The Laszlo Letter

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2012 - A Survival Guide

The following first appeared on the Pharmaceutical Users Software Exchange (PhUSE) Facebook page. 

Happy New Year to you.  I am saying ‘to you’ deliberately since I’d like this post to be read as if we were good friends having a chat in a cafe over a cup of coffee. I realize though that by the time you finish reading this you may not want to be my friend. Let’s see what happens.

First, I want you to know that I consider you a professional; someone really good at what you do. So, I’m not going to dwell on that except to say that you may need to be a bit more open to learning new things so you can survive the hard times ahead. More about that later...

As I write this post, Astra Zeneca has announced another round of layoffs, this time affecting over 1,200 employees. Most of these will be in Sales. Don’t let that make you complacent. While the industry has finally figured out that you can’t have nearly as many reps as there are physicians, they may have also determined that all other professions are fair game too. That means you!

So, how will you survive and thrive? Good question. Let’s come back to that later as well...

I’d like to share with you a cautionary tale. A few years ago, I was helping Elan implement a new clinical data management system. As always, my team had the chance to work with some really bright programmers and statisticians. This did not mean that all of them were enthused about the solution that was selected. You could say that we had the typical bell curve; a few people who were really enthusiastic, a large number who would go along without complaint, and a few others who were silently or vocally opposed.

Anyway, no matter what you believed, the marching orders were clear and you were expected to help implement the new system and the processes that went with it. We had lots of planning meetings and everyone had important tasks that had to be completed on schedule. And did I mention that everyone still had to do their regular jobs! Then, one bright sunny morning we came to the office only to find out that six of the team members were let go the previous day. Not only that, but the entire project was scrapped. We packed our bags and went home.

On the plane back to New York, I had the chance to reflect on what happened. First, I felt bad for all of those who were let go. I then made myself feel a bit better by rationalizing. Specifically, I thought that some of these people probably hated what they were doing or loathed the company they worked for but were afraid to make a move. Now they had no choice and would most likely land on their feet.

Then I thought about the naysayers who were also fired, those who had to be dragged kicking and screaming to adopt the new system we were trying to implement. How ironic, I thought. Whatever job they got next, they would need to go along with whatever system and processes are already in place. They would need to work with whatever cards they were dealt.

So, there are a few important lessons wrapped up in this cautionary tale. The most important one is that you have to keep things in perspective. It’s important to have principles and convictions but you also need to be critical of yourself and not just of others. For example, is it possible that you may be wrong about the new system? Is the real reason for objecting your fear of the unknown or having to learn something new? Would you be protesting as loudly if you knew that you will be out the door the next morning? And finally, why can’t you think of the new system and processes as if you were showing up at a new job with a different company the next day?

Oh, this reminds me. Did I tell you about the conversation I had the other day with my friend Audi. I know, I know, it sounds like the car but it’s a real Arabic name. She came to the United States from Syria and is still struggling to understand our ways. Anyway, we somehow got into a conversation about God. She wanted to know if I believed in God. I told her that it’s not something I think about. But she would not let it go at that saying “Just think about the universe and all the things that exist? It could not just have come from nothing?”  So I gave it another try. I said “Audi, it’s pretty simple for me. We humans are pretty limited. We have trouble thinking outside of ourselves. And besides, it’s arrogant for us to even think that we could know who God is? See, I just humanized God without even thinking!  Is God a ‘who’?  It’s only because we have a big brain and self awareness that allows us to even think about God. And what do we accomplish anyway? It makes no difference whether I believe in God or not. It won’t change anything.” I don’t think I convinced her.

Then I smiled and said: “Audi, did I ever tell you the joke about husbands and wives? The one about big and small decisions?  It’s pretty simple. Wives let their husbands make the big decisions like ‘how we can solve the deficit problem or world hunger’.  Wives make the small decisions like ‘where we’re going to live, where our children go to school and what we’ll do for our summer vacation.’” She laughed at that.

So we have another important lesson. Try not to think or worry about things over which you have no control. Focus on things that you can influence or control. Maybe that is how we’ll all make it through 2012 unscathed!

I know, it’s easier said than done. You come to work every day and do what is expected.  Come to think of it, you’ve been pretty lucky in Biostatistics. All of your customers think of you as a black box. They send in the raw materials and you give them a finished product. They have no idea how you do it and I don’t even think they care. It’s nice that you have control.

Or is it? The company as a whole is in big trouble? Do you know why? It’s probably pretty complex. Maybe you need to understand that better. I guess I’m suggesting that as an employee you have a responsibility not only to do your job but to think about the success of your fellow employees and that of the company as a whole. You know, if you don’t care about them, why should they care about you?

For example, you know that the cost of R&D is astronomical and always going up. Yet, the chance of success with any candidate is going down. So, what can you do to get that R&D buck to go further? Just think about it?

OK, I’ll give you an example. SAS is pretty useful to your job but it’s also very expensive. On the other hand, there is R which may be just as good and perhaps even better at some things. And did I mention that it costs a fraction of the big gorilla?

I know, I know, you have a ton of people who are SAS experts (including you). But if you know that you can save your company a lot of money by switching, why aren’t you doing it and doing it faster? Aren’t you smart enough to make it successful and yourself more valuable in the marketplace? Would you rather risk losing your job so that management can hire someone who knows R better than you? Which is better: Having your friend in the next cubicle keep his job or have some employee at SAS Institute eat as many M&M’s as they want? It’s partly up to you, you know.

Sorry, I got carried away there. Sometimes I get emotional about this stuff. But you have to understand. It’s a dog eat dog world out there and you can’t just stand by as an observer anymore. You have to be active to save yourself and stay ahead of the competition.

You know what the enemy is? Time! The clock is ticking for this entire industry and we are still doing our jobs in slow motion. We used to call this the “Fat and Happy Syndrome.” I have a variation on this that I shamelessly call Laszlo’s Law. This states that change in the biopharma industry takes the same amount of time as drug discovery and development. In other words, we’ve come to accept that it takes 8-12 years to get a product to market and thus, it must take equally long to get anything else done too. Read it and weep!

Since I’m an IT guy, I will give you two examples of this.

Q: How long did it take for Documentum to be accepted and widely used for regulated document management?

A: About 8-12 years

Q: How long did it take for EDC to be used more widely than hard copy CRF’s?

A: About 8-12 years

And yes, you can do something about this. Just look around you, observe and ask questions. Why, for example, is it taking so long to adopt R? Why do we have 3-5 year transition plans from one system to another? Why can’t I get my hands on the clinical data from study X in 3 minutes rather than 3 months? Why can’t I have my EDC system be reconciled with my AE system in real time? Why do I have to re-run 20 programs to modify single footer? Why isn’t it possible to (insert your own question here)?

If you can ask these questions and derive solutions from them, you have all the ammunition you need to take your case to management. No topic/issue should be off limits. If you don’t do something about it, who will? Rest assured, someone will and you may not like the outcome. Proactive beats reactive anytime.

Speaking of Management, you may not know this but you also have the responsibility to keep them honest.

Want to save more money and perhaps some jobs? Look into your company’s travel policies. Is it OK for employees to spend $80 for dinner when their colleagues are being laid off? Can you stand it sitting in coach flying from New York to Frankfurt at $1,000 rather than $3,500 in business class? Are you taking advantage just because you can? How about some self direction? Be proactive and fly coach even if the policy says otherwise. Then let everyone know that you did it and why. Better yet, ask Management to review and revise the whole travel program. Ask them to build in some incentives (Read $$$ and €€€) to get T&E costs as low as possible.

OK, you don’t think that’s important enough? Well, how about this? Do you know if your company and its employees are following corporate governance policies? Did you know that those are even posted on the company web site? How about the ethical guidelines?

Did you hear about that giant company that just paid close to $1 billion to settle an illegal marketing scheme? No admittance of guilt of course. Was it your company? Were you outraged? Here you are doing your job and know that your fellow colleagues are also doing their best. How is it possible that a few misfits are making you into a villain in the eyes of the public? Aren’t you working in healthcare because it actually makes life better for mankind?

Oops. There I go again. But yes, stuff like this happens because someone was only interested in the bottom line. A game, if you will, where you gamble that you’ll make inordinately more than what it will cost you to settle. It’s not only money this time. The reputation of your company and the industry is at stake.

So, yes, it’s up to you to keep your own company honest. To protect it from itself.  That means that you need to understand how it’s governed and evaluate for yourself whether its policies actually work. If not, you need to bring up the issue with the powers that be. Perhaps not alone but with your fellow employees.

 By the way, did you hear that some of the Novartis employees and a local union actually staged a public protest about the layoffs at their Nyon facility? That’s in Switzerland. Amazing!

Happy New Year

George

Friday, 06 January 2012 in 05 Industry Controversy, 70 Ethics and Compliance, 71 Public Relations, 73 Human Resources, 90 Diversions, 94 Random Thoughts | Permalink | Comments (1) | TrackBack (0)

Technorati Tags: Astra Zeneca, biostatistics, clinical trials, data management, Elan, ethics, human resources, industry practices, jobs, Laszlo Letter, layoffs, pharmaceuticals, reduction in force, statistical programming, Survival guide

R&D - The need for accountability. Pfizer weighs in again.

Pfizerlogo 
Matthew Herper of Forbes magazine wrote a review of a press conference held by Ian Read, the new CEO of Pfizer. Of interest to me was the following paragraph:

"One of the main goals of the changes is to try and prevent any repeat of Pfizer’s disastrous investment in Exubera, the inhaled insulin, which the company spent years developing before it hit the market and bombed. Without accountability, Read says, projects were handed off from one team to the next without demands that they actually be ready. 'You get the transfer from one stage to the next stage, always investing in hope rather than strong clarity of signals and clarity of medicine and clarity of mechanism.'"

While I continue to fault Pfizer for their lack of imagination when it comes to R&D, this statement is right on.

Some of you may have read my point of view on the Exubera debacle on this web site. Mr. Read seems to understand that once a project takes on a life of its own within the R&D pipeline it is nearly impossible to stop it.

Why is this the case? Because pharmaceutical firms have gotten so specialized and compartmentilized that people are simply completing the work assigned to them without seeing the big picture. It seems that even Lifecycle Teams are not able to complete a holistic review of a drug candidate. The stakeholders are simply focusing on getting their part of the work done right and on time and are rewarded for doing so. If the incentives are not based on team success then the chances of getting a compound on the market are significantly reduced. This is where the idea of accountability comes in and was highlighted by Mr. Read.

Now, Mr. Read's observation is not original. We have heard many times about the need to "fail early." Unfortunately, the acceptance of failure and the possibility of being rewarded for it has not really become a visceral behavior at most companies. Perhaps Mr. Read will take steps that will make this happen at Pfizer. If that happens others are sure to follow.

 

Friday, 04 February 2011 in 05 Industry Controversy, 10 Innovation & Creativity, 30 CxO Corner, 33 Discovery, 35 Clinical Trials, 45 Sales & Marketing, 71 Public Relations | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: drug pipeline, Forbes, Ian Read, Laszlo Letter, lifecycle team, Matthew Herper, Pfizer, R&D

Leveraging social media by biopharma

IMG_1220 Having just returned from the DIA Clinical Forum meeting in Lisbon, I was happy to see a notice within my LinkedIn account about a new posting by Daniel Ghinn of Creation Healthcare. This is not only a good overview of the Medical Informatics session at the DIA meeting but also makes reference to the recent DigiPharm Europe conference recently held in London. Daniel also delivered an insight packed presentation at the DIA meeting on the use of social media (e.g. Facebook, Twitter, Flickr) by pharmaceutical companies. In this presentation, Daniel cited work done by Johnson & Johnson, Pfizer and Boehringer-Ingelheim. Both are worth your time.

Saturday, 16 October 2010 in 10 Innovation & Creativity, 12 Case Studies, 45 Sales & Marketing, 70 Ethics and Compliance, 71 Public Relations | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: boehringer-ingelheim, clinical forum, Creation Healthcare, DIA, DigiPharm, facebook, flickr, johnson & johnson, Laszlo Letter, marketing, pfizer, sales, social media, tudiabetes, twitter, UCB

DIA Euromeeting: Impressions and Recommendations

Es_0005 I’m writing this on the plane to New York from Barcelona having just attended the 2008 DIA Euromeeting. As a veteran of many DIA annual meetings in the USA, I must admit that this year’s Euromeeting was like a breath of fresh air. A key reason for this may be the calculated risk that the meeting planners took by redesigning the program around themes and sessions.

Suggestion: Click here to see a phenomenal set of Barcelona photos!

Continue reading "DIA Euromeeting: Impressions and Recommendations" »

Friday, 07 March 2008 in 35 Clinical Trials, 36 EMR/EHR, 40 Data and Content Mgmt., 42 Workflow & Process Management, 50 Lab Information Management, 60 IT Infrastructure, 70 Ethics and Compliance, 71 Public Relations, 72 Regulatory Affairs, 73 Human Resources, 74 Legal and Government Relations, 80 Outsourcing & Offshoring, 99 Vendors | Permalink | Comments (3) | TrackBack (0)

Technorati Tags: Barcelona, Biotechnology, Clinical Research, CRO, DIA, Euromeeting, Information Technology, Laszlo Letter, Life Sciences, Pharmaceuticals, Software

Shire: Clinical Trial Results Website

Shire Plc. has released its consumer-focused clinical trial results web site. You can see it by clicking here.

The site is devoted to completed and discontinued clinical trials that can also be found on the clinicaltrials.gov  or clinicalstudyresults.org web sites. No information on future or ongoing trials are included.

My initial reaction to the site is very favorable. The design is clean, uncluttered and to the point, just what's needed by the average consumer.

Shire01 Since this is Shire's first attempt at such a site, a few suggestions are in order:

1. The search screen has four pull-down list boxes for Drug Name, Generic Name, Threapeutic Area and Disease State. Since it's possible to select an item from each of these lists, it is very likely that consumers will create combinations that don't make any sense. In such cases, the system will correctly return the message: "0 records found" and leave the consumer confused, dissatisfied or both. So, either make the pull-down lists context sensitive or allow them to search on one list at a time. A small instruction box next to the search function would also help. And, it would also be nice to have a "reset" button in case a consumer wishes to revise their search selections.

2. Clicking the "View Details" link on a search hit opens a study details screen. The most important part of this screen shows the study summary and gives a link to a PDF file giving a detailed exposition of the study. Unfortunately, the study summary simply repeats what the trial was about without giving any of the efficacy or safety results. For that, you have to open the PDF file and search within that for the results section. In addition, the results (once found) are in typical scientific jargon. So, two suggestions are in order: a. provide a plain-language study summary on the Details screen and b. provide a longer plain-language abstract of the whole study via a second link also on the Details screen. (N.B. - Yes, there are legal implications here, but not any that legal and regulatory counsel can't deal with.)

3. The Main Menu also provides a link to a Glossary of relevant terms. The Glossary itself is very nicely done. To make it more effective, it is suggested that a link from each trial Detail screen open a window showing a subset of the glossary relevant to the therapeutic area to which the drug belongs. This would be easy to do by simply adding another field to the Glossary database signifying the therapeutic area.

On the whole, congratulations to Shire for providing a simple but effective tool to consumers.

Wednesday, 13 February 2008 in 12 Case Studies, 35 Clinical Trials, 71 Public Relations, 72 Regulatory Affairs | Permalink | Comments (0) | TrackBack (0)

Pharma Marketing: Leveraging Healthcare Bloggers

A New Controversy in the Making

J&J seems to have unwittingly given birth to a new controversy by hosting a dinner for healthcare bloggers in Manhattan. As Steve Palter MD noted on his blog, "the big pharma folks are exploring the blogosphere and testing the waters before they tread deeply.  Their goal was to explore the medical blogging environment and garner information to help them decide how to get involved."

Unfortunately for J&J, since bloggers are not known for keeping things secret, the blog traffic started to mushroom immediately after the event.

Mind you, there is no evidence that J&J wanted to keep things secret. (See, this is exactly how innuendo works! You say something in complete innocence or on purpose and make trouble for someone else.)

So, what's the controversy? Well, it's the same as big bad pharma inviting doctors to dinner and influencing (read: buying) their prescribing habits. In this case, the danger is getting bloggers to say nice things about the biopharma companies and/or their products.

The reaction from the bloggers, those invited or not, were predictable.

Continue reading "Pharma Marketing: Leveraging Healthcare Bloggers" »

Tuesday, 27 March 2007 in 05 Industry Controversy, 45 Sales & Marketing, 70 Ethics and Compliance, 71 Public Relations | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: blogs, corporate responsibility, ethics, healthcare, JnJ, Johnson & Johnson, Laszlo Letter, marketing, public relations

Drug Prices and the Big Mac Index

Bigmac Is it just me or has media coverage of drug prices and reimportation from Canada cooled down in the past three months?

Perhaps our troubles in Iraq and the recent elections moved attention away from this key industry controversy. If so, let's hope it stays that way.

However, there is still a huge credibility problem for our industry that neither the drug companies or the PhRMA (or any other industry group around the world) has been able to blunt or reverse. I am not sure why very little change has taken place about the way we try to show the public that we're not an evil group of money grubbing capitalists.

So, here is one suggestion for reversing the bad reputation. Use the Economist magazine Big Mac Index to illustrate to the world why drug prices need to be different around the world.

The Big Max Index? What is that? Read on...

Continue reading "Drug Prices and the Big Mac Index" »

Sunday, 17 December 2006 in 05 Industry Controversy, 45 Sales & Marketing, 71 Public Relations | Permalink | Comments (0) | TrackBack (0)

Technorati Tags: Big Mac Index, Consumer Perception, Drug Prices, Laszlo Letter, Marketing, McDonalds, Public Relations, Reimportation, The Economist

Reader's Digest - A DTC Disaster in the Making?

Rdcover You never know when a connection will be made.

Recently, I started to follow a new series on Healthcare Communications by Mark Senak on his Eye on FDA blog. In his latest posting, Mark begins to discuss the curbs that may be placed on Direct-to-Consumer (DTC) advertising by the FDA. He states that "the sheer volume of the discussion around DTC almost guarantees some change."

A few days after reading this post, the September 2006 issue of Reader's Digest showed up in the mail. As usual, I flipped through the pages looking for the humorous pieces dotted throughout the magazine.

And then it hit me! The number of ads for prescription drugs was astounding. If Mark is right, Reader's Digest will be in big trouble if the DTC ads dry up.

Continue reading "Reader's Digest - A DTC Disaster in the Making?" »

Friday, 08 September 2006 in 05 Industry Controversy, 45 Sales & Marketing, 71 Public Relations, 72 Regulatory Affairs | Permalink | Comments (0) | TrackBack (0)

Using the Web for Public Relations

Novartis_4 With the reputation of the industry in decline, many pharma companies are starting to fight back.

This banner ad in the on-line edition of the Wall Street Journal is a good example.

Continue reading "Using the Web for Public Relations" »

Saturday, 10 June 2006 in 45 Sales & Marketing, 71 Public Relations | Permalink | Comments (1) | TrackBack (0)

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