I would be willing to bet that almost every regular reader of RxTrace knows who Bob Celeste is, and most of you have probably already heard that he is ending his long tenure with GS1 US. Last fall that organization announced that Bob would continue into the new year as a consultant, and shortly after that, he would transition his GS1 Healthcare US work group facilitation work to others. Bob reminded everyone on his weekly industry calls of that schedule about two weeks ago and by the end of this month he will no longer fill that role.
Bob started working for GS1 back when it was still known as the Uniform Code Council (UCC) in 2001. I think I first met Bob at the first EPCglobal conference in Chicago in 2003. Bob was a key motivator in the creation of the EPCglobal Healthcare and Life Sciences (HLS) Business Action Group (BAG) where the pharma industry came together to figure out how to use RFID to meet the Florida and then the California pharmaceutical pedigree laws. So much has changed in the understanding of the hardware and software technologies and their application in the pharma supply chains since that time. Bob has played a major role in seeking the right direction and documenting it.
…AND DOCUMENTING IT
In fact, there is a zig-zag path that the HLS (and later GS1 Healthcare and GS1 Healthcare US) took to get where we are now in 2015. Bob was a very patient and persistent guide through all those twists and turns. He was the collector and keeper of all the documents that each work group generated. For a long time it seemed like every turn was a dead end, but finally around 2011 it was Bob who recognized what that collection of old, seemingly “dead end” documents could be. He and the volunteers on the GS1 Healthcare US Traceability work group began carefully extracting the gold from those old documents and collecting it into a single guideline for “Applying GS1 Standards to U.S. Pharmaceutical Supply Chain Business Processes To Support Pedigree And Track & Trace, Release 1.0” in March of 2013. That guideline was aimed at using GS1’s Electronic Product Code Information Services (EPCIS) to meet the California pedigree law (see “The New GS1 Healthcare US Track & Trace Guidance”).
Despite the blood, sweat, tears and years it took to compile, eight months later, the U.S. Congress passed the Drug Quality and Security Act (DQSA), which contained the Drug Supply Chain Security Act (DSCSA) (see “It’s Official, President Obama Signs H.R. 3204, DQSA, Into Law”), preempting all state pedigree laws, including California’s. Bob and team immediately began working to transform that California-centric document into a DSCSA-centered one. In October of last year, they published that new version (version 1.1) aimed at meeting the DSCSA. But that wasn’t the end of it. Under Bob’s leadership, the group kept working on version 1.2 of that guideline document to include additional information, including exception handling (see “DSCSA Exception Handling: A Preview of Your Next Surprise Headache”). That new version is due to be published this spring.
All of us who work on pharma track and trace owe Bob a debt of gratitude for his vision and persistence over the years. I am personally thankful for Bob’s efforts. Without his leadership, the last dozen years of my career would not have been so eventful, productive and gratifying.
WHAT’S NEXT FOR BOB
Bob has formed a consulting practice called RCPartners as a platform for helping companies understand what they need to know and do, to meet the new FDA regulations. He will make use of new teaching technologies to help ensure that his clients efficiently receive and retain the knowledge they need. From training videos to simulations, Bob will apply everything he has learned through his career to help his clients.