Category Archives: Uncategorized

08Oct/15
Time-Travel

Siemens Industry Analyst Conference 2015

By Sandra K. Rodriguez, Research Associate

Digital Twins Enable Time Travel

If you had a time machine, would you rather take a peek in to the future or change something in the past?   If you could build a digital twin that enabled time travel, would you?

The theme of this year’s Siemens Industry Analyst Conference was Realizing Innovation.   Virtualization and digitalization capabilities throughout the product lifecycle are giving industry the opportunity to do something new – time travel.

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16Sep/15
drip

An Anti-DRIP Campaign

By Ellyn McMullin, Research Associate

Unlocking Big Data to Achieve Business Value

Of the many workshop type of meetings I have attended, this is the best one I have gone to…there was an actual success story!  This is the feedback from one participant at the Executive Roundtable on Big Data in Life Sciences.

That’s what happens when a leading business transformation company provides an environment for its clients and partners to discuss mutual concerns and potential solutions.  On August 27th, Trace3 brought together Executives from Merck, Novo Nordisk, NNIT, BMS, and J&J Janssen to discuss Big Data in Life Sciences in Princeton, NJ.

Trace3 is a business transformation partner, helping organizations through high-end consultancy.  The company empowers organizations to keep pace with the rapidly changing IT landscape by leveraging innovative technologies and organizational health.  Trace3 has a Big Data practice and had one of their principals, Carey Moretti, moderating the roundtable.

The Executive Roundtable explored the challenges and rewards of implementing Big Data and analytics within the complex regulated Life Sciences space. Axendia’s President discussed industry wide trends and FDA’s perspective on Big Data.  He offered insight on how to leverage a multitude of varying data sources from new and legacy systems to gain greater visibility and how to improve product quality while improving revenue and lowering costs.

Jerry Megaro, Merck & Co.

Jerry Megaro, Merck & Co.

The keynote speaker, Jerry Megaro, Director of Innovation and Analytics at Merck & Co. has a degree in Chemical Engineering from NJIT and 15 years of experience of working in Merck’s Manufacturing arena.   He is currently leading initiatives to transform Merck Manufacturing into a data driven organization to enhance Merck’s performance across the Supply Chain.

Reverse the DRIP

Remember GIGO (Garbage in, Garbage out)?  It refers to the fact that computers, since they operate by logical processes, will unquestioningly process unintended input data (“garbage in”) and produce undesired, often nonsensical, output (“garbage out”).  The issue about the quality of the data generally is no longer a major concern, but the use of the data output is.  Unfortunately many companies are the sufferers of DRIP!  DATA  RICH  INTELLIGENCE POOR

Life-Science companies have vast amounts of data (Big Data) generated by a multitude of systems (SCADA, Historian, MES, ERP, EAM, LIMS, etc.) but unfortunately have very little Intelligence on how this information can be harnessed to produce a better quality product.

To request a copy of the Executive Roundtable event note and learn how Merck & Co., Unlocked Big Data to Achieve Business Value, please click here.

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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11Aug/14
CFQ 2

FDA Forum Fosters Candid Discussion Between Industry and Agency

By Daniel R. Matlis

On June 26, the FDA hosted an Executive Forum on the “Case for Quality Initiative.” The forum brought together Industry Executives, FDA Officials and Industry Advisors in a series of roundtable discussions and presentations.

After the event, I had the opportunity to converse with two FDA Officials to gain their perspectives on the forum.

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