The Laszlo Letter

Briefly Noted: IT articles in Contract Pharma

In case you are not a regular reader of Contract Pharma, I wanted to make you aware of three articles that appear in the March 2011 issue:

The first reviews the current market for Laboratory Information Systems (LIS) and their Electronic Lab Notebook cousins. The ability to share data via standard data models is discussed. The impact of outsourcing on LIS is also covered.

The second covers the importance of standards for data sharing. This time it's not about CDISC but the need for similar standards in the manufacturing and supply chain arena. Reference is made to the Pistoia Alliance;

The third discusses IT investments in the areas of drug discovery, drug development, supply chain and manufacturing and sales/marketing. Special focus is placed on the role of IT when operations are outsourced.

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.

 

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!

The Fortune Global 500 - Where is Pharma?

The July 24, 2006 issue of Fortune magazine lists the 500 largest global public companies. So, I was wondering how the pharmaceutical industry fares on this list. Perhaps you will find this interesting too.

Pfizer - Clinical Outsourcing Procurement

The May/June issue of American Pharmaceutical Outsourcing magazine ran an excellent case study from Pfizer, outlining the steps that this company has taken to improve the procurement process and the quality of the work received from selected vendors.

The authors, Adrian Otte and James Taylor, describe the Functional Service Provider (FSP) model, a unique set of characteristics expected from CROs, and the reverse auction process used to select them.

CRO's and Consultants Get No Respect

My friend, Mike Martorelli, poses an interesting question to the readers of the June 2006 issue of Contract Pharma magazine. To whit, "Do sponsors look to outsourcing providers for innovation? Or do they just want their CRO, laboratory, software provider, or instrument/reagent manufacturer to complete the specific task called for in a particular contract?"

Note: The article is not available on the web site. So if you don't subscribe to Contract Pharma, now may be a good time to sign up!

Clinical Trials Offshoring/Outsourcing

A recent article on the In-Pharma Technologist.com web site discusses the potential dangers of conducting clinical trials in countries (primarily India) that do not have either extensive experience with or sufficient regulatory oversight of such trials.

The somewhat alarmist tone of the lead sentence reads: "After recent allegations in the media that poor and illiterate patients in India are being used, often unknowingly, as human guinea pigs to test new drugs for the pharma giants of the West, Outsourcing-Pharma takes a look at how cutting the cost of clinical trials could put patient lives at risk and do more harm than good for PR-savvy pharma firms."

India for Outsourcing

The blog Biopeer has posted an article about outsourcing to India and the new phenomenon of Indian pharma companies going off-shore themselves. Just when you thought that you found the cheapest place to do business, another place pops up that can do it for even less or cost more but add more value.