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LSIT ImageLSIT Minute: October 31, 2006.

Dear Friends,

On October 20, LSIT held a public Executive Briefing where we highlighted how GIP will be a comprehensive body of information of regulatory requirements and currently used standards pulled together in one reference guide for an IT department of a life science or healthcare environment.

In his presentation, Geoff Odell, Chairman of LSIT, indicated that IT vendors continue to develop technologies for our industry, yet they lack an understanding of our needs. He pointed out that all functions within a life science organization require significant use of multiple IT platforms and we're challenged in maintaining trusted, secure systems that hold our intellectual property and data. Adding to the complexity are challenges such as decommissioning or upgrading antiquated systems. We need your help in getting IT vendors to the table as we hope GIP will add knowledge and clarity to these processes and break down barriers to implementing newer technologies.

Andrew Jacobson of Amylin and Paul Laskin of Pifzer presented an update of the progress of the three chapters currently under development. They also spoke about the tools LSIT has implemented to collaborate and develop content for this Guidance, such as MissionFire for project and document management.

Finally, Barbara Nollau of Global Life Sciences, Inc., presented an overview of using the Risk Based approach and gave examples of the variability of risk and the level of rigor or need for mitigation that goes up with the level of impact. The Risk Based approach will be used for all 16 chapters that make up this Guidance Document, and we believe it will add clarity to the level of detail and processes.

- Anette

Briefly:

  1. The Serendipity of Drug Development
  2. LSIT welcomes new member Mission3
  3. Kudos to Coley
  4. People on the Move: Jason Cooper, Leslie Plant
  5. 11/2 Training for Volunteers on MissionFire

- Serendipity: How the Drug Development Process Can Reverse Direction
by Tony Pietsch

For centuries, serendipity has played a key role in drug discovery, but when these examples took place, the drug development process was far simpler than it is today. The best-known modern instance, sildenafil, entered clinical trials as a vasodilator to combat angina, but by 1992, it was clear that it was not going to pan out. Pfizer, the company developing the drug, aborted the trial and asked participants to return the unused drug. Many of the men who had been taking the drug, however, not the placebo, balked. Researchers didn’t make a connection until rumors surfaced about the drug's sexual side effects, and, more significantly, read a paper on the role of the target enzyme in the chemical pathway of erection. The drug, it turned out, affected the arterial enzymes of the penis far more than those of the heart, and today Viagra™ is a mainstay of men's medicine cabinets the world over.

Read the full article here.


- New member provides an invaluable resource...

Mission3, Inc.
LSIT is pleased to welcome our newest member, Mission3, Inc.. Based in Phoenix, Mission3 assists Life Sciences organizations bring much-needed drugs, therapies and devices to market. Mission3's advanced suite of enterprise applications, MissionFire and FastCrossing, allow companies to manage bioscience projects, comply with FDA and other regulatory agency requirements, and submit FDA applications in an automated and managed environment.

LSIT will be implementing Mission3's MissionFire Document and Project management software to assist our working groups with the development and management of the GIP guidance chapters. See Item 5 below for more information.

For more information on Mission3, please visit www.mission3.com.


- Kudos Corner: A special thanks to Coley Chavez

Coley Chavez has been involved with the Security Chapter from the beginning.  He took the helm as Working Group Leader for the Chapter about 5 months ago and really has been an incredible contributor.  With Coley’s insights, due diligence and resourcefulness, he as investigated the best approach and structure to put in place for this chapter.  it will be unique from the other chapters as security basically is dealing with threats at many different levels.  The risk based approach is a given here and Coley has been instrumental in seeking quality throughout this approach.  He has engaged many volunteers and experts who will add tremendous value.

Coley is of great character and a most conscientious and thought-full IT Director and chapter leader.  He does his homework, asks his peers, and goes out in the community to find the truly best practices.  We are grateful and privileged to have his support and commitment.  Thank you Coley.


- LSIT contributors on the move...

Leslie Cirillo Plante, Director of IT Compliance for Novartis Pharmaceuticals has agreed to join LSIT's Technology Advisory Board (TAB).

TAB Member Jason Cooper recently joined Accordant Health Services, Inc. as Director of Research and Metrics.

Another TAB Member, Barbara Nollau has joined Global Life Sciences as an Executive Consultant.

On behalf of the entire LSIT team, welcome Leslie, and congratulations to Jason and Barbara.


- MissionFire training for LSIT contributors...

On Thursday, November 2, LSIT, Global Life Sciences (GLS) and Mission3 will host a training on MissionFire software for LSIT contributors. MissionFire is a web-based, life sciences-focused, project and document management tool that is being implemented by LSIT to assist in the development of GIP chapters. All volunteers/contributors will be provided with a login/password to access the LSIT project online where you can obtain and collaborate on the documents that will ultimately make up the individual GIP chapters.

Please join us from 10:30 a.m. To 1:30 p.m., we’ll provide a brief overview of MissionFire, and provide a short training for all contributors.

Date: Thursday, November 2
Time: 10:30 a.m. to 1:30 p.m.
Location: Heller Ehrman, LLP
Address: 4350 La Jolla Village Dr, 7th Floor, San Diego
Lunch and Parking validation will be provided by GLS.

For more information on this training, please contact of GLS.





LSIT Calendar

11.2.06
MissionFire Training for GIP Contributors



Members & Affiliates

Pfizer, Inc.
Novartis
Sun Microsystems
Amylin Pharmaceuticals
eKM Corporation
Frost & Sullivan
Mission3, Inc.
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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