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.

R&D - The need for accountability. Pfizer weighs in again.

Matthew Herper of Forbes magazine wrote a review of a press conference held by Ian Read, the new CEO of Pfizer. Of interest to me was the following paragraph:

"One of the main goals of the changes is to try and prevent any repeat of Pfizer’s disastrous investment in Exubera, the inhaled insulin, which the company spent years developing before it hit the market and bombed. Without accountability, Read says, projects were handed off from one team to the next without demands that they actually be ready. 'You get the transfer from one stage to the next stage, always investing in hope rather than strong clarity of signals and clarity of medicine and clarity of mechanism.'"

While I continue to fault Pfizer for their lack of imagination when it comes to R&D, this statement is right on.

Some of you may have read my point of view on the Exubera debacle on this web site. Mr. Read seems to understand that once a project takes on a life of its own within the R&D pipeline it is nearly impossible to stop it.

Why is this the case? Because pharmaceutical firms have gotten so specialized and compartmentilized that people are simply completing the work assigned to them without seeing the big picture. It seems that even Lifecycle Teams are not able to complete a holistic review of a drug candidate. The stakeholders are simply focusing on getting their part of the work done right and on time and are rewarded for doing so. If the incentives are not based on team success then the chances of getting a compound on the market are significantly reduced. This is where the idea of accountability comes in and was highlighted by Mr. Read.

Now, Mr. Read's observation is not original. We have heard many times about the need to "fail early." Unfortunately, the acceptance of failure and the possibility of being rewarded for it has not really become a visceral behavior at most companies. Perhaps Mr. Read will take steps that will make this happen at Pfizer. If that happens others are sure to follow.


R&D - No longer untouchable! Pfizer gets the ball rolling.

The other shoe has dropped.

For many years now we have seen pharmaceutical and biotech companies lay off lots of people. With every layoff, however, we have seen a stated commitment to keep R&D untouchable. NO MORE!

The world's largest company, Pfizer, has kicked a small snowball down the mountain. It will now turn into an avalanche. Given that our industry has a herd mentality, the Pfizer action will now give every large and medium size pharma firm the excuse to jump on the bandwagon. It's unfortunate and deplorable. Management has a lack of imagination as made evident by other stated intentions like a new focus on drug targets that are more profitable. Now, if everyone just pays attention to what's more profitable, then how exactly will they all profit? Warning bells should be going off in the minds of employees and investors alike when statements like this are made.

Pity the countless staff at Pfizer's Sandwich, UK facility who will either have to relocate (at best) or lose their jobs (at worst). What will they do next? What will this move mean to the entire economy of the region? 

Is this the only way this industry can save itself? Something is wrong with this picture.

R&D is dead! Long live R&D.

Are clinical trial results all wrong?

And what to do about it if it's true.

One would not normally consult the New Yorker magazine about the scientific method, but a recent article in that publication makes it necessary that we do just that.

In short, this article concludes that most of the controlled clinical trials that have been performed and used to get medical treatments on the market had (and will continue to have) false results.

Now, read that again and let it sink in!

Since we have learned to be paranoid about the integrity of what we do in this industry, it would be natural to think that this claim must be based on evidence that the studies have been rigged. This is not the case. Rather, the various individuals cited in the article claim that it's simply human nature that leads us to reach the results that we wish to reach and that we actually use the scientific method to help us get there.

Now, it's not my objective to summarize or rehash what's in this article. You are perfectly capable of doing that yourself. Rather, I want to share with you my ideas on the ramifications of the core finding of the article. Let me repeat those here in my own words:

  1. It is nearly impossible to come up with a truly objective scientific study design;
  2. It is human nature to (unknowingly) design the study to prove what we wish to prove;
  3. We use scientific tools and techniques to fool ourselves that we are being objective;
  4. We do this all with good intentions (most of the time); and
  5. Other scientists reproduce the false results for the same reasons (see 1 - 4)

If we take all of this at face value, we would need to ask why we continue to design and run controlled clinical trials. Of course, we know that this is what the regulators (i.e. FDA, EMEA) want. Since the regulators are not necessarily smarter than the sponsor's scientific staff or, for that matter, the experts that they call on to pass judgment on marketing submissions, we need to conclude that everyone pretty much has deep faith in the current and accepted methods we use to carry out these trials. Based on this article, we thus need to also conclude that all of these people are wrong!

At this point, you may ask yourself "What is this guy talking about? He must be an idiot!" If you think this, it means that you have not yet read the article (see link above.)

Personally, I found this article to be quite disturbing. After reading it, I could have done one of two things: 1. Put my head in the sand and pretend that I never read it; or 2. Bring it to your attention to give the claims more visibility and lead to its evaluation by our industry as a whole.

Now for the good news:

If we can accept the hypothesis and the evidence presented that it's inevitable that the results of clinical trials are normally false, we can move on to a few ideas that may help get past this problem. Here are the ones that I have formulated:

  1. Continue to design and execute controlled trials but strictly limit the number of them required to gain marketing authorization;
  2. For the trials that remain, focus primarily on safety and less so on efficacy;
  3. Allow for adaptive study design for Phase II and III studies;
  4. Provide marketing authorization earlier for the claimed indication;
  5. Require rigorous follow-up of the actual patient population receiving the treatment including the analysis and reporting of pooled data;
  6. Require the reporting of outcomes to show both safety and efficacy in the actual patient population;
  7. Over time, allow outcomes from different treatments to determine whether a drug stays on the market and/or ascertain its cost/benefit value to society

Does any of this sound familiar? The answer is yes. It's just that we now have even more reason to do it.


Software for Clinical Development - 2011 Edition

It's finally here!

The 2011 edition of Software for Clinical Development is now available and it's still FREE.

Download 2011-ClinDevSoftware-LaszloLetter.

As before, this comprehensive guide comes to you as an MS Excel spreadsheet so you can slice and dice it any way you wish. Over 200 solutions from 95 vendors are represented and categorized by solution area. The following pie-chart will give you a pretty good feel for this.

Most of the acronyms should be pretty familiar to you. If you don't know some of them, it's likely that you have no interest in that category anyway. But, there are a couple that may be unfamiliar to most of you: 

RIMS - Regulatory Information Management System

MIMS - Medical Information Management System

Of course, a glossary defining all of the acronyms is included in the spreadsheet.

As you would expect, over 50% of the solutions come from just 5 categories:

  • EDC - Electronic Data Capture
  • CTMS - Clinical Trial Management
  • ePRO - Patient Reported Outcomes
  • CDM - Clinical Data Management
  • IVRS - Interactive Voice Response

What's more interesting are the emerging software categories that include:

  • Data Analysis
  • RIMS - Regulatory Information Management
  • CDW/CDR/SCE - Clinical Data Warehousing/Repository and Statistical Computing Environment
  • Patient Recruitment

Continue reading "Software for Clinical Development - 2011 Edition" »

Hidden Gold Nuggets: Pfizer's Progress in Drug Development

Pfizerlogo 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

IMG_1220 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.

Can Frog Design figure out Healthcare?

Homer If you have not heard of Frog Design, it's worth checking out what they have done over the years. I won't talk about that here and let you do the research. I promise, it will be fun!

But, I would like to get your opinion on what Frog Design and Microsoft are dreaming up to solve the ills of Healthcare with technology. Even Homer Simpson is in on the act (though not of his own free will). You can get a glimpse of that by clicking here to get to the video on the Forbes Video Network. It's less than 3 minutes long.

Do you like what you see? Are they on to something or are they nuts? Send me your comments and share them with my other readers.

I will hold back with my own opinions until I've heard from you.

Update: Software for Clinical Development - 2010 Edition

The updating of this software list is still in progress. Several new software categories have been added and the list of vendors is growing and shrinking at the same time. In other words, some companies have gone out of business, others have been assimilated and new ones have also been born. At the moment, I am optimistic that the list will be ready to share sometime in November. Your patience is appreciated and hopefully rewarded fairly soon. 

DIA 4th Annual Clinical Forum - Lisbon - October 11-13, 2010

If you are in Lisbon next week, chances are that you will be there for this conference.

This note is just to let you know that I will be there and presenting on a panel related to Clinical Data Warehousing chaired by Peter Stokman of MSD. This will be a 90 minute session focusing on the practical aspects of implementing systems that manage and allow for the analysis of clinical data with full traceability and auditability.

The rest of the program looks great with no less than 40 topics covered over the three days. Check out the program here.

If you'd like to get together and chat about any topic of interest, just drop me a line at my email address.

See you there!