Overview

The Founding of LSIT

The Life Sciences Information Technology (LSIT) Global Institute was founded by Howard Asher, while Global Director of Life and Health Sciences at Sun Microsystems, Inc. Howard described the vision of providing guidance of trusted IT within the global health and life sciences sectors, to Sun's executive management and obtained the LSIT founding grant of $75,000 from Sun in 2003. The founding of LSIT was conducted in partnership with University of California at San Diego (UCSD) within its CONNECT organization. UCSD CONNECT provided great assistance by organizing the LSIT Founding Committee. During the founding, Pfizer, Inc. and Novartis AG, matched Sun's founding grant, providing the necessary capital to bring LSIT to life.

Introduction

In recent years, the integration of information technology (IT) into life sciences and healthcare has progressed rapidly, and the potential consequences are profound. The effective and appropriate use of IT offers the possibility to reduce both the time and cost of bringing new medical therapeutics and products from discovery to the patient. The life sciences industry is the most regulated industry in the world. Paramount to adoption of information technology in the life sciences community is trust. It is critical for all stakeholders and gatekeepers to trust that very complex IT tools, computational processes, and resulting data are accurate and valid. On a global scale, trust is carried one step further, because it has the potential to be a common thread in rapidly advancing healthcare systems around the world.

IT engineering is not a core competency of medical researchers, the life sciences industry, healthcare providers, or the various governmental regulatory agencies. Yet these same groups are attempting to utilize very advanced IT systems to perform increasingly complex computational and data-management tasks, all in an effort to explore diseases at a cellular level, to develop therapies, and to utilize these therapies to treat and cure diseases affecting humans worldwide. Sophisticated, trusted, and reliable IT solutions are required to aid and accelerate this work. The formation of the Life Sciences Information Technology (LSIT) Global Institute is chartered with one purpose: To develop open, publicly available Good Informatics Practices (GIP) for the life sciences and healthcare community.

The LSIT Global Institute is to become a trusted reference body similar to other reference laboratories that develop valid best practices in such industries as automotive, electronics, materials and building construction. The LSIT Global Institute will foster the life sciences, healthcare and IT industries to develop creative designs and unique features while maintaining the fundamentals at the functional core of the computational product to ensure trusted and reliable IT systems. When the IT industry certifies adherence to GIP, users and regulators can expect computational functions that accurately and validly perform their intended function, and comply with security and regulatory requirements.

The LSIT Global Institute is a not-for-profit organization, whose members will become an alliance from:

• Life Sciences Industry
• Information Technology Industry
• Academia
• Research Institutes
• Health care providers
• Regulatory Agencies

The LSIT Global Institute will also invite specialty standards bodies to participate and contribute to GIP Guidance as published by the LSIT Global Institute.

The Institute's Mission is to develop trusted Information Technology guidance for the global life sciences and health care communities. Its Charter is to facilitate collaborations to develop open publicly available Good Information Practices (GIP) for the life sciences and health care communities using a risk-based approach.

The LSIT Global Institute will be a truly global consortium made up of life sciences and health care companies, medical research institutions, IT providers and developers, and regulatory bodies from all major world markets. We are open and inclusive, and we will provide services to any organization or regulatory agency without bias. All findings, products and processes will be shared and published openly to the global healthcare, life sciences and IT communities.

We are committed to the evolutionary development of reliable, reproducible, secure, efficient and trusted IT solutions for the advancement of life sciences and public health worldwide. We will not reinvent systems or processes which have been developed; rather we will work to identify the Good Informatics Practices (GIP) which will be accepted by regulators, researchers, drug/device developers and IT suppliers. Therefore, we will NOT be a standards setting organization dictating to the industry.

We are an independent organization committed to providing leadership in establishing GIP which meet regulatory needs while contributing to significant cost savings for the health & life sciences community. We will not be influenced by political, financial or regional interests that do not advance our mission of accelerating improvements in global health.

Organizational Structure

Board of Directors.
Directors will serve two-year, staggered terms. They have final authority over all Institute business, hire and supervise the executive staff (a president, a secretary/treasurer, and other staff members as needed), and control the budget. The president conducts the Institute's daily affairs, supervises the initiatives, and is responsible to the Board of Directors for the Institute's performance.

Technology Advisory Board (TAB)
Members of the Technology Advisory Board, appointed by the Board of Directors, are prominent individuals who possess scientific, technical, education, or clinical credentials related to life sciences, IT, and related technologies. The TAB will approve, monitor and provide overisght and direction to the GIP Guidance Document.

LSIT GO Team
The LSIT GO Team is chartered to be the "go to source" for all working group challenges. Its Mission is to enable the successful development of the LSIT GIPs by resolving the operational barriers of the working groups.

Industry Advisory Board (IAB)
The IAB provides advisory input to the Board of Directors (BOD) and working committees. The focus of the IAB will be on development of areas of strategic importance to the LSIT mission and to periodically provide overviews on topics where its members have expertise, and to address specific strategy questions as they arise in the course of business.

Global Reach

LSIT will indeed be a Global Institute, with international offices in the Americas (San Diego), EMEA (London), and APAC (Singapore).