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January 28, 2016 0

Just a few weeks ago across the pond, the NHS Physical Health Monitor (for Lithium) was released as an app for smartphones in London, UK. Lithium Carbonate is the most common form of treatment for Bipolar Disorder in the UK. The major drawback to this treatment is that it requires strict regulation and frequent health checks. Back in 2013, St George’s Mental Health NHS Trust and South West London partnered up in attempt to streamline this regulation process and make it easier for the patient. The final result? An innovative app that addresses the need for a safe and convenient way to prescribe, administer, and monitor Lithium. Looking forward, they plan to extend the app’s capabilities to manage a broader range of treatments.

To learn more from Pharmaceutical Technology, click here.

Lily Stauffer


January 28, 2016 0

At this year’s CES conference, MC10’s two showcased products were nothing short of groundbreaking. By debuting two different wearables, one aimed to satisfy the medical community while the other targeting the general consumer, the company succeeded in sparking interest. The first product, known as BioStamp Research Connect, is designed to assist researchers with a multitude of health-related deficiencies. Inside the band-aid sized wearable contains both a gyroscope and an accelerometer, which are aimed towards tracking electrical activity, motor skills, and movement. To top it off, this miniature device can perform a real-time ECG. Moving on to their consumer oriented product, MC10 has partnered with L’Oréal to create My UV Patch. Designed to monitor sun exposure, this stretchy sticker syncs with smartphones to review results, and even includes helpful tips about healthy tanning.

Only time will tell how these two new innovations will fair in the 2016 market. To learn more, click here to read about it in Tech Times by Horia Ungureanu.

Lily Stauffer


January 28, 2016 0

Over the past few years, a new wave culture of fitness and clean eating has grown exponentially in the United States. Many attribute this focus on health awareness to its presence on social media, while others consider the lifestyle fitness apparel trend to be a driving factor. Smartphone apps for at-home fitness such as SworkIt and MyFitnessPal are topping the charts. Whatever the cause, quinoa, kale, and exercise tracking are trending. To match the growing demand for personal tracking devices, popular companies such as Under Armour and Garmin have taken their step-counting wearables to a whole new level. The 2016 CES Conference hosted in Las Vegas showcased a variety of types, ranging from smart hearing aids to infrared technology that is designed for pain relief. Goodbye traditional pedometers, and hello to a new era of highly intelligent wearables.

To read more about wearable technologies featured at CES 2016 as reviewed by Kelly Sheridan from InformationWeek, click here.

Lily Stauffer


January 28, 2016 0

Nowadays, it is nearly impossible to walk down the street without seeing somebody sporting a healthcare wearable. With sales surging at an annual growth rate of 25%, and an impressive $5.1 billion market value, it appears that the healthcare wearable industry is stronger than ever. However, these statics fail to recognize that such wearables are tossed aside by consumers within six months of purchasing. This lack of long-term value can be attributed to a variety of causes, many of which revolve around companies over-complicating their design, ultimately leaving consumers feeling overwhelmed. Further, the clash between fitness trackers and medical wearables is of major concern. In attempt to avoid strict FDA regulations and present shareholders with expedited revenues, companies are dubbing their products as consumer devices used solely for personal tracking. Although this cranks out sales figures more quickly, there is a strong market for medically approved devices, which in turn will lead to long-term use and profitability.

Interested in learning more about the healthcare wearables market? To read Reenita Das’ article from Forbes, click here.

Lily Stauffer


January 28, 2016 0

Considered by many the Woodstock of pharmaceutical conferences, the 34th Annual J.P. Morgan Conference held in San Francisco January 11-13th lived up to its nickname. It was three days of non-stop presentations, meetings, business development opportunities, and endless potential for new partnerships. Among the attendees was a convergence of hedge fund investors, bankers, and pharmaceutical executives. Cara Therapeutics, a small public biotech company based in Shelton, Connecticut sparked particular interest, as they released their data for their new abuse-deterrent formulation peptide. Currently deep into phase II of clinical development, CR845 is groundbreaking in the world of analgesic painkillers, as it does not penetrate the blood-brain barrier; making it virtually impossible to abuse. Looking towards 2016, President and CEO Derek Chalmers was quoted as saying, “based on these encouraging findings, we plan to conduct a larger double-blind, placebo-controlled Phase 2b trial in 2016.” The company is hopeful that by early 2018, CR845 will be approved for the market and forever alter the use of opioid formulations.

For the official press release from Cara Therapeutics, click here.

Lily Stauffer


January 27, 2016 0

By Linda DiPersio, MSM, MSHC

DiPersio-Jan2016artwork1In the book “The Innovator’s Prescription: A Disruptive Solution for Health Care,” Clay Christensen, who developed the theory of disruptive innovation, stated, “There are more than 9,000 billing codes for individual procedures and units of care. But there is not a single billing code… for helping patients stay well.” In the pharmaceutical industry, disruptive innovation improves health by generating ideas that create new drugs at the expense of existing ones. It is an alliance between technological advances and new business models that dramatically changes the performance of the industry. The progressive spectrum of disruptive innovation challenges include lessons from the past showing resistance to change, implications surfacing in the present which emerge from cautious analytics and trailblazing dynamics in the future aligned with patient centricity.

Past: Resistance to Change

Despite the remarkably positive success of antiseptic surgery with carbolic acid saving many lives during active combat in late 19th century Europe, Surgeon Dr. Samuel Gross from the United States said, “Little, if any faith, is placed by any enlightened or experienced surgeon on this side of the Atlantic in the so-called carbolic acid treatment of Professor Lister.” The medical community in the United States not only disapproved of the concept of germ theory that promoted the protection of patients against airborne microbes, and any drug associated with it, but also they fully rejected it – instead believing that miasma or bad air caused infection. After 30 years of successful usage in Europe, the jolting factor of antiseptic surgery acceptance in the United States is attributed to the almost assuredly avoidable death of President James Garfield. His non-life threatening gunshot wound from an assassination attempt was cared for by a team of doctors with germ-laden contact, including non-sterilized instruments, which lead to a major infection most likely being the cause of death.

DiPersio-Jan2016artwork2As the above example shows, the advancement of pharmaceutical innovation efforts are most often prevented by established world views, opinions, customs, attitudes, societal values and complex psychological and emotional issues ingrained in the network of relationships that define individuals singly or collectively. In certain situations, innovation challenges are rejected directly because they are seen as threats to the means of support and character of many stakeholders, such as pharmaceutical companies, Federal regulatory institutions and the American Medical Association, that deploy an intangible but forceful influence on decision-making. Resistance to change in pharma emanates from industry incumbents whose jobs rely on sustaining the existing business model and political power. As Upton Sinclair said, “Never expect someone to understand change when their livelihood depends on not understanding it.”

Present: Cautious Analytics

Currently, pharma believes that marginal innovation is actually “safe” disruptive innovation because it is supported by confirmed targets, proven forms of action and/or established drug classes. In reality, it is extremely risky. Marginal pharmaceutical compounds have a high risk of not achieving end results, not being accepted by regulators and/or not performing up to the standards of existing less costly therapeutics and fail commercially. Recent studies with marginal drugs show a 50% failure rate due to a lack of efficacy or safety.

Safer trials, which are designed to add evidence-based support of the versatility of top drugs, take away the amount of funds from innovations and discovering new cures. There are no pre-competitive consortiums to divide the challenges and costs of developing new knowledge about disease causation. Today, innovation is distributed over a group of partners with universities conducting the riskier early translational research and pharma investing in late development with perceived low risk. Beginning as low risk, low returns and low R&D, cautious analytics eventually equate to bad risk with ill-fated consequences.

Future: Multi-Dimensional Patient Centricity

DiPersio-Jan2016artwork3In the future, the drug lifecycle needs to incorporate many facets of patient centricity, including the use of new technologies such as gene- and proteomics, gene therapy, nanotechnology, and Big Data driven predictive analytics. Precision medicine will identify exact patient needs and tailor molecular profiles to create the most beneficial treatment plans for patients on an individual level. New social media tools will allow patients to share information and participate in collaborative discussions with regulators and pharma.

If pharma practices the five skills of questioning, observing, networking, experimenting, and associating that are outlined in the book “The Innovator's DNA” authored by Gregersen, Dyer, and Christensen, disruptive innovation will be constructively delivered, empowering patients, and effecting positive change through physicians who will proactively treat and potentially prevent illnesses before they become a major source of concern. Creativity that changes behavior will be framed by:

  • Asking controversial questions that confront existing knowledge of the industry;
  • Thoroughly examining behaviors to identify new ways of doing things;
  • Encountering people with fundamentally dissimilar ideas and perspectives;
  • Building interactive experiences that trigger non-traditional responses to discover what insights emerge; and
  • Connecting the dots with questions, issues or ideas from unrelated fields.

In summary, the past and present challenges mapped out on the spectrum provide valuable information that will shape future disruptive innovation in a beneficial way. Lessons learned from the past indicate that attitudes impacted the resistance to effective existing pharmaceuticals. Presently, with pharma’s perception of “safe risks,” engaging in cautious analytics eventually results in bad risks. In the future, leading the way with a multi-dimensional, patient-centric approach to the drug pipeline will allow for increased profits and improved health outcomes. As Clayton Christensen said, “Disruptive innovation is a positive force.”

Sources:

Christensen, C., Hatkoff, C. and Kula, I. “Disruptive Innovation Theory Revisited.” Innovation Excellence. (2013)

Coleman, D. “The DNA of Disruptive Innovators: Will Pharma be Disruptors or Disrupted?” Eye for Pharma. (2014)

“Disruptive Innovation and the Future of the Drug Lifecycle.” PhRMA. (2013)

“Growing the Pipeline, Growing the Bottom Line: Shifts in Pharmaceutical R&D Innovation.” KPMG Pharmaceutical R&D Innovation. (2014)

Munos, B. and Chin, W. “How to Revive Breakthrough Innovation in the Pharmaceutical Industry.” Science Translational Medicine. (2011)

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January 27, 2016 0

By Faruk Abdullah of Applied Predictive Technologies

Abdullah-Jan2015artworkPharmaceutical marketing is changing. With increased industry spend, new marketing channels, a more informed consumer, and a shifting healthcare landscape, it is clear that marketers need to be smarter than ever with their investment decisions. It is also clear that DTC marketing is no longer just about pumping money into national TV ad buys (though they continue to receive substantial investment). It’s now also about targeted messaging. It’s about digital. It’s about patient engagement. In this environment, it is more complex than ever to understand how to get the right message in front of the right consumer at the right time. Marketers will need to innovate.

As organizations try new marketing strategies, they will inevitably realize that not all of their ideas will achieve the desired outcome. In fact, it is incredibly risky to dive head-first into new ideas without empirically validating them first.

The question is how can marketers get the most accurate, data-driven recommendations about which actions work with each customer segment? And, how can they do this without first risking significant budget or opportunity cost of not rolling out the most effective ideas sooner? The traditional method of allocating marketing spend has been to use promotion response models, which rely on historical data to attribute the impact of a given marketing action (e.g., print ads) on KPIs (e.g., NRx). Promotion response models are important tools for the industry and can serve as great sources of hypotheses about what the impact of a given action might be. However, traditional regression-based approaches are unable to uncover what would have happened if the action had not been taken.

It is time for life sciences marketers to move towards a process that leading retailers, restaurants, manufacturers, and banks have been driving for 15 years: rapidly testing their ideas to figure out what works and where they work best before making significant investments. As pioneers of controlled experiments for clinical trials, life sciences companies know that test versus control experimentation is the gold standard in analytics. Trying an initiative with a test group (e.g., in just some markets or with some physicians) and comparing those results with a highly similar control group (not experiencing a change) is the only way to truly understand the incremental effectiveness of each investment. Leading commercial organizations are now also beginning to use this experimental methodology to optimize their marketing and sales programs.

Experimentation is most valuable where the outcome of the experiment will directly impact a decision and create a new learning for the organization. With the consumerization of healthcare, consolidating health systems, new competitors, and a shifting reimbursement paradigm, the outcome of a new marketing action today is highly uncertain. We suggest that organizations should test all shifts in marketing strategy before making any changes.

There are three critical reasons why marketers should begin to incorporate credible, empirical data into their marketing decision-making process.

  1. Correlation is not causation. Promotion response models seek to identify relationships between marketing actions and KPIs. With rich data and complex equations, it’s easy to conclude that this approach leads to optimal recommendations. Unfortunately, because promotion response models are generally not based on test vs. control analytics, they are unable to isolate cause-and-effect relationships between changing a given marketing lever (e.g., increasing digital spend) and a change in KPIs (e.g., TRx).
  1. The future is different than the past. Companies construct promotion response models on the basis that historical relationships between marketing actions and changes in KPIs will continue to hold true in the future. As fast as healthcare is changing today, relying on data from the past to make decisions about a volatile future is a mistake.
  2. It can’t be modeled if it hasn’t been done. Promotion response models rely on measuring the relationship between past marketing investments and KPIs. To state the obvious, there is no real world data from an action that has never been put in market, and thus no way to build a model on that action. For these situations, marketers may rely on market research or analysis of similar campaigns before rolling out a new tactic. However, these approaches may not generate the most actionable, accurate insights. Alternatively, by embracing rapid, statistically credible, field experiments, marketers can know with confidence what will happen before they take the risk of rolling it out more broadly.

In today’s changing healthcare and marketing environment, it is critical that marketers truly know which ideas work and which do not. Organizations should rapidly tests their ideas, discard the unsuccessful ones, and understand how to refine their strategies to dial up ROI.

Faruk Abdullah


January 25, 2016 1

Yes, that is the name of a new documentary that hit theaters Friday, January 22. It is by a documentary film maker Chris Bell. While I doubt it has a wide release, the media will enjoy reviewing it and telling us it is a must see. The only preview I could get was a two minute trailer on You Tube. It may be an entertaining film and I did see Mr. Bell’s first film on steroids which was very good.

In that two minute trailer, the direction of Prescription Thugs was clear and unsurprising. The drug industry makes tons of money preying on naïve consumers. The pharmaceutical industry does not care about preventing or curing disease but likes to manage our diseases with expensive pills. We have become a society addicted to painkillers, anti-depressants, ADD drugs sold to us by big Pharma using advertising and high pressure sales tactics. Sounds like a familiar theme already done by Michael Moore and others.

Bob Ehrlich
“It is getting tiring hearing how evil we are…”
-Bob Ehrlich

Maybe all of us should find work in an industry that is more loved. It is getting tiring hearing how evil we are peddling expensive and unnecessary treatments. The media hates us but loves our ad dollars. The left wing politicians cannot wait to punish us for the crime of providing lower cholesterol, lower blood pressure, normalized blood sugar, cures for hepatitis, management of HIV, etc. Somehow drug makers deserve to get their due for years of screwing the public. Bernie or Hilary will make us pay for the years of thuggery. Iranian missiles, North Korean nukes, and ISIS seem to be less of a threat than drug ads and high prices.

Calling us thugs and enemies is sure to solve the cancer cure mission that President Obama just highlighted in the state of the union. I am sure in some Hollywood fantasy Matt Damon will play a government scientist who finds the cure for cancer. In the real world, Hilary and Bernie will have to count on their enemies in the profit making drug world to develop cures.

Documentaries like Prescription Thugs will be seen by few regular Americans, but cited by many industry critics for its revelations. Given the political focus on drug prices, DTC, and rising insurance premiums, we are sure to get a black eye from the negative publicity. I can see the film maker appearing before Congress, along with the usual drug industry haters to testify how the profit hungry corporations must be subjected to price controls and shorter patents.

If you are getting tired of getting hammered by the politicians, the AMA, the mainstream press, consumer activists, insurers, and your friends and relatives; then maybe we can all do something better for society. After all curing disease may be over rated. Maybe we should just let someone else do it, and hope it plays out like a Hollywood screenwriters’ fantasy.

Bob Ehrlich


January 15, 2016 0

Welcome back to Pradaxa, a drug to prevent stroke, with a new ad campaign. The new television ad is quite unique. It is entirely a simulation of what happens in a blood clot caused by atrial fibrillation. What is really interesting is the use of swimming fish to represent blood cells.

The competition Eliquis and Xarelto have been big DTC spenders since launch. Pradaxa appears to have stopped a heavy DTC television effort in 2014. It seems they decided to return with a heavy television media buy and completely new creative this month. The three heavy spending brands now have very different creative approaches. Eliquis has the very common theme of a patient telling a story of why they chose Eliquis. Xarelto has gone celebrity with golf legend Arnold Palmer actor Kevin Nealon, race car driver Brian Vickers, and basketball star Chris Bosh. All three ads can be seen on Ispot.tv.

Bob Ehrlich
“Pradaxa developed a unique look…”
-Bob Ehrlich

Pradaxa decided to leave its past approaches of doctor testimonial and father and daughter conversation. Instead it changed to a very engaging, but simple visual of the red fish (blood cells) swimming through the circulatory vessels and showing how they can clump together to form a clot that can travel to the brain. I have to say I paid attention to this ad. Somehow the little fish were hypnotic and I could not stop watching.

I am sure the marketing team tested the ad and got very good recall of the visual and the message of how Pradaxa helps prevent the clot. What I like is that Pradaxa developed a unique look that gives it a competitive difference. All three commercials work and I cannot comment on which is actually best at generating sales increases. What I can say is Pradaxa needed something different and could not re-enter using standard vignettes or doctor testimonials. Using a memorable device allows potential customers to discuss the Pradaxa ad with doctors using either the brand name or saying the ad with the fish. I assume the Pradaxa detail force let doctors know about the new campaign in advance or as it aired.

The stroke category spends over $200 million a year and the re-entry of Pradaxa will add to that level. Whether this new ad is just a test by Pradaxa or a major full year campaign remains to be seen. If they are to get competitive share of voice they will need to spend at least $50 million as both Eliquis and Xarelto are saturating the airwaves with $75-100 million each. Usually an ad campaign needs at least three months to measure effectiveness and that means I expect to see Pradaxa ads at least through the spring.

Bob Ehrlich


January 11, 2016 0

Twenty years of DTC advertising has not seemed to be enough time to gain acceptance by physicians, consumer advocates, and politicians. In fact the anti-DTC sentiment seems to be reaching a frenzy this election cycle. I have discussed before why this is happening. In brief, it is because of the false assumptions that DTC raises drug prices, creates demand for over treatment, sets false expectations of efficacy, wastes physician time discussing drug requests, and discourages non drug alternatives.

The drug industry has largely failed to change attitudes among consumers about its image. Surveys show a lot of anti-drug company sentiment and a feeling that there is a problem in drug advertising. Despite the anti-drug company sentiment, consumers seem to rely on drug advertising for their awareness of new treatments. There is no doubt for most brands DTC is a successful investment.

Bob Ehrlich
“DTC marketers should be proud of what they do.”
-Bob Ehrlich

The reason drug companies have PR problems is because of the fundamental issue that Americans do pay more for branded drugs than Canadians and Europeans. American prices fund drug company research budgets. It is hard to explain to Americans that they subsidize drug development for other developed countries. It is difficult to get politicians to stop bashing drug companies even though most are smart enough to recognize what would happen if the United States imposed price controls. Research would decline and government would not pick up the slack. Politicians on the left take the easy route and use prices as a campaign issue.

This PR nightmare is here to stay and drug companies are battling DTC critics as best they can. Mostly they are using tremendous lobbying clout to prevent price controls, tax penalties for DTC, and punitive patent policy.The media and advertising agency trade groups are also fighting any DTC restrictions through intense lobbying.

My recommendation for DTC marketers is to unapologetically market your products through advertising. I am convinced that DTC works because consumers learn important news through DTC and in many cases follow up with their doctors. Consumers may say they have issues with drug ads, but they act on them anyway. DTC is just the start of a consumer initiated process, and there are many opportunities to learn of alternatives to advertised drugs.

The best thing drug companies can do to blunt criticism is to make truly added value solutions that cure or control disease. Ask a Hep C sufferer if Harvoni is a miracle drug. Ask the people with HIV who now live a relatively normal life if drug companies changed their lives. Those drugs would not likely be here without the strong profit motive. DTC is not perfect and does lead to some issues for payers and doctors. On balance, DTC is a net positive and although Hilary and Bernie will disagree, DTC marketers should be proud of what they do.

I expect 2016 to be a strong year for DTC spending and could top $5 billion again. There are numerous media opportunities to improve DTC effectiveness and efficiency across mass and targeted media. These opportunities are in creating better ads and in optimizing media selection. Technology has created opportunities to do deep dives in how consumers digest DTC ads. All DTC advertisers have opportunities to get better ROI if they use the many tools suppliers have developed.

While we have gotten good at creating the basic DTC ad, can we say they are the best we can do? DTC is 20 years old but health care is changing so fast that the learning curve on what motivates consumers is still at its infancy. That makes being a consumer marketer of health products an exciting place to be despite the criticisms.

Bob Ehrlich