Category Archives: Technology

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

12Jan/07

How Soon Can You Get Me That 6 Year Old Data?

By Daniel R. Matlis

The Food and Drug Administration (FDA) announced that it has asked pharmaceutical companies to confirm or repeat all pharmacokinetic studies conducted for them by MDS Pharma Services (MDS Pharma) from 2000 through 2004.

MDS Pharma performed pharmacokinetic testing services for a number of pharmaceutical companies. These studies are used to measure the level of drug in a patient’s blood. The results of these studies are required for the approval of a drug by the FDA.

The action is a result of FDA inspections of two MDS Pharma Canadian facilities that raised questions about the validity and accuracy of test results from studies conducted by MDS Pharma from 2000 through 2004. FDA has worked with MDS Pharma to address these issues concerning its test results and is now following up directly with all pharmaceutical companies with marketed drugs or pending drug applications that may be affected by these testing issues.

The Agency sent over 1,000 letters to sponsors of pharmaceutical products for both brand-name and generic drugs

As you can imagine, drug companies affected by this notification want to review these studies as expeditiously as possible. However in some cases it may take weeks to just find the study data, let alone review and analyze it.

Why, you ask?

Some of these studies are six years old and are most likely collecting dust at archive facilities like Iron Mountain, or if you are lucky they are on a backup tape in a vault.

In either case it will take hours, days and in some cases weeks to find the right box or tape, retrieve it, parse it and find the pharmacokinetic study in question.  Only then will scientists be able to analyze the impact of the study on the drug and the patients.

According to a recent article, the amount of data required to support compliance activities in the Life-Sciences Industry has increased by 400% from 376 PetaBytes in 2003 to 1644 PetaBytes in 2006 (a PetaByte equals one quadrillion bytes).  This data is in Data Islands often connected by Sneaker-net across the enterprise.

This incident highlights the need for our industry to implement technologies that not only ensure that data is stored, archived and protected, but more importantly can be quickly and reliably retrieved to meet ever increasing business, regulatory and litigation discovery requirement.