The Laszlo Letter

DIA Euromeeting: Impressions and Recommendations

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!

Big Brother has arrived

While I can see lots of great legitimate uses for a product of this sort, it's focus on surveillance reminds me of the adage "throwing the baby out with the bath water." In this case, we potentially make a lot of people suffer from the unwanted actions of a few. Strictly my opinion, of course. What do you think?

If you are interested to know what Spector 360 is all about, read on...

AstraZeneca and Corporate Responsibility

In case you have not yet heard, Peter Rost recently broke a story about Mike Zubillaga of AstraZeneca (AZ), who was quoted in an internal newsletter saying the following:

"There is a big bucket of money sitting in every office. Every time you go in, you reach your hand in the bucket and grab a handful. The more times you are in, the more money goes in your pocket. Every time you make a call, you are looking to make more money."

Mr. Zubillaga, was regional sales director for oncology in the Mid-Atlantic region. He was fired by AZ soon after the newsletter was leaked to Peter Rost by an AZ employee.

AstraZeneca spokeswoman Kirsten Evraire, in a reply to inquiries by the Pharmalot web site, said the following:

"...Our company is disturbed by the content and particularly concerned about the impact the content of this unapproved newsletter may have on our employees and others. In addition, we are concerned that a manager in our sales organization used this vehicle to communicate messages that directly contravene our core values as a responsible pharmaceutical company.

Our investigation into the development and distribution of this newsletter continues, in an effort to determine whether our current policies and procedures regarding AstraZeneca communications are being adhered to by employees..."

So, once more we are back to the issue of corporate responsibility. In particular, we need to modify Ms. Evraire's comment by suggesting that they not only look into whether their policies and procedures are being adhered to but whether the policies and procedures themselves are sufficient.

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.

Technological Obsolescence and Electronic Discovery

The Federal Rules of Civil Procedure were amended last year to reflect the growth of electronically stored information. This, of course, means that whenever legal discovery comes into play, companies and individuals will need to find and turn over such electronic information.

The rules now cover all sorts of electronic files (see the list below) that are created or received in the normal course of business.

The rules also state that:

1. information that is deemed "inaccessible" may not need to be produced and
2. parties may be given "safe harbor" (i.e. you are off the hook) if information is inadvertently lost provided that it happens during routine operations

So what exactly is the impact of these rules on a business and especially on the effects of software and hardware obsolescence?

Computer Systems Validation (CSV) and Virtualization

You've been there before. You have been asked to implement a new system (say, electronic publishing or EDC) and you know you can't do it without validating the whole thing.

So, you will need to create three separate environments: Development, Test and Production and make sure that the master validation plan (MVP) gives proper attention to each.

You put together the budget and make sure that hardware and software are ordered to support all three environments. You then finalize the project plan, being very careful to assure that all of the disparate activities required to design, develop, test, validate and roll out the system are done in the most efficient way possible. Not an easy undertaking!

So, is there are better or easier way?

Yes. It's called Virtualization.

The Guidant Potboiler

While I think that Forbes typically does a better job covering the biopharm industry, Fortune also comes through with flying colors once in a while. The October 5th issue is a good example of that with an article called "The (Second) Worst Deal Ever."

Reminding me of many exciting encounters with books of the "who done it?" genre, the article by Shawn Tully recounts the fight for Guidant between J&J and Boston Scientific and the important role played by Abbott.

Security Issues in Life Sciences

One of my goals for this web site, is to make you aware of quality work done by others in or for our industry. In many cases, this work comes from vendors who provide solutions and/or services to the industry. The study that I am highlighting in this post comes from the consulting firm Deloitte Touche Tohmatsu.

The study is titled "2006 Global Security Study: A Global Perspective on Security for Life Sciences." Click here to get to the Adobe PDF version of this study on the Deloitte web site.

Before delving deeper into the findings of this study, I'd like to commend Deloitte for doing this work and promising (hoping?) to do it every year. There is no denying that the consulting business has been getting tougher in the past few years (we'll talk about that another time) and a clear casualty of this are projects of this nature. When revenues are flowing nicely, such projects get done. When revenues slow, the projects get cut.

Now on to the security study.

Monitoring Employee's Computers

The September 11th issue of the Wall Street Journal carried an article titled "At Many Companies, Hunt for Leakers Expands Arsenal of Monitoring Tactics." What caught my eye were the two lead paragraphs which I reproduce here verbatim:

"Tom Bowers, a security manager for a big pharmaceutical company, got a tip earlier this year that an employee had accessed sensitive drug data for which she didn't have clearance.

Mr. Bowers searched the employee's computer, using recently purchased software that tracks file transfers and Internet use. He found she had sent confidential drug-manufacturing data outside the company. The employee was fired. "We have suspected for a long time that this type of activity was going on, but [until buying the software] we had no way to track it," Mr. Bowers says."

In case you are surprised that this type of monitoring goes on, don't be. And, expect more of it.

FDA Seeks Input on Establishment Registration & Listing

Warning: This is going to be a really long posting! But, it's important.

On August 23rd, the FDA issued a proposed rule to make managing drug information more efficient and effective by automating the process by which drug firms register themselves and list their products with FDA.

With this issuance, the FDA is seeking input by those potentially affected by the proposed rule.

In my estimation, if enacted as described in the Federal Register, the rule will place a significant operating and financial burden on each and every company that manufactures and distributes drugs and biologics.

In addition, the proposed rule has significant implications on existing and future IT systems and applications.

So, now is your chance to affect this piece of legislation or be forced to swallow it whole. You have until November 20th to submit your comments.