# Presentation: 717056

## Anti-Counterfeit Drug Initiative Workshop

***Anti-Counterfeit Drug Initiative Workshop***
***Bethesda, MD.***
***February 8,  2006***

***Jim Rittenburg, Ph.D.***
***Authentix ***
***610 385 0540***
***www.authentix.com***

## The Drug Supply Chain at Risk

**Our drug supply chain is at risk today****  **
**Counterfeits are on the increase in the US and Globally**
**Unauthorized distribution and diversion is increasing**
**The supply chain is vulnerable to terrorist attack**
***Technology exists today to address these issues***

## A Question of Focus

**Significant barriers must be overcome**
**Technological **(read rates, interferences, global standards)
**Economical **(cost per tag)
**Political **(privacy, data ownership)
**Widespread use is still many years away**
**Do we have the proper focus??**

**RFID technology holds much promise for the future, however.....**

## A Question of Priority

**Major retailers are pushing the agenda**
**Their primary motive is to improve supply chain efficiency...  ****	****not securing the supply chain**
**Pharma is bearing the costs but not getting the benefits**
**Are the right priorities being encouraged?  **

**RFID technology is being force-fed to Pharma**

## A Question of Timing and Policy

**Strengthen penalties for counterfeiting and unauthorized distribution**
**Establish strong distribution agreements with wholesalers**
**Employ authentication technologies on products and packaging**
**Develop ongoing field audit process - physical, paper, and electronic**
**Strengthen licensing and oversight requirements**
**The PDMA pedigree provisions should be implemented without any ****	****further extensions**
**Initiate mass serialization of product to the unit level**
***Prioritize the use of barcode technology***

**The supply chain can be tightened now **

## Develop a Hybrid Approach 

**2**

**3**

**4**

- Develop a Hybrid Approach

- One Pallet

- Tens of Cases

- Hundreds to Thousands of Bottles or Tubs

- Many Pallets in Warehouse

- Apply serialized code to each **case** that enables association to each product within

- Apply Unique Serialized Code to Each **Product**

- Apply serialized code to each **pallet** that enables association to each product and case within

- Associate product with client or destination

- Barcode	RFID

## Employ Hybrid Strategies

**Mass serialization**
**Datamatrix barcode symbology at unit level**
**Barcode and RFID at higher packaging levels**
**Build out data management infrastructure**
**Standardize the numbering system with EPC compatibility**
**Manufacturers manage and own data for their products**
**Initially utilize “bookend” strategy**
** ****establish database of valid numbers at manufacture**
** ****confirmation validity at point of sale**

** **

**Leverage existing technology - build forward compatibility**

## Establish Early Warning System

**Mass serialize product**
**Establish database of valid codes**
**Product scans at point of sale checked against database**
**Multiple hits from same code flag an alert**
**provides early warning of a problem**
**but does not identify which hit is fake**
**Authentication technology can be combined with serialization****  **

**Each manufacturer has responsibility for their products**

## Phased Approach to Securing Supply Chain

**Phase I - Now**
**Mass serialize product with barcode technology**
**Establish data management infrastructure**
**Utilize “bookend” approach**
**Phase II - Next Several Years**
**Add “pages” between the bookends**
**Involve 3rd party distributors to achieve full traceability**
**Phase III - Five years +**
**Phase in RFID at unit level**
**Build out RFID infrastructure for widespread use **** **