The Laszlo Letter

Hidden Gold Nuggets: Pfizer's Progress in Drug Development

I continue to be amazed by the number of great articles that do not get enough exposure. The key reason is that they are trapped in specific publications that you may never see or even know exist.

I was reminded of this again when opening my latest copy of 'Pharmaceutical Outsourcing' magazine. In this October 2010 issue I ran across an article by Chris Hilton of Pfizer, giving a great summary of the work being done by its Development Operations group.

As you may imagine, a significant part of the article focuses on Pfizer's growing and greater reliance on outsourcing. For example, the article states that in the past 5 to 7 years, the number of internal staff performing such functions like monitoring, data management and clinical programming has dropped from about 3,000 to 400 [no, this is not a typo].

At the same time, the number of external colleagues has gone up from roughly 100 to 2,400, most working for a group of 20 CRO's.

Doing some simple math got me to conclude that the total number of workers has stayed about the same. Of course, I don't know what is really going on here and one would need to ask the author what is behind the numbers. For example, are more studies being done by fewer people? Did the types of work being done change in any significant way? To what extent are technologies used affecting staffing?

Some other interesting facts (gold nuggets) noted in the article are:

• Year after year, the Last Patient Last Visit (LPLV) to Database Release time interval continues to drop
• The number of days from database lock to final CSR has dropped from 200 to 80 days.
• 1.2 databases are locked each day
• Reduction in cycle times ranging from 39% to >60% in several trial processes like Clinical Study Report completion and Protocol Development

 It is not my intention to review the whole article here. The best would be for you to read the whole thing and learn about other practices at Pfizer such as Functional Service Provider use, Reverse Auction Process, Continuous Improvement, Optimized Monitoring and Lean Six Sigma.

Read It! You won't be disappointed.

 

Leveraging social media by biopharma

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.

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).