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This morning, I was reflecting on one of my favourite quotes from the Wharton business school marketing professor, George Day, who said:

“At the heart of a market-driven organization is the deep and enduring commitment to the philosophy that the customer comes first.”

It's also a strategic goal that many of us have strived for because ultimately, if you focus on your customers, the rest will take care of itself, including revenues.

Money follows satisfaction.

Back in my Pharma days, we listened to our customers and patients almost every single day.  We learned how they felt about the disease, the treatments, the company and even our brand while it was undergoing clinical trials.  Patients are wonderful and tell you how well (or not) they are responding, what side effects they have and what their hopes and aspirations are.

Adverse events?

I can hear Pharma having wobblies right now at the mention of side effects.  But they aren't always bad things, sometimes that knowledge is valuable insight.

How so, you might ask?

Well, imagine a world where people talk openly about their rashes, their swellings, their headaches, their muscle aches and pains etc.  We can empathise with those things because no drug is free of side effects and we've all experienced them at some point ourselves when we take our own prescriptions.  Suppose you take those shared thoughts as valuable real life insights and also ask the KOL's what they are seeing in the trials too?  You then put a big picture together and realise that actually, many of them are uncomfortable, but manageable.  Strategically, it makes sense to put adverse events in context for everyone in a rational, fair balanced way.

What next?

Imagine taking these insights and working with your clinical and medical affairs teams and the investigators to devise a practical guide for side effect management for patients, advocacy groups and other doctors in the broader community via practical patient brochures and clinical papers.  Your review team loves education rather than promotion, so do your stakeholders.  You now have a proactive strategy and executable tactics working together to help patients and doctors with potential outlets across multiple areas of the organisation.

That's marketing, not sales.

The patient insights I'm talking about came from social media sites.  Yes, the same social media that everyone seems to get in a tizzy about.

Why is that?

When you stop and think, it's not entirely adverse events per se.  It's often the risk that deep down, some review teams are worried that some brands are more focused on sales and promotion than marketing or education.  They're probably right in that assumption sometimes, but it isn't true for everyone.  Some are pragmatic and focused on common sense.

Action speaks louder than words.

Respect is something that is earned, from actions, from programs, from interactions.  So, if the review team is up in arms, ask yourself why?  Are you truly coming from a strategic and educational perspective based on insights and customer feedback or are you trying to use social media as yet another channel for more tactical push marketing and promotion?

It doesn't always have to be that way.

Some of the greatest moments I ever had in Pharma came from sitting down with patients hearing their personal stories about life, despair and hope or attending an advisory committee of patients, physicians, advocacy groups and others, hearing their perspectives and what they thought at the same table, even though I vehemently disagreed with some of them.  We debated, we listened, we problem solved, we created joint strategies and we created solutions.  Together.  It was a truly amazing experience.  

Openess, listening, insights, collaboration, impact.

What you learn from your customers and consumers in real life in real time is invaluable.  Forget the dingy market research focus groups and hiding behind dark windows; get out, listen, talk to doctors and patients.  Prof Day was bang on the money, but the problem is, many of us have to do it to see and believe it. 

It's absolutely a life changing experience for a marketer though, and
once you see the tangible benefits to your brand and organisation, you
never want to go back but you do want to make more of a difference to patients lives. 

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This was a stunner via a tweet from the Roswell Park Cancer Institute yesterday.  Of course, I clicked on the link because my suspicion was that it wouldn't be the most common O blood that is linked to pancreatic cancer, and no, I don't have blood group O.  A little voyeuristic, perhaps, but sometimes curiousity literally kills the cat.

What was interesting about the link was that it came from the NCI, a well respected institution in the US, which was reporting on a study that has just been published in Nature Genetics confirming epidemiology studies on stomach and other GI cancers going back to the 1950's.  It's not new?  How come we haven't heard much about this fascinating story then?  That's the trouble with science, a lot of great stuff gets lost in the river of noise in daily life and finding the good snippets can be like searching for needles in a haystack, to mix metaphors.

Previously, we have heard that a high fat diet, alcohol and heavy smoking have all been linked with the disease, but that isn't always the case as Prof Randy Pausch and these incredible patient stories have shown.

The NIH summarised the new study succinctly:

"The researchers discovered that genetic variation in a region of chromosome 9 that contains the gene for ABO blood type was associated with pancreatic cancer risk. Individuals with the variant that results in blood types A, B, or AB were at an increased risk of pancreatic cancer, compared to those with the variant for blood type O. This finding is consistent with previous research, some of it dating back to the 1950s and 1960s, that had shown increased risks of gastric and pancreatic cancer among individuals of the A and B blood groups (i.e., blood types A, B, and AB). The latest results provide a genetic basis for those earlier observations."

So what does that mean from a scientific basis?  The NIH continued:

"A person's blood type depends on which form or forms of the ABO gene they inherit from their parents. The protein produced by the ABO gene determines the type of carbohydrates (complex sugars) that are present on the surface of red blood cells and other cells, including cells of the pancreas. The proteins encoded by the A and B forms of the gene transfer different carbohydrates onto the cell surfaces to make A and B blood types. The O form encodes a protein that is unable to transfer carbohydrates. Studies by other researchers have shown that ABO protein encoding in pancreatic tumor cells is different than in normal pancreatic cells."

Most pancreatic cancers are diagnosed late, ie in stage IV, meaning that the prognosis and long term survival is poor but these new findings may help enable earlier detection of the disease.  The researchers performed arrived at their conclusions by conducting a genome-wide association study (GWAS). In a GWAS, researchers analyze common variants, called single-nucleotide polymorphisms (SNPs), in the genomes of people with disease and in a control group (people without the disease).

The team genotyped 558,542 SNPs in 1,896 individuals with pancreatic cancer and 1,939 controls drawn from 12 prospective cohorts plus one hospital-based case-control study.  They also conducted a combined analysis of these groups plus an additional 2,457 affected individuals and 2,654 controls from eight case-control studies, adjusting for study, sex, ancestry and five principal components.

The end result?

They were able to identify several SNPs on the long arm of chromosome
9 that were associated with pancreatic cancer risk and mapped to the
ABO gene.

Still, the big questions in my mind are:

a) Why do people with blood group O appear to have a lower risk? What protective effect is at play?

b) How can we use the knowledge of higher risk factors in blood groups A, B and AB to screen and diagnose pancreatic patients earlier?  Would the spittoon type tests offered by commercial genetic testing companies such as 23andme help with this at all?

It's all very well science finding new relationships and genetic associations with disease, but it would be very sad indeed if we went another 50 years with no improvement in early detection and mortality associated with the fatal disease.

ResearchBlogging.orgAmundadottir, L., Kraft, P., Stolzenberg-Solomon, R., Fuchs, C., Petersen, G., Arslan, A., Bueno-de-Mesquita, H., Gross, M., Helzlsouer, K., Jacobs, E., LaCroix, A., Zheng, W., Albanes, D., Bamlet, W., Berg, C., Berrino, F., Bingham, S., Buring, J., Bracci, P., Canzian, F., Clavel-Chapelon, F., Clipp, S., Cotterchio, M., de Andrade, M., Duell, E., Fox Jr, J., Gallinger, S., Gaziano, J., Giovannucci, E., Goggins, M., González, C., Hallmans, G., Hankinson, S., Hassan, M., Holly, E., Hunter, D., Hutchinson, A., Jackson, R., Jacobs, K., Jenab, M., Kaaks, R., Klein, A., Kooperberg, C., Kurtz, R., Li, D., Lynch, S., Mandelson, M., McWilliams, R., Mendelsohn, J., Michaud, D., Olson, S., Overvad, K., Patel, A., Peeters, P., Rajkovic, A., Riboli, E., Risch, H., Shu, X., Thomas, G., Tobias, G., Trichopoulos, D., Van Den Eeden, S., Virtamo, J., Wactawski-Wende, J., Wolpin, B., Yu, H., Yu, K., Zeleniuch-Jacquotte, A., Chanock, S., Hartge, P., & Hoover, R. (2009). Genome-wide association study identifies variants in the ABO locus associated with susceptibility to pancreatic cancer Nature Genetics DOI: 10.1038/ng.429

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Continuing on from my post the other day about Thinkers and Doers in Pharma, I was pleasantly surprised by the number of emails received and the offline debates that ensued, so a big thank you for all of you who engaged in the conversation, your perspectives and thoughts were much appreciated.

This morning, several thoughts drifted my way during the Healthcare Social Media in Europe tweetup on Twitter, which you can find by searching for the #hcsmeu hashtag.  One of the questions covered by the organisers, @andrewspong and @whydotpharma was what are he differences between the EU and US in this space? 

Perhaps rather than polarise things by region, I was thinking laterally about what is the difference between Pharma companies doing well with social media and those who are not?  Sometimes it comes down to that old chestnut:

Strategy vs. Tactics.

You see, the danger with social media is that digital agencies will start pushing it as yet another new channel for isolated tactics such as a Twitter account, a Facebook page, a YouTube video etc etc.

What Pharma really needs to do is stop and think for a minute.

Firstly, let's focus on strategy – what are the brand/company objectives?  How do any tactics relate to those objectives and how will they be measured?  Strategy is about delivering results, tactics are executional and can be as easy as posting a YouTube video, mission accomplished, never mind it might be dry and boring as @sammielw presciently pointed out in the #hcsmeu chat:

Picture 41 

Developing smart and effective strategies is about putting your head on the block and being judged by the fruits of those labours – it takes time to get right and isn't easy as Seth Godin pointed out:

"Most of us are afraid of strategy, because we don't feel confident
outlining one unless we're sure it's going to work. And the 'work' part
is all tactical, so we focus on that. (Tactics are easy to outline,
because we say, "I'm going to post this." If we post it, we succeed.
Strategy is scary to outline, because we describe results, not actions,
and that means opportunity for failure.)"

Of course, it is possible to be able think strategically and execute tactics, that's what great marketers do, but all too often you get a real disconnect between the Thinkers and Doers and ne'er the twain shall meet.

The link between strategy and tactics, thinkers and doers is insights, as shown by this little interaction between @philbaumann and @whydotpharma in the #hcsmeu discussion this morning:

Insights

Personally, I couldn't agree more with their sentiments – ultimately, insights drive smart strategies and tactics.

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One of the biggest challenges in the Pharma world is meshing strategy with execution in a timely and effective manner. 

My experience in big Pharma taught me that the environment is often full of Thinkers, who sit on their 100,000 ft cloud plinking on their harps contemplating ideas, with little regard the practicalities of execution and Doers, who are focused on execution and chopping down trees, without necessarily asking if they are in the right forest or chopping down the right trees.

It's also the classic Global versus Affiliate wars, although not always.

Great teams come together and either have a nice balance between the Thinkers and Doers or have smart people who can do both.  When those scenarios plays out, something magical happens and the organisation reaps the benefit of a well organised and well executed strategy that truly makes a difference to both patient outcomes and market performance.

Is it as rare as it seems though?

Sometimes organisations become bogged down in analysis by paralysis or paralysis by analysis.  The way forward is to shake things up and bring in decisive leaders who break through the consensus thinking to drive goal driven execution based on real customer insights.  They challenge the team to find the nuggets and focus on what's important.

A thoughtful client recently asked me: "What are insights and how can we teach them?"

Taking a look at the Princeton Dictionary we find:

  • insight – penetration: clear or deep perception of a situation
  • insight – a feeling of understanding
  • insight – grasping the inner nature of things intuitively

If we relate this back to Pharma, insights ultimately come from the customer and consumer:

– How do they feel about your brand, their disease, your competitors? 

– What do they really want and need?

– How can you help them meet those needs?

Sometimes you may need to be more creative and find new ways of looking at data in order to see things differently, much like the facets of a diamond and how they reflect different patterns in the light.  Insights are the same; they help you see what really matters at the heart of something more clearly. 

Other times getting out of your dreary corporate office environment can also help.  Personally, I used to love impromptu small team meetings in a coffee shop or on the terrace of a hotel overlooking a golf course.  Being out and about in a more relaxed environment seems to shake out the cobwebs and get people chatting more informally about the topic and issues at hand.  Several heads are always better than one for such a think tank session.

Perhaps also it is the lack of Powerpoint replaced by sketches on napkins or scraps of paper that brings out the childhood creativity in people to simply be free that makes the difference sometimes.  Certainly, I've seen more creative and effective ideas come out of those loose relaxed meetings when someone said a seemingly isolated and random thought that focused and stimulated the team on a whole new idea. 

That's insight right there – often buried deep inside us and all we need to do is find ways of letting them bubble up or the key to unlocking them.  The challenge is to close off the left brain logical control and let the right brain loose on concepts, creativity and connections between the team members.

Those A-ha! moments are priceless.

Ultimately, social media is more about right brain thinking than left brain logic.  It's about communication, empathy, interaction and engagement, all things that make logical, scientific-driven Pharma extremely uncomfortable.  The key to achieving balance is to use both sides of the brain to create a whole brain strategy.

What does this mean?

Well, it is possible to use the left brain analytical side to evaluate and monitor your market or competitors for useful data driven intelligence to enable the team to develop actionable insights.  Then utilise the right brain to create new ways of engaging and interacting with doctors and patients that improve the all round experience for all concerned.

It doesn't have to be scary if you Think and Do, but in the long run the Pharma companies that crack this dilemma will be bold winners in the race to superior customer engagement.  The losers will still be focused on dying out traditional methods of selling in a brave new conceptual and digital age.

Do you want to be a winner or loser?

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This morning I checked into my database intending to search for some information on lung cancer relating to the SATURN data in maintenance therapy that is being updated at the World Lung Congress in San Francisco.

Instead, the first dozen items were on the FDA approval of Onglyza (saxagliptin).  Oooh.  It seems that the FDA just approved BMS/AZ's joint development in diabetes, talk about a wealth of signalling data all at once.  This product is a me-too, very similar to Merck's Januvia, a billion dollar therapy already on the market.  On checking my emails and Twitter alerts, there was a bunch of information pertaining to Onglyza, Januvia and also Lantus (insulin glargine), sanofi-aventis' novel insulin product recently in the news for potential (but not proven) cancer adverse events.

The amusing thing is that sometimes you forget that you even set these alerts up, but they are very handy when major news or events in the market happen and you have a nice set of warnings and data with which to make a handy assessment of what's going on without having to search for it. 

Even better, 5 mins later a frantic client called asking,

"Help, I'm travelling and need to know the price of Onglyza!  You wouldn't happen to know it would you, please?" 

It took all of 10 seconds to find the intelligence they were looking for in the database – price parity with Merck's Januvia at an average wholesale price of $5.72 per pill for both the 2.5 and 5 mg doses, which seemed to surprise them.  Novartis also have a similar DPP-4 therapy on the market, Galvus, although it not yet approved in the US. 

This market segment is now set for some very serious competition between some heavyweight players, especially as many of the older therapies cause weight gain or do not control blood sugar levels optimally.  Merck's product has done reasonably well, but a wake up call has happened and it will be interesting to see how they respond to competition.

What I'm wondering though, is what patients switching to Onglyza or receiving the therapy de novo will be posting via blogs and social media over the next few months.  It would be an interesting exercise to track if anyone is interested, because these sentiments may help redefine messaging and positioning of the brand against the competition and vice versa for other existing diabetes therapies.  The neat thing is that some web2.0 tools can even enable you to do this in real time.

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Recently, I was talking with a Pharma client about signalling (or signaling as our American cousins call it) and how it can be extremely useful for marketing strategy purposes.

We are all signalling our intent, ideas and thoughts everyday in our daily lives, but imagine if you can aggregate information about a company or brands strategic intent around future business events?  This might take the form of numerous sources including press releases, analyst presentations, discussions with company employees or physicians involved with clinical studies, news articles, RSS feeds, web2.0 tools, online search, social media monitoring etc. 

In fact, you could look at the building of a picture about brand X or topic Y in a simple hub and spoke fashion like this:

Picture 30  

Now imagine monitoring those sources over time and clearer, focused, sharper picture emerges about the strategic intent of the competition and if you're aware of this intelligence, you can use it to your advantage by pre-empting defensive or offensive strategies as appropriate.

Of course, it gets even more fun when you factor in multiple products and companies around a particular topic or disease, with numerous hub and spokes and different sizes of systems depending upon how much information is available or collected and this simplified without intertwined links, which can make the whole picture more akin to solving an evil sudoku puzzle:

 

Picture 40

The beauty of seeing the big picture is that out of the chaos emerges patterns and trends that can be very useful to a marketing team wondering what to do next.  Playmaking and strategy aren't limited to NFL teams, but the smart Pharma marketers can use intelligence and customer driven data insights wisely to better position their brand either now or in the future.

We get a to spend a lot of time on these activities as consultants and thus over time we also get to see general disease area or industry trends emerging ahead of the mainstream.  Ultimately, helping our clients stay one step ahead of the competition can be a very interesting and fun experience indeed.

We regularly conduct market research for our Pharma, Biotech & Medical Device clients by telephone or email.  Often, products in development, new indications or initial market entries require some quick customer feedback that helps guide and direct a larger study or provide new insights for their strategic planning process.  The products being tested made involve drugs, vaccines, devices or new technology approaches.

If you are a physician or surgeon and would like to participate in these studies, do email us and let us know your contact details, specialty and sub-specialty.  All information is kept confidential and all doctors receive an honoraria for any work undertaken.  We are always looking for new perspectives or people with experience in different areas.

All research is aggregated and anonymised; there is no link to individuals but quotes may be used (anonymously) to illustrate points in a report.

Not all our research is US focused, so we are particularly keen to build up our contacts in other countries for our global clients. 

If you would like to participate, drop us a line today; we look forward to hearing from you!

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"Scientists found that by activating a receptor in cells called the liver X receptor (LXR), they were able to inhibit the hedgehog (Hh) signaling pathway, which is involved in the maintenance of tissue integrity and stem cell generation. When stimulated in an unregulated manner, however, the Hh pathway can also cause cancers of the brain, lung, blood, prostate, skin and other tissues.

Blocking such unregulated stimulation of the Hh pathway had previously been shown in animal studies to prevent cancers, according to the researchers. How LXR was able to inhibit tumor cell growth by impeding the Hh pathway was previously unknown."

via www.medicalnewstoday.com

This was a snippet from a study about scientists at UCLA who found a new and unexpected mechanism related to hedgehog pathway signalling, which may turn out to be interesting for developing new therapeutics because current hedgehog pathway inhibitors elicit severe adverse events.

I posted this direct from the newsite using the new Typepad Blog It bookmarklet, which looks to be a very useful tool for sharing articles by reblogging areas of interest.

An interesting and useful way of providing cancer patients access to new drugs is to open clinical trials in expanded access programs, which are often smaller or stripped down versions of existing trials with less onerous monitoring compared to registration trials.

The advantage of this type of program is that patients continue to gain access to treatments, oncologists gain experience in using the new therapies and there is the possibility to improve patient outcomes compared to standard of care or best supportive care if there are no other options available.

In the US, expanded access trials typically run until a drug is made commercially available, thereupon patients are transferred to the marketed drug via Government or insurance payer schemes.  However, it has been suggested that in some countries, patients continue in the expanded access program until progression, even after the drug concerned has been approved.

We are currently researching the topic of expanded access clinical trials, so if anyone has any experience as a physician or patient, or wishes to add any commentary, we would welcome any comments either here on the blog or via email.

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On the hot subject of biomarkers and predicting response to therapy, Scottish scientists at the Edinburgh Breakthrough Cancer Centre have made an important finding.  They have confirmed that PTEN loss can  pred a patient’s response to Herceptin.  Although trastuzumab targets HER-2, it does not benefit every woman who has HER-2+ breast cancer.  The puzzling question has long been why does resistance develop and how can it be overcome?

The research group reported that they:

“… Examined 122 samples of metastatic breast cancer tumours treated with Herceptin. They demonstrated that the amount of PTEN was related to overall survival and patients whose breast cancer tumours had high levels of PTEN survived on average 22 months longer than those with low levels.”

In addition, using mathematical modeling techniques, the loss of PTEN was more predictive than could be determined using standard multivariate or laboratory analysis.

PTEN is a protein that acts as a tumor suppressor gene and has recently been shown to be associated with resistance in some patients to EGFR therapy in colorectal cancer.  Given it's apparent role in the development of drug resistance in cancer, this should be a very interesting biomarker to watch. 

Pintex, a small biotechnology company that was developing compounds around PTEN appear to have gone out our business and sold their scientific and IP rights to Vernalis, a UK biotechnology company earlier this year.

{UPDATE:   Sincere thanks to Dr Wafik El-Deiry at Univ. of Pennsylvania for gently reminding me that the discovery was initially made in 2004 by MD Anderson Cancer Center in Houston, TX.  You can download their groundbreaking paper from Cancer Cell freely HERE}.

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