The Laszlo Letter

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.

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.

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.

Virtual Software Testing with StackSafe

It's not too often that I run into something innovative that leads to the thought: "Why didn't I think of that?"

This is exactly what happened the other day on reading the following passage in the February 4th issue of Information Week:

"Two-year-old StackSafe showed how its first product, Test Center, captures snapshots of the IT production environment, stores them, and then assembles virtualized production environments in which to test software changes."

I then found a somewhat longer article on this product here. In that article you can also learn about a competing product called StageManager from VMWare.

What's intriguing about this product is the possibility of replacing the physical hardware and software instance that we currently use to validate software. Instead of continuously maintaining a development, test and production environment, you keep the development and production environments and create virtual test environments as necessary.

Note: If you are new to the concept of virtualization, read this prior post.

By dropping out the physical test environment, you save both hardware and maintenance costs. More importantly, creating a virtual test environment will assure that the tests you run correctly represent the impact of changes on the "real" production environment. Let's face it, the production environment is never exactly the same as the current physical test environment.

A move to such an environment has regulatory implications that must be addressed. First, the validation program itself will need to change and include the validation of the virtual test environment from creation to use to deletion. In other words, you will need to prove that using a product like StackSafe Test Center for validation can be done reliably and consistently. Second, you will need to have some assurance from regulators (e.g. FDA or EMEA) that using virtualization in this manner is acceptable to them. It never hurts to ask!

The unacceptable alternative would simply be to ignore this method and assume that the regulators wouldn't approve.

Requirements Management with SimpleReq

Software Review

Whether a new software application is intended for a validated or non-validated environment, collecting, documenting, managing and using requirements remains a necessary and often daunting task. With this in mind, a small Pennsylvania-based firm called IM Visions has released a straight-forward tool called SimpleReq to help tackle this chore.

Having come from the biopharmaceutical industry, the founders of IM Visions are very much aware of the added rigors related to validation in a regulated environment. They have designed SimpleReq to meet the needs of the traditional Systems Development Life Cycle (SDLC) and of 21CFR11.

In short, SimpleReq is an MS-Office plug-in that will allow you to:

• Categorize and define requirements
• Associate requirements with test scripts
• Generate project documentation
• Manage releases and simplify documentation associated with application maintenance

SimpleReq is available from the IM Visions web site at an annual subscription price of $99.95. This is for a single instance of MS Office running on a single PC. You can select either the MS Office 2003 or MS Office 2007 version.

iPhone and EDC: Screen shots of the Nextrials Prism system

In prior posts, I have talked about the potential use of the Apple iPhone in the life sciences setting. These have included it's use as an SFA device or a solution for EDC & CTM. I have also discussed whether Apple could compete in the business world.

The EDC post revealed how Nextrials is using the iPhone to give its customers mobile access to their Prism EDC system. At that time I promised that I'd try to get some screen shots of the software in action. I am happy to report that the people at Nextrials took the time to have professional photos made for me. So please click the "Continue reading..." hyperlink to see these photos.

On a separate note, Apple has also announced the coming availability of their iPhone Software Development Kit (SDK).  Read this article to get an idea about the SDK. I'm expecting this SDK to be the catalyst that will prompt many existing and new software companies to build applications for our industry.

IBM buys into Complex Event Processing (CEP)

I have been following the progress of a small company called AptSoft for about two years. AptSoft markets a solution for Complex Event Processing (CEP), a niche capability that is a close cousin of Business Process Management (BPM).

As I have reported here not long ago, I have been struck by the great emphasis our industry has put on process reengineering while almost ignoring the important role that BPM tools could play to make such reengineering easier and more effective. So, I have been reluctant to add CEP into the mix under the assumption that our industry was just not ready for it.

Now comes the important news that IBM has purchased AptSoft and will make it part of its WebSphere business. This move by IBM will give greater legitimacy to CEP even if it only becomes a part of a larger set of middleware and SOA offerings.

The move also means that the biopharma industry should take a closer look at the way that CEP could be used througout the business. But just what are these application areas?

Well, I don't have a nice compact list to share with you. Suffice it to say that CEP can help in circumstances where the potential consequence of a sequence of events are not known. In other words, you can use BPM when you know for sure what effects a certain action can have. You can use CEP if you don't know any or all of the effects that may transpire. Donald Rumsfeld would call these the unknown unknowns. And, as an added bonus, CEP would let you figure out how to handle these unknowns as they happen.

OK, I'll give you one example: Supply chain management in case of a pandemic of unknown size and location.