Category Archives: Technology

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.

24Oct/06

Axendia Joins Forces with Microsoft to Strengthen BioIT Alliance

 Axendia Logo Microsoft Logo                                                          
 

FOR IMMEDIATE RELEASE
Contact: Monica Malave
Director, Marketing & Communications
mmalave@axendia.com

Yardley, PA, October 24, 2006 Axendia, a trusted advisor to Life-Science Executives on Business, Regulatory and Technology strategies, today announced that it has joined forces with Microsoft to strengthen the BioIT Alliance. 

Life science companies have unique technical challenges such as the need for more comprehensive data integration solutions, better technical collaboration and stronger knowledge management capabilities. The BioIT Alliance brings together science and technology leaders to consider innovative ways to address these challenges and use technology to reduce costs, streamline research and market their products more effectively. 

“We are pleased that Axendia, a leading advisory firm in the Life-Sciences Market, has joined the Alliance” said Don Rule, Microsoft’s Program Manager for the BioIT Alliance. “The Alliance unites the pharmaceutical, biotech, hardware, and software industries with leading advisory firms like Axendia, to explore new ways to share complex biomedical data and collaborate among multi-disciplinary teams to speed the pace of discovery in the Life Sciences” 

The Alliance will enable members to share information and to provide technical information about the solutions that they offer to the public. Alliance members will also collaborate on Proof of Concept applications that will address critical bottlenecks in discovery of new knowledge and application to our daily lives. 

“We are honored to join forces with Microsoft on the BioIT Alliance,” said Daniel R. Matlis, Founder and President at Axendia. “Through the Alliance, Axendia joins some of world’s top technology providers, to help the Life-Sciences industry move closer to making personalized medicine a reality”. 

About Axendia:

Axendia is the leading analysis firm focused strictly on the Life-Sciences and Healthcare markets. Our Mission is to be the most trusted advisor to Life-Science Executives on Business, Regulatory and Technology issues. With over 16 years experience in the Life-Sciences and Healthcare industries, Axendia provides a unique combination of hands on experience coupled with strategic vision. This enables us to successfully identify, create and execute strategies which provide lasting business value for our clients. Additional information on Axendia’s can be found at http://www.axendia.com/

About BioIT Alliance:

Formed in 2006, the BioIT Alliance is a cross-industry group working together to improve biomedical information technology on the Microsoft platform. Founding members include Affymetrix, Inc., Accelrys Software Inc., Amylin Pharmaceuticals, Inc., Applied Biosystems, The BioTeam Inc., Digipede Technologies LLC, Discovery Biosciences Corporation, Geospiza Inc., Hewlett-Packard Development Company, L.P., InterKnowlogy, Microsoft Corporation, Sun Microsystems Inc., VizX Labs LLC and other key companies in the pharmaceutical, biotech, hardware and software industries. Additional information about the BioIT Alliance can be found on the BioIT Alliance Web site at http://www.bioitalliance.org/

About Microsoft:

Founded in 1975, Microsoft (Nasdaq “MSFT”) is the worldwide leader in software, services and solutions that help people and businesses realize their full potential.
The names of actual companies and products mentioned herein may be the trademarks of their respective owners.


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20Oct/06

Can Microsoft Accelerate the Pace of Drug Discovery and Development?

Source: Microsoft Corp.

Yesterday, at Microsoft’s biotechnology Executive Forum, Microsoft announced the initiation of the BioIT Alliance’s second proof of concept, called the Biomarkers Project, along with an update on the Alliance’s first proof of concept, the Collaborative Molecular Environment.

The BioIT Alliance is a cross-industry group working to integrate science and technology to accelerate the pace of drug discovery and realize the potential of personalized medicine. The early focus of the Alliance has been to address the data-capture and data-integration challenges that face the industry.

“The life sciences offer one of the best opportunities for information technology to accelerate the pace of drug discovery and development,” said Craig Mundie, chief research and strategy officer at Microsoft. “Our collaboration in the Alliance will help the life science industry move discoveries from the lab to the clinic much faster.”

The Biomarkers Project: Initiation of Second Proof of Concept 

“One of the most important fields of research today is in gaining an understanding of the relationship between genetic traits and clinical outcomes,” said Dr. Michael Hanley, vice president of Discovery Research at Amylin Pharmaceuticals Inc. “The research and pharmaceutical community is hindered by the lack of integration among the software tools that are used to gain this insight.”

To address these challenges of software integration, the BioIT Alliance is collaborating on its second proof of concept, the Biomarkers Project. This undertaking will simplify the process for identifying and validating genomic biomarkers — the characteristics that indicate the presence of a disease or the likely efficacy of a drug.

17Oct/06

A Bar-Code In The Hand Is Worth Two RFID Tags In The Bush

On February 26, 2004, the FDA published its final rule onBar Code Label Requirements for Human Drug Products and Biological Products.  According to the Agency, “Bar Codes will allow health care professionals to use bar code scanning equipment to verify that the right drug (in the right dose and right route of administration) is being given to the right patient at the right time.  This new system is intended to help reduce the number of medication errors that occur in hospitals and health care settings.” 

The Bar-Code rule requires linear bar codes on most prescription drugs and on over-the-counter drugs commonly used in hospitals and dispensed pursuant to an order. The bar code is required to contain, at minimum, the drug’s National Drug Code (NDC) number, which uniquely identifies the drug. The rule also requires the use of machine-readable information for blood and blood components intended for transfusion. The machine-readable information must include, at a minimum, the facility identifier, the lot number relating to the donor, the product code, and the donor’s ABO and Rh. 

During the same month, February 2004, the FDA’s Counterfeit Drug Task Force issued its report on “Combating Counterfeit Drugs”. This report called for the implementation of Radio Frequency Identification (RFID) technology to allow the tracking of pedigree and mass serialization for all drug products. The Agency set forth a phased approach to the implementation of RFID technology starting at the case and pallet level for products likely to be counterfeited and progressively including all products at the case, pallet, and package level by 2007. 

In February of 2006, the FDA conducted a Counterfeit Workshop in Bethesda, MD to get an update from stakeholders on the status of RFID implementations. Affected stakeholders, including manufacturers, distributors and pharmacists, presented progress made and concerns associated with RFID and e-Pedigree initiatives. During my remarks to the Task Force, I stated that RFID technology should be used as an enabler, not a silver bullet. I conveyed the agency’s role to set regulatory requirements, gathered in cooperation with all affected stakeholders. However, in my opinion, the FDA should not mandate specific technologies to be utilized to achieve compliance.  

In June 2006, the task force issued its update on the FDA Counterfeit Drug Task Force Report. The agency admitted that although in 2004 it was optimistic that widespread implementation of e-pedigree was feasible by 2007, unfortunately, this goal most likely will not be met. The report went on to say:

“…it is clear from our recent fact-finding efforts that the voluntary approach that we advocated in the 2004 Task Force Report did not provide industry with enough incentives to meet FDA’s deadline.
We continue to believe that RFID is the most promising technology for electronic track and trace across the drug supply chain. However, we recognize that the goals can also be achieved by using other technologies.
Based on what we have recently heard, we are optimistic that this hybrid environment of electronic/paper and the use of RFID/bar code is achievable in the very near future. We believe that efforts to ensure that hybrid pedigrees are secure and verifiable should be a priority consideration.” 

Is this a case of one step forward and two steps back? I don’t believe so. I see it as a net gain for all stakeholders, especially patients.  The FDA estimates that the bar code rule, once implemented, will result in more than 500,000 fewer adverse events over the next 20 years.

Hospitals have recently made major investments in Bar-Code systems to comply with these regulations and minimize medication errors. Asking them to now reinvest in RFID technology without realizing the benefit of Bar-Codes would be a mistake. 

As the saying goes, A Bar-code in the hand is worth two RFID tags in the bush.
 

Copyright 2006 Daniel R. Matlis – AXENDIA