The Laszlo Letter

Lilly: Implementing SAS Drug Development

Notes from the 23rd DIA CDM Conference

Susan Duke of GSK chaired a session on Tuesday, March 18th, called "Statistical Computing Environments: Collaboration through Metadata, People, Process and Software." During this session, Christopher Colangelo, Associate Senior Statistician, presented Eli Lilly's effort to implement SAS Drug Development (SDD) as a centralized but globally available repository for clinical data.

But first, and for those unfamiliar with this relatively new concept, a Statistical Computing Environment (SCE) is a combination of hardware, software and processes, that enable the collection, management, analysis, and transparency of operational data within a life sciences environment performed in compliance with government regulations and operating best practices. From a technical perspective, it is also an extension of a relatively new software category called "Clinical Data Repository" or CDR.

You can learn more about both SCE and CDR via the following posts on this web site:

• Clinical Data Repository (CDR) 101
• Clinical Data Repository (CDR) Vendors
• Of CDR, CDMS and EDC
• The EDC, CTMS, CDM Confusion
• DIA Reflections: The Importance of Semantics
• Genzyme: Biostatistics with Waban SCE

At Lilly, the selection of SDD arose from the recognition that internal staff in Data Management, Data Delivery, Statistics, Medical Communications and external partners such as CROs needed an environment that would allow for greater collaboration within a secure environment.

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.

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.

Genzyme: Biostatistics with Waban SCE

A few posts ago you heard me rant about the inexplicable secrecy that tends to surround large biopharma IT projects. So, it's with great pleasure that I can report that not all biopharma companies wish to keep everything to themselves.

Specifically, I want to draw your attention to a recent article in eCliniqua and Bio-IT World related to Genzyme's implementation and use of the Waban Statistical Computing Environment (SCE.)

As you will learn from the article, “Waban offers a completely controlled environment where everything done to data is audit-trailed, including when information gets handed off from clinical data management to biostatistics and from biostatisticians to medical writers,” says Dana Soloff (Genzyme’s director of statistical programming.)

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.

First, let's BILL all the lawyers!

OK, I couldn't help it. I just had to edit that famous quote from Shakespeare. Why? Because this post is all about software that can help lawyers bill other lawyers for the services they provide.

In particular, I wanted to highlight two case studies (J&J and Merck) discussing how in-house counsel can make use of software for processing invoices received from outside counsel. Both of these come from the software vendor DataCert based in Houston, Texas and London, England.

The product highlighted is called Advanced Invoice Management System (AIMS) and was implemented by J&J and Merck in the past four years.

Bridging Pharma and IT

"The beatings will continue until morale improves!"

I was reminded of this quote on receiving a brochure from Cambridge Healthtech Institute (CHI) promoting their upcoming "3rd Annual Bridging Pharma and IT" conference. For those who are interested, the meeting will be held in Boston from September 30 to October 2, 2007.

The quote popped into my head after a momentary feeling of dismay that after 20-30 years of discussion this "bridge" has still to be completed. Apparently there has been much talk and little action. Or perhaps, more correctly, very little effective action.

And so, we continue to "beat" the issue in hopes of positive progress. I'd like to suggest, however, that a different approach is needed. Perhaps one that does not require bridges at all.

But first, let me give you my take on this conference.

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."

Roche, Serono & Sigma - HR e-Recruiting

Recruiting, hiring and keeping great talent is probably the most important activity that any company must perform. In Life Sciences, the competition for great talent is a consistent issue. All the more reason that information technology should be leveraged to create an environment that a. removes as much friction from the employment life cycle as possible and b. leverages data about potential and actual employees in support of corporate objectives.

Now, from Taleo, come three case studies describing the Roche Global Talent Sourcing Project, the Serono Staffing Solution and the Sigma e-Recruiting initiative. All three use software solutions from Taleo. Happily, Taleo has earned a top position in Gartner's Magic Quadrant for e-recruitment software (click on the diagram above for a larger view).

IMS Health - Sales Force Effectiveness with BI

My last post focused on the AstraZeneca "Zubillaga" affair. If you recall, Mr. Zubillaga was fired after his crass remarks about physicians offices were made public in the blogosphere.

What was not questioned by anyone, however, was whether what he said is actually true or not. In particular, can the following statement be taken at face value?

"The more times you are in [the doctors office], the more money goes in your pocket."

As a recent article by Chris Nickum of IMS Health nicely illustrates, making frequent calls on physicians does not necessarily translate into increased revenues.

It seems that working smarter (by using business intelligence) is better than working harder.

EDC Implementation Case Studies

EDC adoption continues to move ahead at a pace slightly faster than in 2004-2005. In 2007, expect a handful of large and medium size life sciences firms to select an enterprise EDC vendor and possibly make a move to implement an enterprise approach as well. (Note: These ARE two different issues.)

Also in 2007 and into 2008, expect EDC vendors to push hard on the potential to displace Clinical Data Management (CDM) systems. However, the complete vision will continue to be elusive unless companies come to terms with a global, enterprise-wide clinical data repository solution. Stay tuned for more on this topic.

In the meantime, here is a list of case studies related to EDC. Almost all of them were created in 2006. I will add more case studies as time allows.