Press Release

Critical Need for IT Guidelines in Life and Health Industry According to New International Survey of Top Industry Execs

Proper guidelines seen as opportunity to accelerate regulatory approval process

Media Contact:
Robert Blodgett
Townsend Inc.
rblodgett@townsendinc.com
858.457.4888 xt.160

SAN DIEGO (June 29, 2005) – The Life Sciences Information Technology (LSIT) Global Institute, a worldwide, nonprofit, public benefit organization focused on building trust of Information Technology (IT) utilized within the life and health science community, today announced the findings of its first global study of senior life and health science professionals. The survey found that almost nine out of ten respondents felt that consistent IT practices would accelerate the regulatory approval process in the life and health science community. The same ratio of respondents also agreed there exists a critical need for a global, centralized reference base for IT professionals in this community. Seventy-seven percent of participants felt there is a definitive need for an organization like LSIT to lead the development of industry-specific best practices. Additionally, seventy-six percent of participants felt open, freely available Good Informatics Practices (GIP) guidelines would significantly improve business processes and regulatory compliance.

"LSIT was founded to help form the global bond that will create a path toward raising the trust of IT worldwide in the life and health science community," said Howard Asher, LSIT Boardmember. "This survey clearly demonstrates the need for the global development of GIP guidelines. These guidelines are best achieved by establishing working partnerships with the IT and life sciences industry, medical and scientific researchers, government regulators and healthcare providers," said Asher.

LSIT envisions that GIP guidelines for IT processes will provide as significant a benefit as other important good practices in place today such as GLP, GMP and Good Clinical Practices (GCP), the worldwide guidance developed by ICH for the conduct of regulated clinical research.

Most respondents felt that individual company solutions within the industry do little to mitigate inefficiencies. This becomes even more important as mergers and acquisitions continue to rise causing significant problems for companies attempting to align separate IT processes without uniform global guidelines. The survey also found that seventy-four percent of respondents feel there is a definitive need for industry specific best practices. The four most important areas of IT in need of attention are:

• IT Security (94 percent)
• Data Management (94 percent)
• Testing and Validation (94 percent)
• IT Infrastructure Operations (92 percent)

The survey was conducted by LSIT to identify the key IT issues of most concern within the life and health science community. All parties, including the creator, processor and end user of medical, biological healthcare products, will use the results to formulate practical solutions that will raise the level of trust in IT. The survey was conducted on-line during the month of May 2005.

About the LSIT Global Institute:
The Life Sciences Information Technology (LSIT) Global Institute a non-profit organization dedicated to developing open, publicly available Good Informatics Practices (GIP) Guidelines for the life and health sciences communities. 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 organization's members are an alliance of leading global life sciences and information technology companies, renowned academic and medical research institutions, healthcare providers, payors and representatives from government regulatory agencies worldwide.