Category Archives: Technology

15Feb/07

Are you ready for Virtual Clinical Trials?

By Daniel R. Matlis 

The Kaiser Permanente Northern California Division of Research announced yesterday, February 14 2007,  that it is launching one of the largest research projects in the United States to examine the genetic and environmental factors that influence common diseases such as heart disease, cancer, diabetes, high blood pressure, Alzheimer’s disease, asthma and many others.

The goal of the Kaiser Permanente Research Program on Genes, Environment and Health (RPGEH) is to discover which genes and environmental factors are linked to specific diseases.

During the Press Conference David Kessler, former commissioner of the U.S. Food and Drug Administration and current dean of the University of California at San Francisco School of Medicine (UCSF), commented: “Increasingly we are moving into a world of personalized medicine. What does that mean? Right person, right disease, right drug and right dose”

Researchers hope to explain how genes and environmental factors work together to influence the risk of getting a disease or affect its severity or outcome. The Research Program will also include studies of genetic and non-genetic factors that affect how people respond to specific medications, including the occurrence of side effects.

Cathy Schaefer, PhD, director of the RPGEH and a research scientist at the Kaiser Permanente Division of Research in Oakland, added “Our research could help us identify not only what diseases a person may be at risk for, but also identify how to reduce that risk, or how best to treat the disease. This research program provides an exciting opportunity to make significant progress toward improvements in health and medical care.”

The RPGEH initiative represents a major step towards virtual, life-long clinical trails and personalized medicine.

How?

Imagine the level of knowledge researchers and healthcare practitioners will gain from running clinical trials in-silico based on the data gathered by projects like RPGEH.

We would all benefit from safety and efficacy profiles that are orders of magnitude more precise than those available today. Product testing would shift from clinical trials run on 5-10 thousand volunteers to trials run on millions of virtual volunteers based on real people and the environmental condition surrounding them.

This level of knowledge does not come without its problems. To address security and disclosure issues, Kaiser Permanente said that participation in the RPGEH is completely voluntary. Individual’s genetic information will not be used in genetic studies without their written consent. Furthermore, no research data is stored with identifying information.

11Feb/07

Are You Ready for Y2K7

By Daniel R. Matlis

Remember Y2K?  Well, the world didn’t end, companies spent large budgets in Y2K remediation projects, and computer systems continued to function. 

Just when the memories of Y2K begin to fade, along came the government and instituted Y2K7.

What is Y2K7?

The Energy Policy Act of 2005 included a provision that extends standard daylight time (DST) from the second Sunday of March to the first Sunday of November (currently it runs from April to October).  The change goes into effect March 11, 2007, and will be implemented across the United States except for Arizona, Hawaii, Puerto Rico, the U.S. Virgin Islands, and American Samoa.

Y2K7 will impact automated and computerized systems utilizing functions including:  

  • Calendar and scheduling
  • Date and time calculations (current and historical) 
  • Transaction logs (Coordinated Universal Time vs. Local Time) 
  • Computer generated audit trails

Most enterprise application vendors are providing patches, hot fixes or service packs to address issues resulting from DST change.

Addressing Y2K7 becomes more complex when dealing with departmental, standalone and customized or homegrown applications. Real-time systems, like manufacturing automation and bench-top equipment may require more substantial efforts to address the DST change. In some cases, systems may need to be manually updated, while in others, the application may rely on the date and time from the underlying system that it resides on.

But wait, don’t start downloading patches yet. Given the broad range of technology in use in Life-Science companies today, and the level of integration between them, it is imperative to begin the process by conducting an assessment.  This assessment should identify whether systems use date and time functionality for business or compliance activities (remember, your robot does not care what time it is, it’ll keep working as long as you maintain it properly).  Based on the results of this assessment, firms should determine what actions should be taken to mitigate the affects of DST 2K7.

The biggest issue with Y2K7 is the lack of broad awareness of its impact on computerized systems. As a result, many companies have not developed or implemented action plans to address the upcoming DST change in their computerized systems.

It would be interesting see the number of date/time related helpdesk calls on March 12th. Is anyone willing to share their experience?

25Jan/07

Here Is A Tip That Can Make You 2.6 Billion Dollars

By Daniel R. Matlis

No, it’s not insider trading. This is perfectly legal.

Today, Siemens announced that it will acquire UGS Corporation.  UGS’ software portfolio covers the entire array of collaborative Product Data Management (cPDM), computer-aided design/computer-aided manufacturing/computer-aided engineering (CAD/CAM/CAE) and digital manufacturing simulation (‘digital factory’).

During this morning’s analyst conference call, Siemens CEO Dr. Klaus Kleinfeld communicated his company’s vision to connect UGS’ Digital factory know-how with Siemens’ long standing tradition in industrial automation.

“We are going to see in the future that the combination of the digital factory as well as the real factory will shorten the time from early idea of a product to production of the product by 30%” said Dr. Kleinfeld. He continued “not only will we shorten the time, but we will also be able, due to simulation over the process, to clearly have a more reliable process and a more reliable product.”

If you have been reading Life-Science Panorama for some time, this might remind you of the article I wrote on “Total Business Integration”. That article was prompted by the announcement by UGS’s rival PTC of the integration of Windchill and Arbortext.

According to Helmut Gierse, Group President for Siemens A&D, “we will be the first fully integrate solution provider for an integrated software and hardware across the complete lifecycle of products”.

How does this impact Life-Sciences?

According to The Pharmaceutical Research and Manufacturers of America (PhRMA), it takes 10 to 15 years to get a new drug to market. As our industry moves from discovering new therapies to designing them, we have the unique opportunity to benefit from this fully integrated process.

So here is how you make your 12.5 Billion:

I’m sure you heard that every day you shorten a new drug’s time to market it represents a couple Million Dollars.

Cutting 30% off the typical 12 year cycle represents savings of 1314 days, which in turn mean over 2.6 Billion Dollars.

OK, you probable won’t get to keep all $2.6 Billion, but perhaps you’ll get a nice clock engraved with your company’s logo?

25Jan/07

Here Is A Tip That Can Make You 2.6 Billion Dollars

By Daniel R. Matlis

No, it’s not insider trading. This is perfectly legal.

Today, Siemens announced that it will acquire UGS Corporation.  UGS’ software portfolio covers the entire array of collaborative Product Data Management (cPDM), computer-aided design/computer-aided manufacturing/computer-aided engineering (CAD/CAM/CAE) and digital manufacturing simulation (‘digital factory’).

During this morning’s analyst conference call, Siemens CEO Dr. Klaus Kleinfeld communicated his company’s vision to connect UGS’ Digital factory know-how with Siemens’ long standing tradition in industrial automation.

“We are going to see in the future that the combination of the digital factory as well as the real factory will shorten the time from early idea of a product to production of the product by 30%” said Dr. Kleinfeld. He continued “not only will we shorten the time, but we will also be able, due to simulation over the process, to clearly have a more reliable process and a more reliable product.”

If you have been reading Life-Science Panorama for some time, this might remind you of the article I wrote on “Total Business Integration”. That article was prompted by the announcement by UGS’s rival PTC of the integration of Windchill and Arbortext.

According to Helmut Gierse, Group President for Siemens A&D, “we will be the first fully integrate solution provider for an integrated software and hardware across the complete lifecycle of products”.

How does this impact Life-Sciences?

According to The Pharmaceutical Research and Manufacturers of America (PhRMA), it takes 10 to 15 years to get a new drug to market. As our industry moves from discovering new therapies to designing them, we have the unique opportunity to benefit from this fully integrated process.

So here is how you make your 12.5 Billion:

I’m sure you heard that every day you shorten a new drug’s time to market it represents a couple Million Dollars.

Cutting 30% off the typical 12 year cycle represents savings of 1314 days, which in turn mean over 2.6 Billion Dollars.

OK, you probable won’t get to keep all $2.6 Billion, but perhaps you’ll get a nice clock engraved with your company’s logo?

21Jan/07

FDA to Conduct Evaluation of Pharmacovigilance Systems

By Daniel R. Matlis

On January 12th, I reported on FDA’s request for Pharmaceutical companies to confirm or repeat all pharmacokinetic studies conducted by MDS Pharma Services from 2000 through 2004.

This week the Agency announced that it will be conducting market research on commercially available pharmacovigilance risk management and product safety computer system products. 

Is this a coincidence?  I think not.

According to FDA’s own data, Corrective And Preventive Action (CAPA) findings represent 50% of the 483s issued to companies during inspections. It would be refreshing to hear that FDA is holding itself to the same standards it holds the industry.

I hope this study represents the first step in the agency’s CAPA process triggered by the MDS findings.

If your company provides pharmacovigilance and product safety systems, or you are already using these systems within your organization, the FDA would like to hear from you.  All requests must be submitted no later than January 31, 2007.

Submit your request to:
Food and Drug Administration
5600 Fishers Lane
Rockville, MD  20857
Attn: Ms. Smale/PKLN RM10B31 HFD-70

or

COTSResearch@fda.hhs.gov