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LSIT ImageLSIT Minute: April 13, 2006.

Dear Friends,

Welcome Back! As summer is behind us we are off and running with developing the Good informatics Practices (GIP) Guidance Document. With three working groups in motion we have made great strides in addressing some unique questions that come with doing something that has never been done before in differentiating GIP from the other GxPs, defining our users, and scope. These are not easy questions when you look at our makeup.

LSIT has board members and volunteers that reach each part of the life science industry from Big Pharma to small biotechs and devices. To the needs of an IT department for any size life science company, our range of knowledge, resources, and systems must be as broad as the industry in which we work. We have users that span the scope of regulatory affairs, project managers, and CIOs, so one can imagine the challenge in writing a useful document that serves this greater population.

Our drive is more than just addressing the compliance and standards issues for each area in IT. Our volunteers are striving to provide best practices and information in one source that will truly help the end user do a better job and bring real value to their company. GIP will be a comprehensive IT resource in areas never addressed before.

- Anette

Briefly:

  1. Life Sciences Target Identification & Validation
  2. Welcome RCM Technologies & WunderMarx
  3. New TAB member, John McNeil
  4. Contributor Kudos to Steve Fouskarinis
  5. Barbara Nollau joins Global Life Sciences, Inc.
  6. The Changing Role of IT in Pharma

- Understanding Life Science Product Development: Target Identification and Validation

by Tony Pietsch

In the 1960s, Gordon Moore famously predicted that in the future, computer speed and capacity would double, and size and cost would shrink by half approximately every two years. Modern technology now exceeds Moore’s Law, which is great for aficionados of MP3 players, PDAs and cell phones, but in the life sciences, we are constantly struggling with the disparity between the fast-paced world of IT and the extended timelines of medical device, diagnostics and especially drug development.

How do we ensure good information practices when technology is racing ahead of the products it is supposed to support? How do we ensure proper data collection and transmission when the formats and media we use may undergo several generational changes between the time a product is conceived and delivered to market?

Read the full article here.


- LSIT welcomes new members...

RCM Technologies RCM Technologies LSIT is pleased to announce the membership of RCM Technologies, a leading provider of IT Business Solutions and Professional Engineering Services to over 1,000 clients in the commercial and government sectors, and WunderMarx, an international public relations firm differentiating some of the world's most innovative technologies and ideas.

Thank you to both companies for your support and for your commitment as industry leaders to the development of Good Infomatics Practices.


- John McNeil joins LSIT's TAB.

We are pleased to welcome John Mcneil, President of John McNeil & Company, Inc. to LSIT's Technology Advisory Board (TAB). A former VP of Informatics at Isis Pharmaceuticals and VP of Product Development at Ibis Therapeutics, John is currently developing LabSynch., an exciting and powerful Electronic Laboratory Notebook.

The TAB is charged with directing and managing the conception, development, review, and publication of GIP. TAB seats with key Life Science and IT Leaders, LSIT Members, individuals from regulatory and standards organizations such as FDA, GAMP, CDISC, to provide the technical guidance and expertise in reviewing and developing content in the 12 Chapters of GIP.


- Kudos Corner: A special thank you to Steve Fouskarinis.

Steve Fouskarinis recently returned to San Diego after working on the security project for the Athens Olympics where he now continues his work full time and volunteer with the Life Science Information Technology (LSIT) Global Institute in Project Management. Many of you will know this type of person; Steve’s brain works with at least 10 cycles going at one time, processing, probing, planning and seeking interrelated activities and best routes. Many of us on the Infrastructure and Security Working Groups have gotten to know him and enjoy his energy and enthusiasm driving to action and on-time projects.

A few of LSIT Board of Directors and the Technology Advisory Board have recently enjoyed the probing and questions that Steve has put on the table as we define our end user for GIP, the level of detail in content, and how this guide will be used as a reference tool. Engaging and energetic are just a couple of words that describe this man. All of us who have gotten to know him feel a sense of assurance that the project he is leading is in good hands.

Steve, thank you for your commitment and enthusiasm to our great endeavors here at LSIT.


- LSIT contributors on the move...

Congrautlations and best wishes to TAB Member Barbara Nollau, on her new role as Executive Consultant with Global Life Sciences, Inc. (GLS). GLS is a provider of strategic business, regulatory and IT solutions and services to the global Life Sciences Industry.

Formerly with Watson Pharmaceuticals, Barbara joins LSIT Founder and Board Member, and GLS President & CEO, Howard Asher at her new company, and we wish her well.


- The changing role of IT in pharma.

by Sam Marwaha and Steven J. Van Kuiken

CIOs in the pharmaceutical industry have an opportunity to become true pioneers. That's the good news—and the bad news. With the business model straining to operate at scale, pharma companies are asking their IT leaders to do two things at once: dramatically improve the efficiency of IT and use it to drive business innovation. Never before have CIOs in any industry had to face these challenges at the same time and to meet them so quickly.

Click here to read the full article at The McKinsey Quarterly (free registration required).




LSIT Calendar

09.25 - 09.26.06
DIA: Bridging the Gaps between GCP, Clinical Trial Safety and Postmarketing Vigilance: Regulatory Compliance Challenges for International Pharmaceutical and Medical Device Companies

10.10 - 10.13.06
2006 PDA/EMEA Joint Conference

10.18 - 10.19.06
A National Summit: Moving Toward Interoperability - Technologies for Accessible, Affordable Healthcare

10.18.06
Clinical Data Acquisition Standards Harmonization Initiative (CDASH) 1st Meeting



Members & Affiliates

Pfizer, Inc.
Novartis
Sun Microsystems
Amylin Pharmaceuticals
eKM Corporation
Frost & Sullivan
California State University
Integra International
WunderMarx, Inc.
RCM Technologies, Inc.
BIOCOM
S.D. World Trade Center
S.B.S.
IEEE
GAMP
CDISC
Heller Ehrman
NanoBioNexus
Burnham Institute
Prosanos Corporation
UCSD Global Connect
UCSD School of Medicine
W3C
LINC


What is GIP?

The vehicle by which LSIT will imbue trust in the bioresearch enterprise will be the application of trusted IT guidelines through Good Informatics Practices (GIP). Read about how LSIT intends to develop GIP here


Contact Us

By all means, feel free to call us if you have questions, comments or ideas. We live to the rule of being open and accessible, and listen to our members and colleagues.

LSIT Global Institute
7825 Highland Village Place
Suite 505
San Diego, CA 92129
(858)759-4750
E-Mail: Anette@LSIT.org
Website: www.lsit.org


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