Pharma Strategy Blog

The ravages of smoking and cancer...

We all know that long term exposure to chemical insults and carcinogens from smoking and alcohol can act as irritants, leading to biochemical changes that can induce the development of hyperplasia, and potentially, carcinomas.

Over the weekend I was shocked to learn that Alex "Hurricane" Higgins, former World Snooker Champion, had passed away aged 61 from throat cancer.  He was an incredible talent who will be sadly missed and remembered for many years to come.

I wrote a bit more about it here: be warned though, the before and after photos are rather distressing :(

Monday Mumblings - Life in the fast lane

After taking a week off work decompressing without a laptop (yes really), I've been catching up on my reading over the weekend and browsing the long list of diverse blogs that I follow from tech to venture capital, sports, science, medicine and of course, cancer. One article in particular caught my eye - on preoccupations in the NY Times Jobs section from last Friday. You can get the gist of it from the quote below:

"SIX years ago, fresh out of Stanford with a degree in economics, I had what many would consider the perfect job. I was a management consultant at a prestigious firm, with an office overlooking the San Francisco Bay and a shiny new ThinkPad to boot.

My co-workers were intelligent, ambitious and fun, and I interacted with high-level executives at Fortune 500 companies. My perks included free concert tickets, ski trips and fancy dinners. I was on track to be earning six figures within three years. It was the good life I had been chasing along with my peers at Stanford. 

So why wasn’t I happy? 

After six months of living this supposed dream, my day-to-day life was far from satisfying. I was working 14-hour days, and most of my time seemed to be spent nudging boxes around in PowerPoint slides and agonizing over the wording of bullet-pointed items. It felt wrong to be dreading work at such a young age. I wanted to wake up each morning excited about what was ahead. I wanted to create something of my own." 

Source: NY Times

What was interesting was having just spent time away from the office decompressing and having fun in the real world away from computers, reports, PowerPoint, phone calls and meetings, the comments struck a chord with me about the Pharma treadmill. How many people go from meeting to meeting in a whirlwind, dashing off to catch a plane to yet another weekend Advisory Board or conference, creating endless reports for the higher ups, handling calls from sales reps, even pushing boxes around on PowerPoint? I'm willing to bet it's a lot of people. 

How many people have gone to a major medical conference, only to spend most of the time stuck in their hotel in meetings or writing slides for some deliverable, while the really interesting stuff being presented on the clinical data was missed?

One of the many questions I get as a consultant is would I go back to Pharma/Biotech land?  Maybe, for a truly unique and challenging opportunity to make a difference, but while I enjoyed the time I spent and the most of the people I worked with, work life balance in the US is a lot harder to attain than in Europe. It's gruelling and full of politics and consensus. This means making things happen takes a lot of time and energy, plus if you don't watch out the daily grind can be more driven by the immediacy and urgency of tactics rather than strategy. 

Think about it, those sales trimester meetings come round all too quickly! 

As someone running a small strategic consultancy firm, I can reach out and help more people, be my own boss, focus on the strategic impact, have more fun and be inspired by some wonderful people doing great things. Most important of all, it's like being a kid in the candy store again - full of excitement and exuberance for what's happening in cancer research, discovering what might have an impact on better patient outcomes and improved quality of life.  What's not to like?

Over the last few weeks, I've had the pleasure of meeting or talking with some really dynamic and creative people that stimulated my thinking and made me realise that the future in oncology is still bright and full of enthusiasm for the next big thing. Kudos to them for keeping the vision and inspiration going. Life tends to back winners with imagination, long may it continue.

If your drug, technology or device doesn't make a meaningful difference, what's the point?

Photo Credit: Geus2006

Wishing America a happy July 4th!

By the time you all read this, I will be off somewhere on holiday for the week, or vacation as they prefer to say on this side of the pond.  Many of my consulting friends grumble about the slowdown in the summer as people take time out in July and August.  We seem to get busier!  In fact, look back, we haven't stopped since the beginning of last July when my Mother sadly and suddenly passed away.

This week I'm going to take some time out, honour my departed parents, decompress and reflect.  Losing both parents in some ways meant I lost my country too, which is a strange feeling.  

Still, I promised numerous friends that I would eventually stop and take some time to smell the roses.  

Please don't expect any emails, blog posts etc - like many good Europeans when we take a holiday we really do try to switch off and no, I'm NOT taking a laptop with me either.

Looking at the diary, I see there are numerous client deadlines looming on Friday and the following week, not to mention important meetings and new projects coming up.

The Icarus office will thus closed this week and reopens on Friday 9th July.

Have a great week everyone and a fun Independence Day for all my American cousins!

Photo Credit: tobchasinglight

How cognitive surplus will change the world: Clay Shirky

Here's an interesting and informative TED video I just came across, where Clay Shirky talks about cognitive surplus and how it will change the world.

The idea behind the concept of "cognitive surplus" is that we use spare brain cycles while online to build a more cooperative world.  In other words, new technologies enable loose collaborations to evolve.

I'm not sure I like the term 'cognitive surplus' but Shirky is an eloquent, thoughtful and engaging speaker who is well worth listening to:

The fine line between Hype and Hope in breast cancer

While on the road here in San Francisco at the American Urology Association, I received an email from someone about latest news surrounding the breast cancer vaccine published in Nature Medicine.

Expecting to find some snippets on how this vaccine might work and the usual blah blah blah about clinical trials starting soon, I was rather aghast at the hype and furore surrounding this issue from many reporters touting it as the next big thing - despite not a single study having yet started in humans.

The BBC was thankfully the most measured, but most were not, and do a great disservice to both women suffering from breast cancer and their caregivers/loved ones.

Over the last 10-15 years there have many vaccines developed and tested as anti-cancer agents, yet only one (Dendreon's Provenge) has actually made it to market, and recently at that.  I'm not including the Gardasil and Cervarix vaccines in this category as they are indicated for prevention of HPV, which may lead to genital warts and cervical cancer.

There is no doubt that some cancers may have either an infection or immune component - lung, melanoma, prostate and breast cancer are several that come to mind in this respect, whereas others such as renal cancer clearly have a more metabolic process underlying the biology.  Immune sensitive cancers are more likely to show some positive data down the line, but please, show us some solid DATA first before hyping a theory all over the internets, however well intentioned.

</rant>

Jaini, R., Kesaraju, P., Johnson, J., Altuntas, C., Jane-wit, D., & Tuohy, V. (2010). An autoimmune-mediated strategy for prophylactic breast cancer vaccination Nature Medicine DOI: 10.1038/nm.2161

Bayer’s Nexavar fails to gain NICE approval in liver cancer

"The drug, also known as sorafenib, extended lives by an average of 2.8 months at a cost of 27,000 pounds ($38,853) for each patient, NICE said. The Leverkusen, Germany-based company had offered to pay for every fourth pack of Nexavar when used to treat hepatocellular carcinoma, a type of cancer that starts in the liver. Few patients with the disease are able to undergo the surgery that could potentially cure them, NICE said." 

Source: Bloomberg

No surprises there really and consistent with the approach the National Institute for Clinical Excellence (NICE) has taken over the last few years.  You can read what the agency had to say on the matter here. Basically, Bayer offered NICE a deal whereby every 4th pack of sorafenib (Nexavar) would be free, but that wasn't enough to sway the decision:

"Sorafenib does not provide enough benefit to patients to justify its high cost."

It's interesting that my US colleagues always point to this kind of decision as evidence of rationing but it's really an access issue based on who holds the budget strings.  

In the US, drugs might get approved at whatever cost the manufacturer chooses for now, but insurance companies and the CMS may put all sorts of strings attached such as certain conditions, formulary tiers, pre-authorisation etc and in the end the patient also has a choice whether they can and want to afford the co-pays that go with those decisions.  They may after all, still say no, that the price asked is too high a price to pay based on their means.  A drug in a tier 3 or 4 category will have a very different co-pay from a tier 2 drug, for example.

Still, in the end, who pays the Ferryman is still the moot point and sometimes Pharma forget that the days of charging exhorbitant prices that neither the healthcare systems nor the people can afford will one day come to end with excessive price charging.  

Ultimately, it's an unsustainable business model that gives Pharma a bad name synonymous with oil and tobacco companies. Perception is reality sometimes. Eventually the actions of a few will affect the sensibleness of most and in the US we will all get to deal with more systematic price controls and constraints based on the likes of health economics, comparative effectiveness and cost utilities etc whether we like it or not.

Outside of oncology, very few companies consistently engage in head to head comparative trials to prove their drug is more effective or cost effective than the standard of care.  This will ultimately change over time as the authorities get tougher.

In the long, the cost of doing business ie conducting clinical trials, will go up and the burden of proof will shift dramatically.

End of life care and treatment raises all sorts of poignant yet important questions.  Do we need a greater focus on wellness rather than palliation? What about research into better models and biomarkers so that earlier detection of cancer, where intervention can have most effect, can be initiated? Should the needs of the few (eg in the end of life situation) outweigh the needs of the many? Given the limited resources available, how best should they be allocated and invested?  

If you look at the Nexavar situation on reflection, how would that $38K be best spent for the greatest benefit given that there isn't a bottomless pit of money?

These are always tough decisions for anyone to make, especially when a relative or loved one may be involved.  Rather than the PR and media hysteria that inevitably follows these sort of rejections, hard and tough though they may be, it would be nice to see a broader public debate around some of the wider strategic healthcare issues facing us all.

On valuing the Pharma client - vendor interaction

Recently, I've been observing and watching a number of interactions that I've been part of, from friends, acquaintances, clients and physicians and healthcare practitioners.  It dawned on me that no matter what we do, our satisfaction with the result of those interactions is directly tied to the involvement we go through.  

A nasty ear infection was a salutory case in point. The reaction of my old PCP practice was close to distressing so I decided to change practice, no easy decision after 10 years with the same group.  They resolutely declined to see me despite the pain and discomfort unless I paid a disputed bill even though my insurance told me it was covered and the office hadn't billed it correctly.  The staff were rude and obnoxious in the extreme.  So much for the Hippocratic Oath! 

The first time I nervously met the new Nurse Practitioner, she surprised me by being polite, thoughtful and empathetic, a world away from confrontational New Jersey style I had become used to.  In the space of 10 minutes she explained to me gently that I had a discharge and likely an ear infection that need to be seen by a specialist that day, if possible, for cleaning and treatment.

She phoned around, made an appointment for me and dispatched me 30 blocks south to see the ENT specialist.  He turned out to be equally caring, efficient and happy to take the time to explain the problem and involve me in the solution.  As a result, I felt more involved and willing to commit to the time consuming process of fixing it, which turned out to be significant in my busy schedule. Interestingly, when I in turn explained to clients what was happening, they too understood and didn't feel resentful of the necessary absences, quite the reverse with a hearty "Go get it fixed!"

That's how it should work in an ideal situation.

However, when we don't collaborate, communicate, share or participate in the process, stonewall or or worse, just promote what we want to sell without interaction, the perception of the value offered is less than optimal and the experience is unlikely to be a positive or happy one. This applies as much to the physician-patient relationship as it does to the Pharma-physician one.

In the end, the first practice I would be less than enthusiastic about recommending, while the other two I would enthusiastically recommend to others.  In fact, when we have a bad experience we often go out of our way to warn others to save them the same pain, whereas we don't always remember to pay it forward with referrals and recommendations when we have a great experience.

My own personal medical experiences recently made me think more clearly about client - vendor interactions, to good effect.  Taking the time to involve the client in the experience and take on board their ideas to make it a better product more likely makes them: 

a) more part of the process

b) more likely to be supportive and involved

c) more likely to own it

c) more likely to see the value and appreciate it.

We're all fallibly human and make mistakes, but taking the time to involve others in the process rather than pushing what we think they need is well worth the effort in the long run.  Happy clients ultimately make for more satisfied people who value what you bring to the table too.

In what ways do you think about increasing value with others around you?

Betterness is Good Business even for Pharma

"Good Businesses" are not judged solely by better sales, profits, equity returns and sharholder value - these becoming old measures on their own.  Investors are increasingly asking  "So you made a profit - yawn - but did you also make an impact?"  This is what it takes to outperform today and tommorrow.

What about Big Pharma? Or little Pharma for that matter.

Aren't these companies founded on the ideals of delivering novel life-changing treatments to patients, transforming science into therapies, to serve patients, to deliver meaningful benefits to consumers, and to improve the quality of life?

How does this square with off-label marketing, physician payola schemes, manufacturing failures resulting in product shortages, contaminated or adulterated product, massive corporate lay-offs and outsourcing jobs elsewhere?"

via thebigredbiotechblog.typepad.com

Bruce Lehr of The Big Red Biotech Blog wrote a nice blog this morning that made me sit up and take notice.  He's right; some areas of the industry could do well to clean up their act and focus on the important things that matter rather than skimping on quality or indulging in fluff n puff marketing. And some people wonder why Pharma is held in such distain akin to oil or tobacco companies?

Meanwhile, in the oncology arena, we're always running head to head trials, figuring out how to beat the standard of care and improve overall survival. In other words, finding the compounds that give an edge and make an impact.

It's easy to forget that many other areas of the Pharma business live in fear of not winning, not making blockbuster revenues and thus run an inordinate number of placebo controlled rather than head to head trials. After wading through a mass of non-oncology data at the weekend, I was left wondering, "How on earth do you prove your product is better in that situation?"

If you can't beat the competition, why bother?

Which takes us back to the original review article from Umair Hague in the HBR on why Betterness is Good Business and how great companies focus on the stuff that matters, rather than just profitability and increased shareholder value.

So, I think I'll stick with the dog eat dog mentality in oncology, where we focus more on people and trying to make a difference to the lives of people with cancer. If your compound doesn't beat the standard of care it effectively dies in that indication. My firm belief is if you focus on bettering the competition, the rest will follow naturally and organically. That doesn't mean that some don't fall off the wagon and transgress into the dreaded off-label promotion though.

Still, maybe the rest of Pharma could learn a thing or two from oncology?

Malcolm Gladwell on cancer research

I was reading an article from the New Yorker this morning by Malcolm Gladwell on the Annals of Innovation.  You can read the abstract here.  

The article centres around the story of Synta/GSK's elesclomol in melanoma in 2007.  The drug, like many others, started off promisingly but the final results showed that the patients did more poorly in the treatment arm.  What the researchers didn't know at the time was that the target in melanoma was actually different from the one they were aiming at.  The understanding of the biology had yet to evolve beyond chemotherapies at that time and our understanding of biomarkers in melanoma was sketchy at best.  

Essentially, the author concluded:

“When will we find a cure for cancer?” Gladwell writes, “implies that there is some kind of master code behind the disease waiting to be cracked. But, so far as we can see, there isn’t a master code. There is only what can be uncovered, one step at a time, through trial and error.”

In some sense Gladwell's right, the process of finding new cancer drugs based on the biology of the disease goes one step at a time, science and research is necessarily iterative, after all.  But he missed the reason why. 

It's because cancers are heterogeneous.

Photo Credit: Cnet

Is there a better model for health care?

Recently, I've been doing so much research and analysis of advanced cancers, it struck me that we spend millions of dollars on healthcare at the end of life when it likely won't have much impact, yet the real change happens when we catch and treat, or preferably prevent, diseases such as cancer earlier.  This is not exactly rocket science.

Maybe we need a change in approach?

By that, I mean a greater focus on prevention, health and wellness rather than medicate and palliate end of life care.

How much of illness is as a result of poor body management, for want of a better term?  Obesity, cardiovascular disease, sedentary lifestyles and lack of exercise all take their toll.

Most people don't do anything until a major wake-up call comes, but by then, it may well be too late do much.

What we need is a wellness model and people educating themselves to take better care of things earlier and having more responsibility for their choices.  After all, we can't expect an unlimited pot to be available at the end of the rainbow to cover the inexorable rising cost of treatment.  That's totally unrealistic and impractical.  

Eventually, the pot runs out and there is no more.

What then?

What makes a great Pharma marketer?

A bunch of friends and I have been debating offline about what separates a great from a good brand marketer.  In our case, we've been focusing on oncology, but really it could be any pharma category from asthma to Zellweger syndrome.

To date, the answers and ideas have been stimulating and interesting, but we all agreed that none have really captured the very essence we were seeking to describe.

Until I read Brad Feld's superb post this morning.  He was actually talking about what makes a great entrepreneur:

“A complete and total obsession with the product”

And I realised that's exactly what we were trying to describe for Pharma marketing.

If you're not absolutely obsessed with everything about your drug or brand, from scientific preclinical and clinical data to understanding market research on how your customers feel about it or indeed how anything impacts your product, then you're missing something vital.

Life is too short to just go through the motions.

Thoughts?

New Product Marketing

One of the things about oncology or any other therapeutic are new product development and marketing is that you get to spend a LOT of time at scientific congresses like AACR in DC the other week, which means early to rise and late to sleep:

Source: Personal iPhone - view of over the Potamac and Georgetown, DC from Arlington, VA. 

Anyone who thinks these meetings are junkets or jollies should join me on my schedule next trip;sometimes there isn't time to eat or by the time you do have a free slot it's too late.  Often, it means 18 hour days and a day back in the office is a relative rest.  There's always thought leaders to talk to, sessions to attend, media briefings, poster sessions (you can walk miles at those alone), plenaries etc, not to mention clients as well.  Fitting it all in makes for jam packed days.

The interesting thing about new data though, is that while trends may be obvious to those following the specific disease area, they are not to others.  I always find it amusing watching the teams of young things running around with their crib sheets frantically collecting poster handouts, rudely barging past people and trying to discreetly snap the posters without security catching them.  

In DC, I asked one what they did with all the data they amassed.  It turns out they just dump it all in a report for their client by whatever category seems apt.  No strategic analysis, what it all means or even trend spotting, just a data dump.  Ugh.

Sometimes less really is more.

Are you a crazy deranged fool (CDF)?

The other week someone asked me why I do so much work specialising in oncology and cancer, which admittedly can sometimes bring more sad news than good.  

I answered simply: "because I'm a crazy deranged fool!"

Source: Hugh
 

I follow Hugh MacLeod's cartoons daily and also subscribe to his excellent newsletter.  On bad days he keeps me sane, on good days I laugh out loud.

What on earth is a 'crazy deranged fool' you may be wondering?

According to Hugh:

"A CDF is my term for somebody like me, i.e. somebody who actually has the temerity to TRY to do what he loves for a living, as opposed to shlepping for his daily crust."

Running a consulting business and going to many scientific and cancer meetings has it's benefits - one of them is realising you're getting paid for doing something you love and have a lot of enthusiasm for.

Making sense of data is fun; finding patterns and trends amongst a mass of information on a huge variety of different cancers is sometimes like unravelling DNA.

Are you a crazy deranged fool?

Paralysis by analysis

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.

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

Day off for Easter Friday

My buddy Rob Z posted these beautiful Hot Cross Buns on Twitter this morning.   Made me homesick and a nice reminder of an ages old English Easter Friday breakfast tradition.  

This is a day to take off work and reflect.  The sun is also shining.  Have a great day, everyone!

 
Source: Robert Zarywacz 

The blog is closed until Tuesday, but I might post an Easter egg on Easter Monday :-)