Cambridge Consultants

Hugh Burchett

Leading the way in innovative product development

Cambridge Consultants was established 50 years ago as a leading product development business based in Cambridge, UK and Cambride MA and has been developing anti-counterfeit technology for the past 20 years.

In the area of authentication and anti-counterfeiting, we take a technology-independent approach to addressing a client's situation and assessing which combination of technologies provide the best fit for their needs. We ask: What are the issues? What are the attributes needed by the solution? What are the technologies that possess those attributes? When it comes to anti-counterfeiting, we look at the economics of the balance between threats vs. risks. Uniformity of regulations, legal aspects, i.e. the penalties and other deterences, come into play as well as other business benefits that an anti-counterfeit solution can provide.

Research/Science uniqueness

Counterfeit medicines are a serious and a growing issue globally. Traditionally associated with developing countries and illegal online pharmacies, they are also increasingly being detected in the legitimate supply chains of industrialized countries. The UK's MHRA alone reported nine cases of recalled counterfeit medicine in the past three years which had reached the patient or pharmacy and the U.S. customs seizure of counterfeit pharmaceuticals increased to $11.1M in 2007, which is almost a 500% increase on the previous year. See: http://www.cbp.gov/linkhandler/cgov/trade/priority_trade/ipr/pubs/seizure/trading/07_topirp_seizures.ctt/07_topirp_seizures.pdf

Significance

Patient safety in the biotech and pharmaceutical sectors is the primary driver behind regulatory efforts in the US and around the world, as supported by the industries.

Serialization has been successfully rolled out by a number of companies to address this need as well as countering the diversion of product between markets, which brings additional risks in biotech to due the stringent transportation requirements of biologic products.

Anti-counterfeit technologies have evolved from a number of areas ranging from traditional document security, logistics and medical diagnostic technology.

Background

There is no "one-size-fits-all" solution, technologies need to be woven in a layered solution which takes into consideration the risk (a factor of likelihood of counterfeiting and severity of a counterfeit product to the brand) versus the threat (capability of the counterfeiter and their intent to target the product). Once this balance is clear then we can develop a system to protect the brand and patient using techniques, such as anti-tamper or tamper evident packaging; serialization, or authentication (overt, covert or forensic).

Vision

Regulatory pressures driven by patient safety and diversion of product are strong drivers for anti-counterfeit measures to be implemented. In addition, increasingly biotechnology companies are considering early stage biotech businesses anti-counterfeit strategy during the acquisition process to confirm that this has been addressed as part of the business strategy.

Needs

Addressing anti-counterfeit products is often like trying to hit a moving target. Counterfeiters are technically savvy, well financed and resourceful. This means the challenge is how to use technology effectively across the entire supply chain. From raw materials and manufacturing to the Point of Dispense (PoD), the rise of internet pharmacies has further highlighted the problem where the supply chain is untrusted or indeed virtual.

Challenges