25Aug/15
Image Courtesy of Forbes

Intelligence Based E-Inspections

By Daniel R. Matlis, President, Axendia

Are You Ready to be Graded on a Curve?

Summary

The Food and Drug Administration Safety and Innovation Act (FDASIA) provided the agency with sweeping new statutory authorities, which have not garnered much attention by industry.  A key FDASIA provision is the ability to conduct electronic inspections (e-Inspections) and target onsite inspection based on metrics.

By shifting to a metrics based approach the Agency seeks to encourage industry to implement state-of-the-art, innovative quality management systems that drive industry to focus on improving product quality, rather than simply ensuring compliance to regulatory requirements.

“…we want to encourage firms to prioritize quality and encourage their boardrooms and their pocketbooks because quality costs money,” stated Howard Sklamberg, J.D., FDA’s Deputy Commissioner for Global Regulatory Operations and Policy.

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19Aug/15
FDALogo

ISPE, FDA and the Metrics Future

By David R. Somers, Senior Industry Analyst, Axendia

Manufacturers and FDA to Measure Product Quality

Summary

The continuing efforts by biologic and pharmaceutical manufacturers to join the FDA to improve product quality, reduce inspection costs, increase the effective monitoring of products and streamline reporting requirements have crossed the Rubicon of mere theorizing, discussion and contemplation into firm and pro-active steps. Those efforts have been aimed at the establishment of acceptable and realistic standards of measurement for product development, testing, implementation, distribution and monitoring.  The direction is toward the establishment of acceptable and realistic standards of measurement for product development, testing, implementation, distribution and monitoring. These activities are in concert with the broader effort by FDA to promote innovation, increase stakeholder involvement in quality and enhance the safety of the supply chain.

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11Aug/15
Supply-Chain-Squares (3)

FDA Delayed Enforcement of DQSA Requirements – Part II

By David Lennard, Vice President and Ellyn McMullin, Research Associate, Axendia

Delayed Enforcement Provides Opportunity to Develop Complimentary Systems

The FDA’s delayed enforcement of DQSA requirements until May 1, 2015 and its second enforcement delay for dispensers until November 1, 2015, may be an unexpected “gift” that gives some companies not only more time to implement data sharing agreements but also the opportunity to reap the business rewards of data mapping and visibility into their own supply chain at the same time.

In the initial article in this series, we discussed how organizations can use DQSA data to benefit their business and their relationships with trading partners.

In this article we cover a key provision of DQSA:  the identification, control and handling of suspect and illegitimate product.  Continue reading

28Jul/15
Image courtesy of Dassault Systèmes

Medical Experiments on your Digital Twin

By Daniel R. Matlis

2015 Dassault Analyst Conference

SUMMARY

The Holy Grail of Life-Science and Healthcare is the development of a virtual human model; to enable medical experiments in-silico, rather than in-vivo.

In mid-June, I had the opportunity to see the next link in this evolution of the virtual human model while attending Dassault Systèmes’ analyst conference at the company’s headquarters in Vélizy, France, just outside Paris.  There, I was briefed by company executives on Dassault Systèmes (DS) vision in general and its Life-Science strategy in particular.

During his opening remarks, Bernard Charlès, DS President & CEO discussed the company’s vision to use the 3DEXPERIENCE to create ”Digital Twins” for physical systems across multi-domains (physical, chemical / biological /materials) and multi-scales (from atomic to large scale).

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21Jul/15
Image Credit: Empatica

The Race for Your Wrist and Medical Data is Happening – Now!

By Sandra Rodriguez

Technology and Life Science companies are collaborating at full speed

2015 is turning out to be an interesting year in the world of racing.Race-Winners (2)

Juan Pablo Montoya won the Indy 500, Joey Logano won the Daytona 500 and just a few weeks ago, American Pharoah outpaced all the other horses and won the Triple Crown.

However, there is another even more important race taking place.  It has to do with technology and you. Specifically, a highly coveted 1” wide piece of real estate on your body – your wrist.

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