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.

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. 

Software for Clinical Development

Having recently particiapted in two DIA meetings, I thought it would be useful to pull together a spreadsheet of vendors offering software used in clinical development. This can serve as the basis for a more comprehensive list built and maintained by reader input.

For now, the list is kept in an Excel spreadsheet:

Download ClinDevSoftwareVendors-April2008.xls

Please note that I consider this spreadsheet as the intellectual property of The Laszlo Letter. In other words, it is copyrighted. You may use it as a reference document but not benefit from it in any financial manner or reproduce it without my permission.

To contribute new items or update those that already exist, just use the comment function of the blog. I will take it from there and post new versions of the spreadsheet as necessary.

Thanks in advance for your help.

The "Lowedown" on Lab Notebooks

Rather than listening to me today, I want to draw your attention to a post by Derek Lowe who writes the "In The Pipeline" blog.

Derek is a chemist who works for a Biotech company in Cambridge, Massachusetts although you would not know that from his blog. That's because the blog is purely his own and is pleasantly and refreshingly biased. In other words, he expresses his own opinions and not those of his employer.

Recently, Derek got around to writing about Electronic Lab Notebooks (ELN), a topic that I have not spent much time discussing on this blog. However, lab automation is a critical component of both discovery and manufacturing and does deserve coverage.

So, if you're interested in this topic, go ahead and click on the hyperlink above. You'll get Derek's opinion about ELN software and as an added bonus, the opinions of over 30 other individuals who were moved to comment on it. And, you'll get to know a little bit about the vendors who provide such software and include IDBS, Cambridgesoft, Enso, Symyx, and EMSL.

Apple iPhone: Life Sciences applications needed. Money available.

As you know by now, I am betting that the Apple iPhone will become an important communication and collaboration tool in our industry. This, in spite of many dissenting voices that the iPhone is not ready to handle real business applications.

Apple has now reported that over 100,000 downloads have been made of its Software Development Kit (SDK) since its launch on March 6th, 2008.

Now, Kleiner Perkin Caufield & Byers (KPCB) has launched a $100 million fund to support the development of iPhone applications. According to its web site, the fund "will invest in companies building applications, services and components. Focus areas include location based services, social networking, mCommerce (including advertising and payments), communication, and entertainment. The iFund™ will back innovators pursuing transformative, high-impact ideas with an eye towards building independent durable companies atop the iPhone / iPod touch platform."

According to the FAQ on the KPCB web site, the funding can be anywhere betweek $100K and $15M. The application form can be found here.

So, this is a great opportunity for all you entrepreneurs out there to show how the iPhone can be leveraged to support the R&D, Sales & Marketing and/or Manufacturing & Logistics segments of our industry. Even if you don't end up being funded by KPCB, only $99 stands between you and the SDK.

First, think BIG! Then start coding.

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!

Reminder: DIA eClinical Meeting - March 16-18, 2008

It's not too late to sign up for the upcoming DIA eClinical meeting that will be held in Washington DC from March 16 to 18, 2008. To see or download the program, click here.

The title of the meeting is "Data Management in Transition: Putting the "e" in Data Management." There will be 63 presentations spread among four tracks:

1. Clinical Data Management - Focusing on the Data
2. CDM/eClinical - Management Best Practices
3. Data Management in Transition - From Keepers of Clean Data to Stewards of the Clinical Data Pathway
4. eClinical Technology Trends and Innovations

The topics to be presented/discussed are summarized on this pie chart. For a larger view in a separate window, hold the Ctrl key and click on the chart.

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Yours truly will be the chair of a panel discussion on "eClinical Futures," a session that will focus on process improvements and emerging information technologies that have the potential to alter the way we currently conduct clinical development. This session will have 5 speakers and will devote significant time to group discussion and audience participation. It is scheduled on Monday, from 1:30 to 3:00 p.m.

Having reviewed the program, here are the topics that I would personally find of interest:

Monday 1:30 p.m. - Track 1 - The FDA Revitalization Act, Drug Safety and Data Management: Great Expectations or Bleak House?

Monday 1:30 p.m. - Track 4 - An Honest Look at the eClinical Process: How Biotech Can Learn from Best Practices Outside the Industry

Monday 3:30 p.m. - Track 2 - Tech(cli)nical Project Managers and Their Role in eCDM

Monday 3:30 p.m. - Track 4 - Standard Representation of Trial Design and Data Management

Tuesday 8:30 a.m. - Track 2 - To Outsource or Not to Outsource? What is the Future of Clinical Data Management?

Tuesday 8:30 a.m. - Track 3 - Redefining Data Management’s Role in EDC

Tuesday 10:30 a.m. - Track 2 - The Impact of the Merger of Merck and Serono on the DM Staff

Tuesday 10:30 a.m. - Track 3 - Statistical Computing Environments: Collaboration through Metadata, People, Process, and Software

Tuesday 1:30 p.m. - Track 2 - Business/Research Value of a Shared Collaboration Platform

Tuesday 1:30 p.m. - Track 3 - A Complex Protocol Design to Accelerate Clinical Trials: How to Implement Multiple Database Lock in an Electronic Data Capture System

Tuesday 3:30 p.m. - Track 2 - CDM without Traditional Clinical Data Management Systems

Tuesday 3:30 p.m. - Track 4 - Connecting Two Worlds: Electronic Health Record Systems Clinical Research

Of course, it makes sense for you to review the entire program to determine which topics would be of the greatest interest to you.

Of CDR, CDMS and EDC

Once in a while it's nice if someone else is doing the writing.

So, here is a link to a two-part article primarily about clinical data repositories (CDR) by Mark Uehling of ClinPage. We spent several hours discussing CDRs, CDMS's and EDC systems by phone. Mark then distilled our conversation down to this two part article. Please don't hesitate to give us feedback either on the ClinPage site or here.

IT Sessions at DIA 2007

We are now exactly one week away from DIA 2007.

What follows is a selective and somewhat biased list of IT topics that will be given at the annual meeting. Somewhat biased since it is focused on topics of greatest interest to me. Another way to look at it is that I am less interested in topics that have gotten a lot of coverage over the past 3 years and more so in those that focus on emerging issues/opportunities.

As you will see, some of the sessions fall in the same time slot. I was hoping that the DIA could at least have found a way to put sessions on the same topic in different time slot. Maybe next time.

IT Topics at DIA 2007

The DIA 2007 Annual Meeting is only a month away.

Did you know that there will be 80 talks related to information technology at DIA 2007?

Even if you did, it would take a bit of work to figure out which ones you want to attend. So, I'm going to make that a lot easier for you right here.

Just scroll through the following list. It's sorted by topic. When you have identified a topic of interest, go to the DIA web site and search the on-line program to find the day and time it is being presented.

By the way, don't forget to come to my own session on Thursday at 8:30 a.m. The topic is "The future of information technology in clinical development and R&D."

And here is a nice chart to show you how the topics break out. Hold down the <Ctrl> key and click on the image to see a bigger version.