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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16Jul/15
ABC pic

Food for Thought on Quality and Compliance

By Daniel R. Matlis

Would you rather…

Eat Bad Food in a Clean Restaurant?

OR

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.

          

14Jul/15
FDALogo

FDA DELAYED ENFORCEMENT OF DQSA REQUIREMENTS


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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01Jul/15
QAD-Key-Initiatives-2015-150x50

From Flip Flops To The Cloud!

The Next Step in the Evolution of ERP
QAD EXPLORE – 2015

 By David Somers, Senior Industry Analyst, Axendia

SUMMARY

Sometimes, there are certain occasions which transcend an otherwise seemingly routine activity of business commerce into something truly insightful and innovative. I was privileged to witness just such an event this past May, the origin of which began nearly 40 years ago from a relationship that emerged from a meeting of necessity by two individuals, creating what is QAD today.

Deckers-Flip-Flops

Image courtesy of QAD

Pamela Lopker, Chairman of the Board and President of QAD,  a leader in manufacturing software for industrial businesses and Karl Lopker, Chief Executive Officer, direct all of QAD’s business, including operations, expansion into new markets with a specific focus on a strong regional and industry-specific direction. Formerly Karl was president of Deckers Outdoor Corporation; the makers of the iconic multi-layered rainbow Flip Flops designed to to fill the “Space Below Your Feet.”

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