Pharma Strategy Blog

Commentary on Pharma & Biotech Oncology / Hematology New Product Development

Posts from the ‘Landscape Opportunity’ category

Today I’m heading off to attend the ASCO GI meeting in San Fransciso, and in particular, the pancreatic cancer sessions on Friday.

2013 ASCO GI Meeting in san Francisco

Source: ASCO

The event promises to be an interesting day with a keynote from Margaret Tempero (UCSF), as well as Daniel van Hoff (TGEN) presenting the much awaited nab-paclitaxel (Abraxane) data in advanced pancreatic ductal carcinoma and a poster on masitinib from the French researchers.

Many of you will recall the excitement expressed at ESMO in this data, although the topline data in the Celgene press release on the MPACT study this week suggests the overall responses were good rather than great.

For years, we’ve seen many doublets come along in combination with gemcitabine in clinical trials and largely fail. This is a very difficult disease to treat, with many patients sadly only lasting a year or less from diagnosis.  Partly this can be traced back to the insidiously of the disease with it’s vague symptoms, and partly to the degree of oncogenic addiction to KRAS, which induces resistance and ensures the survival of the tumour.

The key with both the Abraxane and masitinib data will be in the details around potential biomarkers – and whether higher responses are seen in those subgroups or not. In Celgene’s case, it is hoped that patients with high SPARC expression will show better survival, while AB Science have annnounced the finding of a key biomarker of response with out offering any details until the presentation, we will see what each has to offer on Friday.

The other leading question is tolerability. Although gemcitabine is widely considered the standard of care for most patients and is well tolerated, younger patients are often given the FOLFIRINOX regimen upfront, which can lead to better responses at the cost of much higher toxicities, including hospitalisation.

If either Abraxane or masitinib demonstrate a similar survival advantage as FOLFIRINOX, a biomarker for selecting patients and an acceptable toxicity profile, then we may see a change in prescribing in this landscape in the not too distant future. For Celgene, the road ahead may be easier given the drug is already available for breast and lung cancers, whereas AB Science may need another trial with the biomarker first. Time will tell.

The ASCO GI meeting is at Moscone West, a huge black spot for wifi and AT&T reception at the last two cancer conferences I’ve attended there, so there’s unlikely to be much live tweeting.

I will, however, be producing a new report on the advanced pancreatic cancer landscape soon after the event, complete with insights and analysis, so if you would like to receive an early bird warning of this, please fill in the sign up form in the right hand margin.

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Many readers will have noticed that the advanced prostate cancer market is rapidly becoming crowded with three new therapies (cabazitaxel, sipuleucel-T and abiraterone) already approved and several more in late stage development, including Alpharadin (radium-223) and MDV3100, both likely to file this year. In addition, others are focused on bone complications, such as denosumab, which is expected to have a tough ODAC meeting this month, and cabozantinib, a multikinase inhibitor currently in phase III trials.

Unlike breast cancer, where progression-free survival (PFS) is a used as a surrogate measure of survival, in advanced prostate cancer, overall survival (OS) has pretty much become the gold standard by which prostate cancer trials are reviewed. This makes it much easier to judge whether the drugs are having a positive effect on true efficacy, i.e. do patients live longer as a result of treatment.  PFS is particularly difficult to measure in prostate cancer, so it’s not surprising this approach has evolved as the standard measurement.

Interestingly though, Health Authority approval does not always mean reimbursement coverage, as NICE showed yesterday in declining to approve abiraterone in the UK on the grounds that it is too expensive. The BBC quoted a patient who had been on abiraterone for only three months, with a positive impact:

“I have my life back. I have a lot more energy and no pain. My quality of life is excellent. I wouldn’t even know I have cancer now, it’s that good.”

The BBC also quoted his wife, who had an excellent point:

“We know NICE has to take a lot of things into consideration, but when you have a terminal illness an extra four months is very precious.”

Source: BBC

Of course, it’s very much a case of balancing available resources with potential benefits and unfortunately, advanced stage patients will inevitably take the lion’s share in terms of budget for disease management. Post EMA approval, some local UK health providers permitted the drug to be used on an individual basis, raising the old contentious issue of the rather unfair post code lottery (zip code for Americans).

Going forward, no doubt there will be much political posturing and pressure, as you can see from Cancer Research UK, who helped fund the research, but hopefully a deal can still be struck between NICE and Janssen, the manufacturer, on price to enable British men broader access to the drug.

One of the things that has struck me lately, though, is how prostate cancer is attracting serious research focus, such that a heterogeneous disease is slowly being more segmented based on the underlying biology of the tumour. Examples include Arul Chinnaiyan’s superb work on the TMPRSS2-ERG fusion gene and Charles Sawyers’ work on the Androgen Receptor.

Thanks to Sawyers work we now know that the old terminolgy ‘androgen independent’ prostate cancer is an incorrect way of descibing advanced disease because as Clegg et al., (2012) described Scher et al’s original research findings in 2005:

“Despite administration of androgen-depleting therapies, continued androgen receptor (AR) signaling is a common feature of CRPC, attributed to AR gene-amplification, AR gene mutation, increased AR expression or increased androgen biosynthesis in prostate tumors.”

In other words, the AR is very much an oncogenic driver of the tumour’s survival.

This week, we saw promising data for MDV3100, an AR antagonist in the post chemotherapy setting but what of the pipeline beyond abiraterone and MDV3100?

Previously, we came across Aragon’s ARN-509 AR antagonist, which is much further behind in phase I/II clinical trials. Sawyers and Michael Jung, the co-inventors of MDV3100 while at UCLA also developed (along with several other scientists) additional AR compounds, the most promising of which became ARN-509. Aragon is a privately held company formed out of the UCLA discovery with the intent of developing and commercialising this compound.

The obvious question arises – is it a ‘me-too’ or potentially better than MDV3100?

Preclinical data has just been published in Cancer Research by Clegg et al., (2012) addressing this issue. They argued that, based on their findings:

“In a clinically valid murine xenograft model of human CRPC, ARN-509 showed greater efficacy than MDV3100.”

Of course, preclinical data doesn’t always translate to the clinical setting, but my first reaction was ‘Whoa!’

Let’s take a look at the agent in more detail.  ARN-509, like MDV3100, is a pure antagonist of the androgen receptor, unlike bicalutamide (Casodex), which has both agonist and antagonist properties.  The idea behind this is that there will be less resistance and greater therapeutic potential for more comprehensive binding with the receptor.

We know from work in Sawyers lab that MDV3100 targets splice variants, which have been shown to cause resistance in CRPC, but we don’t yet know how ARN-509 will fare on that front.

So why did Clegg et al., (2012) suggest that ARN-509 might be superior to MDV3100?

“Maximal therapeutic response in this model was achieved at 30 mg/kg/day of ARN-509, whereas the same response required 100 mg/kg/day of MDV3100 and higher steady-state plasma concentrations.

Thus, ARN-509 exhibits characteristics predicting a higher therapeutic index with a greater potential to reach maximally efficacious doses in man than current AR antagonists.”

In other words, it’s much more potent and has a greater therapeutic index; these things are important clinically. It also has a longer half-life:

“ARN-509 exhibits low systemic clearance, high oral bioavailability and long plasma half-life in both mouse and dog, supporting once-daily oral dosing.”

Androgen deprivation therapies are more commonly used in castrate-sensitive disease, so this begs the question of whether there is anti-androgenic activity in the non-castrate setting:

“At higher doses of 30 mg/kg/day, robust tumor-regression (>50% reduction in starting tumor volume) was observed in 6/8 ARN-509-treated animals, similar to regressions observed in mice castrated on the day treatment initiated.”

The promising results led the researchers to conclude that:

“ARN-509 is a next generation anti-androgen selected for pre-clinical and clinical development based on its efficacy and pharmacodynamic profile in mouse xenograft models of CRPC.”

They also stated that:

“Unexpectedly, given a similar in vitro profile, ARN-509 is more efficacious per unit dose- and per unit steady-state plasma-level in mouse models of CRPC than MDV3100.”

In other words, ARN-509 is a next generation AR antagonist with a good efficacy and PK profile in mouse xenograft models of CRPC.  It’s clinical development, although further behind abiraterone and MDV3100, will be well worth watching over the next few years.

In summary…

While there has been a lot of activity in the advanced prostate cancer market lately with new approvals making a difference to the lives of men with prostate cancer, there are also several other promising near term agents in development, as well as some potentially more potent and effective treatments in early clinical development.  What we have seen to date is merely the beginning of new advances in R&D.

The early and advanced prostate cancer markets are likely to see some significant changes over the next 24 months, as new products based on rational drug design and an improved understanding of the biology of the disease make it to market.

More on prostate cancer coming soon!

All this new data is very timely, considering on Monday I’m off to the AACR Special Conference on Prostate Cancer, jointly chaired by Drs Chinnaiyan and Sawyers.  I’ll be interested to learn what new events are emerging as biological targets and what factors can help us predict response to treatment.  If you’re going to this meeting do stop and say hello, it’s always good to meet new people in the field.

References:

ResearchBlogging.orgClegg, N., Wongvipat, J., Tran, C., Ouk, S., Dilhas, A., Joseph, J., Chen, Y., Grillot, K., Bischoff, E., Cai, L., Aparicio, A., Dorow, S., Arora, V., Shao, G., Qian, J., Zhao, H., Yang, G., Cao, C., Sensintaffar, J., Wasielewska, T., Herbert, M., Bonnefous, C., Darimont, B., Scher, H., Smith-Jones, P., Klang, M., Smith, N., de Stanchina, E., Wu, N., Ouerfelli, O., Rix, P., Heyman, R., Jung, M., Sawyers, C., & Hager, J. (2012). ARN-509: a novel anti-androgen for prostate cancer treatment. Cancer Research DOI: 10.1158/0008-5472.CAN-11-3948

Scher, H. (2005). Biology of Progressive, Castration-Resistant Prostate Cancer: Directed Therapies Targeting the Androgen-Receptor Signaling Axis Journal of Clinical Oncology, 23 (32), 8253-8261 DOI: 10.1200/JCO.2005.03.4777

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This week I’m preparing an in depth mini series on the molecular target landscape associated with prostate cancer, which will be scheduled for next week, so do check back if that is a topic of interest to you.

In the meantime, I came across this video from MD Anderson, where the new President-elect Dr Ronald DePinho talks about the near term future of cancer research and where he thinks we will be going.

It’s less than four minutes long, easily understandable and well worth watching:

For those of you interested in my perspectives on some of the early clinical trial approaches, there’s a guest blog post on PharmaLive’s R&D Directions entitled “ASCO followup: Patients, pathways, progress in practice” today – check it out!

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Over the rest of this week I’m going to take some topics related to oncology and discuss them in more detail as part of a mini series about how cancer research is changing.

We all know that cancer isn’t one disease, but actually a myriad of different subsets, often even within each tumour type.  You can see the gradual shift aware from treating a type of cancer eg breast, lung, lymphoma, leukemia, melanoma etc to finding the driving the mutations and matching the patient to the therapy.

London Eye and Houses of Parliament

Having just returned from the European Hematology Association (EHA) meeting in London, I can say I was absolutely fascinated by the phase II data on brentuximab vedotin or Adcetris as it is now known (Seattle Genetics and Millennium), the antibody drug conjugate (ADC) in anaplastic large cell lymphoma (ALCL). Previously, we discussed the amazing data in Hodgkin Lymphoma but the photos of the patient responses in ALCL before and after treatment were amazing.

The connection?

Targeting the CD30 antibody on the surface of the cancer cells.

We can clearly see that as we learn more from basic research about the underlying mechanisms of growth, proliferation, survival and metastases, so our knowledge and ability to slow down disease progression and perhaps even stop the disease in it’s tracks also improves dramatically in some areas.

In the future, I can see triple negative breast cancer being segmented in various subtypes, for example, each with a different driving mutation and treating accordingly with carefully selected therapies, rather than treating them all as one homogenous subset of breast cancer, when they are in fact, heterogeneous.

There are several areas where we have made huge strides over the last five years:

  1. Earlier diagnosis
  2. Chemoprevention and slowing the inflammatory response
  3. Identifying biomarkers, both prognostic and predictive of responses
  4. Preventing metastases
  5. Translational scientist-clinicians

Over the next few days, I’m going to take a deeper look at these areas and discuss some of the new technology and research that is emerging in oncology as part of an updated landscape overview in cancer research.

If you have any other areas you would like covered, please do make suggestions in the Comments below.

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“How the mighty have fallen so quickly.  England were national heroes after winning the Ashes.  Now they are national chumps after this shocking and embarrassing defeat.”

Geoffrey Boycott, on England’s surprise defeat by Ireland in Cricket World Cup.

England v Ireland in the Cricket World Cup

England v Ireland in the Cricket World Cup

Some of you readers will be aware that I’m a big sports fan, of cricket and football in particular, so my cheerful mood earlier this morning was somewhat muted after learning that the motherland, England, somehow managed to lose to lowly Ireland.  In cricket!

Ugh, such is life – all good Englishmen will no doubt down another pint and shake their head in sorrow.

Still, that metaphor got me thinking.  In sports, there’s always another game, another tournament, another year – life goes on regardless.  While I was growing up, the mighty West Indies were at the height of their scintillating dynasty.  Now?  Not so much. Yesterday’s champs are tomorrow’s chumps and vice versa.  In clinical R&D though, if a major trial flops or is negative, it is rare that a company will go back and reconsider another series of trials with the agent in the same tumour type, even if the trial design was flawed, unless they have others already ongoing or in very late stages of planning.

You get one shot to get right.  Maybe two, if you are lucky.

Moving forwards, the incredibly high rate and cost of failures is unsustainable.  In the oncology arena, I think we will see the smart companies get smarter about drug development.  What does this mean in practice?

  1. More exploratory, smaller, phase II trials
  2. Focus on pathways and related activities as targets
  3. Increased use of translational research in 1) to determine mechanisms of resistance, adaptive pathways, biomarkers, logical combinations
  4. Greater use of the adaptive trial design to find the best winning combinations
  5. Increased use of diagnostics and biomarkers to select more clearly defined patient populations (ie smaller subgroups)

These trends are slowly happening now, you can see it more clearly in some pathways such as PI3K-mTOR, for example.  The days of taking a targeted therapy and adding it to standard of care chemotherapy in an unselected population, as happened with iniparib in triple negative breast cancer, are unlikely to be the future of cancer research.

What the more intense integration and iteration of basic research and phase II trials will give us is perhaps, a slightly slower development process, but with a much higher chance of success. In my book, that’s a much better approach – cancer patients deserve the best shot we can give them.

Photo Credit: ICC World Cup

Aside: For those wondering, my pre tournament tip was that India would be very strong contenders for this year’s World Cup, if only their bowling manages to get organised. Their batting strength is second to none, but Pakistan have a good chance if the Indian bowling shows any chinks and cracks.  Cricket is a team game, after all.  England regrouped and recovered to beat the strong Springboks from South Africa, so all is not lost yet!  Anybody but the Aussies, that’s all that matters 😉

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Following on from yesterday’s post about FDA approvals, here’s another short Nature Reviews Drug Discovery synopsis, this time on Phase III drug submissions and failures trends between 2007 and 2010.

This caught my eye:

“The Centre for Medicines Research International has noted that the average for the combined success rate at Phase III and submission has fallen to ~50% in recent years.”

Ouch.  Bold highlight mine.

The overall picture looks like this, based on n=83 submission failures:

Source: Nature Reviews Drug Discovery

I was astonished to see that oncology contributes over a quarter of the filings, but much less surprised that lack of efficacy was the reason of the failure:

“Of the drugs that failed to show an improvement in efficacy as an add-on therapy, 58% were anticancer drugs, and of those that failed to show an improvement in efficacy versus placebo, 33% were nervous system drugs.”

The author suggested that perhaps the challenging environment has led to unwise or hasty filings:

“… but is perhaps also a result of the pressure on companies to replenish pipelines with drugs that have high potential for approval and reimbursement, particularly in a period during which patent expiries for major products are threatening future revenues.

Owing to this urgency, it seems that companies have progressed drugs into Phase III trials even though they only displayed marginal statistically significant efficacy in Phase II proof-of-concept studies; consequently, these drugs carry a greater than average risk of failure.”

Sometimes that may well be true, but quite frankly, cancer trials are a bit of a crapshoot at the best of times so I’m not sure I agree with the sweeping perspective.

Promising phase II data can often lead to spectacular and unexpected phase III flops as sanofi-aventis discovered with their PARP inhibitor, iniparib, in triple negative breast cancer only last week.   The phase II data was hardly marginal and was worthy of publication in the New England Journal of Medicine.

In the long run though, we learn more from failures than successes, so that others following in the wake can improve on the trial design and combination therapies used. Still, that’s not much comfort for those who blazed the path initially.

References:

ResearchBlogging.orgArrowsmith, J. (2011). Trial watch: Phase III and submission failures: 2007–2010 Nature Reviews Drug Discovery, 10 (2), 87-87 DOI: 10.1038/nrd3375

Recently, I was talking to a couple of Pharma marketers and market researchers about their products in development, each in entirely different markets.

They had exactly the same issue though – making decisions about which tumour types to target out of a possible half dozen options. That sort of position often leads to total paralysis by a project team and an unwillingness to put their head on the block.

Too many what if's abound.

image from www.ysk.com The problem is drug development is often a leap of faith into the unknown, a total crapshoot.  You have to learn to play the percentages and perhaps consider several smaller phase II trials to minimise the phase III risks and see what data evolves.  Trying to pick only one tumour target at the end of phase I is a recipe for disaster and fraught with issues.

My answer is nearly always the same.  What data do you have so far?

What I've noticed is that the smart companies in oncology rigourously focus on solid proof of concept studies in phase I and even phase II before making the ultimate Go : No Go decision to pursue a phase III registration strategy.  This might mean embarking upon three phase II trials in different cancers before selecting a registration lead rather than just picking one and fretting about the other 5.  

Other times, it makes sense to try two indications in a head to head and hoping one emerges as a lead option, thus reducing your development costs.  This can be done when you have really solid preclinical data that really jumps out.

In the final analysis, making solid decisions based on actual scientific, clinical and preclinical data is a lot smarter than a total leap into the abyss just because a market looks bigger commercially.

No data, no dice.

Photo Credit: YSK

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“I made this letter longer than usual because I lack the time to make
it shorter.” 

Pascal, Provincial Letters XVI, 1660

One of the things that used to drive me absolutely potty as a marketing director was reports masquerading as doorstops, as if more was better than less. 300+ pages of data… blah, blah, blah and no insights or analysis, leaving the hapless reader to try and figure out exactly what it all means and some seek some context for how it might actually be useful. 

PsbSadly, I see the same thing happening a lot even now in competitive intelligence at scientific congresses. Gangs and posses of people marching round grabbing as many poster handouts as they can and illegally snapping as many photos as possible without getting thrown out by security.

Talking to some of those folk was really interesting; what do they do with all the data they gather?  The blithe answer was, “Oh, we reproduce it all for our client and recreate the abstracts for them in a big report after the meeting.”

Uh?  Right, and exactly was does the poor client do with the report?  Use it as a doorstop probably.

And therein is the rub.  

Information isn’t always power. Data is useless without context.  Ultimately, it’s all about insights – what does this all mean to YOU given that your particular situation is unique?  To process such a huge volume of information and give it contextual meaning requires a modicum of intelligence and some knowledge of the disease and therapeutic area in order to sort out the wheat from the chaff.  

Some of my best client reports have been relatively short (30-40 pages or even less) from a conference with a clear focus on relevant insights, trends and learnings, what the implications are and what could be considered next.  Short, sharp and snappy.  No blah, but plenty of insights.  Data with meaning.

Of course, sometimes the hardest part is accomplished up front in pinning the client down; “what exactly do you need to know?”  The distracted stressed client doesn’t know what they don’t know and takes solace in volume, which adds to the problem.  

My smart clients, the partner ones I really enjoy working with, are usually very precise when asked what they really need and are relieved to be asked because oddly, they know they can immediately stop fretting about the answer.  It will come.  This applies to conference coverage or ongoing market surveillance.  

Insights analysis is a craft; making data sing is part art, part science.

It also, as Pascal noted, takes longer to be succinct and precise than it does to merely reproduce what is out there in copious quantities.  Writing shorter, more impactful, reports based on data analysis takes more time too.

Once you’ve done a marketing or new products job in Pharma you know that deep down what matters is to keep moving, preferably faster than the competition, but with a clear strategic sense of what’s going on around you in the landscape and how market changes can impact you so that you can execute flawlessly.

Anything else is just irrelevant noise.  Or doorstops.

What are you doing to filter the signals from the noise?

Earlier this year, we were deep into a consulting report on general trends in the Pharma industry and were struck by data in different yearly reports from PhRMA, the industry body in the US.  Basically, when we pieced the data together, it was clear that the market share of generics was not only growing but also likely to get worse in the next 2-3 years with major expiries expected.

Take a look at this chart we put together from PhRMA reports:

Picture 63
In the last 8 years, the share of generics has increased by an amazing 21% and the future growth may well increase to 9-10% per annum in the near term.

We were therefore not in the slightest bit surprised to read this report in The Economist last month predicting that a huge drop in branded sales revenues is to be expected in 2011, which is very much in line with our own analysis and predictions:

Picture 61 In case you're wondering what's happening in 2011, think blockbusters such as Lipitor, Plavix, Seroquel and Zyprexa to name a few and some of those will experience patent challenges before then.  Interestingly, between 2009 and 2011 Pfizer (Lipitor), Lilly (Gemzar and Zyprexa) and sanofi-aventis (Eloxatin, Taxotere and Plavix) will all see major losses in revenues due to patent erosion as they scramble to make up for the losses with various approaches.

In addition on the oncology front, Taxotere, Doxil and Gemzar are all due to expire next year, so the biggest impact in overall revenues will likely be seen in 2011 when multiple generic entries will further drive the price down significantly.

It's no wonder, then, that Pharma and Biotech companies are starting to rethink their future strategies given the dearth of new products coming through the pipeline at a rate that isn't fast enough to replace the blockbusters going generic. 

What options are out there that can be considered?

a) License late stage or 'hot' products from smaller pharma or biotech companies at a premium.  Many oncology companies are racing to do this such as J&J with abiraterone, Astellas with Medivation and Celgene with romidepsin, for example.

b) Creative life cycle management such as new formulations, branded generics or own-label medications (eg Novartis has successfully tried combinations of these with Voltaren, Sandogobulin and lactulose)

c) Expand into generics in emerging countries such as China, Brazil, Russia and Asia where their is a rapidly growing middle class demand for new medicines to treat lifestyle and aging diseases (eg sanofi-aventis, Pfizer, Novartis, Merck and GSK)

d) Consolidate therapy areas and have a narrower focus with increased licensing ties or acquisitions in specialty areas of interest (eg BMS, Genentech)

e) Greater focus on rarer diseases with a strong focus on rationale drug design and efficacy, leading to higher per patient prices (eg Genzyme, Novartis, Allos Therapeutics)

The recent round of mergers is unlikely to be the last for a while as others are already happening or being worked on.  The rate of licensing deals has begun to pick up significantly lately, driving up the asking price in the process, as Biogen IDEC found recently when Facet Biotech tartly declined their $17.50/share offer for the company.

Overall, I think the general trend for utilising more creative strategies with generics, emerging markets and better life cycle management strategies are here to stay.  There will always be new products coming onto the US market, but with an increasing focus by the Obama Government on pharmacoeconomics and cost effectiveness of new medicines, the Pharma industry must either innovate, diversify or struggle as patent expiries focus everyone's attention on the bottom line.  

It will be interesting to see who comes out stronger and better positioned for the future and who dies.  The difference between winning and losing is sometimes very small, as Vion found this year with Onrigin. Others may well follow suit and seek bankruptcy protection in 2010 if their Russian Roulette strategy doesn't come up trumps.

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As the Pharma and Biotech industry layoffs continue (40,000 this year alone according to the WSJ) and fewer people are left to do more work, I was pondering about consciousness and awareness last night and how they might impact insights.

Sometimes taking time out from the hurly burly of meetings and just stopping to think of absolutely nothing can allow those deep thoughts and ideas to bubble up more freely.  Insights from customers, patients and consumers can help us understand both the market and the needs for a product, but only if we stop and reflect on things as a whole rather than looking at individual pieces in isolation.  Otherwise analysis paralysis will ensue or wrong conclusions made based on incomplete data.

image from www.flickr.com
Source: H. Koppdelaney via Flickr

A client recently asked me how we create big picture ideas from nothing and come up with strategic trends in the disease landscape. 

The answer isn't a simple one, but often, with the volume of reading we do every day across a huge variety of topics things get hidden deep down in memory and may not be immediately obvious at first. This is also true if you want to mine a database for information, you have to know what you are looking for to start with in order to see the wood from the trees. 

For me, I find my best ideas and heightened levels of awareness come from being back to nature while out walking and thinking about absolutely nothing.  Once you have some ideas, you can test them based on the data available and see if relevant trends emerge. This also applies to other related areas such as market surveillance and market research – it's all very well having a big pile of interview transcripts, but you still have to put the story back together in a logical, coherent way that makes sense.

Sometimes, other peripheral things can also trigger new ideas in your consciousness too.  This process can take place over several weeks as a picture emerges from the chaotic jumble, rather like a child puts a painstakingly puts a jigsaw together.  Out of emptiness comes greater awareness, perception and fresh ideas.

How do you put yourself in touch with your own consciousness and awareness?  Do you generate insights differently?

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