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.

Image Courtesy of Forbes

Intelligence Based E-Inspections

By Daniel R. Matlis, President, Axendia

Are You Ready to be Graded on a Curve?


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.

Continue reading


ISPE, FDA and the Metrics Future

By David R. Somers, Senior Industry Analyst, Axendia

Manufacturers and FDA to Measure Product Quality


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.

Continue reading

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

Image courtesy of Dassault Systèmes

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).

Continue reading