This week offers a nice break in science topics on the blog and a chance to look at how technology can be used to monitor social media, physician and patient sentiments about drugs and various diseases in a practical way. I've been interested in analysing trends in data since my undergraduate days when I created the first automated computerised football (soccer) notation system for looking at strategies and tactics employed by winning and losing teams.
There's a LOT of blah blah talk about social media out there, in particular from self styled gurus and experts, which tends to make me tune out for the most part. In my spare time (away from being immersed in preclinical and clinical data), what I'm really interested in is how mathematical algorithms can be applied to speech and words using modern computer techniques to extract feeling, tone and meaning from sentiments in meaningful ways.
After yesterday's 5 minute Lightening Talk at the Sentiments Analysis Symposium in New York hosted by Seth Grimes of Alta Plana, I received a few requests for the presentation, entitled "Next generation sentiment extraction: light at the end of the tunnel, but will it negate the need for human supervision?"
The file is downloadable and I'm pleased to say that the quality is much better than reading it in Slideshare online, which may look a little fuzzy.
I managed to do the brief presentation with 10 seconds to spare. There nothing worse than getting half way through and the buzzer goes before you get to the interesting bits!
If anyone wants any further information, please feel free to contact me. We have several interesting projects ongoing with sentiments analysis in oncology at the moment.
Next week normal service will resume and I will be busy reporting on hot science and research topics at the American Association of Cancer Research Meeting in DC, as they have kindly offered Pharma Strategy Blog a science blogger pass and an opportunity to bring new developments in science and cancer biology to life here. Watch this space!
Sometimes when you sit down with clients you have no idea when conversations may end up or what creative projects may evolve from them. Years ago, I abandoned the dreaded death by Powerpoint where possible, and used Apple's Pages or Keynote to develop more interesting materials, but as handouts at the end of the meeting rather than a crutch to talk from.
It's an old tried and tested technique from my sales days, where I discovered more business could be got when I engaged and chatted with the doctors rather than trying to read from a fancy detail aid with small print upside down.
This strategy has several effects:
1) People loosen up
2) Everyone is engaged and boredom is banished
3) You discuss and brainstorm real live problems and issues to create potential solutions
When clients are amenable to this approach, especially over lunch or in the cafeteria over coffee rather than a dreary office or conference room, you end up with sketches on napkins or scraps of paper and a greater chance of buy-in when you send in a proposal.
Talking about social media strategy and how you can go from baby steps to some real projects that add value while offering a good strategic fit with current company and brand goals is very rewarding. Everybody wins.
My general conclusion is that bottom up strategy driven by end users gets much more buy-in and acceptance from an organisation than top down directives, guidelines and rules.
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.
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.
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 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.
Amundadottir, 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
A recent paper published in the Proceedings of the National Academy of Sciences by scientists from the University of Rome has shown that the administration of nerve growth factor (NGF) stabilizes or reduces the damage to the optic nerve caused by the raised intra-ocular pressure (IOP) associated with glaucoma.
Glaucoma is an eye disease that is the world’s leading cause of blindness affecting 77 million people around the world and causes irreversible damage to vision. An easy to use eye drop that stabilizes or reduces damage to retinal ganglion cells and the optic nerve cells offers exciting potential and is research that will be watched closely by companies with an ophthalmology portfolio.
NGF was discovered by Stanley Cohen and Rita Levi-Montalcini, who received the 1986 Nobel Prize in Physiology. NGF may have a neuroprotective and repair function within the body, which could explain its ability to stabilize nerve damage caused by raised IOP.
In the paper published by Bonini and Levi-Monalcini they administered eye drops with NGF to rats and three human subjects. This caused an reduction in retinal ganglion cell death in the rats, and the patients who received NGF had improvements in their visual field and visual acuity.
The data is extremely promising, but in view of the small subject numbers and the fact that rat models do not always translate into humans, more extensive clinical trials data are needed to validate it as a potential new treatment.
Hopefully more data will be available for presentation at the ARVO (Association for Research in Vision and Ophthalmology) annual meeting in May next year.
Lambiase, A., Aloe, L., Centofanti, M., Parisi, V., Mantelli, F., Colafrancesco, V., Manni, G., Bucci, M., Bonini, S., & Levi-Montalcini, R. (2009). Experimental and clinical evidence of neuroprotection by nerve growth factor eye drops: Implications for glaucoma Proceedings of the National Academy of Sciences DOI: 10.1073/pnas.0906678106
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.
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.
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:
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:
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!
Amgen’s recent announcement of phase III trial data showing that it’s monoclonal antibody, denosumab was superior to Novartis’ Zometa (zoledronic acid) for the treatment of breast cancer patients with bone mestastases is further news that scientifically driven drug development can yield exciting results.
Denosumab is in essence a targeted therapy like Gleevec, Avastin or Herceptin. It’s development came about from basic research that discovered the cellular control of bone remodelling and regulation of bone density is reglated by the RANK Ligand pathway.
RANK Ligand is a TNF famly member, a protein that is expressed on the sufrace of marrow, stromal cells and osteoblasts (the cells responsible for bone formation). When RANK-L binds with its receptor RANK it stimulates the activity of osteoclasts (cells responsible for bone resorption). In the body, RANK-L production is naturally regulated by the protein Osteoprotegerin (OPG), which binds with RANK-L thereby preventing it from binding to its receptor, RANK. When there is insufficient OPG, or too much RANK-L produced, excess bone loss occurs. This occurs in post-menopausal women or in cancer related bone loss.
Denosumab acts by attaching itself to RANK-L, thereby inhibiting its action. Deprived of RANK-L, osteoclasts cannot form, function or survive. The result is less bone destruction and bone loss. Understanding the RANK Ligand pathway has been a breakthrough step in understanding bone biology.
Many cancer patients end up with bone metastases that not only causes pain, but also bone destruction. Roodman, in a 2004 New England Journal article, proposed the “vicious cycle” hypothesis to explain this: Tumor cells produce parathyroid hormone-related peptide (PTHrP), which stimulates osteoblasts to produce RANK ligand leading to less production (downregulation) of osteoprotegerin (OPG), thereby stimulating osteoclasts to resorb more bone. At the same time, production of PTHrP promotes tumor growth directly. Therefore, it should come as no surprise that denosumab would be effective in cancer patients with bone mets and skeletal related events.
What does the future hold for denosumab? In the postmenopausal osteoporosis market, a once or twice yearly injection is extremely attractive given its ease of use. Compliance is a real issue with bisphosphates such as alendronate or risedronate where a daily pill must be taken. Many primary care physicians are not set-up to administer an infusion, which is what Novartis’ once a year osteoporosis treatment, Reclast requires.
However, despite impressive clinical data, Amgen does not yet have a home run. It lacks a large sales force and infrastructure to sell to primary care physicians. Also with generic fosamax (alendronate) available, the cost/benefit trade off is going to be a key factor in uptake. The cost of denosumab will need to be carefully considered for Amgen to enter this competitive market. The FDA advisory board meets on August 13 to discuss Amgen’s BLA application and consider whether to recommend approval for the treatment and prevention of osteoporosis, and treatment of bone loss in patients undergoing hormone ablation for prostrate and breast cancer. Given the positive data from the phase III pivotal studies, a positive recommendation is expected with approval by the FDA expected in October.
For cancer patients, denosumab could become the gold-standard for treatment of bone metastases given its superiority over Novartis’ Zometa. For oncologists, the fact that denosumab only requires an injection while Zometa requires an infusion is less of an issue. The key to success for oncology drugs is based solely on the data. If the positive results continue, Amgen are likely to take market share from Zometa once approval for the treatment of bone metastases is obtained in 2010 or 2011.
So, my take on this is that denosumab is a real winner for Amgen. Whether it will capture the market for postmenopausal osteoporosis remains to be seen, but it is an exciting new drug that will benefit cancer patients. Further data on denosumab can be expected from the September meeting of the American Society of Bone and Mineral Research (ASBMR) in Denver.
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