The latest pharmaceutical disease: what it is and how to cure it

Having written my MSc dissertation on the future of the pharmaceutical business model, I could type for days on end and have you scrolling forever. However, I don’t think that would ever be published as a blog article. To realise that childhood dream of mine for at least the length of this post…

Come into my office, take a seat and let Dr. Lok tell you something:

The traditional business model of the pharmaceutical sector is failing.

It is a disease that if left untreated, will cause the company that has contracted it to perish. Symptoms include diminishing market share, increasing overheads and a thinning profit margin. The only cure is an innovative business model - no longer a one size fits all approach but one that each pharmaceutical company can mould around themselves. Think of a memory foam mattress; sold the same to all but embracing the individual and supporting their sleeping positions.

Outside of this GP surgery in the real world, we see traditions diminish as technology and other breakthroughs move the next generation forward into another era. This idea can be projected onto the pharmaceutical industry:

The main reason why the traditional business model is failing is due to the increasing difficulty to establish blockbuster drugs, and the growing number of patent cliffs that are drawing ever closer and giving way to a new generation of generics.

By looking at the fundamental management model of patterns of strategic change (Johnson and Scholes, 1993) (above), we can see that the industry has seemingly enjoyed continual growth for a prolonged period of time. Firms now face a period of flux unless they are able to successfully employ a transformative breakout strategy. With such a strategy, firms do not only have a chance to be a formidable competitor in the market, but can transform the business model of the sector as a whole.

The usual go-to for a breakout strategy in many industries is mergers and acquisitions (M&A), but it is no secret that these have not been successful for many in the pharmaceutical industry unless they have been planned strategically. Pfizer for example, was described by the New York Times as “Frankenstein’s monster” in 2012. They had carried out five large M&A deals in the decade preceding 2011, and ended up making substantial losses across the company.

To those suffering from traditional business model disease, I write a prescription for market research.

Market research is key in enabling pharma to understand how they might leverage their brand’s brands’ USPs to protect and even continue to grow their market share in the face of ever increasing generic competition. These USPs can no longer be molecular and data focussed but need to be humanistic. We doctors see patients - people - who are experiencing a dis-ease. By fully understanding these experiences, companies can recognise the value in easing the distress of a patient rather than just focusing on the molecular microbiology or clinical data story.

At Branding Science, we are able to gain a real insight into the rational, but moreover the emotional drivers which spur the prescription of different drugs. From pre-launch to post-launch, we use a variety of innovative psychology-based methods that allow us to dive deep into the thoughts of health care professionals when making prescription decisions. By helping our clients understand the reasoning behind the decisions being made, we are able to work with clients to effectively identify which themes they should leverage their brand upon in order to connect emotionally with both physicians and patients. Therefore, branded drugs can still be at an advantage in terms of maximising market share as long as they remember that their brand is an intangible asset that only they can exploit.

Traditional Business Model Disease does not have to be terminal - the cure however may be unique for each and will be found through the understanding of customers and end users. I look forward to seeing which pharmaceutical company will be first to unlock that cure and transform the industry.

The Author: Chloe Lok is research executive at Branding Science. She holds a Masters in Management from the Imperial college in London and a Bsc in biochemistry from the University of Reading.

Edible Tech

We’ve heard about the innovative ways that healthcare is infiltrating the digital world. Technologies such as mobile aps and techy wristbands have been part of the mainstream healthcare conversation for a while now. However Proteus Digital Health have gone one step further and have developed a new type of ‘edible’ tech.

This miniscule wireless device is actually ingested by the user and feedbacks their bodily vitals to an external computing device. The contraption, which resembles a grain of rice and is made almost entirely of silicon, passes through the body over a space of about a week and feeds back information to the user including heart rate, body temperature, activity levels and rest patterns.

What may be the purpose of receiving such information?

For patient’s friends and families, it is a way to ensure that their loved ones are taking their medications, sleeping correctly and getting enough exercise. And through a clever linking system, the family can send reminders or gentle ‘nudges’ to encourage a healthy lifestyle or compliance to medications. Not only may the information be used to aid adherence to both drugs and lifestyle changes, but it also empowers the patient to be more in control of their illness and especially may help to ease the patient back into society after a stint in hospital, by providing a reassuring edge.

Perhaps more importantly though, the information can also be used by physicians to help monitor their patients. The data can be used to help identify ‘at-risk’ patients who may be more likely to require medical help and even recognise those who need to be admitted to hospital rather than waiting for an appointment and allowing their problem to escalate.

What may be the value of ‘edible tech’ for pharmaceutical companies?

Digital health is something pharmaceutical companies are increasingly engaging in. Both Otsuka and Novartis have announced partnerships with Proteus Digital Health. Novartis, in particular, are looking to use the ingestible device to help with adherence relating to organ transplantation; a therapy area where they have a substantial portfolio.

Yet could this captivating new device be used by ourselves within the realms of market research? Perhaps in patient research this could be a way to truly understand adherence to both medications and lifestyle changes, and match up what respondents believe and say they are doing with clinical data showing their real behaviours. A couple of ideas Branding Science have had include monitoring sleep cycles of patients with insomnia or the exercise patterns of type II diabetic patients. However with Proteus yet to announce a launch date, there is plenty of time to work out more ways to include edible tech in market research.

From Runner to Sloth – what’s the value of wristbands ?

 

'....calories were for burning and not counting.....'

At the age of seven I was being taught the rudiments of skiing in the forests above Oslo; by ten I was running everywhere, in my teens I was subjected to rigorous Summer athletics training and as my working life started so I tried to train in 10 day cycles: nine on and one off.  To me and my mates calories were things we burnt and we needed lots of them – we certainly didn’t need to watch them.

But time marches on and drags us all down with it.  In my case it was a matter of going from extreme activity to the normal existence of office life where we tend to take no more exercise than required to replenish our tea or coffee, with the occasional stroll to a meeting or perhaps some long distance travel.  Whatever, these are physically slothful activities in which calories do become important, intakes need to be watched and, if we are not careful, our condition deteriorates.

About two years ago along came a variety of fitness devices – small wristbands that purported to measure activity, and in some cases sleep, calories taken and, in one device, time.  I was instantly entrapped by these things and worked my way through the Nike Fuelband, Jawbone’s UP and now the Fitbit Flex.  Each has its strongpoints, but are they useful or are they just gimmicks ?

After 14 months of trial and error I’ve come to the conclusion that whilst of reduced value to the super-active, they do, within their limits have a very definite place in the lives of we who are members of the vast Tribe of the Human Sloth. 

Why ?

v  They set targets.  For some reason the Health & Fitness industry has decreed that we should move 10,000 steps in each 24 hours and that’s surprisingly difficult to achieve if all you do is go to work by some mechanical means, sit around all day with brain fully engaged but body relaxed, and then go home, possibly via an inviting pub, again by mechanical means.  I’ve noticed that on such a day I rarely surpass 6,000 steps.

v  They measure intake.  After an inactive day it comes as a bit of a shock to see on the App of whichever device you are using, figures in red showing that total calories consumed have exceeded those used up.  We don’t want too many of those days.

v  They provide reminders.  The Fitbit Flex sends little messages when you are getting near the day’s target and then congratulates you if and when you pass the magic 10,000 (it also vibrates at that point, which can cause you to spill that end-of-day glass of wine if the lifting of the latter coincides with the sudden vibration !).

v  They provide competition, which may or may not be a good thing.  These devices can, if you let them, communicate with different social media channels and so allow your friends and colleagues see how you are getting on.  This can introduce an element of fun.  A training regime that has some fun in it will always be more effective than one that’s all about hard work.

As with all things these measurement devices are only effective if used consistently.  Entering food and liquids consumed, and various daily activities can become a bit tiresome.  But if used consistently and with an aim, I do believe that they can change behavior, monitor what we are doing in a positive way and, in some cases, provide clear evidence to our medical minders that we are, or are not, following their guidelines.

I suspect also that we’d better get used to this sort of thing because some day, perhaps not so far off, our Doctors will expect us to pass them a device that they will be able to interrogate as part of their Consultancy in order to find out exactly what’s going on.

The future’s (almost) here !

 

Jonathan Thomson is COO of Branding Science.

As part of our Digital Work, Branding Science has extensive experience with these devices.
For more information, please get in touch!

Bacteria: Good and Bad and how to tell them apart

“I love bacteria because they remind me of God,” said the professor. He was religious and the head of the department of microbiology and biotechnology in Tel-Aviv University, explaining how religion and science can thrive together. “Bacteria are everywhere, you cannot see them and they can do ANYTHING – just like God”, he exclaimed.

Indeed bacteria are everywhere and they are definitely in our bodies covering our skin and lining our intestines, giving us our distinctive smell, eating away our dead cells and share our food. They provide us with valuable source of vitamins that cannot be obtained otherwise and they protect us from infections of other microorganisms. Some of us call them ‘good bacteria’ to differentiate our helpful little friends from the dangerous disease causing microbes. Our ‘friendly bacteria’ are actually symbiotic and opportunistic at the same time. We are dependent on our flora as much as under its’ threat.

Try to remember when was the last time you were prescribed a course of antibiotics. How did you feel?

I have been on such a course only three weeks ago, augmentin it was, a generic brand, and in a way I was relieved the manufacturer was not one of our clients (so I did not have to fill an adverse event form). Nevertheless, I was unwell. The antibiotics killed the bacteria on the lining of my gut affecting digestion and making me uncomfortable (forgive me for not giving more detail). It is a well-known side-effect that made me ponder over a tub of yoghurt, why not try and make targeted antibiotics? Wouldn’t it be grand if you could target bacteria causing disease and spare whole body’s flora? If we could differentiate good bacteria from bad?

What are bacteriophages?

Bacteriophages are viruses that propagate by infecting bacteria, their hexapods land onto their prey (Figure 1) and inject their DNA into the bacteria, giving it orders to multiply bacteriophages until the bacteria bursts, the progeny moves on to the next bacteria and so on. Bacteriophages are specific to a bacteria strain which gives them a potential to be employed as targeted antibiotics.

It is intuitive that we could utilise the specific power of bacteriophages into treating specific infections, but for some reason the technology has not been taken by the western world.

Phage treatment has been approved and in use in Russia and Georgia since the 1920s. It actually had been in use before penicillin was even discovered in 1928. However, somehow the fear of viruses and the excitement over chemicals has led to antibiotics being developed and widely used, and now we are facing a possible crisis of multiple drug resistant strains of bacteria (MDR). Some call MDR risk ‘the perfect storm’, with only a handful of new antibiotics developed since the 1980s, we are not prepared for the next outbreak.

At the Eliava institute in Tbilisi, Georgia, infections are being treated with bacteriophages.  For example, a case of tonsillitis is treated by gargling a bacteriophage broth and the patient is cured in 6 hours, no antibiotics involved.  In the UK a seven day antibiotics course is the standard of care.

Figure 1 Bacteriophages T4 sitting on a bacteria injecting their DNA into it (electron microscopy image Science museum),

What are the difficulties in producing bacteriophage based antibiotics?
First of all safety, the use of an entity that self-replicates and have the ability to evolve is difficult to regulate as a fixed chemical entity or biologic. Bacteria are likely to develop resistance to bacteriophages. When such a resistance develops it is likely that the bacteriophages will mutate accordingly, but that may cause issues with produced batches and regulation in mass production.

Formulation issues - you can’t get bacteriophages through our digestive tract, how can we bring them to their target? Can bacteriophage be inhaled for treatment of tuberculosis?  

Another issue with bacteriophages is that they cause bacterial lysis that releases endotoxins. These are toxic to patient and may cause severe side effects such as fever. 

Bacteriophages can be genetically modified to not lyse their target bacteria so one virus would kill one bacteria without bursting its walls. The dead bacteria will then be cleared by the immune system, also such attenuated bacteriophage would be easier to regulate. Just like the use of attenuated viruses in vaccines.

The main reason is a general lack of interest in developing antibiotics because of low return on investment (until there is an outbreak).

Bacteriophages have been used in the western world, for the invention of the probably the most profitable drug ever made.

In the 1990s the phage display technology was invented and utilised by Cambridge Antibody Technologies (CAT) and BASF. The scientists at CAT engineered bacteriophages to express antibody segments and used the ability of bacteriophage bacteriophages to mutate to create many different antibodies, called a phage display library. This library was reacted against TNFα (Tumor Necrosis Factor), the best matching antibody was chosen, cloned and mass produced as a humanised monoclonal antibody. Manufacturing and marketing were given to Abbot, and the brand Humira was named.  Humira is widely used to treat psoriasis, ankylosing spondylitis (AS) rheumatoid arthritis (RA), ulcerative colitis and Crohn’s disease.

The next most likely development in modern medicine will have to be a targeted antibiotic, maybe a bacteriophage? What do you think?

Figure 2 bacterial culture killed by bacteriophages (Wikipedia). Bacteria –white. Hole formed by dead bacteria in the middle.

Dr Shai Senderovich is a Research Executive at Branding Science,

Any opinions in this article belong to the author and do not represent Branding-Science.

Links:

http://www.bbc.co.uk/news/health-21799534

http://en.wikipedia.org/wiki/Phage_therapy

 

The Invisible Monsters Return - Antibiotic-Resistant Bacteria

 

Antibiotic-resistant bacteria seem like they belong in a Stephen King novel rather than the news, with headlines threatening a return to pre-modern healthcare, when the mildest infection could threaten your life. In a BBC article, Professor Neil Woodford from the Health Protection Agency gives us a worst case scenario example: "You could be gardening and prick your finger on a rose bush, get a bacterial infection and go into hospital and doctors can't do anything to save your life. You live or die based on chance.” He hastens to add "But for many infections that wouldn't happen."

unfortunately, this problem isn't fiction

 

There are a number of reasons why antibiotic resistant strains have developed in recent years. Not only have antibiotics been overprescribed, but animals have also been given antibiotics in mass farming routines. As one of our team members explained, "livestock is injected with antibiotics that stay in the meat. Therefore, eating meat is like taking a low dose antibiotic that will only slow down the sensitive bacteria, forcing them to learn how to break it. This is how resistance strains evolve, through constant exposure to low doses of antibiotics from food."
There is also the problem of drug development. There have been no major breakthroughs in antibiotics since 1987 and, according to Professor Farrar, head of the Wellcome Trust, only four pharmaceutical companies work on antibiotic development today compared to 18 companies 20 years ago. The World Economic Forum attributes this to the lack of incentives for pharmaceutical companies to research and develop new antibiotics, especially compared to the rewards of other diseases and conditions that have seen more investment recently.

 

While researching this blog entry, Branding Science discovered that we have an in-house expert on antibiotic resistant bacteria. Becky Geffen wrote her masters dissertation on antibiotic resistant bacteria and has kindly agreed to answer a few of our questions for the blog today:

BSc: Can you give us more of an idea of how the situation stands right now?

Becky: There are hundreds of different antibiotics out there, with a number of different mode of actions, and so even with the more severe infections, there is a vast range of antibiotics on hand ready to fight the bacteria.

The odd case where people die from bacterial infections are from really unfortunate circumstances where the bacteria have developed a different way of breaking down the antibiotic. These are firstly very rare, and secondly there is generally at least one antibiotics that will work, even if it will present the patient with unpleasant side effects.

BSc: How do you see things improving in the future?

Becky: The main issue surrounding antibiotic development is that we need to first understand how these resistant bacteria are degrading the antibiotics before we can find new drugs to overcome this, and this is where academia comes in. So even if new antibiotics are not at the forefront of pharmas mind, there is research going on in the background surrounding the mechanism of action of these pesky bugs. Until this is done, we almost want pharma focusing on other therapy areas rather than churning out ‘me-too’ antibiotics.

BSc: Do you know any interesting facts about antibiotic resistant bacteria that you’d like to share with our readers?

Becky: I cheated and looked these up as I don’t think anything from my own research would be that interesting to anyone but me! In an Egyptian study, Dr Mervat Kassem showed that green tea could boost antibiotics antibacterial properties by 3 times. So the next time you get ill, start chugging back the green tea. And antibiotics have a sinister side as well; penicillin is the number 1 cause of anaphylactic shock.

Thanks Becky!

 

Written by Alexandra Zaleski in our London office.

Further reading and sources:

http://reports.weforum.org/global-risks-2013/view/risk-case-1/the-dangers-of-hubris-on-human-health/#read

http://www.bbc.co.uk/news/health-21702647

http://www.bbc.co.uk/news/health-21737844

http://www.bbc.co.uk/news/health-24957090

http://www.bbc.co.uk/news/health-24957090

http://www.bbc.co.uk/news/health-25654112

The Benefits of Becoming a Cyborg: improving outcomes by keeping us honest

 

One of the most exciting current developments in mobile health technology is the increasing availability of smartphone-based health monitoring accessories.  Devices currently on the market are mostly focused on cardiovascular monitoring or diabetes testing, but as the space evolves, more diverse technology will become available. 

Why are these tools so valuable?  At a topline level, it’s because they keep us honest.  As market researchers, we’re well aware of common human biases that affect how all of us self-report information to others.  For instance, humans have an inherent bias towards optimism which may cause us to gloss over negative items in our health history, sometimes depending on how they were experienced (see work from Daniel Kahneman, e.g. Thinking, Fast and Slow, 2011).  We might forget how many times we’ve felt terrible due to a chronic condition; or, at our annual check-up, we may neglect to mention the few small health quirks that made us think “huh, that seems weird, I should mention that at my checkup…” over the previous year, especially if we ultimately felt ok after they had passed.

Further, the way each patient talks about their disease can be unique.  A worried or scared patient with a newly-developed issue might recall their symptoms as much worse than they were at the time.  Or, a patient who’s hoping to avoid medications might gloss over or downplay the significance of their symptoms.

 

For doctors and researchers alike, it’s essential for patients’ health information to be as correct, standardized, and reliable as possible.  Wearable health monitors not only ensure that patient data is collected accurately, but they also allow healthcare providers to capture a wide picture of the patient’s health in a variety of settings, granting a more complete picture of health.  For instance, sometimes a patient may come into a doctor’s office with a complaint that can’t be replicated while the patient is there (e.g. heart palpitations or muscle spasms).  More continuous monitoring of the patient’s health can help doctors to gain an accurate understanding of just how frequently and severely these issues are occurring in the patient’s daily life.

 

Who may want to take advantage of wearable health monitors?

In some cases, patients may feel that their annual readings at a doctors’ office aren’t providing their doctor with a full and accurate picture of health.  For instance, a patient who’s nervous about their blood pressure readings (or even just interacting with a doctor in general) may start to panic right before that test is given, resulting in a reading that’s more extreme than their usual levels and subsequently, a bit of a misdiagnosis.  In a case like this, a portable health monitor worn during the patient’s everyday life could help give a concerned doctor a broader look into the patient’s blood pressure in a variety of settings.

 

Other types of mobile health tools, such as cardiovascular monitors, can save patients the time, cost, and effort of coming into a healthcare provider’s office just to have a certain test done.  Though current technologies may not be at this level yet, in the future, perhaps patients who require regular monitoring after surgery or a prescription change can electronically submit their test results directly and securely to their physician, helping to reduce costs to the patient and freeing up the healthcare staff to spend more time seeing patients for more substantive visits.

 

Some devices, like the Scanadu Scout, are designed for a future where we can all monitor all of our vital signs for early warnings of negative events.  In its early stages, such a device might cause a lot of false alarm, as patients may be unable to make reliable, educated judgments from their data.  However, in time, perhaps systems like these can monitor a range of vital signals and health outcomes that are relevant to an individual’s specific risk profile and baseline health (e.g. perhaps a complex disease runs in one’s family, and monitoring for just one vital or another alone wouldn’t catch it effectively). 

At Branding Science, we’re passionate about information and data, and we’re also firm believers that well-organized data tell a story.  The true value of such monitors is in their ability to work in the context of other forms of treatment and help a physician make sense of a patient’s symptoms and future potential for illness.  We look forward to seeing how current and future technologies make sense of large amounts of health data to make a difference in patients’ lives!

http://www.youtube.com/watch?v=RJBL-j6jgt0

Written by Brittani Baxter in our San Francisco Office