The Laszlo Letter

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.

Photo / Slide Animation of the Fun Kind

Many of you have thanked me for turning you on to the Blurb digital photo publishing tool. Continuing in that vein, I want to make you aware of a web site called Animoto.

The concept and the execution is really simple. You select a set of digital photos based on some theme and upload them to the Animoto web site. You then select a sound track (classical, jazz, rap, electronica, etc.) to go with the photos. And last, you tell Animoto to create a video combining the photos and music. The process is fun and the results can be awesome.

When finished, you can email a link to the video to anyone. You can also post the video to web sites like this blog. That's exactly what I did with this sample video created from photos taken on a recent trip to Munich.

I'd venture to guess that there are also some commercial uses for this service. For example, if you are a vendor who will be going to a trade show, you could create a pretty compelling video to replace those ugly PowerPoint presentations you may already have.

Give it a try.

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.

Patient (Self)Recruitment

Notes from the 23^rd DIA CDM conference

Sometimes we tend to forget that everything we do is for the patient.

I was reminded of this when listening to a talk by Laura Esserman of the University of California Medical Center at San Francisco. Dr. Esserman described her clinical work in the area of breast cancer and the recognition that patients themselves could be the source for electronic health records (EHR). Once collected, these records could be used to match patients to clinical trials. In other words, the EHR becomes the source of data for patient recruitment.

Sharing Clinical Data through Application Integration

Notes from the 23^rd DIA CDM conference

While I’m not enamored of attending conference sessions that start at 8:30 in the morning, I was glad that I made it to the Tuesday morning session on “Accessing Clinical Trial Management Information from eClinical Systems and Capabilities” chaired by Paul Bleicher of Phase Forward.

Before I jump into the details, I want to warn you that the words “clinical trial management information” in the title of the session can be misleading. This is because of a key learning that I took away from this session. In short, when we begin to effectively extract and use data and metadata from all of the transactional systems at our disposal, they become (in aggregate) a comprehensive clinical trial management environment. In other words, we no longer need a CTMS because we have achieved a CTME(nvironment).

Quotations from FDA CDER Head Janet Woodcock

Notes from the 23^rd DIA CDM conference

In the next few posts, it is my intention to share with you some of the information presented at the 23^rd DIA Clinical Data Management (CDM) conference. It is also my intention to give you some of my own thoughts about what I saw and heard.

The title of the conference was “Data Management in Transition: Putting the “e” in Data Management.” I am happy to report that the conference organizers did a great job keeping the majority of speakers focused on this topic. So, kudos are in order for Sue Dubman (Theravance), Kristin Neff (Boston Scientific), Paul Bleicher (Phase Forward), Shahla Farr (FDA), Rebecca Kush (CDISC), Denise DeRenzo Lacey (Waife & Associates), Johann Prove (Bayer Schering Pharma), Don Rosen (Rosen Consulting) and Steve Wilson (FDA.)

I could not think of a better approach to get things rolling than to simply convey several quotations from the talk given by the conference keynote speaker, Janet Woodcock MD, of FDA. As you may know, Dr. Woodcock was recently put in charge of CDER and she wasted no time telling us what she thought her division, and indeed all of FDA, should be doing.

These quotes nicely reinforce the tone of the CDM conference, one that was palpable if not always directly stated, namely that The time for change has arrived.

While I was initially tempted to put these quotes in context, I resisted that urge since they are as applicable to what we do in general as to the specific issues being discussed by Dr. Woodcock.

So, mull these over at your leisure and stay tuned for more about the meeting in future posts.

Quotations from Janet Woodcock

“current methods are not sustainable”

[there is] “almost a crisis in the United States to get clinical trials done”

“there is too much data being collected”

[we] “need to link EHR to clinical trials”

“we need to get out of the way we are doing things now”

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!