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The Pulse of the Pharmaceutical Industry

Healthcare Agency Roundtable 2015

Written by: | andrew.humphreys@medadnews.com | Dated: Thursday, December 10th, 2015

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Executives from the 2015 and 2014 Manny Award winners and finalists share their views on a variety of industry-related topics.

 

1. Med Ad News: According to polling, only 1 in 10 Americans think pharma and the drug industry are “… honest and trustworthy.”  What can be done to improve this negative image?

Charlene Prounis, CEO and Managing Partner, Flashpoint Medica: Pharma’s reputation has been in a slide for over a decade (~15 years ago, pharma was still ranked among the top 10 most admired industries), largely driven by the poor perception of pricing policies/big profits, lack of transparency in corporate activities – how trials are conducted/data reported and marketing activities, off-label promotion/penalty fines and payments physicians. Much has been done to correct this, some through regulation, like the Sunshine act and others through corporate announcements that all trial data will be published, but generally, the public is unaware of these actions.

For pharma to right itself and regain the public’s trust, first and foremost, transparency is key – and that means more communication. Two areas emerge: education on research and education on the value of medicines. First, they will need to educate the public on the good they do in funding important research, as well as the economic activity they support in communities, and, second, educate on the value of new medicines in changing people’s lives.

Regarding the good they do, they need to get out the following type of messaging:

Simply put, people are living longer and more productive lives, and that’s what we all want. Five-year cancer survival rates are up 30 percent across all cancers, with 2 out of 3 people surviving at least five years, people with HIV/AIDS now live with a chronic condition, not a fatal disease, multiple sclerosis patients have dramatically improved outcomes with disability being tremendously slowed and hepatitis C therapies have cure rates of more than 90 percent. These are the miracles of medicine that the pharma companies have to remind the world about.

The value message needs to be heard with some of the key points being:
• Spending on prescriptions remains the same at ~10 percent from 1960; more has shifted to patients in terms of co-insurance, high tier status
• Pharma industry is #1 for R&D expenditures per employee, above all other sectors (chemical, semiconductor, computer, aerospace etc), so it is the pharma companies that are undertaking the responsibility of improving human health.
• Large economic reach supporting jobs – Biopharmaceutical industry supports 3.4 million jobs across the economy
• Industry-sponsored clinical trials contribute to communities ($25 billion in economic activity)
Source (PhRMA.org)

Regaining trust takes time and doing the right thing day after day, and communicating about it, will help pharma regain its rightful position as one of America’s most admired industries.

Ken Begasse, Co-Founder and CEO, Concentric Health Experience: This has been coming for some time. I remember sitting in a cab on my way to Pfizer in 2001 and hearing the first anti-pharma backlash story on NPR highlighting the role of DTC advertising, physician marketing practices, and the rising profits of pharma. As a young executive, I sat listening and silently implored our industry leaders to stand up, defend us, and help America understand all the good we do. Unfortunately, I’m still waiting, and the situation is more dire than ever.

At the turn of the century, 9 in 10 Americans had a positive impression of pharma; today, it’s 1 in 10. We know that history can provide some of the most powerful lessons for the present, and as I examined what was responsible for such a strong sentiment historically, my hope was renewed and my conviction galvanized that now is the time for the industry to regain the public’s trust and admiration.

When WWII ended, it ushered in the Golden Age of pharma. Novel drugs were being developed that changed lives. Vaccines were eradicating devastating diseases like polio. Contraception was introduced as an important tool in the women’s rights movement. We were exploring treatments for cardiovascular diseases and cancer. This was a period of resounding success.

The downside, of which we are all painfully aware, was brought to life in that NPR story. Pharma became “big business,” with a focus on blockbuster drugs and the marketing of disease states. Novel therapies fell away, and the flood of “me too” drugs hit the market. As a result, the public sentiment toward pharma plummeted.

The exciting news for industry leaders is that we have the tools at our disposal to reignite the love affair with pharma. It’s a simple formula, really – human ingenuity and collaboration, the advancement of science, and improving quality of life.

When you evaluate pharma against those criteria, consider the accomplishments and pending innovations that can drive us into another Golden Age. We have treated and are close to curing many cancers. A Hep C cure is in our grasp. HIV has been downgraded to a chronic disease. Cardiovascular disease and diabetes are areas where we see collaboration between diagnostic, pharmaceutical, and device players to create effective treatments. These will essentially be the rockets we can ride into the future.

Yet that is only part of the equation. More than ever, a company’s value is determined by customer sentiment. Turing Pharmaceuticals showed us that when your principles go awry, the public’s voices can unite and take you down in a matter of 24 hours. We have to change the public conversation away from profits and M&A to how we’re helping patients. We need to demonstrate how novel therapies and cutting-edge scientific advancements are improving quality of life and eradicating disease.

If we as an industry act on these principles – and act quickly – aligning with what people need and showing the world who we really are, I have no doubt that Americans will fall in love with pharma all over again.

Stefan Armstrong, Partner and Director of Analytics, Greater Than One: Many of the problems with perception of the pharma industry are related to the fact that the pharma industry has let itself be promoted by advertising agencies that do not understand medicine, and confuse consumeristic value propositions with the values and ethics of illness and recovery, death and struggle. Consumer advertising is based on the pleasure principle, eros, a fundamental drive of human experience. Pharma is based mostly on the corresponding principle of thanatos, what has ungracefully been translated as the death drive, but is more accurately translated as reality- and meaning-based values.

An example of this in practice: If pharma would embrace explaining the risks of their products as opportunities rather than as threats, demonstrate more respect, interest and provide solutions for the way their treatment fits into the patient’s overall journey, we believe this would win over countless Americans.

Michael Schreiber, President, AgencyRx (part of  The CDM Group): The pharmaceutical industry has always had to reconcile the costs of medicine with the gargantuan investment needed for scientific advancement. Therein lies the public’s frustration: a misconception that industry is purely motivated by financial objectives, and not by research and development of therapies that address the high-unmet medical needs of patients. We can only improve that perception by being much more transparent, and by putting the needs of patients first.
For starters, our industry has to initiate and embrace greater data transparency. Proactive data sharing builds trust, and even creates opportunities for more insight. We’re living in the Internet Age and the time of Big Data; there’s simply no hiding. The more that data – the good, the bad, and even ugly – is made available to the public (and especially HCPs), the more we can close the trust gap.

Wide scale open-source data sharing is also a great way to fuel the industry and help propel future R&D. In fact, pharma companies might consider their own “Big Data R&D” groups. If clinical and data scientists had access to all data (not just their own), they might find useful answers or insights that advance medicine without even having to fund a new trial.

The second area in which we can re-earn the public’s trust is through patients. Every company we’ve worked with has patients at the center of their mission statement. I’m not questioning the sincerity of this sentiment … but actions speak louder than words. The industry must be more genuinely patient-focused, more relationship-focused, and less transactional.

Our clients and we must act as though patients are in the room with us at all times by asking ourselves: “How will this improve patients’ lives? How will this lessen suffering? How will patients be able to access this innovation? How can we be clear about the value of this innovation?”

We also have to help people in their disease journey. Drugs are a key part of the solution, but developing adherence and wellness programs that help patients live better over time can have the greatest positive impact on a company’s reputation. Adding real value through programs that do this serves the industry in two ways – by demonstrating a genuine commitment to patients’ health, and by ensuring that patients realize the full therapeutic potential of their medicine.

Kristine Ryneska, Strategist, MicroMass Communications: Research shows that consumers tend to judge brands the same way they size each other up. According to Chris Malone’s and Susan Fiske’s book, The Human Brand: How We Relate to People, Products and Companies, consumers base their perceptions largely on 2 aspects: 1) their beliefs about a brand’s intentions and 2) the capability of the brand to carry out those intentions. This notion of connecting brands with consumers isn’t new. And in the age of social sharing, where every move a company makes can draw commentary from the masses, the pressure for brands to behave in a decent and caring way – and to treat their customers the same – is now greater than ever.

When brands act this way, the brand is rewarded with praise from consumers and perhaps even more, consumer loyalty. When brands act differently, the backlash can be harsh and may leave a lasting mark. For instance, think of the public outcry when pharma executives drastically, and without explanation, raise the price of generic drugs.
Unfortunately, it’s this behavior that has reinforced suspicions that the pharma industry does not have our best interests in mind. The public perception is that drug makers enable price-gouging, and sometimes even inflict greater harm – like holding back on finding cures to earn endless profits from their brands.

It seems like a tall order to rebuild this reputation. But actually, it’s an optimal time to tackle that challenge. With the communication channels that are already in place, the public seems willing to listen to what brands have to say and engage in conversations that can actually help brands help themselves.

So how does a pharma company go about acting like a decent and caring human being? Here are a couple of good places to start:

1) Get personal. A recent IBM study revealed that 4 out of 5 consumers feel that brands don’t really know them. With the amount of consumer information available to companies today, this isn’t acceptable. For patients to trust pharma, they need to believe that the companies know and care about who they are as individuals. Pharma needs to move beyond demographics, psychographics, and media preferences, and make an effort to understand patients on a deeper, more personal level. They need to uncover what shapes patient perceptions and motivates patient behaviors when it comes to taking their medication and improving their health. If pharma can address those underlying behavioral drivers, the upside could extend well beyond building trust in the brand. Patients will be more inclined to interact and respond to content or services because of their personal relevance. This increased interaction will be more effective at driving patient engagement, which will help drive better outcomes.

Having a deeper understanding of the patient is an excellent first step toward achieving something even more beneficial: patient-centered care. Putting the patient first in every decision on the surface seems like a selfless act – a company putting customers’ needs ahead of their own. But, let’s be clear, patient-centered care is not a zero-sum game where the patient benefits at the expense of the business. On the contrary, when it’s executed correctly, patient-centered care should establish a win-win paradigm, where business goals are inextricably tied to patient needs.

2) Embrace transparency. Transparency is another buzzword that is less frequently mentioned in the drug industry. But if any industry could benefit from more transparency, it’s pharma. The equation is proven: openness breeds trust. But who is willing to trust a company that hides information? In fact, the notion of transparency in pharma seems counterintuitive based on its reputation.

The Sunshine Act provides the pharma industry with a great service. Pharma is now forced to be more open and honest about the extent and nature of payments made to physicians. But while this transparency is government-driven, there are initiatives that drug companies can voluntarily undertake to help build public trust.

One way to be transparent is through social media engagement. Social media provides a forum for interpersonal and individual interactions, but allows for content control. Social media facilitates an exchange of information between the company and the patient, giving the latter an easy and familiar way to ask their questions, state their needs, and even offer criticism. This approach may seem too risky for an industry accustomed to pushing carefully crafted messaging to audiences primarily through 1-way channels. But while those communication approaches may feel safer, they won’t help build trust in a company. Thankfully, there’s enough FDA guidance around social media now that, when combined with thoughtfully drafted internal governances and community guidelines, pharma should feel comfortable exploring this exciting medium.

• Social media permits companies to quickly admit and correct their mistakes.
There’s nothing more humanizing than a company that is willing to say, “Sorry, we were wrong.”
• Even with regulations, drug companies have more latitude and are actually expected to act more human in social media. In fact, it’s one of the best forums for expressing personality and exposing intent. The more genuine, the better.
• In social media, the assumption is that there is an individual (or team of individuals) posting a brand’s content, responding to comments, etc. This perception makes faceless corporations seem less intimidating and more accessible. And, it can help patients feel more comfortable interacting directly with a large drug company.

The late motivational speaker Zig Ziglar once said: “If people like you, they will listen to you. But if they trust you, they will do business with you.” If recent polls are any indication, then they confirm that the pharma industry still has work to do to rebuild its reputation and regain the public’s trust. It’s a challenging task, but not insurmountable. If pharma can make an effort to really understand patients as individuals and engage with them in a more direct and open manner, they will be moving in the right direction.

Stephanie Berman, Partner, The Bloc: It has been quite a month for pharma. In the space of a few short weeks, Turing hit the public consciousness when it increased pricing for Daraprim by over 5,000 percent, a scandal followed quickly with price-gouging accusations against Valeant. Novartis just settled its specialty pharmacy kickback lawsuit to the tune of $390 million, as a former Sanofi paralegal accused her former employers of destroying documents rather than presenting them as evidence in a trial. Is it any wonder the public is horrified?

And what a shame, because it completely overshadows the very real difference that most pharma organizations and their employees are making in the lives of the patients that they serve.

So what’s to be done? First of all, there is a phrase that has been floating around every pharma company over the past couple of years: patient-centricity. It’s the phrase-of-the-moment, but it’s time for it to be way more than that. It should be truly internalized so that it guides every decision and action throughout an organization. If the question becomes “what is best for our patients” instead of “what is best for our shareholders”, then pricing, access initiatives, negotiations with regulators, marketing, and sales operations start to look very different. Stronger relationships can be built with NGOs and patient advocacy groups, and above-brand initiatives that deliver real value to customers then become the norm. To be clear, this does not lessen responsibility to shareholders; it enhances it. Reputation has a marked and measurable effect on share price. Start with serving the patient, and the rest will follow.

Secondly, the industry could do a better job of communicating its worth. Educating around drug cost-drivers, taking a vocal stance on ethical issues, celebrating patients whose lives have been positively affected – there are opportunities to transparently share the other side of the story. Even better, look for ways to have the validation come from customers and stakeholders that have been honorably served. Like all PR, way better to have someone else toot your horn than honking it yourself.

Steve Wray, CEO, Cadient (a Cognizant Company): Which industry spends more than $10 billion a year rigorously testing its products with more than 1 million customers across all 50 states, and yet consistently rates as one of the least respected industries in the nation? The answer is obvious – and we live with the implications of that ironic situation every day. Car manufacturers routinely advertise their safety testing; food companies tout the natural sources and health benefits of their organic products, and even razor companies demonstrate the advanced technology behind a safe shave. However, pharmaceutical companies have seriously failed to create equivalent campaigns highlighting the seriousness and rigor of the clinical trial testing process. If the general public could begin to truly grasp the enormous scientific effort, investment and genuine spirit of goodwill that goes into clinical trial testing, there would be a marked improvement in how the industry is perceived.

Related to the scientific rigor of clinical trials, the pharmaceutical industry could also benefit from taking a cue from Silicon Valley, where although companies enjoy enormous profits, they are still lauded and celebrated because of their advanced technology and 21st century impact. Today’s pharmaceutical breakthroughs – especially with the emergence of specialty biotech innovations – are every bit as dramatic as the latest Apple iPhone design, and are certainly worthy of equal attention, publicity and widespread acclaim. Controlling diabetes. Saving people after heart attacks. Eradicating rare tumors. Solving the challenge of deadly antibiotic resistance. Each of these innovations has the potential to save and improve lives – which should be a compelling reason to reshape the public’s perception of 21st century technology-driven biopharmaceutical innovation. Perhaps we should paint a very clear picture of what the quality and expectation of life without these breakthrough medications might be.

Stan Woodland, CEO, CMI/Compas: There’s very little public view into the R&D process, specifically the level of investment. Maybe as part of a push to improve transparency, pharma companies should promote the investments that they make into critical discoveries, including how few actually make it to market, and the fact that it doesn’t get them to stop continuing to invest in trying to improve health in our society. If you consider the cumulative investment that’s made in R&D in the various disease areas where companies are trying to find cures and improvements and then divide by the number of people it impacts, that’s a meaningful investment they’re making.

James Woodland, Chief Operating Officer, CMI/Compas: Increasing level of transparency is a positive trend that should continue. Pharma companies can be selective about what they’re proactively transparent about, and still improve their image.

Robin Shapiro, President, Corbett: The pharmaceutical industry is working hard to rebuild its image, most notably through an increased focus on patient-centricity – doing a better job of meeting the expectations of patients and patient groups, who are pharma’s key stakeholders. Companies have a better understanding of patients’ needs through active collaboration with patient organizations and advocacy groups. Companies are creating more personalized, focused, educational materials (not just marketing materials) and opening up the dialogue with patients through social media; and, where needed, through offering cost-effective patient access to drugs.

Another area of focus that is gaining momentum is the push to make health industry data more transparent. There are new initiatives making data publicly available, including previously closed clinical trial data, patient real-world outcomes, and financial relationships between physicians and pharma companies. Examples include the following: pharmaceutical and medical device manufacturers are contributing clinical trial data sets to Project Data Sphere (open to anyone with an Internet connection) and the Yale University Open Data Access Project. In 2014, the FDA launched the open FDA initiative, providing a public database for analyzing drug and medical device adverse events, recalls, and labeling information. Patients and physicians can search the data sets to examine the real-world frequency of side effects associated with specific products. In September 2015, the FDA’s Open Payments Law (formerly the Sunshine Act), went live. Open Payments makes public, for the first time, the financial relationship physicians have with the drug and device industries.

Christopher Tobias, PhD, President, Dudnyk: The pharmaceutical industry does so much around the world to help with social and medical good. It is unfortunate that there is such a halo of negativity surrounding a sector that has such tremendous possibilities for positive impact.

Because the pharma industry is so heavily regulated, however, there is a powerful history of reservation and conservativism when it comes to communications about research, therapies, marketing, and patient outcomes. In turn, this has hampered the industry’s consideration and adoption of the most inventive marketing strategies and methodologies. At the same time, educational deficits in this country continue to rise. Science, medicine, product commercialization, statistics and success measurement are all complex subject areas that the majority of the U.S. population does not well comprehend. The dispensation of inaccurate information through the internet and social media is not regulated or validated in any meaningful way. Furthermore, the ACA age begs questions about pharma pricing policies and the complexities of tiered coverage. Adverse event news can be misconstrued in the media, and the legacy of pharma companies leveraging healthcare professionals (thought leaders) “on payroll” is a dark cloud that still looms. It is no wonder that pharma is not considered honest and trustworthy.

The solution is really quite simple: Actions speak louder than words. Pharmaceutical companies should do good and promote that. In general, the pharma industry (like many other industries) needs to acknowledge and adjust to massive shifts in the marketing and selling environment. It needs to understand brand strategies that have to do with purpose rather than selling and messaging to products themselves.

My favorite recent example of this comes from outside the pharma/healthcare space: Volvo.

Volvo has always stuck to its roots in remembering that cars are driven by people. The company’s vision is a great one, well articulated and true to the definition of vision: No one dies or sustains serious injury while driving a Volvo. Motivated by its vision, Volvo Cars introduced LifePaint – a water-based reflective safety spray for bikers and walkers, which glows brightly in the dark when in the direct glare of car headlights.

“Our job isn’t just to advertise our clients,” said Nils Leonard, chairman and CCO of Grey London, “it’s to help them make a positive impact on culture. With the creation of LifePaint, we’ve turned Volvo safety inside out, giving it away to the most vulnerable road users. What more positive action can a brand take than to try to save lives?”

All customers are more likely to trust products that come from a company they care about and believe in. Brand purpose underlies big ideas in action, really showing customers and not telling them. All the research, resources, thinking and passion that goes into bringing a therapy to market to possibly help people – this is what buyers and stakeholders will trust. Pharma, by and large, is an industry that is born out of trying to do something good to make sick people well. Yes, products must be sold in order to support ongoing research and turn a profit for shareholders. Products will sell as a result of doing something wonderful, inspiring and worth talking about. Sometimes the best advertising doesn’t walk, talk, or act like advertising. Rather, it’s authentic and honest, and in turn, generates trust.

Ed Mitzen, Founder, Fingerpaint: Companies should collaborate to earn the public’s trust. A drug company’s primary reason for being is to eradicate disease and improve patient care. Get the CEOs from the top four diabetes manufacturers (as an example) to stand together and communicate in a united front all the progress that has been made over the years, as well as the exciting advancements on the horizon. The public doesn’t care about individual manufacturers. The drug firms must unite and remind the public in a thoughtful, compassionate way of the advancements that are making the human race healthier.

Christine Armstrong, Managing Director, Brand Experience, Giant Creative/Strategy: Honesty and trust will grow when Pharma invests in better understanding the barriers to access and adherence. Patients most often don’t look like the patient in the ad or website. There are many cultural, economic, and behavioral aspects to consider. Programs, narratives, and communication channels need to be put in place, both personal and non-personal, in community settings with regional considerations. Pharma needs to better convey to their patients that they understand them and can customize to their needs.

Jonathan Peischl, SVP, Director of Innovation and Digital Marketing, Giant Creative/Strategy: Pharma and the drug industry are trapped between the capitalism that has fueled innovation in medicine and the right to health and well being that has been established as the government plays a greater role in access to care. Pharma and the drug industry are being held to a new set of standards and there’s no getting around it. The best move for the industry at this point is to act with total and complete transparency to the public. The rationale for drug development programs, pricing, investments in marketing, etc. must be clearly communicated to the public.

Dave Sonderman, EVP and Executive Creative Director, GSW: GSW is driven by a belief that all people – patient, caregiver, prescriber – prefer to be communicated with like real people. And, it’s true that the pharma industry struggles with communicating in authentic, human terms. The messy imperfectness of real life has trouble finding a foothold in the clinical clean rooms and statistical safe rooms of the healthcare industry. So communications can feel confusing at best, condescending at worst.

To see this in action, GSW created a real-world experiment (wespeakpeople.com) to see what would happen when everyday people were confronted with a clinical healthcare rendition of the most commonplace brand experiences. The Speak People Experiment involved a hidden-camera takeover of a coffee shop, restaurant and flower shop to show what happens with simplicity, authenticity and stories go missing in brand communications.

It’s an easy crutch to blame the regulated nature of healthcare. But even the FDA recognizes the industry can do better. Recent draft FDA guidelines for consumer print advertising place a heavy emphasis on communicating with simplicity to create better understanding of health benefits and risks for patients. In imagining a new “Consumer Brief Summary” for instance, the draft guidelines recommend that risk information be prioritized and thoughtfully designed using whitespace rather than the typical densely formatted text. The draft cites examples from consumer over-the-counter packaging.

It almost sounds too basic. But simplifying the complex and relying on the basic human communication construct of storytelling can help any brand or industry feel authentic and genuine.

Boris Kushkuley, Executive VP, Intouch Solutions: Over the past several years, pharma has been redefining the business they’re in. Is it selling drugs alone, or is it a combined approach with measurable outcomes initiatives and the end goal of making people healthier? I think the answer is clear. Today, long-term outcomes trample old-school clinical-trial endpoints focused on drug efficacy and safety. Long-term quality-of-life measures, readmission rates and the ability to keep patients compliant to medication have moved to the forefront.

With a renewed focus on personalized and precision medicine, our industry is embracing this change and facilitating additional services – patient education, behavior modification, counseling about diet and exercise – that are often needed in conjunction with medication itself. This shift allows us to demonstrate our continued commitment to improving health for all stakeholders, including patients, caregivers, physicians, payers and policy decision makers, and will do much to change the public perception about the pharmaceutical industry.

Anshal Purohit, EVP, Strategic Development, Purohit Navigation: As we all know, there are many factors impacting the negative view of pharma to the average American. Of all, I believe that the perception of lack of access is at the forefront of this issue, and drives much of the negative judgment that trickles down to things like DTC advertising, pharmaceutical sales, and overall industry spend. It is inherent that most people believe health as a public good – it is something we all need, and should have access to. There has been an abundance of communication indicating that industry is working against this view, pricing products ‘too high’, and making coverage ‘too difficult’. When consumers hear about the astronomical costs of medicines, and then see well-produced DTC advertising in prime time, they walk away with the feeling that pharma’s interests are not actually in line with the good of the people.

This view is further supported by actions like the recent AMA request to ban DTC advertising.
I believe that a strong focus on disease awareness and access support can work to turn this perception around. Disease awareness campaigns can serve to educate and fulfill unmet market needs; access programs can show that pharma is as invested in public health as the average American – and both can serve to improve industry reputation in the process.

2. Med Ad News: Research shows that two-thirds of new medicines do not meet pre-launch consensus sales expectations during their first year on the market. What are the factors behind this?

Jay Carter, Sr. VP, Director of Strategy Services, AbelsonTaylor: Even if your brand is a true breakthrough (think Sovaldi, Harvoni, Opdivo, and Keytruda) the time to arrange for payment has increased. If your brand is NOT a breakthrough (no names need be mentioned), it will take even longer to make sure that access happens. The biggest change in the launch of products is a good one; drug development teams are increasingly including health economics outcomes data into the development plan.

Maureen Wendell, Managing Director, PALIO (an inVentiv Health company): Several factors can slow a drug’s launch trajectory. One factor could be lack of focus. Strategy is about making choices – it’s the great art of sacrifice. Frequently, companies set their financial sites so high they lose sight of the core target audience or the desired behavior. They want the PCP and the specialist; they want the patient who is new to the category along with the dissatisfied patient looking for a change. Oh, and let’s not forget about the caregiver! Those audiences have different needs and those behaviors all have different drivers. To the extent your communications platform stretches to accommodate all, it becomes diluted and impact is lost. Changing beliefs and behaviors is a tough business – when you dilute your brand story for the sake of volume, it becomes downright impossible.

Another factor could be lack of thinking time. Ideally launch planning begins in phase II, following proof of concept for a molecule. More and more, we see clients coming to us with 12 months to go until launch. Not only are phase III trials (and therefore claims) locked, there is insufficient time for exploration around brand strategy, positioning and creative. While a year may seem like a lot of time, when you factor in stakeholder alignment, market research time, and several rounds of regulatory discussions, it’s a tactical race to PDUFA that can short change a brand’s potential.

Rob Peters, SVP, Strategy, MicroMass Communications: It is not surprising that most new drugs fail to meet sale expectations in the first year after launch. While many people would point to generic competition, coverage challenges from managed care, or limited sales rep access as some of the reasons for not meeting sale expectations, the real reasons are likely due to stubborn adherence to traditional drug development and marketing strategies.

Pharma has slowly made strides to operate in a more patient-centric fashion, but drug development still lags behind in this trend. Most drug development is focused on identifying the clinical potential of molecules in the pipeline, designing clinical trials that optimize the likelihood of statistical differences against comparators, and delivering clinical data that result in regulatory approval. The missing element is to better understand why patients aren’t achieving better outcomes on existing drugs. Too often, pharma believes that new MOAs or better clinical profiles are the key to optimizing results. However, more often than not, the barriers to better outcomes are found in the knowledge, motivation, and skills that physicians and patients both possess. Until pharma recognizes these intrinsic challenges that their customers face and helps to address them, pharma will continue to develop drugs that fail to deliver on their commercial potential.

Marketing strategies often do not do enough to address these fundamental patient and physician factors in new drug launch plans. The traditional approach to pre-launch marketing involves disease education and awareness campaigns for patients and publishing clinical data for clinicians. However, what often happens is that customers are unprepared to adopt and utilize a new drug successfully because they still lack fundamental motivation and skills that are needed to initiate and manage a new treatment option.

Pharma has a great opportunity to turn around the current trend of disappointing sales performances by adopting a few relatively simple changes to their development and launch strategies. By incorporating deeper insights about patient and physician behavior into drug development and launch-marketing strategies, new drugs can be introduced that are more aligned with real-world needs. When pharma companies incorporate marketing plans that go beyond basic awareness and actively change underlying behavioral barriers, the clinical promise of new drugs can be better realized, leading to greater commercial success.

Chuck Wagner, President, CDM Princeton (part of  The CDM Group): About 400 new products are forecast to enter the market over the next 3 years. Some will offer impressive clinical data, leading investment pundits to claim that these products will change the way medicine is practiced and fortunes will be made. Not so fast.

Only a few of the entrants will have such an immediate impact. A recent analysis by McKinsey suggests that many of those products appear to be only moderately differentiated, if at all, from the current standard of care. Those products will succeed only with insightful and very deliberate positioning. On the other hand, roughly a quarter of new drugs will indeed offer a significant advance in disease treatment. Those, however, are often priced at levels that challenge market perceptions of value – especially in an age of government austerity.

Unfortunately, past examples of launch success aren’t helpful, because markets and launch behavior have changed considerably. It was not that long ago that treatment decisions were controlled by physicians and patients. That simply is not true anymore. A successful product launch must now consider the beliefs of an entire ecosystem of influencers – including key opinion leaders, payers of all types, advocacy groups, and the community at large. Failure to properly plan for and integrate each of these points of influence can have a nasty impact on a launch brand’s performance. Most critically, investment in value development – what the real value of the new therapy is for each of these groups – must begin earlier in the development process.

Another trend affecting launch success has been the speed to commercial launch. Under pressure to demonstrate a rapid return on their investment, companies are short-changing launch preparation. In the past, brands would not launch until all commercial planning was complete. Today, many brands are introduced to the market within hours of label approval. Marketers have coined this pivotal moment as a “PI launch.” Actual brand-positioning efforts can be delayed by months, in some cases leaving market influencers to develop their own impressions – with little positive input or framing of value. In fact, competitors are often more prepared to shape the early dialogue about launch brands that the brand itself.

It remains true that a brand has only one opportunity to launch. Today, the more we can help marketers prepare for post-label approval – and do this effectively with a clear value story across the full ecosystem of influencers – the better the chance for success.

Art Chavez, Partner, The Bloc: Factors may include underinvestment in market preparation. The foundations for differentiation and value stories should start to be set well before approval. An overestimation of market access success levels (insurers accepting the drug at a lower tier) or the ability of co-pay discount cards to neutralize formulary decisions and timing may also contribute to this trend. For many launch products, there has been a tendency to communicate a broad range of features rather than selecting a key area to own and build upon for differentiation. This has the effect of diffusing the impact of a product’s strongest message by blending it in with several other messages.

Another factor may be related to the reliance on market research to drive uptake estimates. Market research feedback should be tempered because “likelihood to prescribe” ratings don’t always reflect actual behavior.

A final factor – and perhaps the biggest one – is the underestimation of the inertia that a new product will need to overcome in a satisfied market. The biggest challenge facing most new brands is the need to displace any part of a prescriber’s “personal formulary.” To do this requires a clear-cut, persuasive rationale and time to deliver to effectively, which in turn may extend the uptake curve well beyond year 1.
 
Dr. Susan Dorfman, Chief Commercial Officer, CMI/Compas: Sometimes there’s a disconnect between pharma expectations and Wall Street expectations. There are many different factors you must account for when setting goals, including adoption curve, audience, managed care restrictions, formulary coverage, awareness, the list goes on and on.

CENTRON Team: Agencies, of course, work with a wide range of clients and brands, and have seen this phenomenon play itself out a number of times. What’s at play? Sometimes there’s an over-estimation of the unmet need that gets caught up in the client’s enthusiasm for their brand – they are, after all, the champion of the brand. As therapeutic categories have become more saturated, and the magnitude of clinical differences may have decreased, there is still a sense of optimism and possibilities that gets infused in every launch. In that ownership process and optimism, the realities of the appetite the market may have for your drug may get clouded. It’s often very difficult for teams to deliver a forecast that is modest – but realistic. Trying to look at upsides, stretch goals, and leveraging all your tools to make those forecasts a reality is a much more engaging and motivating approach – and is an approach that’s embedded in any company that has products they want to be successful.

Taking a more modest – albeit realistic – approach, and assessing what the impact might be of the biggest barriers to faster and more uptake – can be both difficult to quantify – and also a difficult message to deliver to management. So forecasts remain optimistic – with the hope that a well-orchestrated launch plan, with all the necessary pieces in place, can mitigate some truly challenging barriers.

On the other hand, we’ve seen clients who are pretty plugged into the barriers and challenges they are walking into – and have set very realistic, achievable sales targets – and exceeded them. So maybe trying to overcome these hurdles and exceed a forecast is more motivating that trying to stretch for something that seems very hard – virtually impossible – to achieve.

Anshal Purohit: There are several factors that can contribute to this dynamic, but two that we see most commonly are:

1) Access-based performance suppression: Though projections typically include access-related inputs, the market has increasingly underperformed even the most conservative of estimates in this area. Access programs and rebate cards have become price of entry, and companies are beginning to see the need to innovate beyond these ‘block and tackle’ tactics.

2) Lack of comprehensive communications plan: So many brand teams are thinner than ever, multi-tasking in ways that they never had to before. As a result, we see more and more launch plans being handled in a piecemeal/ad hoc fashion. Even when a comprehensive plan is formed, it is increasingly difficult for brand managers to execute against the full plan based on bandwidth alone. Leaning on partners to supplement workload and ensure that projects move as they should is becoming more critical than ever.

Ed Mitzen: Managed care and prior authorizations are ensuring that expensive me-too drugs aren’t utilized. It isn’t enough that you lower side effects by 10 percent or reduce some other marker by a small amount. If the drugs aren’t truly different and advancing the treatment significantly, people aren’t going to pay for them.

Ken Begasse: There is a very finite window in which to make an impact when it comes to launching a new medication, so a robust pre-launch and launch strategy is imperative; without it, you’re dead. That’s the story behind this statistic. Luckily, there are many ways to avoid crashing and burning upon launch, and one of them is to avoid hurrying. Speed is always a factor, but you have to make sure you are sufficiently conducting market preparation as you move toward launch. Educate the marketplace, interface with your constituencies, and incorporate their feedback.

FDA approval delays or post-launch changes are additional launch realities that must be addressed expertly. Scenario planning is key. In the months before a medication hits the market, every single player in the launch should collaborate on a roadmap that identifies – and solves for – every likely eventuality. This way, the unknown can be (mostly) known, and you are prepared for the obstacles that nearly every launch faces.

Stan Woodland: I’d look first at target audience selection as the culprit. Is that target audience large enough and the right audience to help them reach that revenue goal? We often find that initial revenue goals don’t match up to what the chosen target audience will support. We counsel our clients to be open to two things – looking at target audience in a different way, and looking at promotional tactics in a different way. When it comes to the target audience, by doing an audience analysis we can often uncover hidden opportunities as well as avoiding red flags, so we can help them have a more successful launch. In terms of promotion, often the company wouldn’t have enough personal selling resources at a scale that can hit established target goals – but if they also utilize non-personal promotion to communicate effectively, stimulate trial and usage, now we have a real way of reaching potential customers, communicating with them, getting them to try these medications with their patient populations with a very positive return on investment, often with a target audience they’re not accustomed to.

Steve Wray: Most pharma companies rely on outdated approaches to launch, which fail to reflect the reality of how patients and HCPs access information in today’s digital environment. Recent data regarding online usage suggests ePatients have truly come of age, bringing with them the expectations of transparency, speed and crowd sourced feedback that they enjoy in other B2C transactions. Fortunately, powerful marketing platforms and service offerings are available to fuel accelerated launches that target these customers and meet or exceed their heightened expectations. Moving forward, successful launches will be characterized by targeted reach, personalized content, and detailed metrics that will truly engage today’s fully empowered ePatients.

For brand teams, some key strategies for driving success launch in this new environment include a legendary approach for listening to customers, a compelling brand narrative, inspired channel selection and a dedicated, digitally savvy team. Our engagements with HCPs need to focus upon access instead of call plans; our patient engagements should emphasize simplicity, context and service. When all of these elements are brought together and seamlessly executed, the launch results are truly transformative.

 

3. Med Ad News: Regarding the Turing Pharmaceuticals pricing controversy, Hilary Clinton urged the FDA and FTC to determine how to bring lower-cost generic drugs to market more swiftly and combat anti-competitive practices in the pharma arena. Is this a realistic request, and if so, how can it be done?

Ellen McCarthy, SVP Director of Medical and Scientific Services, The Bloc: As stated above, the request may not be unrealistic, but it is a tall task given the current regulatory and approval climate. The pharmaceutical industry, and the variety of companies that comprise it, is in the business of making new and innovative medicines. This is not a cheap business; research, development, and commercialization of new medications all carry high price tags. A 2014 report published by the Tufts Center for the Study of Drug Development estimated the cost of bringing a new prescription drug to market at ~$2.6B, a 145 percent increase over the number from 2003.1

While substantial, this number is not an excuse for the lack of timely approval of lower-cost generic drugs. There are 2 critical factors involved in the drug commercialization process that require serious reconsideration to improve the current generic situation: patent time and market exclusivity. Current patents expire 20 years after the date of NDA filing; this includes clinical trial and development programs as well as commercialization. However, there are legal loopholes that can extend this time period, and the pharmaceutical industry as a whole has become adept at extending patents (and blocking generics) as long as legally possible.2 Consider this scenario: a generic company files an abbreviated new drug application (ANDA) and attempts to enter the market with a generic drug prior to brand-name drug patent expiry. If this generic filing is challenged by the brand-name company within 45 days, the FDA is mandated by law to block approval of the generic drug for up to 30 months (or 2.5 years). This can lead to hundreds of thousands of dollars in costly, and arguably wasteful, legal battles that benefit no one in particular, least of all patients and healthcare providers. Instead, this money could have been reinvested in the R&D system to create and develop even better drugs for the future.

Add to this the laws and statutes behind marketing exclusivity, and the road to fast, low-cost generics becomes long, twisted, and complex. Perhaps the FDA and FTC should consider the suggestion made by Matthew Herper of Forbes Magazine in 2002 and grant patents for 15 years from FDA drug approval, period.3 This still allows for ample commercial gain (and investor satisfaction) while, more importantly, sparking scientific innovation. Instead of putting money toward timely and expensive legal battles, the pharmaceutical companies could (should?) reinvest in bench science, including academic partnerships, and work to bring cutting-edge science to new and better medicine – and to the patients who could benefit from it most.

Footnotes:

1) http://csdd.tufts.edu/news/complete_story/pr_tufts_csdd_2014_cost_study
2) Hemphill CS, Lemley MA. Earning exclusivity: generic drug incentives and the Hatch-Waxman Act. 2011.
http://law.stanford.edu/wp-content/uploads/sites/default/files/publication/259458/doc/slspublic/ssrn-id1736822.pdf
3) Herper M. Solving the drug patent problem. Forbes, 2002. http://www.forbes.com/2002/05/02/0502patents.html

Andrew Gottfried, Managing Partner and Director of Client Services of Entrée Health NY (part of  The CDM Group): Given the way our economic and legal systems are structured, it seems that this kind of initiative will be tough for government agencies to implement. It may, however, not even be necessary; the market moved quickly to come up with a solution to Turing’s pricing approach. When Imprimis offered an alternative to Daraprim at $1 per pill, their stock increased more than 17 percent while Turing posted a loss.

The underlying tension, though, remains – between investment, reward, policy, and public health. Ideally, a resolution will come from within the pharmaceutical and biotech industries, rather than waiting for one to come from the outside, imposed by politicians or regulators.

That will take courage and transparency. The rationale for drug prices should be more transparent to both payers and consumers. Healthcare costs should move beyond “whatever the market will bear” to value-based pricing. Developing a genuinely compelling value proposition for new therapies has to be job number one for anyone in industry today.

Nevertheless, pricing still has to provide manufacturers with an incentive to develop new therapies (or commercialize older ones) and account for their value. It still has to fulfill a corporate responsibility to shareholders, including the need to recoup investments and fund future innovation. It still must accommodate the realities (and costs) of regulatory approval. Without fulfilling all of that, pharma companies will not be able to create innovative solutions that advance science and improve health. If industry does not do this, who will?

James Woodland: I personally don’t think the current proposals (as of early November 2015) are realistic, and ultimately will harm the engine that’s brought so many of these great products in the first place. Don’t roll out something that reduces incentives for something new.

Ken Begasse: This just goes to show the fragile state of pharma’s public perception. One bad apple has the ability to spoil the bunch. When these stories emerge, they overshadow the valuable things our industry does. The reality is that the best in our industry are involved in not just addressing disease states, but in supporting patients and their families and caregivers in myriad ways. We help brands ensure they are always addressing the humanity inherent in every scenario, because we truly are in the business of saving lives, or at the very least, enhancing them.

What it also shows is how quickly greed and the lack of value get addressed in the consumer marketplace. We are dealing with people’s lives, literally, and so expectations are incredibly high for our industry – perhaps higher than for any other. Patient opinions and perceptions are what drive this market above all else, and this is why we are seeing political action as a direct result.

Christopher Tobias: There are many factors behind this trend, which will persist as pipelines shrink, biosimilars emerge, patents expire, and generic competition and new product introductions increase. Every business situation is different and subjective, despite a strong inclination among marketing teams to be formulaic about how they go about commercializing. With so many moving parts, it’s hard to be great at all of them and yet, what could success look like if this occurred?

1) Marketing success today – Many brand teams are so focused on the product, they forget other key elements that influence market success. Product features and benefits, reasons to believe, and messages are not enough to build a compelling brand or drive buyer behavior. The customer experience has to be front and center, no matter what the therapy or category. This idea isn’t new, but it gets applied more readily outside the healthcare marketing space. Accordingly, a great and recognizable example of this from outside of pharma is Nike, which does such a brilliant job of building and maintaining brand loyalty through complementary offerings such as the Nike+ Training Club and Running apps. These apps not only elevate the customer experience of Nike products, but also serve as vehicles for word-of-mouth and social sharing. They make being a Nike user intimate, personal, and special.

2) Courage to make choices – In order to create a winning customer experience, the customer needs to be really well defined. As much as possible this involves listening deeply to what users have to say and then analyzing it well. To do this, old research methodologies and tools don’t always apply anymore. Traditional approaches to collecting qualitative and quantitative user data became too focused on asking “what customers want or like,” and this doesn’t necessarily get to that gripping strategic insight around what is needed. Listening, sentiment and analytics platforms, if selected carefully and used well, have really opened up the opportunity to aggregate real data in a more agnostic, cleaner, and larger scale manner. Similarly, new platforms have emerged for qualitative sharing. An example of this is You Shoot, an on-demand customer feedback platform in which a question can be posed to subscribers, and respondents shoot a selfie video and submit it back. Really challenging the whole market observation and assessment process is required to more effectively get at the qualitative, quantitative, attitudinal, and behavioral data points that will lead to driving insights.

3) Focus – Launch teams say they define the competition, but more often than not, they are forced into going after much broader targets than they should and aren’t disciplined enough to put a stake in the ground. Without that, the commercial effort can end up being a mile wide and an inch deep.

4) Organizational dynamics – Great work comes from great people who are unified behind a great movement. Especially in large pharma settings, teams aren’t thinking sideways enough; they’re not agile enough; they’re too driven by consensus; and their accountabilities aren’t lined up closely enough with a common purpose.

5) Timing – There’s an old saying: “There is never enough time to do it right the first time, but there is always enough time to do it over.” How can commercial teams learn to balance between investing and planning ahead and chasing their tails? Rushing is definitely not a recipe for great execution.

6) Refining – So many launches are all about hitting the delivery deadline. Once everything is delivered, it takes too long to begin tracking and assessing utilization and impact and to make refinements. Organizations need to have a more flexible and agile framework instead of clinging to linear approaches to commercialization. In other words, they need to be willing to benchmark responsibly, analyze success or failure, and adjust quickly. The whole commercial process needs to become more iterative.

Ed Mitzen: The free market is already addressing the issues raised, and lower-cost medicines will continue to be pushed in all appropriate scenarios by managed care. When drug manufacturers raise prices, they are subjected to more public scrutiny than ever before due to social media. The market will keep things in check more so than any governmental interference.

Jonathan Peischl: Turing, and its CEO, crossed a line in the name of capitalism and in doing so dragged the industry reputation backwards by almost a decade. Its hard to disagree with any politician that actions like this must be controlled and ultimately prevented in the future. However, regulatory and compliance hurdles are in place for good reason and must be evaluated independent of financial pressures; whether it be a new agent or a generic equivalent, the safety of the public must come first. As to the legal actions taking to slow generics and biosimilars, we again find ourselves in a place where we are stuck between capitalism and society’s right to health and well being. Should pharma and the drug industry play by a separate set of rules when it comes to intellectual property? It seems like a slippery slope.

 

4. Med Ad News: What could be the next technological and digital breakthroughs/advancements to help shape the healthcare communications industry?

Cheryl J. Fielding, Senior VP, Director of Client Services, PALIO (an inVentiv Health company): Increasingly in the pharmaceutical advertising industry, we are excited about new technologies but it can take a while for us to adopt and execute against them. The realities of the world in which we do business, and sometimes the appetites of our clients, can mean we struggle putting innovation into practice. That being said, both wearable technology and telemedicine are due to take a bigger grip over our industry imminently. We are dealing more and more with specific and defined patient populations, genetically targeted drugs, and small disparate target audiences. On the other side of the equation we face reduced access and less reliance on personal selling. Technology that connects an increasingly savvy patient audience with their healthcare providers and care teams is certainly a movement that we will see dominate more and more. We will need to find and deliver on new and different platforms that aid in this progression. So, although these are not new breakthroughs, we will finally get a chance to fully deliver on their promise.

Carlos Fernandez, Technical Director, Natrel Communications: Wearables and iBeacon technology will have a major impact on healthcare. With an iBeacon network, any brand, retailer, app, or platform can determine where a customer is and send hyper-contextual content to each user based on location. In healthcare, iBeacon will manage quality of life before, during, and after treatment.

Until now, patients have been tethered to their beds during a hospital stay, but wearables are about to transform healthcare in several ways. Patients with mobile devices can be connected to an iBeacon network and be alerted when a particular healthcare provider is available, offering patients more freedom to move around the hospital. Wearables, in conjunction with mobile devices, can alert the network of an emergency – if a patient falls or otherwise needs medical assistance – without the patient being physically connected to stationary medical equipment. Also, wearables can help patients monitor symptoms, show patients how to deliver self-administered medication through videos, and overall enhance communication and knowledge regarding patients and their health.

Forrest King, Managing Partner, Chief Innovation Officer, JUICE Pharma Worldwide: Social listening software can uncover insights through conversations on “traditional” social media channels such as Facebook, Twitter, and blogs. However, it’s estimated that up to 80 percent of social sharing happens through “dark social,” the sharing of URLs and links via email, text messaging, and other channels that can’t be measured by Web analytics. We’re in the early days of software development that is specifically designed to detect, track and measure dark social interactions, uncovering a vast amount of untapped insights regarding user behavior and sentiment that have been beyond the marketer’s reach.

David Windhausen, Executive VP, Intouch Solutions: Tech must become smarter, able to predict and provide what we want or need, when we want or need it. For example, imagine an in-home device – similar to Amazon’s Echo – that can ask health-related questions and then provide feedback or motivation based on what it knows is working well for you (when you take daily walks, your knee pain decreases, etc.). The more we can create a seamless intersection between technology and human behavior, the more likely people are to adopt that technology, and the more opportunities we have to influence behavior, and in turn, health outcomes.

Jose Andrade, VP, Director of Creative Technology, Flashpoint Medica: In many ways, “next”, is “now” but also “not yet”. The explosion of wearables, IoT (internet of things), big data, and cognitive computing advances, have created a sort of revolution where healthcare is finding itself at the epicenter of innovation. The challenge, however, like a lot of current technologies is its speed to market without appropriate due process, especially in regards to healthcare.

There have been key advents over the last two years that have further expedited this advance (e.g. Apple HealthKit, ResearchKit, IBM Watson Health) and as such have provided fertile ground from which to grow. As key concerns such as privacy, compliance and FDA guidelines evolve and mature, healthcare marketers and brands will be better able to reach audiences in areas where they had to tread carefully in past (e.g. social, EMR, data mining, DTC).

Mechanisms that make big data smaller, more accessible and reliable will find their way in areas such as smart watch interfaces, vehicles, even appliances. This will be highly instrumental in tying back the metrics across such channels giving brands, marketers and healthcare professionals even greater windows into understanding their target audience’s journey. This has the potential to close gaps in areas such as treatment adherence, doctor/patient relationships, even patient education.

Jennifer Samuels, Director of Client Services, CENTRON Advertising: I think we’re already seeing how technology and digital are shaping healthcare and healthcare communications. Wearable tech, and connected healthcare are connecting patients and their healthcare professionals more and more. With that kind of connectivity, there is the potential for so much real-time knowledge about how a patient is faring with their condition, on their medication, and to provide patients with content that will help them. It will mean driving individualized communication – navigating that process, and how that inbound and outbound communication will transpire efficiently and effectively. This communication process is destined to evolve very quickly in the short-term. Clients and agencies are going to have to learn how to navigate through that complexity of content development and dissemination, and how to do it within all the existing regulations – and in a timely way. We’re not dealing with a one-size-fits all set of content or communication anymore. We have to keep evolving how we can deliver very tailored information on a very real-time turnaround basis.

Jo Ann Saitta, Chief Digital Officer, The CDM Group and iVenturesHealth: Several exciting technologies that will help shape health and communications will be available in the near future.

Among them is 360 video, the potential of which is just beginning to be realized thanks to advancements in capture, quality, and accessibility. For example, new hardware (Freedom360), software, and editing tools will enable the capture of real and virtual reality experiences like never before.

These advances will allow us to create more immersive experiences through wearable headsets that will be used increasingly in the near future. We’ve just scratched the surface of this technology with some amazing work for clients using first-generation Oculus Rift and Google Cardboard. As this technology advances, we believe immersive video will become a new channel of choice.

With this new technology, video will be everywhere, surpassing traditional digital tactics and bridging the digital and physical worlds. Skill and expertise in content-creation and the blending with ad delivery will be essential to the future of video-based healthcare communications, in addition to the necessity for video ad analytics. The other major technological breakthrough is true interoperability of healthcare systems and data liquidity in healthcare. What that means is a growing connectivity among EHRs and institutional, patient, and caregiver platforms in order to enhance outcomes. So we will have to deliver digital ecosystems that are more comprehensive and go beyond the walls of traditional pharmaceutical brands.

Major technology players such as Oracle, Salesforce.com, IBM, and Adobe are jumping into the game, creating “Marketing Clouds” and “Health Clouds,” which enable the processing of large amounts of unstructured health data. We and other healthcare communicators will have to learn how to operate, execute, and take advantage of these new environments.

Finally, interoperability and data-liquidity will enable programmatic communications. The growth of proximity tools such as beacons, wearables, and implantables will make it possible to deliver dynamic and custom healthcare content to both individuals and locations. The next-generation Apple watch will know your blood sugar, how much you’ve exercised recently, and the time of day – and will make a healthy suggestion at the Starbucks counter, where you are standing. That is almost here now…

Prodeep Bose, Executive VP Multichannel Strategy, The Bloc: Remote (tele)medicine has had a long history of false starts, but today it is poised for widespread adoption for consults between patients and physicians due to several driving forces. Lower costs, at par outcomes, the ubiquity of high bandwidth internet access, and digitization of health records are all powerful enablers of a trend that will reshape how we engage with doctors and the overall healthcare continuum. Today, patient education and physician communications are based largely on the assumption that both audiences will read/view our content between, not during, consultations. If that were to change, then real-time access to doctors and patients while they’re in consult would present the greatest single opportunity for highly relevant customer engagement.

Michael Spitz, VP Strategy, Klick Health: The next tech and digital breakthroughs shaping healthcare communications will be the “personalized ubiquity” of biometrics through wearables, and the “simulated world” through virtual reality.

Wearables will, without a doubt, pave the road to the quantified self. With their built-in biosensors and ability to acquire, analyze, and share biometric data, wearables will provide healthcare companies with unprecedented opportunities to provide personalized messaging and support tools to patients throughout the process. Privacy and security concerns will always be paramount, but the convenience and utility will make engagement necessary and inevitable. Virtual reality will erode the barrier between the analog and digital experience. And through its digital simulations of the world, virtual reality will offer similarly powerful opportunities to contextually embed healthcare content and resources. As users travel within the digital construct, messaging can take any form and perform any conceivable function, giving marketers incredible power and flexibility to provide personalized value well beyond the treatment itself.

Together, both wearables and virtual reality are a formidable force that will propel a profound paradigm shift in how the industry communicates, and what our audiences expect.

Joshua Yoburn, PhD, VP of Medical and Scientific Strategy, Giant Creative/Strategy: It’s tempting to think wearables will gradually dominate the healthcare technology landscape in the near future and, while that may be true, I’m personally more excited about Apple’s ResearchKit platform and all of the amazing recruitment and data collection capabilities it promises. Just the simple idea that any one of the millions and millions of iPhone users can readily consent, participate, and track a live study is incredible to anyone who has seen first-hand the challenges associated with the traditional clinical trial process. I think we’ve barely scratched the surface on how important this framework will be in terms of reducing study cost and recruitment time while simultaneously increasing participant reach and relevance.

Emily Tower, VP, Digital Strategy and Analytics, AbelsonTaylor: If only we could isolate just one that would shape the industry? Most will agree that 2016 is the year that we may finally be able to realize the power of the connected patient. The availability of low-touch, always-on tracking through our phones may not be a silver bullet, but will provide behavioral insights on the 8,760 hours a year that patients are truly “living” with their condition outside of what they remember to report during a physician visit. If healthcare can harness this data, this opens new doors to meaningful content and interaction.

Boris Kushkuley: There are two major areas that are about to explode in healthcare: The first is personalized, tailored communication with customers made possible by real-time feedback, big data and predictive analysis, which can help us understand behavior patterns and attitudinal biases. The fact that every channel now has a digital component (and this includes personal) provides the opportunity to account for and understand customer interactions with the brand. This, coupled with the ability to dynamically serve the right content to the end user will drastically redefine the relationship between manufacturer/brand and customers. The second area is behavior-modification programs that leverage connected devices and sensors. We are on the brink of a great transformation of what product support, disease education, medication reminders and real-time clinical-data monitoring will look like. Most of us are already connected 24×7. The next step is to make it benefit our health and wellness.
 
Ed Mitzen: When I was at Cannes Lions Health last summer, you couldn’t walk ten feet without hearing about significant advancements being made in wearables. From patches that measure blood glucose to contact lenses measuring and reporting intraocular pressure, these new diagnostic tools are super exciting. The question is, will they hit the market like a freight train or drag on due to regulations and bureaucracy at the FDA? Think about how excited we were for electronic medical records, yet we still fill out a paper form every time we visit a new physician.

Dave Sonderman: Immersive augmented reality platforms (from Oculus Rift to Google Cardboard’s “Oculus Thrift”) provide healthcare professionals unheard of empathetic experiences to help better understand and relate to patients: How does a migraine affect your ability to be mobile throughout the day? What does an epileptic aura or seizure feel like? How does a stroke victim experience emergency care? As this kind of empathy moves to increasingly physical experiences, our human understanding of health issues – and the authenticity with which we communicate them – can only improve.

Christine Armstrong: HIPPA compliant secure global communications as well as the leveraging of marketing automation platforms that are broadly used in consumer markets but are just beginning to develop traction in healthcare communications. These platforms will allow for the ability to provide more relevant and contextual information to recipients, both HCP and patient.

Jonathan Peischl: The answer is less about a “technological breakthrough” and more about how we apply the technology we use today. When it comes to communications, standards must emerge that earn industry a right to be at the table. Today, each brand, each team, and each company provide information in wildly different ways to healthcare providers, patients, and caregivers. A common, universal standard for the delivery of information would go a long way towards making industry a valuable, trusted resource. Imagine a standard for HCP and patient brand.coms, where the basics about the brand, reimbursement support, and education were all in the same place. Within that you could add in the “what makes us unique” area where the manufacturers could deliver unique programs and offerings.

Christopher Tobias: The technology and digital opportunities for shaping healthcare communications are immense and profound. Specifically, the impact of immersive experiences in healthcare communications could be explosive. Going even beyond augmented reality and virtual reality is the idea of mixed reality – combining the best of virtual and real, evolving from having to use headsets, glasses, or gadgets in order to create immersion. The experiential technology movement is rapidly unfolding, resulting in new learnings and disciplinary development areas such as design learning, trust engineering, understanding systems, and gaming design.

Going a step even further, we will begin to see the impact of hyperbolic visualization from an analytics perspective as it is already used to aggregate social data, but it will mean something even more powerful when it takes the place of current ways of searching for or finding information, as well as assessing the quality and quantity of information. Augmented paper-based books are a perfect example of mixed reality and will be used to amplify learning and retention for a more seamless, robust book experience. Furthermore, the use of pictographic barcodes to replace QR and traditional barcodes, will represent a powerful new branding element that will change the experience of a call to action.

All of this is so amazing because it will lead to extraordinarily better education, better treatment experiences, greater disease understanding, and of course more motivating brand and product experiences. Imagine a world where immersive technology is embedded in medical training curricula to allow the students to viscerally experience a disease state not just to read about it. Imagine students actually journeying through chemical or physiological reactions. Imagine a world where a patient’s fear of treatment can be lessened because one can actually preview what one might go through before initiating a therapy. Or by contrast, consider what it could mean for patients to balance negative therapeutic effects with a virtual experience that mitigates or softens them. Immersive technologies will take the world of healthcare communications beyond customer engagement for even deeper, more profound emotional, physical and intellectual meaning.

Robin Shapiro: Large technological leaps in wearable devices and the data they provide will continue to advance the utility and relevance of the quantified self-movement. Devices will become smaller, lighter, and collect more biometric data. Devices that can measure things like anxiety, mood, fatigue, and tone of voice will unlock unprecedented ability to create hyper personal opportunities for healthcare communications, including education, connection, and prevention. For example, a device may be able to preemptively offer healthy eating and movement suggestions to de-stress and re-energize after a tense meeting or the afternoon slump.  However, digital technology alone is only a means to an end. The true value for healthcare communications will be a larger focus on human-centric care, realized through prioritization of the patient and personalized medicine. The evolution from advocacy to collaboration with influencers through content partnerships and communities will establish brands as credible, authentic partners throughout the health journey.

Ken Begasse: Global adoption of new communications technologies by patients, physicians, and HCPs is quickly altering the global healthcare ecosystem. According to research we just conducted, 64 percent of Americans use smartphones and 76 percent of Europeans use them. When you look at physicians, the numbers jump to 84 percent and 82 percent, respectively. Tablet adoption is also incredibly high in the U.S. (though the U.K. lags at 34 percent). What this tells us is that handheld technology is here to stay in the healthcare environment. What we haven’t measured statistically, but know to be true anecdotally, is that we have just scratched the surface as to how technology can be integrated across the patient, physician, and HCP populations in a way that helps meet our objectives for successful connection and engagement across all of these audiences.

The bottom line is that we live in a connected world. As we look to the next 5, 10, 20 years, we’ll see continued innovation from players that aren’t healthcare companies at all. Tech giants like Google, Apple, and Samsung are all creating products, wearable and otherwise, that impact the quantified self. When you look at something like your car, you’re essentially looking at a massive computer system. How soon will biofeedback systems be able to recognize that a patient with epilepsy is experiencing the onset of seizure while driving, activate automated controls, and safely pull the car to the side of the road? My guess is very soon. These innovations will provide new opportunities for us to be a part of the patient journey.

Stan Woodland: When the loop gets closed – and iterative – between the quantified self and healthcare providers. And once that loop’s been closed, you’ll have the ability for other vested stakeholders to tap in and contribute. Payers will have the ability to connect in and make available a wide range of services. Equipment companies, nutrition and food organizations, a number of stakeholders that can all support better health habits. It won’t all be rosy – there will be legal and governmental issues coming into play, but overall it will be incredibly impactful for our industry and for health as a whole.

James Woodland: That will also bring the delivery of care into the real world, out of the office, into an ongoing connection between patients and their doctors rather than an episodic one. People can talk to doctors on an ongoing basis, the care will always be monitored and given, rather than waiting for that moment. You doctor can text you to eat a banana because your potassium levels are low, as shown on your next-gen diagnostic smartwatch.

Dr. Susan Dorfman: This is not only reflected in wearables technology but also other forms of technology, telehealth for example. The biggest changes for our industry from a communications perspective will come when the patient is at the center of the initiatives – not just the Internet of Things but the Internet of People as well.

 

5. Med Ad News: As year two of the ACA comes to a close, what have been the positive and/or negative effects of Obamacare on the industry?

Nina Greenberg, Managing Partner and Creative Director, Entrée Health NY (part of  The CDM Group): The impact of the Affordable Care Act (ACA) has certainly been mixed. On a positive note, 16 million more Americans now have access to insurance coverage that includes pharmacy benefits. That is important and incredibly valuable to patients, who now have better access to the healthcare they need. It is also a positive for the pharmaceutical industry, which has gained access to a greater number of insured customers, with expanded Medicaid coverage in many states.

But from a payer perspective, it has been a real challenge. Many plans have found it difficult to translate their increased membership to increased value for their company or shareholders. That is because they did not price plans appropriately, or they deliberately used low-price plans as loss-leaders but now have populations that have coverage … but at a collective loss.

What we are seeing now is that plans are being forced to raise premiums at levels that far outpace the consumer price index, which will be challenging for covered individuals. From an industry standpoint, however, increased premiums will hopefully translate into greater access to products due to MLR requirements. This is simultaneously good for those covered, who will get access to more innovative therapies.

The ACA also poses some real challenges to the pharma and biotech industries. What is happening is a lot of consolidation, which increases the negotiating power of insurers – not something manufacturers welcome, but a reality nonetheless. Moreover, the emergence of Accountable Care Organizations, which currently cover more than 23 million lives and are the fastest growing segment of the US insurance landscape, brings a very sophisticated buyer into the healthcare marketplace.

With those changes has come an increased focus on the value of all healthcare goods and services, which has amplified the need for thoughtful, compelling, data-powered value-communications to all parties – payers, prescribers, and patients. Without a good and clear value proposition, the ACA does not afford much opportunity to pharma. This is where the right partner can help.

Angela Tenuta, Executive VP, Intouch Solutions: First of all, more people are insured, so that’s a positive. Additionally, technology in the doctor’s office is advancing rapidly; also a positive. Although there are always setbacks when things change, it reminds me of when we were at the beginning of digital health care; there’s a lot of potential. With regard to pharma, some of the restraints we previously faced are falling away.

Jay Carter: I think that the requirements for EHR have been disruptive to physicians and patients alike. The disruption to physician practices has made pharma’s job harder. Many practices sold to IDN’s to avoid implementing EHR on their own; this led to those practices following IDN policy and restricting access to reps. That makes pharma’s job harder. However, we’re finding that many more patients are more aware of their health due to the ability to access their chart at home. A patient who knows their “numbers” is a more informed patient who is empowered to ask for the best care. That makes pharma’s job easier. Net/net, it’s a win in my book.

Dan Sontupe, EVP Payer Strategy, The Bloc: The Affordable Care Act continues to orient the industry toward the magnetic north of value, rather than volume, in healthcare delivery. Nonetheless, reform remains a work in progress. More consumers have coverage, but some can’t afford high deductibles and/or their networks are too narrow. Marketplaces offer a range of plans, but insurers may pull out because of financial losses. Providers welcome newly defined rates of reimbursement, but struggle with the burden of regulations. Despite mixed results in another year of health reform, there’s no denying the momentum building toward controlling costs and improving care. This means that the industry must focus more on overall value and drive profits through ensuring patient engagement, which helps to drive better outcomes. Just having more patients is not enough; we need to build programs to engage patients and make them more accountable for their own care.

 

6. Med Ad News: 2016 will bring with it a newly elected president. Which candidate(s) do you think could have the most significant impact through their policies on the drug industry?

Ed Mitzen: I think the jury is still out on this one. However, I can’t help but think that a Carly Fiorina White House (either in the top job or as VP) would give strong knowledgeable business leadership to government. As a small business owner myself, she gives me the greatest level of comfort when it comes to business policies. And it is clear she can provide critical unbiased leadership when it comes to the drug industry.

Prodeep Bose: Healthcare policy is as complex a legislative landscape as it gets, but a simple binary way to think about it is to consider the policy spectrum – on one end is the marketplace approach that lets competition define how providers, insurers, and manufacturers develop and price their products and services. On the other end is a single-payer system in which pricing, reimbursement, and provider costs would be driven by outcomes measurement, or so Bernie Sanders proposed in a bill he authored in 2013. Almost all of the candidates in the field seem to want to repeal or significantly modify current legislation, but Senator Sanders is the only one who wants to do it for the opposite reason from the rest. To follow the model set by Denmark, Canada, Taiwan, and France means to set price and cost controls based on outcomes, which is a fundamental shift that would redefine how all corporations operate within the healthcare continuum, regardless of how many payers there are.

Andrew Gottfried: No candidate can implement price control policies without Congress. President Obama used that to his advantage in creating the Affordable Care Act. What we really should be looking at is the overall political landscape that we expect to see in 2017.

It is really too early to place bets on specific candidates (although Bernie Sanders would by far take the most aggressive stance toward price controls). A Democratic administration will clearly support extending and strengthening the regulatory framework for the Affordable Care Act (ACA). The first phase of the ACA was mainly about expanded access. A Democratic president will likely make the next phase about tackling healthcare costs, including pharmaceuticals, in a more aggressive way, whereas a Republican administration will likely look to more market-based solutions. So we could expect to see more support for initiatives such as the NCCN Evidence Blocks and less direct government oversight and intervention.

The key to this question is the specific impact the next president will have on the drug industry. Keep in mind here that the big legislation for this question is the Medicare Modernization Act of 2003 (not the Affordable Care Act). A Democratic president is likely to fight hard for the government’s right to negotiate price concessions from industry. If Medicaid (where the government does control pricing) is any indicator, such a move could reduce pricing by about 20 percent, and make aggressive price increases complicated or impossible from which to benefit (Medicaid’s rule of “best price” makes price increases above the consumer price index push government prices even lower). Price concessions for Medicaid have been survivable. Price concessions for Medicare, however, could be a total landscape changer for biotech and pharma in a negative way.

 

7. Med Ad News: How will the industry adapt to the marketing and advertising challenges of biosimilars as they become more commonplace in the U.S. marketplace?

Lila Shah, Senior VP, Client Service Director, CDMNY (part of  The CDM Group): Marketing and promoting biosimilars has to extend beyond lower pricing. A lower price may differentiate a biosimilar from an innovator product, but that is not a sustainable position against the same biosimilar made by another company. There needs to be a distinct value proposition for each identified stakeholder: for example, What’s most important to HCPs? Payers? Pharmacists? Governmental/regulatory bodies? Patients? That is where value-added services can distinguish one biosimilar from another, and possibly drive demand for a biosimilar made by a particular manufacturer.

The time is now for pharmaceutical companies that are manufacturing biosimilars to invest in market development. Awareness among HCPs is low about biosimilars. That presents an opportunity to familiarize HCPs with biosimilars through channels such as public relations, social media, and corporate advertising. Such efforts should prime the market for the entry of biosimilars.

In our experience, a key question companies need to address is whether to market their biosimilars as individual brands or as company-branded biosimilars. There are strategic virtues and challenges to either scenario, and they need to be explored. We also believe it is important to consider when to initiate market development efforts to ready the marketplace for the entry of a new biosimilar. These are not uncomplicated, small molecule therapeutics; they are sophisticated biologics that, even as biosimilars, will need scientific and company credibility – in addition to attractive pricing – to succeed.

Rob Poestch, General Manager, CENTRON Market Access: Although the regulatory and marketing path for biosimilars is becoming clearer, some key obstacles still remain. First, these products are not generic and are only “highly similar.” Therefore, the current generic interchange/substitution laws do not apply and states are in the process of amending their outdated legislation. Unfortunately, the legislation varies by state and no consistent provisions exist. Secondly, there are marketing challenges with biosimilars. Marketing must ensure stakeholders believe in the similarity of the two products, while differentiating it from the same branded product. Thirdly, the price of these products will dictate where payers place them on their formularies. Finally, prescribers are much more comfortable substituting products sharing the same nonproprietary name (which will not be the case for biosimilars); however, that comfort level could be altered by additional education which is something clients and their communications partners need to have on their radar screen and help foster.

Faruk Capan, CEO, Intouch Solutions: Biosimilars will follow a path different from that of the typical generic drug. It will be necessary to develop an entirely new branding strategy because companies that develop biosimilars will not be able to say they are identical to a drug counterpart. What’s encouraging about the rise of biosimilars is that they will present valuable opportunities to learn and to educate doctors and the public. We as marketers can play an important role in this process.

Jay Carter: The industry will have time to figure it out. Launching a biosimilar is not like launching a generic, where 70-80 percent of share goes away immediately. A study was done to evaluate the uptake of biosimilars in Europe from 2007 to 2010. Share of three key agents grew from 0.3 percent in 2007 to 15.5 percent in 2010. While losing 15 percent of Humira is still a whole lotta money, it will take time to figure out how to implement biosimilar sales in the U.S.

James Woodland: From a marketing and advertising perspective, it likely won’t be that different from generics. When generics come to market, the brand is undercut and the market share goes away. It will be the same model on a smaller scale. They’ll likely use the same playbook. But overall it doesn’t seem as though it will be that big of a change to the industry.

Robin Shapiro: The introduction of the first biosimilar to the US market earlier this year represented a significant event. Whether marketing the innovator brand or the competing biosimilar, we anticipate a significant need to shift the conversation away from “cost” and move to a focus on “value.”

For biosimilars, the marketing and communications challenges are paradoxical – how does one express differentiation while trying to communicate similarity? While cost is the leading advantage of biosimilars, if the conversation focuses solely on dollars and cents biosimilars may risk being compared to simply generic versions of a brand – which may increase access to care but decrease brand loyalty. In contrast, many biologics (especially in oncology and inflammation) have made a great impact on patient lives, engendering brand loyalty. In addition, the US regulatory environment has been driven with more caution than other markets, especially the EU market, where customers have already been exposed to several biosimilars. In order for biosimilars to shift mindsets and gain market traction they will need to emphasize the rigorous regulatory pathway they’ve been through to demonstrate similarity (Phase 3 trials, etc).

The cost of biologics has been a debate for quite some time. As innovator brands they must also shift the conversation away from cost and focus on value, including the delivery technology (devices, etc) and other differentiating attributes from biosimilars.

With both biologics and biosimilars focusing on value, we anticipate both to focus on more robust patient support programs and product-plus services in order to differentiate from each other.

Joshua Yoburn: At Giant, we’ve been working very intensely on a number of biosimilar related initiatives over the past two years. Some clients are looking to defend multi-billion dollar portfolios against loss of exclusivity and pending U.S. biosimilar arrivals, whereas other clients are faced with the challenge of advancing innovator biologic portfolios while simultaneously pursuing biosimilar manufacturing themselves. Regardless of one’s corporate position on biosimilar participation, at the end of the day, the healthcare community is going to be most interested in a couple of key issues. First and foremost, cost and potential healthcare savings are of paramount interest although the marketplace is not expecting the kinds of price reductions historically seen with generic entry. And last, but certainly not least, long-term safety, interchangeability, and indication extrapolations are serious topics that require appropriate attention and marketplace education.

Given that the next wave of biosimilars on U.S. soil will include a number of monoclonal antibodies targeting various chronic diseases and cancers, it is crucial that we take the necessary time to proactively address marketplace questions, diffuse concerns, and educate our audiences on the critical differences between generics and biosimilars in terms of approval pathway, manufacturing process, safety, and efficacy requirements. It’s all very exciting and manageable, we just need to be clear, proactive, and nimble marketers as this new wave of important products approaches.

Dave Sonderman: Biosimilars by nature are, well, similar. Marketing and advertising have traditionally been about focusing on the differences of a product, on what separates it from the rest of the market. In short, promoting sameness is not in any marketing professional’s DNA. How do you celebrate unoriginality? There are three ways industry will need to adapt:

First, company brand equity, not the product brand identity, will be the key driver of identity for biosimilars. We will see a lot more marketing from the corporate “mothership” brands to lay a foundation for the pedigree of the biosimilar products. It’s something pharma is not that great at. Historically, they have built their company’s strength and identity on how unique their products benefits are. Without that uniqueness, the story will be about where the drug came from – from intangible corporate reputation to tangible manufacturing process – rather than the drug itself.

Second, biosimilar product marketers can toss out the traditional media playbook. The FDA/EMA doesn’t want biosimilar drugs to take on brand wars with the reference products. Their goal with providing incentives for development is to inspire market competition that can help increase access and lower the cost burden to the healthcare system. As such we likely won’t be seeing a flood of media dollars associated with the promotion of biosimilars. Instead, promotional budgets will be hungry for innovation.

Third, biosimilars can differentiate by creating new patient value with those who need it most. Because clinical parity is table stakes, biosimilars will need to invest in understanding crisply defined segments among those with clinical need – rather than the homogenous “buckets” pharma typically puts patients and doctors in. This deeper understanding will open the door on problems brands can solve in educating and supporting underserved patients and doctors – true value creation. Smart marketers will realize that they can win based on the supportive experiences they create that appeal to the financial, social and emotional triggers of a specific audience.

Michael Spitz: As biosimilars become increasingly commonplace, the industry will adapt by taking advantage of the unique value-adds tech and digital innovation can provide brands through superior healthcare communications. Pharma companies are already well on their way to recognizing the importance of “going beyond the pill” and evolving capabilities from the development and distribution of treatment options to becoming experts in health management and even disease prevention.

As that shift continues, patients and physicians will increasingly rely on pharma to offer innovative tools and sophisticated resources to better understand, educate, and motivate diverse target populations. Expecting the same kind of personalized, immediate, geo-located service they already receive from the likes of Amazon and Uber, consumers will turn to brands less for their molecules, and more for their ability to improve public health through cutting-edge tech and fully dedicated services.

Art Chavez: Expectations are that biosimilars will enter the U.S. market at a discount compared to their branded biologic competition, but probably not at the deep discounts seen with generic competitors to small molecule brands. As a result, this is attractive business for organizations with the manufacturing expertise to develop biologics and the marketing infrastructure to fully capitalize on this coming wave of opportunity. It is likely that many manufacturers will follow the path set by Novartis: the organization’s resources were brought to bear to gain approval for Zarxio; this new biosimilar brand will now be marketed by the organization’s “generic” division. This separation of branded product promotion from biosimilar promotion will clarify the role and focus of each part of the organization. Presumably one part of the organization will deliver marketplace value through continued R&D and innovation while the other focuses on improving the value equation by devising new, more cost-effective alternatives to vital but expensive biologic treatment options.

The implications for marketing and advertising in support of these 2 tracks will have several dimensions. First, it is likely that other organizations will opt to separate their branded NCE and NBE assets from their biosimilar assets. Over time, this may lead to the biosimilar and generic expertise divisions to be spun off from the R&D driven parts of the organization. Marketing approaches for original discoveries will continue to emphasize the incremental benefits and value delivered by each brand while the focus of biosimilar promotion will not only emphasize improved value, but also quality and consistency guaranteed by a proven provider of sophisticated biologics.
 
Dan Sontupe: The mirror perspective to this process is how will biosimilars be perceived by insurers, integrated delivery networks, and the traditional “payers.” Since efficacy will need to be substantiated through phase 3 clinical trials and manufacturers are targeting satisfied classes of drugs, will the discount be enough to counteract the contracting already in place? It is highly likely that biosimilars will simply be viewed by payers as a “late-to-market” me-too. Since the discounts will not rival the deep discounts provided by multisource generics and effectiveness will most likely only be considered the same at best, biosimilars are going to need a strong value marketing approach to build differentiation. Will they offer the same patient support programs, nursing involvement, call centers, and financial assistance as their original equivalents? These tools equate to overall brand value and it is highly likely the simple cost difference will not be enough. The marketing of biosimilars will be even more crucial than that for their original equivalents.

 

8. Med Ad News: How is your agency improving client value?

Josh Prince, President of The CDM Group: It takes a village – literally – to effectively market healthcare brands today. Physicians have to care about you. Patients have to know about you. Communities have to advocate for you. Payers have to value (and be willing to pay for) you. Our clients have to communicate with this entire village – across multiple channels – often through multiple agencies. That is where The CDM Group really adds value.

We are obsessed with being world-class collaborators, because we know that it takes lots of smart and creative people, with a diversity of specialties and perspectives, to really help our clients’ brands reach their potential. So we are intent on assembling the right people from the right agencies to help them succeed.

The CDM Group has separate agencies and offerings that handle professional, patient, payer, production, and even DTC. But we also work extremely hard to have a collegial, egoless culture, where folks want to collaborate with each other. And we have a structure called a “One Voice Model” that coordinates this seamlessly for clients. What clients see – and get – is our best thinking, sharpest ideas, and most innovative solutions…without having to worry about agency infighting or turf wars. We have even taken this approach a step further, pressing our agencies to be “super-collaborators” with anyone – other Omnicom agencies or anyone else. We know it takes a “marketing village” to succeed, and we want to be a great citizen of it.

We are also improving value through technology. We see clients struggle at times with their digital offerings, especially at the enterprise level. So we have invested in building a dedicated technology offering, iVenturesHealth. It is led by Jo Ann Saitta, with experienced technical development, commercial product, and analytics staff from the technology industry. The group is really helping add value to clients by deploying technology in ways that enhance communications and drive commercial results.

iVentures partners with tech giants to bring fresh – and doable – ideas to the table for clients. We even commercialized several of our own software products, which clients are taking advantage of to drive deeper insights, detail better, and even manage media more efficiently. Doing digital is nothing new; in healthcare, however, there is plenty of room to do it better.

Jennifer Matthews, Managing Partner, The Bloc: Recognizing that clients are increasingly pressured to do more with less, we’ve launched a new business and workflow model that uniquely drives growth of top-line revenue with operational efficiencies that improve the bottom line. It enables clients to reduce what they spend on must-haves to free up more budget for more market impacting initiatives. Additionally, because projects are developed in a streamlined way, it enables speed to market. This is not simply a cost play – it is a new way to work with our clients. The result? Several clients have consolidated significant portfolios of brands that span customers, channels, and geographies with us and we are expanding that offering as we go into 2016.

Tamra Micco, SVP, Director of Client Services, Natrel Communications: Natrel’s Bilateral BrandingSM process brings equal attention, discipline, and analysis to both the intellectual and emotional aspects of branding, ensuring that brands are differentiated well beyond what data and claims alone might achieve.

Our approach to building a brand is multifaceted and thorough. Our scientific strategists provide sound clinical guidance and also support our intellectual analyses with critical insights that lead to brand opportunities. On a parallel track, our Persona IDSM methodology targets the emotions, leveraging the power of personality to reveal the brand’s soul. Once a unified, compelling, and differentiating brand platform (intellectual and emotional) has been created, our tacticians establish a plan for consistent delivery of messaging and branding. This consistency promotes and reinforces instant and lasting brand recognition and understanding across all channels.

Additionally, we encourage transparency regarding feedback on our teams and our deliverables. We can’t fix what we don’t know is broken. Transparency allows us to make any necessary adjustments in real time to ensure a lasting and productive relationship.

We listen. Listening is critical to understanding what keeps our clients up at night and gives us clear guidance on where to focus our efforts.

We become fully integrated into our clients’ businesses, serving as a true extension of the commercial team. The more we know, the more we can anticipate client needs and recommend solutions that are relevant and actionable.

This integration also includes collaboration with our clients’ other partners to ensure a consistent marketing approach across disciplines.

Our staff of 90 represents decades of diverse experience in every dimension of pharmaceutical marketing, including professional and patient strategic services, medical/scientific support, creative development, and tactical implementation. This collective experience – along with our highly disciplined processes – allows us to manage workflow expertly, efficiently and cost-effectively.

Natrel builds brands through uncompromising strategic discipline and world-class creativity. Then we seamlessly execute branding solutions across the full spectrum of traditional and cutting-edge media.

Finally, as an independent agency, we are streamlined and flexible. We answer to no one but our clients, and we can turn on a dime.

John Hamilton, VP, Client Services Director, MicroMass Communications: Many of our pharmaceutical clients are used to working with general agencies that offer, without much surprise, general experience across a wide variety of marketing communications and channels. MicroMass takes a very different approach. We provide highly specialized services and deep subject-matter expertise in applying health psychology to change the behavior of patients and healthcare professionals.

This has proven increasingly valuable to our pharma clients as they react to shifts in the healthcare landscape that emphasize quality of care and health outcomes.

Lois Moran, President and CEO, JUICE Pharma Worldwide: We’re not just about building brands, we’re about helping our clients build their business. JUICE agency teams are purpose-built to hit the ground running based on specific category expertise. We operate with a business-building mind-set focused on helping clients amortize their investments, achieving the best possible ROI. And because we’re independent, we can – and do – invest significantly in strategic initiatives and provide top-tier industry talent that can be pulsed in as needed to address any marketing challenge.

Madeleine Gold, Director of CENTIGRATION, CENTRON’s strategic planning group: CENTRON has partnered more and more with smaller and mid-size clients who may be embarking into new therapeutic areas and who may not have all the infrastructure and resources available to them as might be in large pharma organizations. We have really stood by our original vision and mission for CENTRON – to put senior level people on clients’ business, and not disappear from the business after we win a pitch. We have also made our integrated offering of advertising, scientific communications, public relations, and market access, available to all of our clients, with the strategic planning function central to doing what right and best for a brand. Our model lets us be truly channel-agnostic on behalf of a brand: if market access is the biggest barrier to uptake, and that’s where the effort and budget should be focused – that’s what we’ll tell a client. And then we’ll help them on the road to developing a meaningful value story for their brand. Our integrated group of senior leaders across all those disciplines lets that process happen in a very real way – without territorial budget concerns that can often stand in the way of doing what’s right and best for a brand. It also makes for a cohesive and consistent strategy and communications platform across the company. We also think it’s a great way for clients – especially those with tight budgets – to get the most out of the agency, and their spend. Our model can save the time and co-ordination involved in trying to develop a meaningful and consistent story across multiple agencies or vendors – our senior team can do it all from one place, with one voice on behalf of the client and their brand.

Jeff Berg, Sr. VP, Director of Client Services, AbelsonTaylor: One of the great advantages of working at a large advertising agency is the perspective that is gained from working on multiple brands simultaneously. At AbelsonTaylor we currently have 71 brands. We have launched 16 and are in the process of launching 9 more. Seeing real world sales and marketing strategies play out on the battlefield provides us with the perspective to understand what works and what doesn’t. The differences aren’t always obvious but one of the keys to great marketing is the art of sacrifice. The brand cannot be everything to everyone and no amount of wishing will make it so. When clients engage us as a true strategic partner we help develop winning strategies and tactics that almost always involve making difficult choices. We add value by helping our clients narrow their focus and then providing brilliant solutions.

Anshal Purohit: Improving client value is a core focus of ours. As a mid-sized, independent agency, we make it our mission to prove the benefits we bring in comparison to some of our larger competition. Although I could list quite a few things we do to drive value, I think the single most significant is our ability to leverage cross functional areas of expertise under one roof, literally. Our account team is expected to (and does a tremendous job at this) understand and coordinate with colleagues in strategy, market research, digital, print and medical education. They are the single point of contact for our clients, no matter the account size, and ensure that each and every dollar spent gets spent wisely, effectively and with efficiency.

Boris Kushkuley: Today, providing good service is not enough. Clients are looking for value that, for us, can be expressed in two words: effectiveness and efficiency. We are striving to continuously enhance and expand our services in both areas. For us, effectiveness means contemporary, data-driven marketing that engages customers, addresses their needs, and shepherds them through the customer journey. While efficiency is an operational construct, what keeps us up at night is the need to continue optimizing our internal processes and techniques, often leveraging the latest marketing automation tools to help reduce marketing “waste,” improve quality and shorten time-to-market.

Dave Sonderman: The most valuable thing an agency can do is avoid becoming its clients – something so many clients and agencies seem to forget. At GSW, we encourage and celebrate the naiveté that comes from being unencumbered by pharma constraints. It’s embedded in our belief that all people – doctor to patient to caregiver – prefer to be communicated with like real people, with simplicity, authenticity and stories. To do it we hire talent from outside of healthcare who want to apply their considerable creative minds to helping people choose something more important than kitty litter or jockey shorts. And we move that talent frequently so as to not get too wrapped up in native thinking. We seek analogs from successful brands outside of healthcare (as well as those within) and challenge clients with “why not?” thinking. One tangible example is “What Could Be Day?” workshops that bring the best of digital and culture trends, consumer brand analogs, and cross-functional talent from client and agency together with core brand strategies to exploit the health opportunities that live right around the corner from this year’s marketing plan.

Joshua Yoburn: Giant has always been committed to exceeding client expectations. Sometimes we do this on a project-by-project level. Sometimes we do this over the course of a multi-year relationship. Regardless of the tactic, channel, or timeframe, we are known for putting our senior level talent on the front-lines of our client’s business and this has always lead to stellar results. In fact, about a year ago, we took this approach to the next level by building a Strategy team with the goal of exceeding our client’s business objectives faster, more efficiently, and with far greater customer engagement. The Strategy team is a pure think tank with leaders from key disciplines including analytics, media, innovation, and medical. There’s real magic when you put the right people in the room together and task them with developing high-impact solutions to serious brand challenges. Moreover, it’s super rare in this industry that agencies take the time to consolidate highly experienced and strategic talent into a single client-facing team. We think this is a strong agency differentiator and the results have even exceeded our own expectations.

Jonathan Peischl: The answer here is simple. We are setting aside status quo and taking a fresh look at everything we do on our clients’ behalf. A great example is how we approach digital selling. We’re not going to our clients and taking them through an expected path of print sales collateral to digital. We’re looking at the user experience and the sales engagement so that we can better understand how sales interactions really happen, and how we can help make the rep AND the HCP’s life easier.

Jose Andrade: As vigilant scholars of the digital landscape, we keep a laser-focused eye on where the convergence of conversations is taking place. We characterize “conversations” not just in the literal sense such as social, email, or SMS, but also areas where a user is engaging a brand, information, support, as well as when, how, and why. Gaining insights from these key data points allow us to understand better what is resonating with target audiences at these conduits that can then be translated into client strategy and tactics.

Many of these newer trends may often be at their early stages, so we as an agency mitigate which technologies and solutions make the most sense to consider and evolve. We run said considerations through a series of checklists that ensure we are providing the client with trends worth embracing. For the areas that look the most promising, we go as far as creating proof of concept pieces and prototypes.

This may also include securing devices, launching data servers, creating front and back end emulations, integration across environments, user flows, etc. The goal is to ensure we’ve thought through all client and landscape considerations before presenting to clients. In that regard, we often become the clients’ digital eyes and ears.

Ed Mitzen: We are entering into risk-share agreements with several of our clients, where Fingerpaint has some skin in the game. If the product exceeds plan, we’re rewarded. If it underperforms, our fees are reduced.

Robin Shapiro: We are focused on 3 monumental shifts that are positively shaping healthcare over the next decade: digital technology, patient as priority, and the personalization of healthcare. We’re creating and developing individualized health service apps to help patients navigate the healthcare system for better patient outcomes. We’re leveraging today’s broader variety of decision makers and influencers, with a greater focus on patients, caregivers, and advocacy groups. We’re developing programs that improve the value of our clients’ brands among these increasingly important stakeholders. We’re seeing deepening investment in genomic opportunities in our clients’ categories, with a specialized practice area devoted to genomics-based medicine, in order to identify the future of personalized health for their brands. And our global Clinical Trials Solutions practice is innovating the use of social media for faster clinical trial patient recruitment, leading to faster commercialization and revenue.

Ken Begasse: We like to think of our agency as a value-creator, helping our clients reimagine their brand or organizational trajectory through insight and attainable innovation. This comes to life in real, tangible solutions that either uncover hidden value or reorganize existing capabilities into a differentiating position. This “attainable innovation” is achievable for every client. An example: We helped a client meet a real business challenge through doing an analysis of its core infrastructure, identifying a core customer insight, and reorganizing its distribution process to minimize the gap between treatments, thus improving the brand experience. This simple solution improved the patient experience while improving business performance, winning through customer focus and attainable innovation.

Stan Woodland: We’re taking direct responsibility for their revenue growth – helping them with their decisions on who they promote to – and how, giving them a much deeper view of who their customers are. We’re assuming greater accountability for understanding our clients’ current customers, and equally important, uncovering new customers, and having an effective and measurable way of increasing the number of patients who could benefit from our clients’ products.

Steve Wray: Cadient, a Cognizant Company, is increasingly focused on delivering an end-to-end customer experience that integrates a seamless brand story between devices over time. This focus on customer experience drives value for our clients by generating higher levels of engagement with more focused, measurable and efficient promotional spending. Not only does this focus on experience create campaign efficiencies, but by carefully identifying the patient micro-moments that matter, we are also able to accelerate meaningful customer interactions.

In short, digital experiences are radically transforming the client value chain by delivering extremely targeted results much quicker for less money. We believe this is a powerful recipe for ongoing commercial innovation – driving sustainable business growth for brands of all sizes.

We also recognize that it’s the dawn of the age of the marketing technologist. Lines between the CMO and CIO organizations are blurring. Marketing and sales require technology to perform; technology requires customer insights, business requirements and data sophistication to deliver value. Cadient, a Cognizant Company, is generating the expertise, innovation and solutions required to address these dependencies for clinical research, commercial and operations disciplines across the industry.

Emily Tower: Selectivity. We can find our customers everywhere, but that doesn’t mean we should. As brand stewards, we tackle the challenges of not only identifying those channels ripe for interaction, but tagging those channels that may not be worth the brand investment in the near term. We find that in this distillation effort, we make the investments work harder, and deliver stronger results.

 

9. Med Ad News: How is your agency helping improve patient outcomes?

Adam Scott Roberts, Senior VP, Media, CMI/Compas: At CMI, we keep the wants and needs of patients at the center of our strategy to remain true to those suffering from chronic diseases. Where a patient is in their health journey matters as we want to provide value and utility to patients across all stages of a disease journey from symptoms, diagnosis, treatment, adherence and support. In today’s multi-channel multi-screen world, providing the right information at the right time is critical to providing value when a prospect is in a health seeking moment.

There is a balance to providing information and options to a prospect and sometimes this supersedes brand-specific messaging and advertising. In doing so, we can match the message with the moment by being nimble and making an impact in a health decision. By providing prospects with valuable information, resources and often questions to ask their doctor, we help empower power patients and caregivers to participate in their treatment journey and as a result this may improve their life, decrease their suffering and help patients lead the best life they can while also managing a serious condition that will be with them throughout their lives.

Dina Peck, Managing Partner, Executive Creative Director, CDMiConnect (part of  The CDM Group): It is no exaggeration to say that improving patient outcomes is the driving force behind everything we do at CDMiConnect. In fact, our agency’s philosophy is entirely focused on putting the needs of patients first.
Take Health Literacy, for example. An abundance of research shows that better comprehension of healthcare information ultimately leads to better outcomes. For us, however, that comprehension stems from more than using “simple language” and writing at a 6th grade reading level; it is critical to tell a succinct, engaging story complete with visual aids.

To improve patient outcomes, the work we do also must be accessible and address the communication barriers that patients face as a result of their conditions. That is why we have created an entire site experience for patients with macular degeneration that accounts for vision loss and is designed accordingly. And why we’ve built a mobile app for patients with rheumatoid arthritis to accommodate for limited dexterity. We have to make health information accessible to patients, including making the entire experience accessible.

Digital Empowerment is yet another area of focus for us. Every day, digital advances give patients more control over their personal health. Some provide deeper insights by using personal health data, while others promote adherence through personalized engagement. At CDMiConnect, we have an Emerging Digital Group (affectionately called “Edge”) to not only explore these advances but to apply the right ones in the right way, for the right patients. Knowing the possibilities and how to deploy them allow us to reach an incredibly varied patient population through the use of kinetic e-mails or best-use social to create behavior change.

Ultimately, we believe that everything we do should help empower patients to make better decisions about their health – decisions that will lead to better outcomes.

Meredith Terry, Senior Behaviorist, MicroMass Communications: MicroMass works to help improve patient outcomes across a variety of disease states. Some of these diseases are rare, while others are common. Some are chronic, while others are curable. Some are terminal, while others can only be managed for the rest of their lives.

Yet, despite these differences, there’s one thing that’s consistent across all of these disease states.

All of these conditions have a significant impact on the patient’s daily life and psychological well-being. Patients are expected to do many things to manage their condition – make treatment decisions, take medications that are complex or produce significant side effects, and change their daily routines. These changes can be overwhelming, especially when the disease already takes an emotional toll on the patients’ well-being. Patients cannot get to where they need to be clinically when these nonclinical barriers are in their way.

MicroMass partners with pharma companies to improve patient outcomes by addressing the patient in a holistic manner. We know that a lack of information may not be what stops a patient from taking their medication, but instead it may be a lack of the ability to cope with the disease. An overwhelmed patient won’t be as willing to start a new treatment. Patients take their ingrained habits and perceptions into each appointment. These ingrained beliefs won’t be changed by a doctor or nurse telling a patient they need to change. Only the patients can change themselves. But most importantly, we know the evidence-based research from behavioral science and health psychology can provide solutions to the most relevant questions – what can help patients change their thoughts, feelings, motivations, and behaviors? At MicroMass, we start with the existing evidence-based research from academic institutions, hospitals, government agencies, and nonprofits, and then translate those findings, approaches, and strategies into marketing campaigns that actively engage the patient in a behavior change process. Changing behavior isn’t easy – but it is possible.

Lisa Hunt, SVP, Director of Patient Engagement, Natrel Communications: Thoroughly understanding and completely meeting the needs of each key stakeholder along the treatment journey is ingrained in Natrel’s process. These key stakeholders include all of the HCP targets (physicians, nurses, pharmacists, allied healthcare professionals), as well as patients and the caregivers involved in the treatment journey. Empowering, educating, and engaging all stakeholders at the various critical points along the journey – from initial diagnosis to treatment initiation through successful adherence – is our ultimate goal. Creating a unified and cohesive plan facilitates appropriate actions and decisions that ultimately improve health outcomes. We want to enable shared decision-making, getting patients and their circle of care more involved in the process, and to effectively communicate factors that may impact decisions. Great care cannot be delivered without effective communication among the circle of care. By meeting the needs of each key stakeholder from the beginning, a positive, patient-centered journey can be fulfilled.

Elizabeth Elfenbein, Partner, The Bloc: The Bloc recognized that the caregiver plays such a critical role in not only the physical and emotional care of the patient, but they are also at the center of the patient’s treatment decisions and instrumental in keeping patients adherent to their medication, affecting their health outcomes.
Understanding this, The Bloc created a new division called Caregiver Connect that provides scientific and ethnographic expertise around caregivers and supports clients’ needs to communicate specifically with this audience. As proof of concept, The Bloc tapped into an unmet need amongst caregivers and created the Caregivers Speak Up social platform to put a spotlight on the more than 34 million unpaid caregivers in the United States by giving them a voice so that their struggles are heard. The initiative includes a web platform and features an ethnographic-based documentary series, Facebook, and Twitter page where caregivers can share their stories and connect with other caregivers. They recently hosted their first Caregivers Speak Up meetup during National Family Caregiver Month to help bring the virtual caregiver world into a real-world supportive meetup. The Caregivers Speak Up Facebook page has been highly active since its launch in May 2015 and has given us a direct connection to caregivers who we can enlist to ensure that the communications that we create for them are in line with what they need. The ultimate goal? By helping caregivers, we can help the outcome of the patient.

Jeff Berg: Several studies on how physicians consume information about drugs have shown that pharmaceutical companies and their sales representatives remain an important source of knowledge about drugs. Our job is to help our clients share complex scientific information in a clear and compelling manner. When this information is delivered to the healthcare professional, it permits them to make informed decisions as a learned intermediary on behalf of their patients. We help improve patient outcomes by developing information that enables the HCP to select the patients that will benefit the most from our clients’ drugs.
 
Steve Wray: Ultimately, patient outcomes are driven by a wide range of factors, many of which are out of our control. That being said, the growing presence of digital devices among everyday patients is providing us with an opportunity to educate, inform and hopefully even inspire better compliance and healthier behaviors. It’s increasingly feasible to imagine a contagious outbreak of healthy behavior and exercise, driven by the widespread use of digital reminders, integrated coaching and wearable devices. For chronic lifestyle-driven conditions, we are seeing a dramatic transformation in how patients manage their conditions and interact with their healthcare providers. Increasing streams of data and feedback are becoming cost-effective and commonplace, allowing for personalized, timely and responsive treatment regimens that can be implemented at scale. At Cadient, a Cognizant Company, we view our role as a catalyst for meaningful engagement, allowing patients to access and realize the possibilities of these newly emerging digital technologies for managing their health and wellness.

Stan Woodland: All of us who work in pharma marketing aim to improve patient outcomes in the same way – by giving better access to our clients’ products and services. We take a different approach, though, on how we do this. By beginning with deep audience analysis, we expand the number of patients who would benefit, who otherwise wouldn’t be aware of the treatment options. And, we utilize social listening so that we hear from the patients themselves, in their language, their wants and needs.  Our clients’ programs have been developed and implemented based on that feedback. Our clients really want to better understand the needs of consumers are, and we’ve been able to help fill that gap with strategies like these.

Ken Begasse: Concentric Health Experience is focused on improving the customer experience. Everything we do is centered on finding the common center, which is the shared problem to be solved in the brand experience. Centered on addressing the practical, rational, and emotional challenges shared by our customers, we seek to build an evolving and desirable engagement experience. These brand experiences are perpetually co-created, enabling engagement that is informed, shaped, and shared by the customers it serves. Although each experience is unique, we’ve been successful at helping activate and retain patient engagement and improve the prescribing experience.

Christine Armstrong: The most important way our agency is improving patient outcomes is by identifying far more touch points and opportunities to impact outcomes beyond the Rx. We’ve widened the lens on barriers through more specific research and intelligence and devised programs that create a continuous connective tissues between education, access, and adherence across a multitude of platforms.

Angela Tenuta: Recent research on the pairing of an app and a drug has shown that it’s possible to improve patient outcomes when the two are used together, instead of a drug being used alone. We are incorporating passive apps to help improve health outcomes, and we are seeing results. Being able to track patient behavior and use what we learn to provide insights for patients and pharma improves outcomes and informs our future projects.

Boris Kushkuley: Intouch started as a digital agency with a strong technology foundation. We were one of the first companies to create a companion mobile app to support treatment of chronic diseases like diabetes. This foundation and heritage puts us in a very unique position to develop effective patient-compliance tools. Realizing how important compliance, adherence and behavior modification is in the treatment of most diseases, we recently started to leverage behavior economics/psychology in designing patient-support initiatives. This has provided tremendous value in focusing on improving treatment outcomes in conjunction with leveraging technology and patient education.

Anshal Purohit: Our agency is helping patient outcomes in partnership with our clients, all of whom have a focus on this as a primary measure of success for their products. We view disease awareness, product promotion and education as three critical spokes of the communication platform and therefore focus not only on promotional communications even in the most truncated of plans, but also on disease awareness and branded education as a key part of the mix. This ensures that not only are HCPs aware of the products that we represent, but also that we provide context and support to ensure that patients get diagnoses and products when, where and how they need.

Dan Sontupe: The Bloc Value Builders use the Affordable Care Act’s Triple Aim, lower net costs, improved patient experience, and population health outcomes as a foundation for their customer engagement strategies. Most recently, we’ve been driving better patient outcomes by developing innovative population health- and value-based benefit design programs with our clients. These programs are developed in tandem with a manufacturer with the end user – an Integrated Delivery Network (IDN), Accountable Care Organization (ACO), or health plan – in mind. The goal of Population Health Management (PHM) is the improvement of the health of a group by identifying appropriate patients within that group. It uses multiple data sources (demographic, socioeconomic, health statistics, etc) to provide a comprehensive clinical picture of each patient with the goal of helping providers impact clinical outcomes while lowering costs. These data are applied across the continuum of care by integrating information on electronic health records (EHRs), medical claims, labs, and pharmacies.

For PHM to be successful, patient care management is a critical component. This includes a number of comprehensive, coordinated, and targeted functions including development of care plans, multidisciplinary care teams, patient health/wellness coaching, periodic telephonic-based follow-up, automated alerts/notifications for providers, and in-person and remote patient monitoring. In the end, a properly executed PHM program satisfies the goals of Triple Aim by improving the patient experience of care (including quality and satisfaction), improving health outcomes, and reducing the cost per patient. Further, this partnership with organized customers helps to prevent the targeted disease, and benefits the pharma customer by working with providers and members as true partners.

Additionally, the Value Builders have been working to impact outcomes to drive awareness through important provider and patient influencers. One brand agnostic tool, the Case Manager Toolkit (CMTK), is built by the manufacturer and offered to organized customers as a suite of assets created for the case manager, the patient, and the caregiver. The CMTK aids in engaging each to help improve the patient’s experience throughout their journey and is designed to support the patient and caregiver with the ultimate goal of a more motivated patient. Through this support, it is the goal to improve outcomes. What also helps the CMTK stand apart from other programs offered to customers is that it is endorsed by the Commission for Case Manager Certification (CCMC), the certifying organization for case managers.

 

10. Med Ad News: What are your expectations of the 21st Century Cures Initiative?

Lynn Macrone, Managing Partner and Chief Creative-Strategic Officer, JUICE Pharma Worldwide: At the heart of it, this initiative is a welcome step toward modernizing the approval process of medicines and devices. In turn, the goal is to ensure patients can benefit from the latest advances in science and technology, as manifest through these new approaches to treating – and even curing – diseases.

Advocates of the initiative feel that purging “unnecessary” hurdles – de-bureaucratizing the regulatory process – is a critical next step to keep up with innovations in science and technology. Others worry that the standards for approval of medical products may become compromised, or that patient privacy and confidentiality will be at risk. It is my hope that these concerns will be resolved, and we can keep our sights focused on the ultimate prize – providing the American public with the confidence that their prescribed products are safe and effective, and represent the latest scientific advances in medicine.

Eric Fink, Executive VP Strategic Planning, The Bloc: Like any major overhaul of governmental regulations, the 21st Century Cures Act should ultimately have a mixture of positive and negative effects on the ability to deliver safe and effective medications to patients in need. The intent to capitalize on recent advances in data collection and analysis as part of the assessment of pipeline agents is meant to both inform and speed up drug approval – and speed is certainly an unmet need. All too often we’ve seen patient groups waiting, often desperately, for the promise of an agent that is seemingly stuck in the development process. Outside of trial participation, patients and their families must wait and hope that FDA approval will come in time to help them. And yet the ability to speed the approval process through “multisourcing” of data from real-world case histories and anecdotal evidence is, in itself, the major weakness with the proposed legislation.

Celine Vita, Associate Partner, Client Service Director, CDMNY (part of  The CDM Group): The 21st Century Cures Initiative will be a defining moment for our industry, re-energizing the desire for investment in new pipeline agents in key areas such as rare disease and high unmet need (like oncology, Alzheimer’s, and ultra-rare diseases). It could also dampen some of the recent controversy around business models lacking commitment to R&D, or using polarizing/controversial pricing strategies.

An exciting element of this initiative is that it puts patients and their pressing medical needs first. While the FDA has recently been collaborating on rare diseases with patient groups, advocacy groups and foundations, this initiative really puts patients at the center of development.

This creates the chance to make data more powerful and relevant than ever. There’s a huge opportunity to use data collection, aggregation, and analysis throughout all stages of discovery, development and delivery. We think companies that invite technology partnership – and really take analytics seriously – are best poised to take advantage of data, and use insights to help patients.

We’re doing something like this right now in oncology, where we’re leveraging data to understand entrenched treatment practices; optimizing our digital ecosystem and engagements; and encouraging evidence-based practices that improve patient outcomes. We’re also exploring innovative data solutions through our iVenturesHealth group.
Ultimately, our hope is that 21st Century Cures decreases the time, barriers and cost to get new products to market for patients. But we’re also hoping for an important side effect: more data collection to inform how treatments might be used most effectively, impact disease progression, and improve overall healthcare utilization.

Ed Mitzen: I have healthy skepticism whenever the government tells us it is doing something to streamline the discovery, creation and delivery of the next generation of anything, let alone medicines. That being said, if H.R.6 can accomplish half of what it sets out to do, it will help tremendously. I am most excited to see if the goal of greater use of patient registries to speed clinical trial recruitment will work, especially as it pertains to rare diseases. As a marketing partner with many drug firms, we are often asked for solutions to speed patient trial recruitment.

Christine Armstrong: We are optimistic that the 21st Century Cures initiative will light the right fires to shorten the time from innovation to implementation across digital medicine, drugs and device development, and delivery of not only therapeutics, but all the necessary components that contribute to positive health outcomes.
We are already seeing the change in many large pharmaceutical companies creating entities that live above the brick and mortar organization to assess partnerships, collaborations, and share resources, to have broader, faster, more meaningful impact.

As long as we can all devise ways to vet, fail fast, and move forward with learnings shared across more open platforms, we can change the rate of actualize meaningful innovation for our patient population globally.

Robin Shapiro: Despite overwhelming support from both sides of the aisle, this initiative has created quite a debate within the scientific and clinical community as evidenced by a biting review by Dr. Avorn in this past June’s NEJM: “The 21st Century Cures Act — Will It Take Us Back in Time?” However, whether one supports the initiative or feels it is fraught with issues, we expect the ongoing debate to produce meaningful changes in the ways that pharmaceutical and biotech organizations approach bringing new drugs and devices to market.

For example, we expect this debate to elevate the importance of patient-reported outcomes (PROs) in designing clinical trials. The initiative will help fuel new ways of thinking about, measuring, and reporting endpoints important to patients outside of standard measures of morbidity and mortality. Additionally, it will encourage the incorporation of companion and complementary diagnostics when bringing new agents to market, helping to fully realize the potential of personalized medicine.

We expect patients to be the winners as a result of the Act and its debate. This initiative represents a significant milestone in medicine. It signifies that change is needed in order to advance medicine beyond where we are today. It declares that we need to start thinking differently and we agree.

Stan Woodland: In general, if you’re in the pharma business long term, your lifeblood is to bring to market new products faster. So even if you’ll have stiffer competition, if you have a strong R&D pipeline everyone will benefit. In particular the modernization of clinical trials will have an incredible impact, potentially knocking a year or two off the overall process.

Steve Wray: National Institutes of Health (NIH) funding was a major component of the 21st Century Cures Initiative, providing much needed resources for basic medical research across a host of chronic conditions. For example, the NIH research budget for Alzheimer’s disease is currently only $1.8 billion, while the annual cost to Medicare/Medicaid is more than $150 billion. A more strategic spending focus on costly and chronic disease categories should start to pay large dividends later in this decade.

Streamlining the FDA approval process should bring new products to market faster, increasing the importance for brand teams to embrace a digital launch process. Because patient experience data will now be considered in the approval process, the overall patient experience will be elevated in importance for brand teams, from clinical trials, all the way through launch and beyond.  

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