Life Science Leader: November 2009
"Molecular Screening: It's Time to Stop Thinking Outside the Box with Counterfeit Drugs"
HealthCare Distributor: February 2009" CBI Seminar Focuses on Anti-Counterfeiting; Anti-Diversion Strategies in the Supply Channel "
The National Frontiers: July 2008
"High-Stakes Hide and Seek "
HealthCare Distributor: May 2008
"The Future and Safety of Supply Chains Discussed at Secure Pharma 2008"
Authentication News: January 2008
"EDXRD Provides True Authentication"
News Media
Pharmaceutical Manufacturer and Packing Sourcer: Autumn 2009
"Thinking Inside the Box"
By Alan Clock
The editorial piece discusses analyzes the
various segments of anti-counterfeiting technology and introducing EDXRD and material
screening as a robust tool in combating counterfeit, adulterated and fraudulent
medications within the global supply chain.
The phrase, “Thinking Inside the Box” refers to EDXRD’s capability to screen
and authenticate materials inside their sealed, unit-of-sale containers without destroying or degrading the materials.
This unique solution allows all members of the pharmaceutical supply chain to efficiently, accurately and inexpensively
test and screen product to ensure that their inventories are safe and efficacious.
Today, the various members of the
pharmaceutical supply chain find themselves in an expanding global marketplace and in the midst of an ever
growing epidemic that threatens each relevant party. As globalization
increases, so too does the risk of counterfeit, substandard or fraudulent medications within the supply chain.
This increase in risk threatens both the economic and physical health of the pharmaceutical industry and its consumers.
Here are a few staggering statistics related to this scourge:
- The World Health Organization (WHO) conservatively estimates that counterfeit medications will be a $75 billion global industry in 2010.
- The WHO projects the annual growth of counterfeit medications to be between 12 and 16 per cent annually, worldwide.
- According to the WHO, more than 2,000 children in Africa alone die each day as a result of taking counterfeit medications.
- The WHO reports that, across the world, 10 per cent of pharmaceuticals are counterfeit, fraudulent or adulterated. Proliferation and percentages
are much higher in developing countries in Asia, Africa and South America, with up to 50 per cent of the supply chain projected to be identified
as counterfeit or adulterated.
TRACK AND TRACE
To date, nearly all of the solutions for this global epidemic emphasize what are known as ‘track and trace’ methods (such as barcodes, holograms, RFID,
pedigree, taggants and serialization). These solutions are primarily based on traditional technology for inventory control and security and are common within most sophisticated supply chains.
They are incredibly effective in tracking products, especially in direct or short supply chains, where the additional cost can be justified in their inventory control capabilities because the
members of the supply chain use common systems and tools for tracking, distribution and sales. However, track and trace solutions have their limitations. They generally require some sort of
addition to the outside of the box or package, and a common technology to be read and documented. These processes and technologies add further cost to the product and are difficult to maintain
across large global supply chains. In addition, because of its external placement, the track and trace item may be easily replicated, and it does not verify that the material inside the package
is safe and efficacious.
To read the complete article visit PMPS at www.samedanltd.com/magazine/15/issue/122/article/2531
To view pdf
click here.
back to top
Life Science Leader: November 2009
"Molecular Screening: It's Time to Stop Thinking Outside the Box with Counterfeit Drugs"
By Brian Mayo
"Molecular screening represents the newest generation of security measures against counterfeiting. It allows you to perform
nondestructive testing anywhere along the supply chain, and it easily scales to match a distributing, repackaging, returns
logistics, or dispensing company’s needs."
While the pharmaceutical industry struggles with counterfeiting and adulteration of drugs, most of the proposed solutions focus on track-and-trace methods,
like 2-D bar codes, holograms, RFID devices, and pedigrees. Each of these methods adds a level of authentication to the outside of the packaging containing the product.
Over time, so many variations of these have spread throughout the industry, which now screams for standardization. The evolution of track-and-trace technologies
has become so complex that the industry is almost in analysis paralysis….Maybe the industry should instead just step back a bit and take a completely different perspective on the same problem.
Management training has drilled into our brains to “think outside the box” to come up with the best solution to our problems. Perhaps it’s time we stop thinking outside the box and start looking
inside the box for the best solution…
Molecular screening represents the newest generation of security measures against counterfeiting. It allows you to perform nondestructive testing anywhere along
the supply chain, and it easily scales to match a distributing, repackaging, returns logistics, or dispensing company’s needs. Moreover, molecular screening can analyze the drug inside any sealed
container for proper formulation, correct dosage, contamination, or adulterations, all without requiring any changes to existing drug products. Since each drug has a unique molecular fingerprint,
you can use that molecular fingerprint to accurately identify the drug…
Molecular screening works for everyone along the supply chain. Pharmaceutical manufacturing companies do not have to change anything with their products
to support molecular screening. Repackagers and mail-order facilities can ensure that they have not only received valid inventory, but that their own processes have functioned properly.
Dispensers, the last point in the supply chain, can verify their received inventory before passing it along to the patient. Even returns logistics can benefit from molecular screening
by verifying whether the drugs being returned are valid or not….
To View Full Article at www.lifescienceleader.com. . .
back to top
HealthCare Distributor: February 2009
" CBI Seminar Focuses on Anti-Counterfeiting; Anti-Diversion Strategies in the Supply Channel "
By Bruce Kneeland
A two day seminar on Anti-Counterfeiting and Anti-Diversion strategies held Oct. 20-21, 2008, at the
Sheraton in Tyson's Corner, Va., attracted
over 100 industry executives. They Gathered to learn the latest on how technology is being deployed to help stem the ever increasing number of potentially harmful medications that
threaten the United States pharmaceutical supply channel....
Alan Clock, Senior Vice President,
Sales and Marketing, XStream Systems Inc., provided an interesting new insight
into the questions of drug authentication. According to Clock, much of the thinking and regulations contemplated to date have been directed toward finding ways
to track and trace product as it moves through the supply chain. Clock says that while these procedures make sense and are on the verge of becoming practical,
they fail to look at the product actually being shipped.
Clock’s company is touting the advantages of a technology called X-Ray diffraction. In this process, a low watt
x-ray beam is directed at the actual, unopened pharmaceutical package and the unique way this beam is diffracted is captured and compared to a baseline
standard. Clock explains that each pharmaceutical product has a unique molecular “fingerprint” and the XStream unit is able to determine how the product in the
sealed package compares to the product standard. Clock says the system is being pilot tested currently in a secondary supplier, a major returned goods company
and a regional wholesaler’s returned goods department; and that it is proving to be a cost effective way to ensure the security of their inventories....
To View Full Article . . .
back to top
In-Pharma Technologist: February 2009
"XStreams' XT250 Helps Distributors See Through Fakes"
By Garath McDonald
"Authentication and track and trace methods, like pedigree, should be combined to provide layers of protection against counterfeits, says
XStream Systems' CEO, Brian Mayo.
XStream’s X250 energy dispersive x-ray diffraction (EDXD) technology, which is used to identify the molecular
contents of sealed products, was recently employed by a major US drug distributor to authenticate 20,000
bottles at a single site.
To View Full Article . . .
Pdf of Article . . .
back to top
The National Frontiers: July 2008
"High-stakes Hide and Seek"
By John Mather
New Scanning Technologies are bring increased transparency to everything
from long-haul cargo to carry-on luggage. John Mather reports
While Mr Mayo believes all these technologies will increase security
in the UAE, he says they remain flawed. However, he says, his firm has developed a technology that is 99 per cent accurate. Originally used to
find cracks in concrete, Xstream’s energy-dispersive X-ray diffraction technology analyses objects at a molecular level. The Department of
Homeland Security and the Transportation Security Administration in the United States asked Mr Mayo and his brother, who is an X-ray expert at
Rutgers University, to develop the science in the wake of Sept 11. By determining the space between atoms, which Mr Mayo calls an object’s
“unique fingerprint”, there is no mistaking or missing threats.
In fact, he says, as demand for detection products increases, the traps
available to airports and customs agents will continue to improve. “I think you’re going to see in five to 10 years’ time some impressive
solutions in technology.”
To View Full Article . . .
back to top
HealthCare Distributor: May 2008
"The Future and Safety of Supply Chains Discussed at Secure Pharma 2008"
By Bruce Kneeland
It seems that despite the best efforts of industry associations, company executives and government regulators,
no industry wide consensus has been reached on the most practical ways to protect the integrity of the pharmaceutical supply chain....
Secure Pharma 2008, held at the Philadelphia Hilton, Feb. 26-27, attracted more than 300 people. Most of the attendees were from pharmaceutical manufacturing and distributor companies
that came because they were eager to find ways to solve the problems of counterfeiting and drug diversion that besets the industry....
One new piece of technology that was discussed during the event appears to be approaching the problem from a completely unique direction. Up until this time, most of the efforts
in ensuring the supply chain have involved tagging, tracing or otherwise
making it difficult to insert product into the supply chain through more regulation and procedures. But, a new product from XStream
Systems is reported to be able to use a modified type of x-ray analysis that can actually determine if the chemical structure of the product contains all the necessary ingredients in
the proper order.
According to Alan Clock, SVP Sales & Marketing for XStream Systems, this new technology can be used to "scan" the product, without the need to open the package, and determine if the
product is counterfeit, or even if the cold chain has been broken in shipment resulting in molecular degradation. Clock believes the
benefits of this technology will make it possible
for any member of the supply chain to be absolutely certain the products they handle are legitimate
and can be sold and dispensed with confidence.
To View Full Article . . .
back to top
Authentication News: January 2008
"EDXRD Provides True Authentication"
By Alan Clock
The article 'Test the product, Not the Packaging' in the November 2007 issue of
Authentication News examined the new breed of technologies that enable products to be tested by analysing their characteristics without
removing or displacing the packaging. One such technology is Energy Dispersive X-Ray Diffraction, which XStream Systems is developing
for authentication purposes. In this article, the company's SVP of Sales & Marketing, Alan Clock, explains more.....
To View Full Article . . .
back to top