Time for Resurrection

Dear Reader,

After much thought, I have decided to re-start The Laszlo Letter. Since I last wrote roughly 1 year ago, my business and personal interests have changed and evolved a lot. With this blog already in place, I thought it best to simply change direction here rather than start an entirely new blog.

While I am still very much interested in Life Sciences and the impact that information technology can have in that space, I am also interested in the broader Healthcare arena. For various and sundry reasons, I have also become interested in the worldwide taxi and limousine business and continue to enjoy my hobbies of travel and photography. Once in a while, I also get turned on (i.e. aggravated, upset, disgusted) by things that are going on in the world or in my own back yard.

So, the NEW Laszlo Letter will cover all of these topics. I realize that some of you will drop out, some will stick around and some new readers will also show up. I will keep writing as long as there are readers or until it's no longer fun.

So, stay tuned for my first entry and a somewhat revised look and feel for the site. Since many people find what I have written in the past to be of value, I will leave it here for posterity.

Thanks for dropping by,

George


About (the future of) this blog

As a lot of you have noticed, I have not created any new posts on this site since February, 2012.

The reason for this inactivity is fairly simple. My own interests have changed and I find myself spending most of my time on things that have nothing to do with my career in the Pharmaceutical / Biotech sector.

All of us experience transitions in life; some that are imposed on us and some that we choose to make ourselves. Luckily, I have been able to control my fate in most cases, including my decision to explore opportunities outside of our industry. Because I do not want to bore you with those details, suffice it to say that I need to cut back (drastically) with my contributions to this web site.

I have considered taking down the site entirely but have decided against this since a lot of people still find the content that is already here of continuing value. And who knows? I may decide at some point in the future to refocus my energies on this always fascinating and controversial industry.

Finally, I want to thank all of you (who have followed this site and/or have commented on what has been written here) for reading my opinions. I truly hope that they have made a difference.

Sincerely,

George

 


Roche to implement Google Apps for 90,000 employees

You are probably aware by now that Roche has made a deal to roll out Google Apps on a global basis. This was reported by many news organizations and bloggers. One that is quite interesting, however, is on ZDNet since it generated quite a bit of heated discussion.

The rationale for this important move has to do with interoperability issues, or lack thereof, between the two solutions used previously by Roche and Genentech. This is stated by Roche CIO, Alan Hippe, on Google's Official Enterprise blog.

Reactions to the announcement focused on three issues:

1. Data Security

2. Data Privacy

3. Usability

In particular, comments pointed out security flaws in Google Apps, the probability that Google would inappropriately mine the Roche data/documents for their own purposes, and that users would get a much weaker set of email and MS Office-like functions.

These concerns may be real but also show that the commentators do not know how Roche operates. First, nothing at Roche is done in haste or without due diligence. The type of questions raised by those reacting to a press release would have already been studied to death by Roche staff and made available to senior management including risk, QA, procurement and legal staff. The decision would not have been made without Google agreeing to a detailed set of system requirements and the contract no doubt contains an equally strong Service Level Agreement (SLA). There would also be strict controls on privacy and security including what Google could or could not do with the data. Indeed, it is likely that the only thing Google will be able to do with Roche data is to provide appropriate technical support. And yes, it is also likely that an agreement is in place to govern how data moves (or not) between borders.

Then there is the rollout. Although I have worked quite closely with Roche IT on application implementations in the past, I am not privy to the way Google Apps will be rolled out. What I can predict is that it won't be done on a one-shot basis. One probable scenario (given what Dr. Hippe has stated) is for the email and calendaring functions to be rolled out first and even that in a phased manner to the 140 countries where Roche operates. It will probably start with the USA and Switzerland, then the UK, followed by the rest of Europe. Other regions would follow with double-bite countries like Japan going last.

You can then expect word processing, presentation and spreadsheet functions to follow. However, I would be willing to bet that other collaboration features (e.g. blogging, social networking) may come out before or in parallel with the more traditional office functions.

Although Roche and Google maintained radio silence on the current systems, it does not take a genious to see that Microsoft is in jeopardy at Roche. Given that this industry tends to follow the leader, Microsoft may suffer the fate of Blackberry in the biopharma sector. You may be elated or deflated by the prospect.


IT Trends for 2012 by SAFE-BioPharma

The following was recently released by the SAFE-BioPharma Association. Although the IT trends they cite may be on the adoption curve, it is not clear how long the adoption will take. As with almost anything in our industry, don't expect it to happen overnight.

THREE MAJOR IT TRENDS WILL SHAPE LIFE SCIENCES IN 2012

Fort Lee, NJ (January 19, 2012) -- Three trends will shape the life sciences in 2012, according to an analysis by SAFE-BioPharma Association. They are the expanded use of standards-based interoperable digital identities, cloud computing in clinical trials, and the use of electronic trial master files for clinical trial management.

1. STANDARDS-BASED INTEROPERABLE DIGITAL IDENTITIES

Industry leaders are rapidly increasing use of these unique digital identities among employees, collaborators, and clinical investigators. Issued once every three years, they take the place of multiple on line identities and can be used to control access to information and physical facilities. They also provide the ability to apply legally-binding digital signatures to electronic documents. The benefit of interoperability is that the digital identity is recognized and accepted by US government agencies, by other companies [broken sentence]

2. CLOUD COMPUTING IN CLINICAL TRIALS

As demonstrated in a study between the National Cancer Institute and company-based cancer researchers, significant time and cost savings are realized when trial-related documents are accessed from the cloud rather than delivered by courier or mail. Interoperable digital identities (NCI researchers using government provided digital credentials; company researchers using SAFE-BioPharma digital credentials) give researchers access to the cloud-based electronic documents as well as the capability to apply legally-binding digital signatures.

3. ELECTRONIC TRIAL MASTER FILES

“Trial Master Files – the central record containing the files associated with clinical trials – are one of the last areas where clinical development records are primarily paper-based,” explains Mollie Shields-Uehling, president and CEO, SAFE-BioPharma Association, Multiple pilot studies scheduled to start in the next few months indicate that pharmaceutical companies are preparing to make the process electronic. Companies will use SAFE-BioPharma digital identities to manage access to documents and to provide participants with the ability to apply legally-binding digital signatures.

The global SAFE-BioPharma digital identity and digital signature standard is used throughout the biopharmaceutical and healthcare communities to meet specific security and confidentiality needs. It was created with participation from the US Food and Drug Administration and the European Medicines Agency. The standard and its ongoing development is managed by SAFE-BioPharma Association, a non-profit supported by its members. For more information visit http://www.safe-biopharma.org.


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


What's Wrong With EMRs

Short Rant

Cart-horse

The following is a quote from a recent article by Guy Boulton of the Milwaukee Journal Sentinel newspaper. Read it and weep.

Hundreds Of Physicians At ProHealth Care Hospitals Switching To EMR.

"In the next year, several hundred physicians who practice at ProHealth Care's hospitals in Waukesha and Oconomowoc will move from paper to electronic medical records [EMR], enabling them to improve the coordination and quality of care for patients." These "physicians will lease software that ProHealth uses at its hospitals and clinics." This "will allow the doctors to work from a single medical record on a central database, as opposed to each practice buying different software with little or no ability to share information."

Bold and italics above were inserted by me.

On the surface, one would be happy to read that more physicians and practices are finaly adopting EMR's. Unfortunately, the last sentence in the quote points to a serious problem with EMR adoption, namely the lack of data interchange standards. More specifically, the legislation that is busy throwing billions of tax dollars at healthcare providers for 'meaningful use' of EMRs does not also put a strict requirement on interoperability. Thus, we have hundreds of software companies and service providers who are competing for the EMR business but have little inclination or incentive to focus on the ubiquitous exchange of the data being collected. So, as more and more practices/hospitals implement EMR systems, the problem is going to snowball and the promise of electronic health records will not be met. 

Message to Obama and the Administration: A focus on data exchange standards should be the #1 priority for meaningful use. Throwing money at adoption is putting the cart before the horse. Change it now or wait for inevitable failure.


Reward Yourself. Make a Donation to Wikipedia

If you've connected Wikipedia at any time over the past two months, you know that they have been asking people to donate money so they can keep the site up and running. This is one of the few really useful web sites out there that don't rely at all on advertising.

So, today and tomorrow are the last two days when you can make a tax deductible contribution.

Click HERE to go to their site.

DO IT. You'll feel really good as soon as you click that payment button.

Happy New Year

George


Change of Direction for 2012

As you all know, the focus of this web site has been on leveraging information technology in the service of R&D. While there is plenty to talk about on this topic, I have been getting more and more frustrated with other aspects of our industry. Specifically, I am extremely upset and frustrated with politicians, pundits, corporate executives and (sometimes) mere employees who are actively undermining and possibly trying to destroy one of the most successful and useful industries on the planet. So, in 2012 you will be subjected to my opinions on any topic/issue that I feel may undermine the continued success of the biopharma sector. Of course, I will still talk about IT matters.

So, get ready!

As a line in one of my favorite movies goes: I'm mad as hell and I'm not going to take it anymore.


Site Back Up - Sorry About That!

I only learned today that anyone trying to get here was being redirected to the BLOGBAR web site. After contacting my blog provider, TypePad, I was told that the problem is being caused by a widget that I used on this site. That widget was provided by Blogbar! So, I removed the Blogbar widget and we are now back in business.

A special thanks goes out to my good friend in Massachusets who brought this problem to my attention.


Civil War 2.0 - The 'Haves' vs. the 'Have-nots'

Until now, I have refrained from stating my political and societal views on this site. There is, however, a disturbing trend gaining steam in the United States (and to a lesser extent in the rest of the developed world) that all of us should be aware of and (through careful consideration) guide our actions as citizens of this great country.

The trend I am speaking of is the expanding chasm between the economic upper class and those in the middle or lower classes. I was reminded of this again through an article by Joseph Stiglitz in the May issue of Vanity Fair. The title of the article was "Of the 1%, by the 1%, for the 1%" and was neatly buried on page 126. Even the editors of Vanity Fair felt that Rob Lowe, Golman Sachs and the Royal Wedding deserved more attention.

The title of the article is both catchy and correct. When 1% of the population is pulling in 1/4 of total income every year and has 40% of the total wealth of the country, you know that something is out of balance. You could argue that this is OK as long as the rest of the populace is also benefiting from an upward income and wealth trend. Unfortunately just the opposite is the case and has been so for years.

Although most of us working in the biopharmaceutical industry have been quite fortunate to make a comfortable middle class living, the trend is not headed in the right direction for us either. Witness the latest headline on the on-line CBS Interactive Business Network (BNET): "Teva Merger: Cephalon CEO Gets $5M for 3 Months’ Work; Staff Gets Layoffs."

In the latter article, we learn exactly what the headline says (i.e. CEO walks away with $5 million) and what is also implied (i.e. that layoffs are expected to save $500 million within 3 years). Although Teva is a first rate company and certainly better run than Cephalon, the layoffs from the merger are inevitable. Personally, I am not upset about the $5 million payoff even if Cephalon's President is getting it after only 4 months on the job. After all, we all would love to be in his position. Unfortunately, those getting laid off are in for a great deal of anxiety given current market conditions.

Disclaimer: I have personally done work for Teva in the past and completed a small engagement for them just this year.

 As for the Stiglitz article, what cought my eye was the following penultimate paragraph:

"Alexis de Tocqueville once described what he saw as a chief part of the peculiar genius of American society—something he called “self-interest properly understood.” The last two words were the key. Everyone possesses self-interest in a narrow sense: I want what’s good for me right now! Self-interest “properly understood” is different. It means appreciating that paying attention to everyone else’s self-interest—in other words, the common welfare—is in fact a precondition for one’s own ultimate well-being. Tocqueville was not suggesting that there was anything noble or idealistic about this outlook—in fact, he was suggesting the opposite. It was a mark of American pragmatism. Those canny Americans understood a basic fact: looking out for the other guy isn’t just good for the soul—it’s good for business."

In short, it is natural as one gets richer and richer to have less and less empathy for your fellow man. The rationalisation goes something like this: "I worked hard to become successful. If the guy next door could not do the same, that's his problem." It is thus up to our government to recognize that hubris and arrogance must be held in check using legislative means and via social programs that adequately balance capitalism with the social good.

Given the current political climate I fear that not much progress will be made on this front in the coming years. And certainly not if Obama is defeated in 2012. So take heed, just as we now clearly know that our first Civil War was an economic vs. human rights issue pitting north versus south, if the gap between the rich and not-so rich widens further, our next Civil War will be a lot messier and will pit the 'haves' vs. the 'have-nots.'