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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


Medical Experiments on your Digital Twin

By Daniel R. Matlis

2015 Dassault Analyst Conference


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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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.

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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Food for Thought on Quality and Compliance

By Daniel R. Matlis

Would you rather…

Eat Bad Food in a Clean Restaurant?


Eat Great Food in an Unsanitary Restaurant?

I shared this dilemma with Industry Executives and FDA Officials to illustrate the distinction between compliance and quality in a restaurant setting during the most recent MDIC Case for Quality (CfQ) forum in Washington DC.

Restaurant Quality v Compliance

Click on thumbnail to see image full size

The CfQ forums afford FDA and Industry the opportunity to engage in open, candid, and constructive discussions on ways to improve product quality.  Discussion topics range from identifying barriers to investment in prevention and product quality to generating actionable ideas to overcome industry / regulator obstacles.

Since this topic got such positive response, we decided to flesh it out into an infographic.

Think about this dilemma the next time you discuss the distinction between quality and compliance with your management or when you head out to dinner.

Compliance should be the baseline. Quality should be the goal!  

To download the infographic as a PDF, click here.




Delayed Enforcement Provides a Business Opportunity

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

On July 1st, FDA  published guidance stating that: “FDA does not intend to take action against dispensers who, prior to November 1, 2015, accept ownership of product without receiving the product tracing information, as required by section 582(d)(1)(A)(i) of the FD&C Act.”

Last December, FDA published guidance informing industry that it did not intend to Supply-Chain-Squares (3)take action against manufacturers, wholesale distributors, or repackagers who did not, prior to May 1, 2015, provide or capture the product tracing information required by the new Drug Quality and Security Act (DQSA).

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