All posts by Administrator

31Jan/07

FDA Moves Closer To Becoming An Information Broker

By Daniel R. Matlis

FDA Commissioner Dr. Andrew C. von Eschenbach recently announced the creation of the Office of the Chief Medical Officer. The position will be held by Dr. Janet Woodcock, a strong advocate for modernization and transformation at the FDA.

“FDA is a science-based agency and science-led Agency; science provides the foundation for our regulatory decisions and the work we do on a daily basis to promote and protect the nations’ health,” said Dr. von Eschenbach. “Creation of this office, and position, will better ensure we achieve this mission with the highest scientific quality and effectiveness needed.”

As the Deputy Commissioner and the Chief Medical Officer, Dr. Woodcock will oversee scientific and planning-related operations for FDA. In this capacity, Dr. Woodcock shares responsibility and collaboration with the Commissioner of FDA in planning, organizing, directing, staffing, coordinating, controlling, and evaluating the agency’s scientific and medical regulatory activities in order to achieve the mission of FDA.

John R. Dyer, MPH, will take Dr. Woodcock position as the agency’s Deputy Commissioner for Operations and the Chief Operating Officer (COO). Mr. Dyer will concentrate on strengthening the management, business processes, and information technology of the agency. In addition, Mr. Dyer will work with the other Deputy Commissioners and the Chief of Staff to provide management leadership and oversight to FDA.

“With almost 24 percent of the products in the marketplace regulated by FDA it is imperative we apply and incorporate modern management tools and techniques to our regulatory decisions. Mr. Dyer’s deep experience in management is ideally suited to meet the emerging challenges and opportunities involved in protecting and promoting the health of the American public in the 21st century” said Dr. von Eschenbach.

Mr. Drier brings significant experience in Information Technology to this position. From 2001-2003, Mr. Dyer worked in the private sector for information technology and executive leadership companies. In his federal career from 1972 to 2000, Mr. Dyer held increasingly responsible executive positions with the Social Security Administration (SSA), including the Chief Information Officer and Principal Deputy Commissioner where he assisted the agency by leading the effort to automate and modernize systems and improve the level of customer service.

These appointments represent an important step by the agency in implementing Dr. Woodcock stated goal to transform the FDA into an information provider as well as a regulator.

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.

07Jan/07

Democrats First 100 Hours May Have a Big Impact on Life-Sciences

By Daniel R. Matlis

The Democrats are coming in full force with a very ambitious agenda for their first hundred hours in control of the senate and house.

During the first 100 legislative hours of the 110th Congress, Democrats plan to bring to the floor the following issues:

  • Tuesday, January 9 – Implement the 9/11 Commission Recommendations
  • Wednesday, January 10 – Increase the Minimum Wage
  • Thursday, January 11 – Expand Stem Cell Research
  • Friday, January 12 – Allow Negotiation for Lower Prescription Drug Costs
  • Wednesday, January 17 – Cut Interest Rates on Student Loans
  • Thursday, January 18 – End Subsidies for Big Oil and Invest in Renewable Energy

From a Life-Science perspective two of these stand out. Stem Cell research and Lower Prescription Drug Costs.

A Republican Executive and Democratic Legislative are going to make for an interesting two years for our industry. But as a Zen master would say:”Who is to know what is a blessing and what is a curse?”