Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts from the ‘Landscape Opportunity’ category

One of the challenges facing Pharma product managers and marketers today is the huge overwhelming wealth of data that is available online.  It can be overwhelming and even if you do a Google search for something very specific you may need to wade through many pages of irrelevant information before finding out what you need, if you can even find the needle in the haystack.  The information isn't sorted in any useful format for analysis or comparisons.

Image via WikipediaOne very useful tool is to use bookmarking services to see general trends.  I like Delicious for this purpose because it's easy to use and has Firefox add-ins that allow you to bookmark or clip articles with a bookmarklet from the browser window in either Windows or a Mac.

Recently, I was interested in general trends relating to several pharma companies.  Let's take a quick look at 4 of them, Novartis, Pfizer, Genentech and Amgen.  Once signed into Delicious, I can search for information where people have tagged the companies, drugs, pathways etc.

Here's the basic search for Novartis.  You can see my bookmarks and those of others as well:

Novartis

As expected you find stuff on drug development, the Novartis Institute and Foundation, clinical trials, job searches and careers information etc.  The tags reflect that too, all benign stuff but interesting none the less.

When looking at Pfizer, however, we get a completely different story!  Nothing on jobs and careers but plenty on Nigerians suing the company after some drug development went wrong and Viagra spam from zombie company computers.  On the positive side, we see some mentions about Web2.0 and Enterprise 2.0 so we might reasonably conclude that Pfizer is looking to be more active in the social media space than the cautious Swiss.  Novartis do at least have a Twitter account, as do other forward thinkig companies such as Boehringer Ingelheim. 

Pfizer

On the Biotechnology side, we also see an interesting trend.  Company news dominates, but there is also information on cloud computing and online grants applications.  The rounded profile suggests the company is active in research and little negative news is topical here. 

Genentech

Amgen, on the other hand, has a fair amount of negativity to contend with – an embattled CEO, an ongoing fight with J&J over EPO, competition from other companies etc.  On the plus side, there is the cycling tour of California sponsorship except that cynics might wonder why the manufacturer of EPO is sponsoring a cycling race!

If you wanted to be more granular, you can track the individual tags for each company, total them up and compare/contrast them in more detail to get a deeper picture.  The topline analysis tells quite an interesting story though.

You can also search Delicious for novel pathways and find out about what research is being bookmarked.  One such example in oncology is to select a kinase, such as PI3 kinase or PLK1 and see what that brings:

PI3 kinase-1
 
I found some interesting articles using that search since I was interested in what drugs were being tested against that particular pathway.  A Google search yielded pages of information that was overwhelming but mining Delicious tags found more useful information more quickly.  You might be interested in several pathways and what's trending in each, thus searching bookmarks is a quick and simple way to get started.

You can also search by drug name and compare different drugs in the same category or tumour type, for both number of bookmarks and the types of bookmarks.  Searching for Herceptin, for example, produces an interesting profile with an emphasis on the data:

Herceptin2
 

If you wished to, you could do the same thing for a competitor, lapatinib, and search for Her-2 to see what other compounds are being tested, ie their competitors… so you get the general drift. 

You can use bookmarking services such as Delicious, Mento, Diigo, Connotea, CiteUlike etc to build up a picture of the market you are interested in.  That data can then be tracked and tabulated in a spreadsheet if you need more detailed information.  The bookmarks can also be clicked on, giving you easy access to information shared about the company, drug, tumour type or pathway that you might be interested in. 

Overall, it's a simple and easy way to use web 2.0 and cloud computing tools to perform competitive intelligence gathering from the public domain behind the scenes.

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“People at the top don’t just work harder than everyone else. They work much, much harder.”

“Excellence at performing a complex task requires a critical minimum of practice.”

Malcolm Gladwell, Outliers

“The emerging picture from such studies is that 10,000 hours of practice is required to achieve the level of mastery associated with being a world class expert – in anything.”

Daniel Levitin, Neurologist

What is messaging and why is it important? 

Well, in this context, it is essentially a communication about a company's product(s) or even the pharma/biotechnology company itself.  It takes the form of either the written word or verbal communications about data or a product's features.  These can be from employees of the manufacturer, the press, patients, caregivers, members of the public or doctors. 

From a company's perspective, having everyone on the same hymn sheet across promotion, PR and medical education is the desired goal, but few achieve this nirvana mainly because it is constantly like herding cats and requires an enormous amount of confidence, energy and effort, although it can be done.  The marketers nightmare is realising that there are different messages from the sales force, key opinion leaders and company press releases.  This limits the effectiveness of the overall message and ultimately will lead to confused and unsure patients and doctors.

The most successful brands are often those with a coherent, cogent and potent message that convey the essential essence of the product in a few simple words.  Rarely do you see a successful brand with poor messaging, but brands with poor messaging generally do less well.  Gleevec and Avastin are two recent blockbuster cancer drugs that spring to mind as examples of utilising effective messaging strategies to generate share of voice.  Constantly referring to new data, new clinical trials and extended survival of patients in the earlier trials adds to the body of evidence that the drugs are safe and effective.

The other side of the coin is that smart companies continually evaluate their competitors messaging and the intentions that they signal in the process.  This is competitive intelligence at its best; honing and refining your brand to best take advantage in a highly competitive market, so that you can proactively respond to your rivals rather than react six or nine months later down the line as you assess the market data.  Often by then it is too late and momentum has been lost. 

Another example would be an existing brand on the market and a new competitor is due out in the same indication; what can be done to effectively limit their market share?  Information about competitor messaging can be gleaned from press releases, conference data, online forums, key opinion leader research, third party medical education etc. 

Using these in-depth strategic analyses, brand teams can better understand the competitor positioning and message signalling in order to put in place their own effective brand strategy to defend their market.  Two recent examples of this were Gleevec (Novartis) in the CML market, which effectively limited Sprycel's (BMS) penetration while extending it's own in other indications and ImClone's Erbitux, which continued to grow it's revenues across several indications in the face of stiff competition from Amgen's Vectibix.

How companies position themselves and their portfolio is also important – Genentech's success with Herceptin, Rituxan and Avastin was no mean feat.  Each drug and new indication added not only new data, but also a clear message that monoclonal antibodies worked and were here to stay.  Contrast that with the experiences of the vaccine companies during the same period.

Messaging then, is not only important to brands already on the market but also to new products in development and company portfolios.  Getting the messages right is partly about leveraging your data, but also one of simplicity, especially if you have several drugs targeting the same tumour type, for example.  How should they be differentiated?  Is the messaging to customers clear and explicit?  It is a partly art and partly science; in oncology at least, it is important to understand the science and biology of the disease, the competitor set you are competing against and having the boldness of imagination to execute a strategy well.

At Icarus Consultants we advise companies on brand messaging, competitor messaging signals, how to work with key opinion leaders to maximise messaging and for companies with a portfolio of products, evolving a messaging strategy to take to avoid confusion between the brands.  After all, it's all about driving peak sales as fast as possible.

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"You don't get to choose how you're going to die.  Or when.  You can only decide how you're going to live.  Now."

Joan Baez

The same approach could very well apply to Pharma and Biotechnology companies managing their pipelines and drug portfolios.  Everything is about what's happening right now and what can be done to move the development along to market, preferably as fast as possible.

Increasingly, the oncology market is becoming more and more complex with both chemotherapy and targeted therapies and different combinations, sequencing and mechanism of actions all playing their part.  As we learn more about the science and biology of each cancer type, so there is a proliferation of different inhibitors designed to target specific pathways.  A part of this ongoing series, today we look at PLK1 inhibitors.

According to an article in Nature, Polo-like kinase 1 (PLK1) is essential during mitosis and in the maintenance of genomic instability, as well as being overexpressed in some tumours (NSCLC, oropharyngeal, oesophogeal, melanoma, NHL), which may offer some prognostic potential.  It is yet unclear whether it is critical to tumourigenesis and hence useful as a therapeutic target, but cell cycle inhibitors are clearly worth a punt.

There are a number of PLK1 inhibitors in development.  These include  Scytonemin, a natural marine product that was originally being developed by SKB and now appears to be under the auspices of Merck KgA and EMD, ON01910 (Onconova Therapeutics), Wortmannin and BI 2536 (Boehringer Ingelheim). 

The most advanced programs at present are BI2536 and ON 01910, which are both in phase I development.  ON 01910 is being tested
in over 90 different human cancers, both as a single agent and with
other existing cancer drugs. Johns Hopkins Medicine and Mt. Sinai
Medical Center are conducting the first clinical trials of
ON01910 in patients with advanced and metastatic cancers. 

It is too soon to tell how effective these agents might be, but the class has a solid scientific rationale and some interesting data may therefore be available at the annual AACR meeting in 2009.

{Update – new data has been released on BI 2536 at the EORTC-NCI-AACR meeting at ECCO in Geneva this week – you can find out more here.}

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"Most executives, many scientists, and almost all
business school graduates believe that if you analyze data, this will
give you new ideas.  Unfortunately, this belief is totally wrong. The
mind can only see what it is prepared to see.
"

Edward de Bono

This is also the challenge with cancer drug development, which is becoming more complex and sophisticated with various therapies and regimens spanning the gamut of surgery, chemotherapy, radiotherapy, targeted therapies and increasingly, vaccines.  Many tumour types now have an array of options and each could be treated differently.  Which then begs the obvious questions:

  • which combinations work best together
  • what sequencing would optimise outcomes
  • how best should new therapies be incorporated into the guidelines. 

The old fashioned approach to portfolio analysis and competitive intelligence involves a bottom up gathering of data to derive current approaches and make decisions on what your competitors are thus doing right here, right now.  It also leads to blinkered, narrow thinking that merely repeats what has already been done before.

As de Bono suggests, sometimes thinking outside the box and visualising the future and adapting to a new direction might yield more productive blue ocean strategies.  This involves forward thinking, but does not preclude a less rigourous approach because it is dependent upon top down thinking that tests the hypotheses whether your future scenarios are valid or not. 

In fact, De Bono's idea turns the whole process on it's head and demands that you both understand your market, while at the same time visualising a space you could own and occupy that is different from your competitors.  It might be more creative and risky, but it also might just be the ticket and the difference between having a blockbuster and yet another me-too cancer drug in your development portfolio.

Poster childs for cancer treatment don't just happen, they are made in the minds of creative people with vision and drive to execute, often against all odds.

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After discussing the merits of web2.0 tools such as RSS feeds and Google Reader in competitive intelligence yesterday, it seemed a neat idea to look at what else is useful for finding and parsing information.  One of the coolest tools I use on a daily basis on the internet is Google Insights.

It's great for getting general trends and an indication of what is current in an area that you might be interested in.  Clients often call while travelling, for example, and want a general idea about a particular cancer topic.  Using Google Insights or Trends can be a boon in these cases.

Supposing someone calls and is interested in top line information on breast vs. lung cancer?  Now, while many of us might have a huge database in an aggregator such as Google Reader, it's a database and not so easy to use pictures to paint the picture to the question framed.

Using Google Insights, we can get a snapshot like this:

Picture 29

We can see immediately that breast cancer has a greater volume of interest on the internet than lung cancer, even though more people die per year from lung cancer.

We can also see what topics influence the upward trends and what topics have very little impact and see those trends over time.  A picture tells a thousand words.

On the simple one page report there is other useful information, such as which subjects are most newsworthy by tumour type based on the search volume:

Picture 30

And what ones are rising at the moment:

Picture 31

What's fascinating about the above table is inflammatory breast cancer is quite rare and yet there is a lot of interest in the topic at the moment.  Clicking on the topic tells us more detail about what women are specifically searching for there:

Picture 32

Few appear to be searching for treatments, but early signs and symptoms such as rash and itching are prominent.  Now, if you were a drug company developing a new therapy in this area and wanted to reach out to those patients, that could be useful information both for helping provide education on diagnosis, signs and symptoms etc and also for how the drug being developed might be positioned on their website should they be trying to attract patients into clinical trials, for example.

The lung cancer statistics tell us they people are searching for more general symptoms, the impact of smoking on the disease and treatments:

Picture 35

In contrast, the Insights information on rising topics in lung cancer tells a very different story.  The most searched term here is 'stage 4 cancer', which would sadly fit in with the typical diagnosis for the disease, as are the related organs, suggesting that these patients are already experiencing common metastases (spread of the disease to other areas of the body):

Picture 33

Overall, this is just one example of how powerful online tools such as Google Insights can be used to drill down for relevant and timely information on current trends and influencers.  Even in this simple exanple, you can see the differences between the two biggest tumour types and of course, other cancers may also show subtle, but different trends on analysis.  Thus, not all cancers are the same – they have different patient groups, influencers etc and should be treated as different diseases rather than just as 'cancer'.  Knowing that when researching the topic is important in itself as an analyst.  The information gleaned could also be useful for competitive intelligence when looking at tumour types or comparing different cancer drug trends.

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As the pharma market becomes extremely competitive with increased competition, fewer new approvals, generic threats with blockbuster patent expiries and major layoffs, making the marketing dollars go further is an imperative.

One way to do this is through smart and judicious use of competitive and market intelligence.  These approaches allow the collection of primary and secondary data sources, including key opinion leader interviews, to help form a strategic picture of the marketplace or answer critical questions that drive the brand forward efficiently and cost effectively.

Many CI companies rely on junior analysts in India and China to do the research in a bottom up approach of data gathering.  However, these anlaysts, while bright and sharp, often do not know much about the disease area in question or the nuances of the US marketplace.  Fortunately there is, however, another way.  What we prefer to do is the complete opposite i.e. a top down approach that takes the critical questions posed by the client and then create and test models or hypotheses to verify the answer.  This is much more data intensive but more rigourous.

But how is this done in practice? 

Even within my specialty, oncology and hematology, there are masses amounts of information floating around each day, and bearing in mind most tumour types are treated differently, almost as a different disease, it might be easy to get overwhelmed before you even start.  There are efficient ways of sorting out the vital nuggets though.

One really useful tool is judicious use of an aggregator such as Google Reader, Bloglines etc.  This is one of my favourite web gadgets; you add RSS feeds for journals, science magazines, industry websites and sources, company websites etc and then scan them daily for the hot new information to get a snapshot like this:

Picture 12

Along the way, you can 'Star' any interesting articles for later reading or sharing with friends and colleagues.

You can also use this database to search for current information on a given topic, eg renal cancer either by list or search synopsis view:

Picture 13

Picture 16

Once you find what you need, you can 'star' the items for later retrieval in the starred items window.  It also makes scrolling through the items very easy and much more intuitive on the eye graphically.  Interesting articles can also be viewed at a click in the expanded view, which shows a little more granular detail:

Picture 24

Now, that's a powerful way to drill down for useful data.  It's a very quick and fast way of finding relevant information at your finger tips.  Of course, you can use PubMed or Google Scholar to find journal articles, but the challenge is you will often get a lot of irrelevant or highly obscure stuff on preclinical research that you have to somehow troll through to find the one nugget you actually need, like this:

Picture 26

By controlling the input, ie the types of journals and magazines you want to search, you can current clinical trends or news much more quickly.

Once interesting and relevant articles have been found and starred, you can view these en masse in the starred items section as an overview for speed reading, but there is another technique I use to gather and mine the intelligence.  What you really need is a database for assimilating the selected data asa group.  Enter Evernote.

Evernote is a Web2.0 tool fantastic way to clip information on a given topic and save it in one file for easy reading and mining.  You can add tags for easier searching.  It can also house the websites, references etc that are needed for a final client report.  It makes the job so much easier.  Here's a snapshot of my Evernote database; you can see the list of notebooks on the left hand side and a sample of some articles clipped to my science notebook on the right hand side:

Picture 27


There is even a new cool facility to import Delicious bookmarks – I had over 500 of them, mostly on science and medically related topics, including many on cancer.  Importing them into Evernote added to the powerful search within the overall database of information and saves me hunting through two different sets of data.

Each of these notebooks contains a veritable treasure trove of information, all stored, tagged and ready for searching at a moments notice.  It can even be used on the iPhone to answer a question quickly when a client calls with a query.  Yup, it has happened and the solution was right at my fingertips!

These are just two of the tools I use in my job on a daily basis to undertake competitive and market intelligence.  Finding trends and patterns amongst the mass of data is suddenly made a whole lot easier and faster.  And time is money for clients, especially in the current downturn when marketing dollars are tighter and scarcer.


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A new drug in development, Afinitor (everolimus, RAD001) appears to extends life without tumour growth by almost 5 months compared to 1.9 months with placebo.  In addition, a quarter of the patients in the study remained progression free beyond 10 months of treatment.  This is the first therapy to show significant benefit after failure with initial tyrosine kinase therapy (Sutent or Nexavar).  It is currently being reviewed by the FDA for treatment of advanced kidney cancer after failure of initial therapy.

Initial therapy with kinase inhibitors has demonstrated signifcant progression free survival (PFS).  Nexavar, for example, demonstrated a doubling of median PFS in patients with no prior
cytokine therapy of 25 weeks vs. 12 weeks with placebo.   Sutent was compared to interferon-alpha and demonstrated a PFS of 47.3 weeks compared to 22 weeks with interferon-alpha.

What makes Afinitor different and why does it appear to work well, even in patients who have failed stand therapy?  Well, the answer lies in it's mechanism of action.  Both Sutent and Nexavar are multiple kinase inhibitors, principally of Vascular Endothelial Growth Factor (VEGF), that appears to be important in renal cell cancer.   Solid cancers survive by extending their network of tumour vasculature, a process known as angiogenesis. Inhibiting VEGF therefore inhibits the tumours ability to grow.  They also inhibit Platelet Derived Growth Factor (PDGF), which is important in cell proliferation.

Afinitor, on the other hand, inhibits the mammalian target of rapamycin (mTOR) is an intracellular protein that
acts as a central regulator of multiple signaling pathways (IGF, EGF,
PDGF, VEGF, amino acids) that mediate abnormal growth, proliferation,
and angiogenesis in cancer.  mTOR is a critical component of the PI3K/AKT pathway, a key signaling pathway that is frequently dysregulated in many cancers.

RAD001_IMG

Image courtesy of Novartis Oncology

By targeting a different pathway, the activity of the tumour can be further reduced, even after patients have stopped responding to their initial therapy.  This is one of the new key approaches to attacking cancer – find multiple inhibitors of different critical pathways and then determine the best sequencing for the regimens, thereby improving survival.

All three drugs mentioned so far are oral therapies, which are convenient and easy for cancer patients to take each day.  Another drug approved for renal cancer is Torisel (temsirolimus), a mTor inhibitor that is given by intravenous infusion over 30-60 minutes on a weekly basis.  This drug significantly extended survival in renal cancer patients compared to interferon-alpha treatment (10.9 vs. 7.3 months).  When standardised in weeks to enable comparison to Sutent, this means the PFS was approx. 49 weeks compared to 47 for Sutent.

It should be noted that rare bowel perforations are possible with these therapies, a class effect of inhibiting the VEGF pathway.  Sutent and Nexavar have also been asssociated with raised blood pressure and hypertension, whereas Torisel may result in hyperglycemia and hyperlipemia. This may result in the need
for an increase in the dose of, or initiation of, insulin and/or oral
hypoglycemic agent therapy and/or lipid-lowering agents, respectively.

Additional new results with these agents are expected at the Annual Society of Clinical Oncology meeting in mid 2009.  Afinitor is currently being evaluated by the FDA and EMEA for approval and could be available on the market by March-April 2009.

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A new study reported in JAMA suggests that compared with white individuals, black men and women have a higher
incidence and mortality from colorectal cancer and may develop cancer
at a younger age. Colorectal cancer screening might also be less effective
in black individuals, if there are racial differences in the
age-adjusted prevalence and location of cancer precursor lesions. 
Colon polyp on a short stalk.Image via Wikipedia

The study also found that blacks are more likely than whites to have large colon
polyps, and their tumors tend to be located higher in the colon where
they are harder to detect.

Blacks
are already known to have higher rates of colon cancer than whites and
up to 43 percent higher death rates from the disease, which kills
52,000 Americans annually.  Since 1985,
colon cancer has risen among black men and is unchanged among black
women, while declining by as much as 25 percent among whites.

Early detection of colon cancer is considered key to successful treatment.

In
a study of approx. 5,500 blacks and 80,000 whites who had
colonoscopies, researchers at Portland VA Medical Center found nearly 8
percent of blacks had one or more polyps sized more than 9 millimeters
in diameter, compared to slightly more than 6 percent of whites.

The
tumours detected in blacks were more likely to be in the upper part of
the colon where a sigmoidoscopy would be unlikely to find it because the procedure that looks only at the
lower half of the colon.  In addition, the
incidence of large polyps was noticeably high among black women younger
than 50, the age when adults are recommended to begin getting
regular colonoscopies.

Several factors may
account for the racial disparity in colon cancer rates, including
genetic differences that account for about a third of all cases of the
disease.  However, blacks also have poorer access to health care and lower
rates of participation when screening is offered.  These results, if repeated in other studies, strongly suggest that consideration should be given to initiation of screening before age 50 years in black women.

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