The Laszlo Letter

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”

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!

First, let's BILL all the lawyers!

OK, I couldn't help it. I just had to edit that famous quote from Shakespeare. Why? Because this post is all about software that can help lawyers bill other lawyers for the services they provide.

In particular, I wanted to highlight two case studies (J&J and Merck) discussing how in-house counsel can make use of software for processing invoices received from outside counsel. Both of these come from the software vendor DataCert based in Houston, Texas and London, England.

The product highlighted is called Advanced Invoice Management System (AIMS) and was implemented by J&J and Merck in the past four years.