The Economist magazine recently weighed in on the state of technology within the healthcare industry. From the article:

You can read the full article at the magazine's website.

DIA Summary: "Risk-based computer system validation is a process many companies developed long before the August 2003 Guidance for Industry document on Part 11 Scope and Application was issued by the US Food and Drug Administration. The main differences between prior existing risk models and this guidance is the emphasis on patient and product safety, product quality, and record integrity, as required in the Part 11 Scope and Application Guidance. When computerized systems are used to collect data on which decisions are made on drug efficacy and patient safety or are used to control the quality of drug during a manufacturing process, the point of focus has to change. This article outlines a consistent and justifiable method for determining the risk of a computerized system with the emphasis on patient and product safety, product."

You can download a pdf of the full article from LSIT's web site. And a special thanks goes out to our friends at the Drug Information Association for allowing us to make it available.

LSIT members may be interested in an upcoming course from the UCSD Rady School of Management, "Biotech Demystified: the Science Behind the Business." The program is designed for non-scientist executives and professionals and is offered in collaboration with the UCSD's Division of Biological Sciences.

The course addresses the technical gap for many professionals interfacing with the life sciences industry with an intensive coverage of the basic sciences combined with exposure to upcoming cutting-edge technologies. To optimize the learning experience, this interactive course incorporates both laboratory and classroom components including business scenarios, case discussions and role plays. The program's faculty comprises both leading academics and industry experts, including LSIT Founder and CEO of Global Life Sciences, Howard Asher.

The course will run from June 18-21, and more information can be found here.  

Optimize Magazine has a good article looking at the role of CIO as a "CEO decision-support specialist," and offers some tips on being more effective in communicating technical issues with non-technical executives. You can read the article at Optimize.

The nation’s pharmaceutical, biotechnology and medical device companies report that the U.S. FDA has made progress with improved guidance, expectations and approvals, but the industry remains concerned about a number of regulatory challenges. A national report issued in part by BIOCOM outlines a series of issues that still need to be resolved to improve product review delays and shorten the approval process via user fees.