingelehim, Bristol-Myers Squibb, UCB Pharma, CSL Behring and Purdue Pharma) on Driving Innovation in Our “Slow-Moving-Ultra-Conservative” World of Pharma: Closing the Gap Between Knowing and Doing, which then led into other sessions featuring case perspectives of organizations pushing this innovation.

We hope to see you at Digital Pharma West in June to join a growing number of pharmaceutical and medical device companies providing high level case studies in their area. You can become part of the story and help further drive this industry past their fears and drive digital innovation in an industry that needs it.

Utilizing mobile devices for storing health information presents a number of security headaches. According to a recent Health Information Trust Alliance (HITRUST) report, more than 21 million patient records were breached with 45% caused by device theft. Laptop theft constituted 25% of these breaches. The loss or theft of mobile devices exposes sensitive health information to the wrong parties. As a result, proper security methods must be implemented to prevent access to confidential patient information. Unfortunately, most mobile devices are not adequately configured to protect data access and insufficient security settings can be easily bypassed. Additionally, mobile malware which can be appended to an email or other software, can be used to access information on a device as well as collect and transmit it to ot her devices.

Consumers are understandably concerned about the safety of their medical information. A recent PwC Health Research Institute study  showed that 69% were concerned about the privacy of their records as providers utilize mobile devices for access to them. The report also revealed that only 46% of hospitals had some kind of security strategy in place for mobile device use.

To fully comply with HIPAA Privacy and Security Rules, HealthIT.gov recommends steps that providers can take to prevent data breaches from mobile devices.

1. Before allowing and implementing mobile devices in the health care setting, know the risks and decide how the devices will be used to access and transmit information.
2. Identify threats by conducting a risk analysis. After identifying  threats and vulnerabilities, implement mobile device safeguards. These safeguards must also be routinely evaluated to ensure they are protecting information effectively.
3. Develop mobile device policies and procedures with attention to device management, restrictions on mobile device use, and security and configuration settings on devices.
4. Provide ongoing training in security awareness and device privacy to providers who use mobile technology.

Although the use of mobile devices in the health care setting brings the risk of data breaches, the above guidelines can prove useful in preventing these occurrences.

Pinterest has now reached 15% market saturation of Internet users, according to a Pew Internet report, and pharma companies are beginning to take notice. Bayer, Novo Nordisk, and Boehringer Ingelheim, are among the biggest pharma companies getting involved, but smaller companies are exploring the site now too. Bayer alone, now has seven pin boards on the site and effectively uses it to reach Internet users on a wide range of searchable topics.

Sure, hospitals such as The Mayo Clinic, The Cleveland Clinic, and numerous others are finding that the use of video and images makes Pinterest the perfect choice for their needs. But pharma is sure to find a similar niche for itself once the U.S. Food and Drug Administration develops more specific regulations on exactly how pharma will be permitted to interact with consumers on social media.

For now, some pharma companies may continue to view social media as more of a tracking tool than a way to communicate with consumers. Whereas this may be the safe approach, it could also be potentially damaging. Comapanies that fail to react quickly enough to the growing popularity of social media in general, or perhaps more specifically Pinterest, will run the risk of falling behind the times. As reported by Tech Crunch, Pinterest has already reached 10 million visitors faster than any other independent site in history. Pharma companies would be wise to pay attention and not let an opportunity to keep a presence on Pinterest in the social media world pass them by before it is too late.

Forgetfulness is usually the reason why we neglect to take necessary medications. More often than not, however, patients with chronic illnesses who are on a large regimen of pills find it difficult to keep track of their medications. Others just get caught up in the hustle and bustle of their hectic schedules and innocently forget their required doses.

Thanks to digital technology, patient adherence with medications is improving. Products such as Vitality’s GlowCap, MedMinder, and MediSafe utilize innovative methods to remind patients when it’s time to take their pills. The GlowCap which was launched in 2009, uses a “smart” pill cap that communicates with information entered by the patient online. When it is time to take the pill, the cap glows and plays a melody. MedMinder, on the other hand, contains trays for multiple medications and sends phone call reminders, text messages, or email reminders. Even remote caregivers can be notified when the trays have not been opened on time. Perhaps the most innovative reminding solution comes from the MediSafe Project which uses a cloud-based app to remind patients on their smartphones when to take their pills. The app uses a series of graduated reminders that become increasingly difficult to ignore. Should those go unnoticed, the app will notify a spouse or other family member that the patient has not responded to their reminders.

Other medication adherence solutions were presented at the 2013 Consumer Electronics Show. GeckoCap, geared to children on inhalation medication for asthma, uses a smart cap and app to track inhaler use. It also gamifies the process to keep the kids engaged so they keep up with their medication schedule. uBox, a smart pillbox, communicates through an app and uses calendars and schedules to track doses. It also can notify family members about missed doses. Proteus Digital Health has even developed smart pills that are used in conjunction with an adhesive patch that can act ually track and report the pills are actually being taken. Through the collection of metrics that the pill can track, Proteus Chief Products Officer David O’Reilly believes that this type of system can allow patients to directly understand the direct benefits of taking their medications.

Another issue that can be addressed through this technology is that of medications originating from different providers. Since many unpleasant side effects can occur with the mixing of certain medicines, many patients will stop taking them. With improved communication systems, mobile solutions, and apps, these problems can be better addressed.

With the continued development of smart pills as well as better communication between providers and patients, compliancy and adherence will no doubt improve. This can result in decreased return hospital and physician encounters which will lessen the burden on our already strained health care system. Developments such as this and more will be a theme at our 5th Annual ePatient Connections conference coming up this September, which will be co-located with our Patient Adherence and Advocacy Forum. We hope you take part in the conversation and the many developments in this area.

At the same time, smartphones and tablets are increasingly common fare among children. The convergence of mobile device use and the gamification of medication adherence should be a natural response to the need for children to get the prescribed medications that they need.

Overall failures in medication adherence are estimated to generate an annual economic impact approaching $100 billion (PhRMA, 2011).

Now, a company called Gecko Health Innov ations is making gamification a key element in a new device that addresses adherence to asthma medication among children. The reasons for the explosion in the number of asthma diagnoses among children are still unclear, but today, one in seven children in the U.S, have the disease. Overall, asthma is a $15 billion a year disease in terms of treatment costs.

Inhaled corticosteroids effectively control symptoms. Current non-adherence to treatment results in many avoidable asthmatic episodes and even ER visits. An estimated 50 percent of all costs related to the chronic condition could be eliminated simply with the proper use of inhalers.

Now, a collaboration of physicians and engineers from the Massachusetts Institute Of Technology has resulted in the introduction of the “GeckoCap™.” The innovative new device was appropriately unveiled at the 2013 CES in Las Vegas in January. The cap is a colorful and smart button that can be affixed to an inhaler in seconds. It glows to remind a child to take the next dosage. Simultaneously, it can transmit data to a parents’ mobile devices so that adherence can be monitored. Data can be automatically transmitted to the child’s physician as well.

The GeckoCap utilizes ultra-low power and patent-pending proprietary technology. Setup is simple and data transmission is automatically synced.

Gamification is also a major asset in the use of the GeckoCap. A gamified mobile app encourages kids to self-manage their asthma. New GeckoCap users can quickly link to their own online profile. Reward mechanisms exist to gamify the ongoing need to take medication in a regular and timely manner.

Company founder and CEO Yechiel Engelhard, M.D. explains, “Our platform leverages mobile technologies, cloud computing, and reward mechanisms to empower families and their children in their own health.”

These topics and more are a big part of our co-located ePatient Connections and Patient Adherence conferences this September.