Success in pharmaceutical industry depends on innovation. We are in the constant race with mutating microbes, viruses and cells. New regulations, stakeholders and disruptive competitors are changing industry landscape every day. Innovation (Photo credit: Thomas Hawk)
At the recent Pharma Customer Experience Management Summit in Berlin, where I was one of the speakers, the innovation was a leitmotif. One particularly strong accord was played by Alexander Simidchiev from GSK. In his presentation, Customer-Centric Approach in Pharma: Future of Healthcare?, Alex has pointed out what I believe is the best approach to smart innovation in pharmaceutical marketing.
Inspired by Daniel Burrus’ methodology described in the book Flash Foresight, Alex advises pharma marketers to look for the “hard trends”.
[box type=”info” ] Hard trend is a projection based on measurable, tangible, and fully predictable facts, events, or objects. It is something that will happen: a future fact that cannot be changed.
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In the day to day practice of pharma marketing we can often see urge to innovate based on the opposition of the hard trend. Something, that Burrus would call a “soft trend”, something, that only might happen.
[box type=”info” ] Soft trend is a projection based on statistics that have the appearance of being tangible, fully predictable facts. It’s something that might happen: a future maybe.
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Such “soft trend” is easy to be sold by marketers and consultants. You may hear that we should go mobile (the smartphones are on the rise, aren’t they?). You may learn, that eDetailing on tablets is a must (everyone has an iPad, buy one too, quickly!).
It is not a bad thing to identify such soft trends and use them for your innovation. The thing is, however, that soft trend can be influenced and changed. It is the change of this trend that innovator should capitalize on. Followers of those soft trends risk being punished with the next disruption.
However, such approach is not enough. As Alexander Simidchiev said, basing on his experience in pharmaceutical industry, for K-message.com:
Most of what I currently percieve is cosmetic changes in the industry which has changed little since the hayday of anilin based medical wonders, currently addressing mainly short term priorities and tactical issues. The result is that the industry chronically suffers from suboptimal reputation, and we are always “on the back foot” trying to defend past practices, instead of treading the virgin soil (together with other partners and stakeholders) of how to overcome the current challenges facing the healthcare system, for which (my personal deep belief) pharma is one of the possible, if not dominantly positive solutions. This requires that current marketing practices refocus from talking product to joint solutions for societal needs.
To be prepared for what will happen, you need to look at hard trends. This will not change, and it provides a solid foundation for growth. Hard trends are derived from demographics, regulations and technological advances (in terms of growth of “three digital accelerators”: processing power, storage and bandwidth).
Alexander Simidchiev in his presentation has applied this approach to look at pharmaceutical industry. Hard trends derived from demographics facts are stunning. Simple combination of current knowledge of age profiles for public expenditure on healthcare in EU countries (how much is spend for the healthcare of people in certain age), with data on ageing of the population shows, that current system cannot be sustainable in the near future.
Age profiles for public expenditure in health. Economic Policy Committee (2001) “Budgetary challenges posed by ageing populations” p. 34 [PDF]. An arrrow added by K-message.comOn the other hand the same fact of ageing population affects how HCPs of today are working. 2014 was a tipping point, when the majority of HCPs in the EU is digitally native. All newly qualified doctors now, were born after 1988, and started their studied in 2005, which means they used the Internet to learn medicine (PubMed has started in 2006). They find digital more natural than printed materials for acquiring professional knowledge.
Those are hard trends, not guesses, and pharma marketers have to face it or their companies will struggle. We need to be prepared for dramatic shift in our business model, with less money for much bigger population in public healthcare system. We have to use digital channels to be understood by new generation of HCPs, and to provide information the new, digitally savvy patients.
It is not about nice mobile apps or shiny presentations on iPad. It is about the future. As Alexander Simidchiev, quoting Peter Drucker, has closed his presentation: The best way to predict the future is to create it.
Dallas Buyers Club is a powerful movie. Based on true story of Ron Woodroof it shows how patient has to fight the system instead of receiving a treatment for the deadly disease. Everything seems to ally against suffering patient. Health Care Professionals driven by greed offer inefficient therapy under strict clinical trial regime. FDA officers are enforcing cruel regulations confiscating “illegal” but life-saving medications. Even the judge from liberal California, although compassionate is forceless. Dallas Buyers Club is a coalition of suffering people turned into outlaws for trying to save their lives.
Is pharmaceutical industry and its regulators really so cruel? Why Woodroof and his club were persecuted instead of receiving help? Is it possible that such story happens today with some other disease?
Clinical Trials – Why Ron could not get AZT in the proper dose in the hospital.
At the moment depicted in the Dallas Buyers Club, AZT (zidovudine, also known as azidothymidine, trade name Retrovir) in the U.S. was in the clinical research, probably in Phase III of the process.
English: AZT (zidovudine), the first medication shown to be effective against HIV. From the National Institutes of Health website. (Photo credit: Wikipedia)
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Phases of Clinical Research
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Phase 0: The first in-human research of new drug is called an exploratory investigational new-drug study or phase 0 study. It is done before traditional phase I trials. Smaller than therapeutic doses of a new drug are given to a small group of patients (typically fewer than 15) for roughly a week to determine pharmacodynamic and pharmacokinetic properties.
Phase I: Researchers test a new drug or treatment in a small group of healthy volunteers for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase II: The drug or treatment is given to a larger group (about 100 -300) of people who have the disease or condition that the product potentially could treat. In this phase researchers see if the medicine is effective and are able to further evaluate its safety.
Phase III: The drug or treatment is given to large groups (1000 to 3000) of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase IV: Studies are done after the drug or treatment has been marketed to gather information on the drug’s effect in various populations and any side effects associated with long-term use.
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[/box] Phase 2 and Phase 3 clinical trials generally involve a “control” standard. It means that some of the participants do not get tested substance, but inactive placebo or other, existing treatment if available. To avoid any bias, there is a special process to randomly decide who gets a tested substance, called randomization. At this point no one knows if the new therapy is efficient or maybe dangerous, so getting placebo is not necessarily worse option. Additional process to avoid bias in the results of the research is called blinding. Single-blinding means, that patients do not know whether they are treated with tested substance. Even better procedure, double-blinding means that also the research team does not know who receives what. Patient is informed about the substance s/he receives only at the specified time of the study, when it cannot impact the results. Due to this procedures, it is not possible for patient to decide a dosage or even to be sure that the specific drug is given. In the story of Dallas Buyers Club, Ramona starred by Jared Leto could not be sure that her medicine is AZT and not just placebo. Clinical studies are necessary to identify adequate dosage and eliminate risks that could overwhelm benefits of new therapy. There is always limited number of participating patients with specific conditions, so it takes long time to gather representative sample and see the results of the study. The whole process takes years to be completed, but it is needed to approve new drug to be available on the market.
Expanded access – Would it be possible to import medicine for Ron legally?
AIDS patients could not wait for clinical trials, this is why Dallas Buyers Club and other similar communities existed. In that time, there was no easy, legal way to provide access to the treatment for patients in need. This experience affected current regulations in the U.S., and now there is a number of ways that allow access to the investigational or non-approved therapies for serious or life-threatening conditions, including but not limited to HIV/AIDS. Additionally, there is a way to expedite process of approval for the treatment in so-called FDA fast track drug development program.
Access to Investigational Drugs Outside of a Clinical Trial (expanded access)
Expanded access, sometimes called “compassionate use,” is the use of an investigational drug outside of a clinical trial to treat a patient with a serious or immediately life-threatening disease or condition who has no comparable or satisfactory alternative treatment options. FDA regulations allow access to investigational drugs for treatment purposes on a case-by-case basis for:
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individual patients, including in emergencies
intermediate-size patient populations
larger populations under a treatment protocol or treatment investigational new drug application (IND)
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To permit treatment of a patient with an investigational drug under an expanded access program, FDA requests following conditions to be met:
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The patient’s disease or condition has no satisfactory approved therapy. An example of this is a rare type of cancer that has no known or approved treatment. Or, it may be the case that the available treatments did not work for the patient.
The potential benefit for the patient justifies the potential risks. An example of this is the potential for longer survival with a disease or condition.
The expanded availability of the untested drug will not interfere with that product’s development. For example, access to an investigational drug should not interfere with enrollment in clinical trials needed to demonstrate the drug’s safety and effectiveness.
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Additionally, the drug manufacturer and the patient’s doctor must make special arrangements to obtain the drug for the patient. These arrangements must be authorized by the FDA. These safeguards are in place to avoid exposing patients to unnecessary risks.
Just as in clinical trials, these investigational drugs have not yet been approved by the FDA as safe and effective. They may be effective in the treatment of a condition, or they may not. They also may have unexpected serious side effects. It is important for you to consider the possible risks if you are interested in seeking access to an investigational drug. [box type=”info” ]
How to Get Expanded Access to an Investigational Drug?
The process must begin with your healthcare provider, who should follow these steps:
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Your healthcare provider must contact the company that manufactures the drug to make sure it is willing to provide the drug.
Your healthcare provider must submit an Investigational New Drug (IND) [link to section below] application to the appropriate FDA review division.
In an emergency situation, the request to use the drug may be made via telephone or other rapid means of communication, and authorization to ship and use the drug may be given by the FDA official over the telephone. With emergency INDs, shipment of and treatment with the drug may begin prior to FDA’s receipt of the written IND submission that is to follow the initial request.
In a non emergency situation, the IND must be received by FDA before shipment of and treatment with the drug may begin. These non emergency requests are known as individual patient INDs.
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The IND Application
The IND application is required to gain access to an investigational drug outside a clinical trial. The application should include the following information:
Statement that this is a request for an individual patient IND for treatment use (specifying whether it is an emergency IND or individual patient IND), which should be included at the top of the correspondence and on the mailing cover.
Brief clinical history of the patient including:
Diagnosis
Disease status
Prior therapy
Response to prior therapy
Rationale for requesting the proposed treatment, including a list of available therapeutic options that would ordinarily be tried before the investigational drug, or an explanation of why use of the investigational drug is preferable to the use of available therapeutic options
Reference for a published protocol or journal article, if appropriate
Proposed Treatment Plan including:
Dose (how much and how often)
Route of administration (by mouth, injection, etc.)
Planned duration (how long the product is to be taken)
Monitoring procedures
Modifications (e.g., dose reduction or treatment delay) for toxicity
Chemistry, Manufacturing, and Controls Information and Pharmacology and Toxicology Information, including a description of the manufacturing facility. This can be done by providing a letter of authorization (LOA) that refers to this information if it has been previously submitted to FDA (for example, to an existing IND or new drug application). The treating physician should contact the sponsor of the previously submitted information for the authorization and letter. The LOA should include identifying information, such as the sponsor’s application (e.g., IND) number.
Informed Consent Statement noting that informed consent and approval by an appropriate institutional review board (IRB) will be obtained prior to beginning treatment. In the case of an emergency, treatment may begin without prior IRB approval, provided the IRB is notified of the emergency treatment within 5 working days of treatment.
Investigator Qualification Statement that specifies the training, experience, and licensure of the treating physician. The first two pages of a curriculum vitae typically contain this information and are usually sufficient.
FDA Form 1571 completed with the treating physician listed as the sponsor. Download Form 1571 and view the instructions.
For the drugs that are the first available treatment or have advantages over existing treatments, the Food and Drug Administration has developed four distinct approaches to make such drugs available as rapidly as possible:
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Priority Review
Accelerated Approval
Fast Track
Breakthrough Therapy
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Priority Review
Prior to approval, each drug marketed in the United States must go through a detailed FDA review process. Since 1992, under the Prescription Drug User Act (PDUFA) a Priority Review designation is used to the evaluation of applications for drugs that, if approved, would be significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications. A Priority Review designation means FDA’s goal is to take action on an application within 6 months (compared to 10 months under standard review). Priority Review does not affect the length of the clinical trial period.
Accelerated Approval
It takes many years to fully assess whether a drug provides a real effect on how a patient survives, feels, or functions, and brings a clinical benefit. To make drugs for serious conditions that filled an unmet medical need approved earlier, FDA can use Accelerated Approval process and base its decision on a surrogate endpoint. A surrogate endpoint is a marker of therapeutic effect, that is thought to predict clinical benefit but does not measure it. Drug still needs to be evaluated after approval in Phase IV studies, and basing on the results of this Phase IV FDA can change its initial decision on approval (ie. withdraw one of labeled indication, or completely withdraw drug from the market if confirmatory tests do not prove enough clinical benefit).
Fast Track
Fast track is a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
A drug that receives Fast Track designation is eligible for some or all of the following:
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More frequent meetings with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval
More frequent written correspondence from FDA about such things as the design of the proposed clinical trials and use of biomarkers
Eligibility for Accelerated Approval and Priority Review, if relevant criteria are met
Rolling Review, which means that a drug company can submit completed sections of its Biological License Application (BLA) or New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. BLA or NDA review usually does not begin until the drug company has submitted the entire application to the FDA
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Breakthrough Therapy
Breakthrough therapy is the latest program at FDA that will complement the programs listed above. It facilitates and expedites drug development and review for serious conditions and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).
A drug that receives Breakthrough Therapy designation is eligible for the following:
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All Fast Track designation features
Intensive guidance on an efficient drug development program, beginning as early as Phase 1
Early access to the innovative drugs is still a topic for regulators not only in the U.S. In the United Kingdom the latest development is an Early Access to Medicines program unveiled by the Government on 7th of March 2014. The program aims to accelerate access to innovative medicines for serious conditions, allowing doctors to prescribe the drugs after an initial scientific assessment by the Medicines and Healthcare Products Regulatory Agency (MHRA). The program, funded by pharmaceutical companies, will be launched on April 2014. Suitable drugs will receive a “promising innovative medicine” (PIM) designation. PIM designation will be based on several years of clinical data assessed by MHRA, but before completion of Phase III trials. This will probably save several years in comparison to the standard process for approval, that will be run in parallel to the new program. Early Access to Medicines is modeled after the FDA’s breakthrough therapy designation. British regulatory agency estimates that one or two therapies could be designated under the scheme each year.
It seems there is no need for Dallas Buyers Club anymore.
Quantified self, mHealth and wearable technology. While you could hear about those trends in the past, the tipping point has been reached at the CES 2014. What was supposed to be the future is our present much faster than industry expected. Enterprise market is again far behind consumers. Health care industry tethered by regulations just cannot catch-up quickly enough.
At K-message however, we can take a look at the forefront of the consumer technology and assess its possible impact on the industry, and our focal point – pharmaceutical marketing. But first, let us define what we are talking about.
What is quantified self? Who wears technology? What is mHealth?
Quantified self (QS)
Quantified self (QS) is a trend of personal data collection via technology. The idea is to acquire data on person’s state, actions and performance using wearable technology and/or mobile applications.
Track Yourself Map of Quantified self apps by Rachelle DiGregorio
Wearable technology is a description of any electronics that one can wear. It may be something with a sensor for quantified self purposes, but it can be also a T-shirt with LEDs intended just to look nice. From quantified self perspective, wearable technology is a trend that enables the whole movement by devices that can capture personal data.
mHealth is a general term for usage of mobile devices (mobile phones, smartphones, tablet computers etc.) in connection to medicine or health care. mHealth includes providing information to the patients or HCPs, but also collecting patients data.
Is Quantified Self big and mature enough to have an impact on health care industry?
The topic is huge. On the Quantified Self Guide – a website that collects different Quantified Self applications, there are 505 different tools listed at the time of writing this article. Of those 65 are tagged with medicine and 124 with fitness category tag. Wearable technology was main topic of CES 2014. If you look around in the office of any healthcare corporation (or, even better, on the jogging path) in the developed world, you will notice wearable sensors in form of bracelets, chest bands or small items in the shoes used by increasingly high population. Users of the smartphones install “measuring” applications on their devices.
Gary Wolf: The quantified self
What are the numbers? Runtastic, a mobile app dedicated to track running performance has recorded 60 million downloads worldwide and 25 million registered users on Runtastic.com. Similarly targeted device and app Nike+ platform claims 18 million users. Fitbit.com, the website that allows to see the results of tracking with Fitbit range of devices according to Quantcast has around 2 million users from the U.S. only. Quantified Self is definitely mass market now and it will not fade away. Instead it seems it will get more devices and applications as the tech industry embraces it.
Quantified self: dangers versus benefits
From the pharma marketer perspective quantified self may be even more disruptive than the raise of social media (which, by the way is still not accommodated properly). As it gives more knowledge to the user it takes away control from the HCPs. Fitness trackers are obviously beneficial as they encourage the best prevention against disease – exercise and movement. On the other hand the trend brings some risks with it.
PBS: The Quantified Self: Data Gone Wild?
Interpretation of the data gathered by the device or application, even if supported with some mHealth resource filled with scientifically proven knowledge may lead to wrong decisions. Innocent life-logging app that counts calories intake may lead to starvation, or at least to non-balanced diet for some users who want to lose weight too quickly (not mentioning here eating disorders). A non-calibrated blood pressure and pulse tracker may put people with cardiovascular issues at risk (I cannot breath but the reader says I can still run…). The device alone can affect users health by allergy (that happened with Fitbit Force recently), heat, permanent exposure to radiation. There was also at least one occurrence when using activity tracking device, and competing for better score was connected with a tragic death of one too motivated biker. In pharmaceutical industry there is a lot of pressure put on the patient data privacy. Quantified self puts those data in open, sharing the very personal information on the activity publicly, sometimes without informing user about it. This was a real case when Fitbit.com allowed public to see users who were logging their 30 minutes very active sexual encounters. What is fascinating in Quantified Self movement is how the application can change focus from empowering by giving the knowledge to the patient to enslaving by enforcing control over users behavior. In one of the quantified self business use cases, not related to health care, a QS device called Hitachi Business Microscope worn by office workers was mapping their communication patterns within organization, pinpointing unnecessary meetings, organization social graph and communication issues.
If we take it to the field of pharma marketing, QS may be seen as a great tool to improve patient compliance or to provide personalized healthcare, but also as a menace of higher insurance rates for any misbehavior – be it sitting too long on the couch or having one drink too much.
Yuri van Geest – The quantified self: within 20 years no doctors needed
Quantified self and EHR, EMR and PHR solutions
One of the promising features of the quantified self is possibility to include the data acquired by sensors directly into electronic health records systems (EHR). Electronic Health Record is not exactly what industry widely embraces as EMR – electronic medical record. Although the data gathered, stored and processed in EHR are more or less the same, the source is different. EMR can include only data provided by medical institutions and healthcare professionals. EHR is open to any source of data. It includes what can be gathered from EMR, but also accepts patient input, quantified self devices and applications feeds and other sources. A specific range of EHR, that includes only data provided and managed by the user (in this case – patient) is Personal Health Record (PHR). The most renowned solutions of this kind are Google Health (decommissioned) and Microsoft Health Vault, but there are also other providers.
Microsoft HealthVault – an example of PHR
This brings new opportunities as we get really Big Data in EHR, but also some risks. Data in EHR and PHR cannot be really trusted, as they come from not validated sources and can be contradictory. The sampling (how often you take a data point) is not standardized and quality of the input is questionable. Nowadays, adoption of EHR and PHR is very limited, as is their functionality and usability. However with the growth of the quantified self we can expect rising importance of such hubs for the medical information.
Quantified self and regulatory compliance: HIPAA and HITECH
Quantified self movement adoption is nowadays limited to developed nations, and the biggest market for those solutions is in the United States of America. There are two regulatory bodies in the US that overlook quantified self devices and applications. For non-medical use the main authority is FTC. Privacy and access to the health related data is regulated by HIPAA and HITECH regulations.
HIPAA Compliance Checklist
Have you formally designated a person or position as your organization’s privacy and security officer?
Do you have documented privacy and information security policies and procedures?
Have they been reviewed and updated, where appropriate, in the last six months?
Have the privacy and information security policies and procedures been communicated to all personnel, and made available for them to review at any time?
Do you provide regular training and ongoing awareness communications for information security and privacy for all your workers?
Have you done a formal information security risk assessment in the last 12 months?
Do you regularly make backups of business information, and have documented disaster recovery and business continuity plans?
Do you require all types of sensitive information, including personal information and health information, to be encrypted when it is sent through public networks and when it is stored on mobile computers and mobile storage devices?
Do you require information, in all forms, to be disposed of using secure methods?
Do you have a documented breach response and notification plan, and a team to support the plan?
If you answered no to any of these questions you have gaps in your security fence. If you answered no to more than three you don’t have a security fence.
Quantified self and regulatory compliance: FDA guidance on medical mobile applications
For medical mobile applications relevant authority is the FDA. The Agency considers mobile phone as a medical device as soon as it meets one of the following:
It works expressly for medical purposes and offers medical or health-related apps
It acts as an effective accessory or component to aid medical health
While assessing medical mobile applications the FDA applies the same risk-based approach as for other medical devices. The guidance document provides examples of how the FDA might regulate certain moderate-risk (Class II) and high-risk (Class III) mobile medical apps. The guidance also provides examples of mobile apps that are not medical devices, mobile apps that the FDA intends to exercise enforcement discretion and mobile medical apps that the FDA will regulate in Appendix A, Appendix B and Appendix C. For many mobile apps that meet the regulatory definition of a “device” but pose minimal risk to patients and consumers, the FDA will exercise enforcement discretion and will not expect manufacturers to submit premarket review applications or to register and list their apps with the FDA. This includes mobile medical apps that:
Help patients/users self-manage their disease or condition without providing specific treatment suggestions;
Provide patients with simple tools to organize and track their health information;
Provide easy access to information related to health conditions or treatments;
Help patients document, show or communicate potential medical conditions to healthcare providers;
Automate simple tasks for healthcare providers; or
Enable patients or providers to interact with Personal Health Records (PHR) or Electronic Health Record (EHR) systems.
The quantified self will gain more importance in the healthcare industry. However, there are still some issues to be addressed before embedding them in the marketing strategy. Before building your own application or choosing one from the market consider them carefully.
Tracking versus privacy
Regardless of HITECH privacy considerations, the pharmaceutical company has to be extremely careful about patient data privacy. It has to be absolutely clear to the patient and the organization, that all data are owned by the user of the application and not the company. You need to have users’ direct consent if you are going to aggregate, store, process, or use the data in any way.
Data reliability
Your quantified self-application or device will gather data in connection to patients’ health. Therefore it is important to achieve possibly high level of accuracy and ensure the integrity of this data. It should be also clearly stated what are limitations of the sensors and technology used.
Fallback in case of failure
You need to make sure that in case of failure or loss of the device, patients will still be able to be treated or diagnosed with a fallback solution.
Interoperability
If your application allows data exchange with EMR, make sure it uses open standards, so that it can be used regardless of the health care provider chosen by the patient. This applies also to interoperability with PHR solutions.
Clear guidance for the interpretation of data
Make sure that the data gathered and provided to the patient are not subject to misinterpretation. There should be a clear explanation of the result provided, and if not possible the instruction should point the patient to the HCP who will be able to interpret the data. Even the best result on the application should not encourage patients to be not compliant with the treatment ordered by his doctor.
Co-operation with HCPs
If every patient comes to his GP with gigabytes of life-logging data, there is no time for a proper diagnosis. Valuable information will be hidden in the noise like a needle in a haystack. Not to mention different UIs of the applications and general annoyance with non-standard requests coming out of the blue. To avoid this you need to provide HCPs with clear instructions on what to look for and make sure they will know it at the first glance. Think about a separate dashboard for the physician or even better – distribute the app through the trained HCPs.
Example of quantified self in pharma marketing: Eli Lilly’s Talking Progress.
Talking Progress – Eli Lilly & Company Quantified Self mHealth App Screenshots
Talking Progress (this name applies for UK & Ireland markets) is an application available for iOS and Android, that was presented by Claire Perrin on the recent Social Media in the Pharmaceutical Industry conference in London. Talking Progress is dedicated for adults suffering from depression. Using this app patient can record his/her mood to produce progress charts which can track the recovery and help inform discussions with the doctor. It is extremely important, as one of the symptoms of depression is lack of focus and gaps in the memory.
The app also contains useful hints and tips about lifestyle changes as well as information on causes of depression and treatments. Talking Progress Features:
Educational information about depression
Mood Diary
Note pages
Healthy living advice
Medicine reminder alarm
Together with an app Lilly provides a booklet for the patient and small information desk stand for the HCPs. Embedding quantified self elements (diary and note pages) with mHealth features (educational information, lifestyle advice and compliance reminder) makes this app a perfect companion for patients suffering depression. Providing HCPs with the information pack (they are supposed to “prescribe” an app) guarantees that the data gathered via the app will be used and understood by the doctor.
Quantified self in pharma marketing – an opportunity for everyone
It looks like the quantified self movement will stay with us for longer. Lilly’s example described above shows that properly used it may be beneficial for all – patients, HCPs and pharmaceutical industry. We can without doubt add payers to the list. Correctly applied quantified self is great way for prevention via changing lifestyle habits, increasing disease awareness and improving patient’s adherence to the prescribed treatment. Will we use this opportunity? Quantified self may save lives and money. It seems that even regulatory bodies are up to date with the trend, so the only thing missing is pharma marketers involvement. Do you plan to include quantified self and mHealth elements in your brand strategy?
On 22nd and 23rd of January in London I was honored to be a speaker at the Social Media in the Pharmaceutical Industry conference. Now back in Swiss Pharma capital city – Basel, let me summarize the key lessons on the social media in pharma industry I took back from the United Kingdom.
Social Network Analysis book cover (Photo credit: Matthew Burpee)First of all, the event itself was really worth to attend. If you heard alarm bells buzzing on the bullshit bingo sequence of social media in pharma, this time it would be a false alarm. Not because of my humble presence, but because of the other participants and the content of their presentations. The chairwoman of the event, my ex-colleague at Roche, now enjoying freedoms of the external consultant, Alexandra Fulford (@pharmaguapa) made sure that we were not lost on the way. Having said that, let us digest the content of the conference.
Social Media in Pharmaceutical Industry Key Learning #1: Social Media is not a marketer’s toy, but a source of powerful intelligence data. A Big Data!
A diagram of a social network (Photo credit: Wikipedia)My senior colleague from Roche, Dr. Alfred R. Steinhardt now in the hat of PA Consulting Group and his own Alfred Steinhardt Consulting, showed us an incredible power of the Social Media used not for standard “what they said about us”. Dr. Steinhardt provided example of social media used by pharmaceutical industry for recruitment to clinical trials (social patient). We could also see social media as a tool to identify and engage with Key Opinion Leaders (in this new world, aren’t they rather Influencers?) who do not necessarily recruit from academia as in the past. Maybe most striking, even if not the most common usage of Social Media was tracking origin of counterfeit drugs sold online. As we discussed after the presentation, Social Media is not such a big revolution as some pundits say and it will not replace scientific method with statistical analysis of huge amounts of data. Still it is an extremely useful tool that should be looked at out of plain pharma marketing perspective. Which was further confirmed by Dr. Sherri Matis-Mitchell, an Associate Principal Information Scientist R&D Information at AstraZeneca Pharmaceuticals. Dr. Matis showed us how Social Media, when properly used, can provide important answers to R&D teams in pharma industry and help identify unmet needs of patients.
Social Media in Pharmaceutical Industry Key Learning #2: Legal Team is not a threat (and can be a savior) for social media in pharma.
Let’s Make It Legal (Photo credit: Wikipedia)An eye opening presentation of Audrey Hagege, a Legal Manager and Todd Kolm (@toddkolm), VP and Head of Global Digital Strategy from Sanofi showed us not only what Legal Teams think about Social Media. Even more important was how distorted is an image of legal teams in the eyes of us, digital marketers working on social media in pharma. At the end it is easy – just let your legal or compliance officer know what you are going to do. They are in the organization to help and protect, and not to stop any activities. On the other hand, while social media in pharma is becoming more and more regulated, I had an impression that some of our colleagues are going dangerously close to the line. Ms. Müge Gizem Bıçakçı Akalın (@MGizemBA), a New Promotional Models Manager at Boehringer Ingelheim’s Turkish affiliate shared with us plans to promote a Facebook page of a feminine avatar with a name very closely resembling a brand of prescribed drug for menstrual pains. Is it already promotion and communication DTC, or still just a disease awareness campaign? Let’s hope Gizem has very good friends in her legal team and they are crystal clear about their legal framework.
Social Media in Pharmaceutical Industry Key Learning #3: Social media in pharma can be measured and data driven (but not always is).
Gary Monk (@Garymonk) from Havas Lynx and John Pugh (@JohnPugh) from BI shared similar thoughts on how to measure efficiency of pharma activities in social media. As we were sitting in the UK, for obvious reasons there were not much about direct impact on sales. However, we could see important metrics on the engagement. Both speakers provided some hints on what can be improved in Facebook and Twitter presence of the analysed brands, but it is not what is the most interesting from my point of view. What is more important is just an attempt to step back and look at those activities and try to measure them against each other. Then track what works and what is not. How your facebook page welcomes user? How fast do you respond (do you)? How often do you tweet? Do you follow others and do you retweet or share their posts? What makes Eli Lilly or Boehringer more successful in Social Media than in the market? We can find those answers, and we should as we are no longer pioneers in the social media. It is time to treat it as a serious communication channel with real budget and real targets to meet. The lessons on social media in pharma listed above are not a comprehensive list. I have learnt much more, and I am going to share those lessons soon on K-message in other posts. There were great examples of social media and digital in action. Mobile app helping patients to fight against depression (Claire Perrin), Catz against Asthma (Ben Furber@BenFurber), Knowledge database available online to HCPs thanks to Merck and their Univadis (Thibaud Guymard@thibaudguymard), I will not be able to mention them all now. But I can now say thank you to all participants, speakers, and SMi for making this event so inspiring. Thank you!
Pharmaceutical brands are not loved. Products of the pharma industry are saving lives every day (not to mention removing headaches of the day after). Still, an average John Doe is not grateful to the manufacturer. To be honest even if he knows the brand, he rarely likes it. Pharma is rarely connected to wellness or innovation, almost always to disease and its cost.
Why is that? The answer may be in something that pharma marketing is lacking. At K-Message we believe, that pharma brands are not understood by people. They are not understood, because they do not refer to archetypes.
12 Primary character archetypes English: Carl Gustav Jung, full-length portrait, standing in front of building in Burghölzi, Zurich (Photo credit: Wikipedia)
According to Carl Gustav Jung, a Swiss psychiatrist, human is not born with a clean mind or tabula rasa. Instead, we all universally share some embedded events, figures and motifs that are easily understood by anyone and that trigger unconscious reaction, similar to most if not all the people. Those universal patterns of mind are called archetypes.
Regardless of the philosophical questions about human nature, archetypes are extremely useful in marketing. Whether they are embedded in the human nature or learned through socialization process, the effect is the same. Archetypes allow us to build strong, appealing and memorable stories.
The concept of brand is intended to produce unconscious emotional reaction and attitude towards it and affect conscious behavior of target audience. Jung would tell, that brand has to influence psyche to react in a certain way. Archetypes are doing just that. Therefore if you want to make your brand narration efficient, you should look for the archetypes that are connected to reactions and attitudes you want to trigger.
There are 12 main archetypal characters, from which marketer can select the one that fits the best his brand. This will allow to focus content marketing on the story that reflects brand character. There are also so called archetypal events (ie. birth, death, end of childhood, creation of the world, journey or quest) and archetypal people (mother, father, old wise man, villain) that embedded into the story will make it emotional and moving for the audience.
Pharmaceutical brands for many reasons, including regulatory, cannot promote products with more than factual stories. However it is not forbidden to build their own image in a way that makes them more human. From 12 primary archetypal characters there are eight that are reflecting exactly what most of pharma companies would like to be known for.
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8 Archetypes for Pharma Marketing
The Innocent
Is the archetype that believes in a beautiful, protected world where everybody can be happy. It is full of faith and optimism. It’s greatest fear is to be punished for doing something bad. It is an archetype that looks good for all pharma companies, as at the end they want to eradicate disease. Vaccines may be the best example here.
The Orphan
Known also as a regular guy or the everyman, the Orphan believes in equality. It also wants to connect with others and does not want to be left behind or stand out from the crowd. This makes it great archetype for any generic drug manufacturer.
The Caregiver
The Helper is an obvious choice for Healthcare Industry, it is the one who help others. This archetype who shows compassion and generosity and fears of selfishness is like created for pharma marketers.
The Explorer
The seeker looks for the freedom to explore the world. This archetype fits to disruptive companies, to those who change old rules.
The Creator
The creator is an artist who can create valuable things out of a dream. What he fears of is the failure to deliver completed masterpiece. Doesn’t it sound like pharma development?
The Sage
This is the sage, the scientist, the researcher. The Sage believes in the truth and is always looking for it. The only thing he fears is ignorance. While this archetype sometimes is not able to act, it’s wisdom makes it perfect for innovation in pharma.
The Magician
The magician, known also as the healer tries to understand the universe and make dreams come true. What he fears are adverse effects of his action, but this archetype is also very close to what pharma does with its research and application.
Which archetype reflects your pharma company the best?
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To be clear, we are not sure whether we are born with embedded stories in our guts. It is more probable, following the Ockham’s razor, that archetypes are just a way of describing something that is shaped by our historical and cultural heritage. It does not matter, as what we can observe is that archetypes indeed are embedded in the best stories of our times. From Harry Potter and the Lord of The Rings to the Wolf of Wall Street we can see the figures and events as described by Jung and his followers.
As soon as you identify the archetype that fits your brand, you do not need to really tell anyone, just brief your agency having in mind what Jung discovered. What is the story behind the Archetype Character, what is it looking for and what are the values it follows?
Pharma marketing knows real stories about the most archetypal events of human birth and death, it is all about heroic fight against disease and looking for truth that changes world. It is hard to understand why looking for examples of branding with archetypes we never see pharma. Is it because pharma marketing does not ember those “magic” patterns in their stories. Why don’t we change it right now?
Federal Drug Administration (FDA) has announced its draft guidance on Social Media in Pharma. What question does it answer and what remains still unregulated? What are the consequences of this guidance and expected next steps?
English: Logo of the FDA. (Photo credit: Wikipedia)
When finalized this guidance will regulate all Internet activities of pharmaceutical companies operating in the United States. The guidance was long expected by the pharma industry. According to earlier announcements from FDA more comprehensive guidance shall be released by July 2014.
Main proposals of the new FDA guidance for Social Media in Pharma
Pharma companies responsibility for the content published in social media:
[box type=”shadow” align=”aligncenter” ]
A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.
Under certain circumstances, a firm is responsible for promotion on third-party sites.
A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.
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Pharma companies obligation to submit interactive promotional materials to FDA:
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At the time of initial display, a firm should submit in its entirety all sites for which it is responsible on Form FDA 2253 or Form FDA 2301. For example, the firm should submit the comprehensive static product website with the addition of the interactive or real-time components.
For third-party sites on which a firm’s participation is limited to interactive or real-time communications, a firm should submit the home page of the third-party site, along with the interactive page within the third-party site and the firm’s first communication, on Form FDA 2253 or Form FDA 2301 at the time of initial display.
Once every month, a firm should submit an updated listing of all non-restricted sites for which it is responsible or in which it remains an active participant and that include interactive or real-time communications. Firms need not submit screenshots or other visual representations of the actual interactive or real-time communications with the monthly updates.
However, if a site has restricted access and, as such, FDA may not have access to the site, a firm should submit all content related to the discussion (e.g., all UGC about the topic), which may or may not include independent UGC, to adequately provide context to facilitate the review. Screenshots or other visual representations of the actual site, including the interactive or real-time communications, should be submitted monthly on Form FDA 2253 or Form FDA 2301.
When submitting the site, FDA recommends that a firm take formatting factors (e.g., appearance, layout, visual impression) into consideration to enable the Agency to view the communications as a whole.
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What the industry expected to be addressed? Is it addressed with the new FDA draft guidance?
In general FDA has addressed two of five main points raised by pharmaceutical companies. Those are responsibility for the content published in the Internet and in Social Media, and 2253 Submissions requirements.
Internet control and 3rd party controlled social media responsibility
FDA has defined scope of responsibility for pharma companies. In general pharmaceutical companies are responsible for any content that they have control or influence on. Let us repeat the phrasing of the document:
[box type=”info” align=”aligncenter” ] Pharma companies responsibility for the content published in social media: 1. A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm.
2. Under certain circumstances, a firm is responsible for promotion on third-party sites.
3. A firm is responsible for the content generated by an employee or agent who is acting on behalf of the firm to promote the firm’s product.
[/box]
2253 Submissions
FDA requires all prescription drug labeling and advertising to be submitted at the time of initial dissemination through an FDA Form 2253. [21 C.F.R. § 314.81 (b)(3)(i)].
Until this draft guidance however, it was not clear what are companies obligations for submitting social media content. For the sake of security social media activities were limited to the safe topics and avoided mentions of any product. It may change now, as the guidance states clearly what and when should be submitted to the Agency. While industry may not be happy with the request to feed FDA with all User Generated Content that may be considered promotional, at least now everyone knows what to report.
What is left unanswered by the new FDA Guidance on Social Media in Pharma?
Space limitations and one click statement rule
FDA requires that every promotional material includes comprehensive information about the product, including safety information. Due to space limitation and “hypertexted” nature of the digital media, pharmaceutical industry developed theory of so called “one-click rule”. The assumption was that to meet FDA’s expectation it is enough to provide on the interactive promotional material a link to the website that would include required information.
This has been questioned by the Agency which issued enforcement letters to 14 companies who used Google display advertisement where risk information was available under “one-click”. In the following statements FDA declined existence of any one-click rule, but did not offer any alternative. New guidance does not refer to this aspect of the regulation. Therefore any promotional activities mentioning pharmaceutical products on platforms with limited message space ie. on Twitter are still not possible.
Off-label discussions
Another issue that is not addressed by the guidance is off-label use discussion. Promotional messages may not recommend or suggest the drug for off-label uses. Technically it means that anyone in relation to the company is not allowed to even mention any use of the drug that is not approved by FDA. Any response to such mention in social media by pharmaceutical company may be considered as suggesting and therefore promoting off-label use. As we are discussing here open communication channels available to general public, even scientifically valid and supported by pending trials question about any product use that is not approved has to remain unanswered. This limitation remains in force with the new draft guidelines.
Drug Safety and Adverse Events Reporting
Drug Safety or Pharmacovigilance is probably the most important reason why embracing social media in pharma marketing is so slow. It is extremely important (human life is at stake), and there are too many questions unanswered around it.
The first obligation is to provide possibility to report any adverse event to the public. For websites addressed to US-based audience it is usually solved by adding MedWatch icon/link, or easily available report form. In social media this is much more difficult, as there is no way to include such link in every message.
If the company engages in social media, should not it also proactively monitor this space for any possible adverse events? Companies are obliged to report any AE found within limited timeframe, but there is possibility that report is discovered long after it was posted online. It may be written in exotic language and not recognized immediately.
Another question is if the company is obliged to actively pursue any post that may be adverse event but does not include all necessary information for AER. If that would be the case the workload could be overwhelming. Another complication is when the post mentions generic name of the drug manufactured and distributed by many companies. Shall all of them contact the original poster to find out missing information?
Those questions remain unanswered with the draft guidelines.
What will happen next?
All interested parties can submit their comments to FDA within 90 days from the date of publication in the Federal Register (01/14/2014) to www.regulations.gov electronically or in written form to the addresses provided in the document. We also expect more comprehensive guidance as mandated in FDA Safety and Innovation Act (FDASIA) of 2012. Section 1121 of FDASIA orders FDA to, “issue guidance that describes FDA policy regarding the promotion, using the Internet (including social media), of medical products that are regulated by the FDA.”.
Although in his e-mail conversation with Regulatory Focus Stephen King, FDA’s spokesman maintains that the guidance released on 13 January 2014 actually meets the statutory requirements of FDASIA, FDA “plans to issue additional guidance for drug and device manufacturers related to the Internet and social media,” Those documents, according to the same spokesman: “Issues with character space limitations, links (the appropriate use of links), and sponsor correction of misinformation about their products disseminated by third parties.” We may then wait longer than expected for full set of regulations, but at least some steps have been done and we know that there is no need to submit every tweet to FDA before publication.
Full text of the FDA guidance: Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics Federal Register link
Approaching end of the year experts have two options to choose. The first and a safer one is to summarize past twelve months. The second, more dangerous but also more exciting is to predict what will happen next year. At K-message we find the latter option much more useful and interesting. Please enjoy our prediction of the Top 5 pharma marketing trends of 2014 below. Top 5 pharma marketing trends for 2014
1. Integration of digital tactics within multi-channel marketing. Leveraging Closed Loop Marketing and Big Data advantages by more mature organizations.
CLM – Closed Loop Marketing
For years digital marketing was treated as a fifth wheel in pharma business. Whatever we say, the truth is that those organizations are made of sales force. And digital marketing for sales force was just another marketing gimmick that does not add value but a workload and cost.
However, during past few years this traditional sales force thinking was challenged. Payers pressure forced companies to reduce ranks of sales representatives. Regulatory decisions have limited possibility of sales reps to meet HCPs. The result is that sales rep cannot meet his Client often enough to detail the product and maintain relationship in the same time.
Digital came to help with e-detailing and web-based self-detail solutions. CRM software supports reps with data that allow reps to have a meaningful conversation with HCPs they barely know. Combining detailing during visits with digital tactics and good old direct marketing is our new buzz word: a Multi Channel Marketing (MCM).
This Multi Channel Marketing approach allows even better results with something Pharma marketers call Closed Loop Marketing (CLM). What does it mean? It is a feedback loop that feeds every next action with the information gathered in previous touch points.
[box type=”note” align=”aligncenter” ]For example: If doctor X has logged in to the website of the product or disease area and searched for particular information (be it safety data or Mode of Action), his activity is logged in the system. Sales who will prepare for the meeting will get his eDetailing story focused on the topics that were of interest of doctor X during his journey on the website. eDetailing application also logs data about activity of the doctor X. It will note which parts were opened longer, which multimedia were presented, what answers doctor X gave to the quizzes embedded in the story.
Those data combined may be used to shape the content of personalized newsletter send to the doctor X as the follow-up for the visit. When doctor X clicks on the link and goes to the self-detailing website his activities will feed any next action that company can offer (be it web conference or CME online course assignment proposal).[/box]
The concept is easy to describe, but very hard to achieve. Big Pharma usually has many different tools for each activity used by different business units at the same time. The data gathered across different channels are not only not standardized, but often they are not gathered at all.
Our prediction is that 2014 will be the year of integration of digital with other channels. Multi Channel Marketing campaigns, made better or worse will become a standard approach. Digital channels will become a core of those campaigns as they offer the most advanced and effortless data collection capabilities. When integration is done, more mature organization will start to play with Big Data, looking for the behavioral patterns, segmentation and optimized content.
2. Virtual conferences
Medical conferences are vital for pharma business. Unfortunately the cost of attending is too high for participants, and regulations are limiting possibilities of the industry to sponsor the attendance. The emerging trend is to compliment (if not replace) physical meetings with a digital, virtual presence.
Virtual conferences have many advantages that may not be obvious. They are cheap to organize, free to attend, accessible worldwide, and they do not have to be limited in time. Additionally virtual conference attendee can go to all the sessions one after another, pause and replay. While in real time of the event, there is possibility to network and perform Q and A sessions. If the event is replayed there is also possibility to maintain asynchronous communication via discussion boards or e-mail lists. Virtual event can be live for months and create a community around.
Webcasting Virtual Conference – Source: ON24
There are still some regulatory compliance objections (ie. no discussion on off-label, still researched use can be broadcasted and replayed outside of the physical event timeframe). There is still a group of attendees that strongly prefer physical meetings due to networking opportunities and informal chats. Technical solutions are not perfect and most of 3D meeting environments look like a joke in comparison with what consumer market offers for massive multiplayer online games.
Still, virtual conferences will become a common digital marketing tactic for pharma marketing in 2013. We recommend an exhaustive presentation on virtual conferences by Len Starnes below.
3. Embracing Social Media
It has to come some day: Pharma in Social Media. To be honest this trend is on the list since 2010 at least. Anyway, the time has come we believe. There are many factors that make 2014 a year when pharma should finally embrace social media. 20111230 NodeXL-Twitter-pfizer network graph (Photo credit: Marc_Smith)
The major one is coming from the unexpected corner. Industry was long hesitant to enter social media space due to the drug safety consideration. If you participate in Social Media it means you need to actively monitor it against any adverse events reports. The standard practice was however, to assume that if pharma is not listening it cannot be obliged to report. On the other hand such assumption may be wrong, so as soon as there is a tweet that meets all four conditions, pharma company will be probably considered obliged to find it and report. Thus, we believe that drug safety teams should push their organizations towards monitoring of social media.
[box type=”info” align=”aligncenter” ] Reminder: information needed for valid Adverse Event
An identifiable patient
An identifiable reporter
A suspect drug or biological product
An adverse experience or fatal outcome suspected to be due to the suspect drug or biological product.[/box]
Another change that may increase Social Media priority on digital pharma marketing tactics list is Google’s algorithm. Social signals are more important than backlinks and Google+ or YouTube presence is a shortcut to the first page on Google Search results. If pharma wants to have their web presence visible, especially on the US market where DTC marketing is allowed, Social Media is a must have.
Third factor to consider is, well, social. The generational change in attitude towards social media affects HCPs too. They are active in Social Media, and they will talk about industry in this space regardless of pharma marketing presence there. At K-message we believe that big platforms, and especially Google+ will continue to grow in 2014 at the cost of closed niche communities like Sermo or Doctors.net.uk. To be efficient Pharma marketing should listen to the conversation, and engage whenever appropriate. Influencers of 2014 are in the social web, not in the conference room.
4. Mobile apps decline, raise of the mobile web.
This trend is not limited to pharma marketing. Mobile applications are really dead end for marketers in 2014. Due to the war of ecosystems and difference in mobile usage habits between regions and countries it is just not viable to create mobile applications. To reach your target audience you need to prepare few versions customized per OS, data usage etc. Very often such costly effort is done only to find out that the content not compliant week after launch and cannot be updated.
QRcode – K-message.com
Still, mobile is on the rise, and you will definitely see John Doerr’s abbreviation “SoLoMo” (Social, Local, Mobile) on some slides in 2014. The answer is not the app but the mobile web. The content pharma marketing has to create should work on the small screen from the beginning. Every new website should be designed starting from mobile and tablet experience or at least have a mobile version available. And “mobile” does not mean that it fits the small screen. It is about making the content fit for mobile experience.
5. More visual content marketing
Pretty Pinterest (Photo credit: mkhmarketing)
This fifth (although probably not the last trend you will see in pharma marketing 2014) trend is directly connected to Social and Mobile trends we discussed above. Content is the king for marketers in pharma for years, but in the age of social and mobile it cannot be text-only content.
On small screens and in social space image is worth more than thousands words. We will see videos, interactive infographics, images and animations. YouTube, Slideshare, Instagram, Pinterest. This is the content that is accessible on mobile, but also shared on social platforms. Of course pharma marketing cannot skip the text, but even for scientific, medical information there is a way to visualise it.
Gamification in pharma marketing is one of the hot topics of recent years. In this article you will learn what is gamification, see the examples of gamification used in pharma business (both marketing gamification and education gamification). We will also show the potential of social gamification, and try to show how to insert gamification into your app, website and other digital activities.
What is Gamification? Definition not only for Pharma Marketing.
One of the simplest and most appealing definition of gamification is: [box type=”info” align=”aligncenter” ]”Gamification isthe use of game design elements in non-game contexts” [Source: Deterding, S., Dixon D., Khaled, R., and Nacke, L. From game design elements to gamefulness: defining “gamification” (2011). Proceedings of the 15th International Academic MindTrek Conference: Envisioning Future Media Environments, ACM, New York.].[/box]
What does it mean? “Gamification” refers to
[starlist]
the use (rather than the extension) of
design (rather than game-based technology or other game-related practices)
elements (rather than full-fledged games)
characteristic for games (rather than play or playfulness)
in non-game contexts (regardless of specific usage intentions, contexts, or media of implementation).
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Game design elements can be divided by the level of abstraction, starting from using game interface patterns (ie. using badges or leaderboards), to game design methods (ie. value conscious game design).
game design patterns
game mechanics
game principles and heuristics
game models
game design methods
badge, leaderboard
time or resource limitation, player turns
clear goals, recognition of different game styles
Mechanics-Dynamics-Aesthetics (MDA), Core elements of gaming experience (CEGE )
Playcentric design, value conscious game design
Most applications of gamification in pharma marketing nowadays limits use of game design elements to the first three levels. It is relatively easy and a no-brainer to add some badge or status to the user profile in hope that it would increase activity or completeness of the data provided. On the other hand, using game models and designing user journey with conscious application of game theory may bring the highest level of engagement and the best conversion rates. As we mentioned “game theory” it is worth to explain this term as well. Basically, game theory is a study of how people make strategic decisions. The foundation of modern game theory is a classic 1944 work Theory of Games and Economic Behavior by mathematician John von Neumann and economist Oskar Morgenstern. Game theory tries to explain and provide mathematical models for decision making process. Using game theory in real life is difficult as the world does not provide to players full information, and “utility” or the prize in the game does not have to be considered equally by players. Still for the digital marketer game theory provides useful models to make some actions more attractive for users than others.
How to Apply Gamification in Pharma Marketing Campaign?
There are six essential elements of gamification that you can use to improve your key message delivery.
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Playful design. Going through your campaign should be attributed to the world of play, not work. Your audience should be attracted to the message because it is enjoyable for them, not because you paid them or they were ordered to participate. It is easier said than done, but you should make an effort to provide user with the environment that is not connected with daily work routine, use positive stimuli or feedback whenever possible etc.
Clear rules. Every game has its rules, and going through your message delivery should have it too. There has to be clear logic in how user goes through it
Defined objectives and intermediate goals to meet. Put within the message some smaller tasks that can be quick-wins for users, as well as a big hairy goal to be rewarded for at the end of the journey.
Competition. It does not have to be based on other players, it can be competition against time. Still leaderboards, badges and points are one of the easiest tricks that encourage participation and accomplishing tasks. On the other hand, this competition should not be too hard, unless you want players to drop-off frustrated early in the game.
Rewards. Provide a constant feedback in form of the rewards for accomplishment of the task (to encourage progress) or just staying in the game (to maintain user-retention).
Continuous challenge. Achieving each next step in the game should be bit harder. Otherwise the game would be boring. You do not want to make the tasks too hard either. Thus the best option is to make sure that level one prepares user for level two. If you properly match achieved skill with the next challenge the game will have a “flow” that will keep your users fully engaged.
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Looking at the list above, you probably noticed, that gamification as a concept must be embedded in the campaign even before the content is created or the channels and technologies of content delivery are selected.
Gamification in Pharma Marketing: Can We Do It?
Pharma marketing approach to gamification is somehow ambivalent. On the one side, gamification is a buzz word that flies around industry conference rooms. We see some examples of gamification in pharma marketing that worked or not, we also tend to call gamification activities that were just games, and we are bombed by the agencies who can name every product gamification as long as Big Pharma is going to pay for that. But when we flip the coin, there is this other side. In general it is not very inline with regulatory compliance to even think about “games” or “playfulness” in the context of life and death. Which is the usual context of pharma marketing. Even if you think about CME – your patient does not have three lives to lose in case his pathologist did not score well a cancer on the tissue sample. The questions remains: “Can we do gamification in pharma marketing? And shall we?” At K-message we believe, that pharma marketing not only should implement gamification, but it has an obligation to do so. This is especially because of the purpose of the pharma marketing job – we work to deliver the best possible treatment to the suffering patients. And if we have any means that can possibly help us in this task, ignoring it is equal to negligence. There is only one thing to keep in mind, the gamification, as every other marketing tactic in our toolbox, has to be implemented by in a professional way. It means it has to be done by a specialist, after careful consideration of all the campaign elements that we are going to gamify, and with a solid smart objective behind it. While researching for this piece we encountered many examples of pharma marketers being misguided. It is very important to remember
[box type=”warning” align=”aligncenter” ]Gamification is not “making a game”. Yes, even if this game is an application for the iPad.[/box]
Gamification is use of game design elements in non-game contexts. If it is a game only, it is not gamification. It is just a game. This common mistake makes plenty of examples of apparently successful gamification in pharma marketing just a gimmick.
Good and Bad: Examples of Gamification in Pharma Marketing
It is a pharma marketing game but not a gamification!
In the same time Boehringer Ingelheim has properly used gamification in their Predicting a Biological Response competition made with Kaggle. In the contest with a $20,000 awards poll participants were looking for a model to predict mutability of new, previously unseen compounds. Kaggle – Boehringer Ingelheim Study Similarly to Predicting a Biological Response, a good example of gamification that supports pharma R&D is a Cell Slider. This application was Cancer Research UK and Zooniverse. This simple app presents a snap of a tissue, blood cell or irregular sample with cancer. Users are able to classify samples. So far game uses breast cancer samples. The yellow stain indicates levels of a protein found in cancer cells called the oestrogen receptor (ER). Click to Cure – Cancer Research UK and Zooniverse Cell Slider
The job that would take months or years of work of trained pathologists is now crowdsourced. So far almost 2 million images were analysed and classified. Game provides a constant feedback and challenge varies depending on the sample. If user has a profile created, elements of game design are applied, including results saving.
Gamification in Pharma Marketing DTC
Another good example of gamification in pharma marketing is GoMeals, a set of applications developed for sanofi-aventis U.S. by specialized digital pharma marketing agency Intouch Solutions. GoMeals is created for people living with diabetes and promotes Sanofi’s diabetes drug Apdira. GoMeals® Application for Healthy Living
The app, available on the web and for smartphones encourages users to make healthy choices with features for eating healthy, staying active and tracking blood glucose levels. GoMeals allows patients to see how their daily habits impact their diabetes. It also provides HCPs with the ability to see how their patient is actually doing. GoMeals uses game design elements providing users clear reports on “burnt calories”, intake from their meals, and glucose readings. Another example from Sanofi is a gamification of diabetes tracking targeted to younger audience. A Monster Manor is a game for children with diabetes type 1, that encourages users to track their glucose levels. It is integrated with BlueLoop glucose tracker application. The app is created for Sanofi by Ayogo Health agency. IPhone Monster Manor – Ayogo.com
Every time children enter their BG information into the BlueLoop app they are rewarded with a “piñata” to crack open in Monster Manor. Piñatas are items with all sorts of fun inside, from “Beanz” that will help children collect more monsters, to “Gold” that will buy their monster new pets. Note that contrary to BI’s SYRUM this game has an effect outside of the game, as we gain better tracking and insights into the patient, so the whole game design was used in the context of diabetes tracking.
Gamification for CME
In the field of CME (Continuing Medical Education) gamification is seen as one of the ways to retain interest of the HCPs. One of the examples is Septris a web-based mobile application focused on Sepsis education. Created by Stanford University School of Medicine, Septris may be used on iOS, Android and from desktop web browser. To achieve its learning objectives it introduces a game in which user is diagnosing and treating virtual “patients” while learning about Sepsis.
Gamification in Pharma Marketing: Looking Forward
As listed above there are good examples of gamification in pharma marketing. We can all learn from them, but there is still a big room for improvement. Gamification in pharma marketing goes hand in hand with mHealth, and as mobile healthcare grows there will be more of game design elements in pharma marketing campaigns. Current focus of pharma marketers is on gamification in direct to consumer (DTC) marketing. Indeed gamification as a tactic can be very efficient in increasing patient compliance to the prescribed treatment. However this focal point has to change, as regulatory and compliance rules out such application outside of U.S. market for any branded activities. Disease awareness and prevention campaigns will always be worth the effort, but our prediction is that gamification may be more and more used in self-detailing and CME. So far we could not see any good example of game design application in e-detailing. We really hope that in 2014 we will start to see first integrated campaigns with e-detailing, self-detailing combined in one “gamified” design. At the end, if we want HCPs to self-detail themselves should not we make it a playful and rewarding experience?
Every December we can see plenty of ads with Santa Claus theme in the copy. One of the best this year is a disease awareness campaign for Alzheimer Nederland. Created by Dutch agency N=5 (Creative Director: Lukas van de Ven; Art Director: Hans Bolleurs; Copywriter: Paul Bakker) intensive image reminds the public what is a daily experience of people suffering Alzheimer’s disease. #paashaas disease awareness advertisement for Alzheimer Nederland by N=5
The ad quickly went viral on Twitter and made hashtag #paashaas [Easter bunny] a trending topic in the Netherlands by 5th of December. According to the N=5 it already gathered more than 900,000 impressions, which is a great result for a low-cost disease awareness campaign for such a difficult topic as Alzheimer’s disease in 16,77 million population.
Pharma marketing costs the most when it is not compliant to the regulations. Any unlawful or improper marketing campaigns in pharmaceutical can result in fines counted in billions of dollars. A report “Pharmaceutical Industry Criminal and Civil Penalties: An Update” by Public Citizen ranks the largest settlements by drugmakers, and shows these companies paid out 74 settlements to the tune of $10.2 billion from Nov. 2010 to July 2012. Public Citizen’s report does not include recent Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals settlement regarding Risperdal, Wellbutrin and Avandia misleading promotion.
Basing on the report of Public Citizen and U.S. Department of Justice data, K-message.com has compiled a list of top 5 most expensive failures of pharma marketing that resulted in heavy fines.
1. $3 000 000 000 – on 2nd of July 2012, GlaxoSmithKline LLC (GSK) has agreed to pay total 3 billion dollars to resolve its criminal and civil liability arising from the company’s unlawful promotion of certain prescription drugs, its failure to report certain safety data, and its civil liability for alleged false price reporting practices. There were three brands that GSK promoted against the law. Paxil (Photo credit: ~!)
The first, Paxil was unlawfully promoted for treating depression in patients under age 18, even though the FDA has never approved it for pediatric use. NB. Paxil, as other antidepressants, included on its label a “black box warning” stating that antidepressants may increase the risk of suicidal thinking and behavior in short-term studies in patients under age 18.
The second brand included in the settlement was Wellbutrin. From January 1999 to December 2003, GSK promoted Wellbutrin, approved at that time only for Major Depressive Disorder, for weight loss, the treatment of sexual dysfunction, substance addictions and Attention Deficit Hyperactivity Disorder, among other off-label uses.
The last brand involved was Avandia. In this case GSK failed to include certain safety data about Avandia, a diabetes drug, in reports to the FDA. Since 2007, the FDA has added two black box warnings to the Avandia label to alert physicians about the potential increased risk of congestive heart failure, and myocardial infarction (heart attack). [Source]
2. $ 2 200 000 000 – on 30th of August 2013, Johnson & Johnson and its subsidiary, Janssen Pharmaceuticals settled for 2.2 billion dollars in total multiple civil and criminal cases arising from allegations relating to the prescription drugs Risperdal, Invega and Natrecor, including promotion for uses not approved as safe and effective by the Food and Drug Administration (FDA) and payment of kickbacks to physicians and to the U.S. largest long-term care pharmacy provider. English: Risperdal (United Kingdom packaging) (Photo credit: Wikipedia)
Janssen Pharmaceuticals Inc., a J&J subsidiary, promoted the antipsychotic drug Risperdal to physicians and other prescribers who treated elderly dementia patients by urging the prescribers to use Risperdal to treat symptoms such as anxiety, agitation, depression, hostility and confusion. The medicine was approved at the time only to treat schizophrenia. Risperdal was also promoted for use for elderly, children and individuals with mental disabilities, against repeated FDA warnings (Until 2006 Risperdal was not approved for use in children for any purpose). For all this groups drug posed certain health risks that J&J was aware.
Similar allegations were made regarding to the newer J&J antipsychotic drug, Invega. Although Invega was approved only for the treatment of schizophrenia and schizoaffective disorder, the government alleges that, from 2006 through 2009, J&J and Janssen marketed the drug for off-label indications and made false and misleading statements about its safety and efficacy.
J&J and another of its subsidiaries, Scios Inc., caused false and fraudulent claims to be submitted to federal health care programs for the heart failure drug Natrecor. In August 2001, the FDA approved Natrecor to treat patients with acutely decompensated congestive heart failure who have shortness of breath at rest or with minimal activity. Government alleged that, shortly after Natrecor was approved, Scios launched an aggressive campaign to market the drug for scheduled, serial outpatient infusions for patients with less severe heart failure – a use not included in the FDA-approved label and not covered by federal health care programs. Scios had no sustainable evidence to support medical necessity of these outpatient infusions. [Source]
3. $1 500 000 000 – on 7th of May 2012, Abbott Laboratories Inc. has agreed to pay $1.5 billion to resolve its criminal and civil liability arising from the company’s unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective by the Food and Drug Administration. depakote (Photo credit: JTony)
Abbott admits that from 1998 through 2006, the company maintained a specialized sales force trained to market Depakote in nursing homes for the control of agitation and aggression in elderly dementia patients, despite the absence of credible scientific evidence that Depakote was safe and effective for that use. In addition, from 2001 through 2006, the company marketed Depakote in combination with atypical antipsychotic drugs to treat schizophrenia, even after its clinical trials failed to demonstrate that adding Depakote was any more effective than an atypical antipsychotic alone for that use. The FDA approved Depakote for only three uses: epileptic seizures, bipolar mania and the prevention of migraines. [Source]
4. $1 200 000 000 – on 11th of July 2012 a judge in Arkansas ordered Johnson & Johnson and its subsidiary Janssen to pay more than $1.2 billion in fines on Wednesday, a day after a jury found that the companies had minimized or concealed the dangers associated with an antipsychotic drug Risperdal. For details of the allegations see number 2 of this list. Risperdal case generated also other, smaller fines in Texas ($158 million), South Carolina ($327 million) and Louisiana ($258 million). [Source]
5. $950 000 – on 22nd of November 2011, an american pharmaceutical company Merck, Sharp & Dohme has agreed to pay $950 million to resolve criminal charges and civil claims related to its promotion and marketing of the painkiller Vioxx® (rofecoxib).
Rofecoxib (Photo credit: Wikipedia)
Merck’s criminal plea relates to misbranding of Vioxx® by promoting the drug for treating rheumatoid arthritis, before that use was approved by the Food and Drug Administration. The FDA approved Vioxx® for three indications in May 1999, but did not approve its use against rheumatoid arthritis until April 2002. In the interim, for nearly three years, Merck promoted Vioxx® for rheumatoid arthritis, conduct for which it was admonished in an FDA warning letter issued in September 2001. Additionally Merck representatives made inaccurate, unsupported, or misleading statements about Vioxx’s cardiovascular safety in order to increase sales of the drug. [Source]
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