The LSIT Minute
Dear Friends,
It's been a few months since we've touched base, but I'm happy to report that we've been anything but idle. Our teams have been going full steam, and the beginning of this year saw some significant advancements in our GIP development efforts.
Also, we've added to our roster of tireless volunteers with the establishment of an Industry Advisory Board. I would like to personally thank the founding members for their commitment to helping us keep abreast of the issues most pressing to our cause, as well as those issues on the horizon that will likely challenge our community in the years to come.
Incidentally, one of the founding IAB Members, Paul Allen of Clarkston Consulting, will be moderating a panel at this month's BIOCOM Breakfast. The April 16 panel will look at "Changing of the Guard: Different Approaches to Mergers & Acquisitions." For more information on the breakfast, click here.
- Anette
Briefly:
- LSIT's new Industry Advisory Board
- LSIT Google Group for Volunteers
- An Invitation from Microsoft
- Warnings over FDA's IT Systems
- The Convergence of Risk and Regulation
- More Convergence: Governance, Risk & Compliance.
LSIT Introduces Industry Advisory Board
On March 28, the LSIT Global Institute's Board of Directors today announced the formation of an Industry Advisory Board to help guide the development of Good Informatics Practices (GIP) guidance for the life and health science communities. The primary goal of the IAB will be to provide advisory input to the Board and working committees in areas of strategic importance to the LSIT mission. In addition, the IAB will periodically provide overviews on topics where its members have expertise, and will address specific strategy questions as they arise in the course of business. The LSIT Board of Directors has invited an initial group of six distinguished industry leaders to be founding members of the IAB.
Several IAB members joined the recent Board of Directors meeting, and identified some strategic topics and trends for future presentations and dialogue that include: database intelligence and pedigree, the changing environments of clinical trials and collaboration of commercial industry with non-profit research organizations, data visibility and its roadmap from discovery to commercialization, translational medicine and the collaboration tools for research, diagnostics and pharmaceuticals working together, and the validation challenges faced by combination products.
Read the full press release.
Launching the LSIT Google Group
In an effort to give our members and volunteers more options for connecting and sharing ideas, we are establishing a new forum: the LSIT Google Group. This group is intended to connect like minded professionals working toward enabling trust of information technologies utilized in medical research, medical product development, governmental approval process and patient management. By connecting everyone through this Google group we will share amongst one another lessons, best practices, resources, meetings and other relevant information regarding Good Informatics Practices.
This group aims to be another avenue for supporting GIP as an open, publicly available guidance to assure quality driven IT governance for global life sciences and health care communities where GIP will help companies leverage better, faster, and less costly IT solutions from Discovery to the Patient.
If you are interested in joining the group, please e-mail groups@lsit.org or visit www.google.com/group/lsit-global-institute and request an invitation to join.
Microsoft Health & Life Sciences Conference 2008
Microsoft has asked us to pass along word of their upcoming Health & Life Sciences Developer and Solutions Conference in Atlantic City, NJ from April 22 through 24, 2008. The event is free to attend, and offers a unique opportunity for developers, architects, technical and business decision makers in the healthcare industry to discuss the software and services delivered to the Health & Life Sciences.
For more information, visit the Conference Web Site
FDA Science and Mission at Risk
Among the alarming findings of the U.S. Food & Drug Administration's recent Report of the Subcommittee on Science and Technology was the conclusion that "The FDA cannot fulfill its mission because its information technology (IT) infrastructure is inadequate."
From the report:
The IT situation at FDA is problematic at best — and at worst it is dangerous. Many of the FDA systems reside on technology that has been in service beyond the usual life cycle. Systems fail frequently, and even email systems are unstable — most recently during an E.coli food contamination investigation. More importantly, reports of product dangers are not rapidly compared and analyzed, inspectors’ reports are still hand written and slow to work their way through the compliance system, and the system for managing imported products cannot communicate with Customs and other government systems (and often miss significant product arrivals because the system cannot even distinguish, for example, between road salt and table salt).
There are inadequate emergency backup systems in place: recent system failures have resulted in loss of FDA data. Critical data reside in large warehouses sequestered in piles and piles of paper documents. There is no backup of these records, which include valuable clinical trial data. The FDA has inadequate extramural funding programs and collaborations to accelerate the development of critical health information exchanges in order to support clinical trials and pharmacovigilance activities.
Download the full report here. (pdf, 736k)
SunGard White Paper: The Convergence of Risk and Regulation
In their White Paper, The Convergence of Risk and Regulation, SunGaurd looks at the convergence of the elevated need for reliability, privacy and accountability brought about by significant events in the last decade.
From the paper:
The heightened level of concern and scrutiny we are seeing from government agencies did not happen overnight. Rather, it has been progressive and consistent, building slowly but steadily. And, while there may be disagreement regarding the specific genesis of this current regulatory climate— some mark it at Year 2000 initiatives and others view the earlier 1993 World Trade Center attacks as the watershed moment—all agree that it shows no signs of abating.
There is also consensus regarding the general motivation. That is, a universal governmental desire to ensure the continuation of a servicesbased world economy by mandating an ideal level of preparedness within industries and individual organizations.
Our dependence on technology has grown such that technology disruption has become one of the requisite components when calculating operational risk. But the underlying truth is, regulators react to threat and the perception of threat.
You can download the full white paper here. (pdf, 327k)
The case for converging governance, risk and complianceby Peter Williams, Senior Analyst, Bloor Research
Regulatory compliance is now a burning business issue with major IT implications. The appointment of a compliance manager is becoming commonplace—and yet compliance, like risk (for which there is often a risk manager), is part and parcel of governance—and needs to be thought of as such.
Typically, good governance is a key responsibility addressed at board level and policies to achieve this then filter down through the organisation. Risk assessment and the consequent risk reduction measures are part of this, with regulatory and statutory compliance needed also to minimise company risk and achieve good governance. (Security comes under this umbrella too and is a major subject in its own right, but in this context it is often considered part of the risk reduction function).
Read the full article.
