The Laszlo Letter

Patient (Self)Recruitment

Notes from the 23^rd DIA CDM conference

Sometimes we tend to forget that everything we do is for the patient.

I was reminded of this when listening to a talk by Laura Esserman of the University of California Medical Center at San Francisco. Dr. Esserman described her clinical work in the area of breast cancer and the recognition that patients themselves could be the source for electronic health records (EHR). Once collected, these records could be used to match patients to clinical trials. In other words, the EHR becomes the source of data for patient recruitment.

2008: IT budgets to fall?

If the pundits are right, IT budgets will be smaller next year. Or, to put it more correctly, the percent increase for 2008 over 2007 will be less than the percent increase for 2007 over 2006. Are you still with me?

As an example, take the recent article by John Soat of Information Week, who cites two separate surveys involving CIOs. Both predict smaller budget increases for 2008. Mind you, this is across all industries and it's not clear what will happen in the Biopharma sector.

We can guess, however, that based on the somewhat dismal performance of most pharma and some biotech companies, CEOs will be looking for savings wherever they can be found. And that includes IT.

From my perspective, this is quite unfortunate since I am convinced that our industry has squandered countless opportunities to leverage information technologies to improve both day-to-day operations and improve the R&D pipeline. If you want examples, I'll give you several:

• document management and electronic publishing
• data management and exploration
• electronic data collection (EDC)
• clinical trial management
• master data management

Now, you may be saying: "Is this guy nuts? These are the areas where we have made the most progress!"

And no, I'm not nuts. These are great examples where lots of time and money have been wasted or investments underperformed. Despite glowing reports at DIA meetings and other venues, the reality is that we still don't know how to properly leverage IT.

I'll offer just a few reasons why our IT dollars/euros don't get us the returns we need:

1. Lack of resolve and leadership to change course;
2. Continued disconnect between the business community and the IT organization;
3. Missing or half-baked strategy for improving productivity;
4. Cowardly management disguised as management by consensus;
5. Focus on regulatory compliance rather than operating efficiency;
6. Failure to create a learning and innovative organization;
7. Over-reliance on selecting technology rather than setting strategy that drives technology.

So, it's possible that we don't actually need to increase the IT budget. Maybe it would be enough to just stop wasting it.

Pfizer: Irrational EXUBERAnce

The other shoe has dropped!

Pfizer has decided to stop selling Exubera, it's highly self-touted inhalable insulin product. As you have read here before, Exubera may be a technical breakthrough but it's also one without a proven benefit to the consumer. For whatever reason, management at both Nektar (the developer of the inhaler) and Pfizer got too enamored about the technology and chose to put their head in the sand about market demand and acceptance for such a product.

The consequences are devastating for both companies financially and highly damaging to their reputations as both researchers and marketers. On the financial front, Pfizer is taking a $2.8 billion pretax writedown. This, in light of blockbuster sales projections of $2 billion per year and an actual performance of just $12 million.

Biopharm IT Leaders - The Infoweek 500

The 19th Annual Information Week 500 list has been published.

Here, we will only concentrate on the Biotechnology and Pharmaceutical companies that made the list.

As the publication states, "to be ranked, companies with at least $500 million in annual revenue are asked to complete a qualifying application that examines business technology strategies. The application contains a quantitative section on technology initiatives and priorities, and a qualitative section of essay questions. The responses to these two sections are evaluated, weighted, and combined into a total score to rank the companies."

The following Biotech and Pharma companies made the list:

• BD Biosciences
• Beckman Coulter
• Eli Lilly
• Genzyme
• GSK
• Merck
• Pfizer
• Roche Diagnostics
• Schering Plough
• Solvay
• Thermo Fisher Scientific
• Wyeth

Of these, only three made it into the top 250 list. These are:

• Eli Lilly - #50
• Wyeth - #59
• Roche Diagnostics - #231

Read on to learn a bit more...

Leadership - The Fortune Rankings

Under the heading "Leader Machines", the October 1, 2007 issue of Fortune magazine listed the top companies around the world where leadership is taken seriously.

Although no Life Sciences companies made it into the Top 10, there were three in the Top 20:

• #12 - Medtronic
• #13 - Eli Lilly
• #17 - Glaxo SmithKline

So why, exactly, did these three companies make the list?

Merck - The Born Again Pharma Giant

It should come as no surprise that people are moved to action only when tragedy strikes.

Such is the case with Merck, a company that for years lived in a cocoon of complacency. Yes, this was a much admired company that had a right to boast of its research and marketing muscle. As it often happens, inertia set in and it became easier to go with the status quo rather than seek continuous improvement. The latter, of course, requires being honest with yourself

Now, following the Vioxx debacle, Merck seems to have woken up. It is taking steps that should have been taken in any case. What I'm suggesting, of course, is that Merck had problems wholly unrelated to Vioxx that needed fixing.

Witness the latest article in Business Week, wherein CEO Richard Clark confesses to the inertia noted above. Here is just one quote from that article:

"Clark had watched the company degenerate into a collection of fiefdoms more focused on advancing their own agendas than on getting the right drugs to patients."

The Apple iPhone SFA Solution

Let's face it. SFA has always been the perennial under-performer in our industry.

Sales Force Automation vendors have always oversold the benefits to be gained from their systems and the buyers have never come to terms with the real needs of the sales force or what can reasonably be expected from it.

Thus, we need to recognize that technology by itself will not solve these problems. Having said that, and as exemplified by the iPhone introduction by Apple, our ability to tackle them can be greatly simplified by such newer technologies.

Note: Photo is the copyright of Apple, Inc.

Is It Time for ISLN?

Those of you who are familiar with the publication Drug Discovery News, may have noticed a simple but highly effective number at the end of each article.

This number (e.g. E120608) is a printed ID number that allows you to go directly to the electronic version of the printed article on the Drug Discovery News web site. They call it EditConnect. I call it brilliant!

So, I got to thinking, is it not time for everyone to do this? Is it not time for ISLN, the International Standard Link Number?

2007 IT Resolutions for CIOs

On this first day of 2007, I'd like to suggest a few resolutions for potential adoption by CIOs within the life sciences industry.

While there's a laundry list needing the undivided attention of anyone trying to do IT right, the following three top my concerns:

1. Changing the Operating Model of IT
2. Consolidating IT Assets
3. Adopting a Holistic Approach to IT

Each of these deserve lots of scrutiny and discussion followed by action. It is not my intention, however, to belabor any one of these. I will be happy if you simply give these serious consideration and then take steps to make things happen.

So, fasten your seat belts and read on...

Note to Jeffrey B. Kindler: Take Pfizer Private

Wall Street pundits began to question whether Jeffrey Kindler was the right guy to run Pfizer no sooner than it announced the halt of all torcetrapib trials.

Perhaps I'm missing something. I was under the impression that getting a drug out of the lab and through clinical trials takes a bit longer than six months*. So, in what way can Mr. Kindler be held responsible for the failure of this compound?

Is he to blame since he is a lawyer and not a scientist? Is he to blame because he is part of the collective management group within a very large pharma company? Is he to blame bacause he did not demand more input from his management team?

These questions, of course, don't make sense.

So, what is a company like Pfizer to do when the short term mentality of the investors is at odds with the long term reality of drug discovery and development?

I say, it's time to take Pfizer private. After all, the energy it takes to keep the investors happy is a huge distraction at best and leads to bad strategic decisions at worst.

Am I off base? Let me know what you think.

* - Note: Jeffrey Kindler was named President of Pfizer on July 28, 2006