Globaltrackandtrace.org will try to build industry consensus on pharma security, traceability
There is enough industry attention being paid to product serialization and pedigree, apparently, that a new group can form up to try to move the technology forward. The group is called globaltrackandtrace.org, and is being founded by Excellis Consulting (Devon, PA) and Axway (Scottsdale, AZ). A first-time “Leadership Forum” will be held on Nov. 5 in Newton Square, PA.
“Past efforts to move this technology forward have suffered because the players involved—manufacturers, distributors, retailers and government—often were focused on their own agenda,” says Greg Cathcart, president of Excellis (and a former executive at SupplyScape, the now-defunct pioneering company that developed some of the original drug-pedigree methodology). “By bringing trading partners together in an open forum, we hope to get them talking about common goals.”
“Our expectation is that this will be more about deriving business value from serialization, and less about meeting a regulatory deadline,” says Sia Zadeh, director of business development at Axway. He also emphasizes that serialization needs to be looked at in a global context; in fact, serialization activity is more active now in Europe than in the US.
The GS1 organization, coordinator of product identification technology standards, and AMR Research, a market research company, will also be involved in the initial meeting.
An Exploration of Compounding Practices
May 22nd 2025In a Q&A with Pharma Commerce, Kurt Lunkwitz, ProRx Pharma’s COO, uncovers the stringent requirements that 503B outsourcing facilities must abide by under the Drug Quality and Security Act, while also shedding light on the FDA’s impact when it comes to improving the safety, quality, and trust in compounded drugs.
FDA Outlines Updated Requirement for Placebo-Controlled Trials in Vaccine Research
May 21st 2025In an article recently published by The New England Journal of Medicine, FDA higher-ups Vinay Prasad, MD, MPH; and Martin A. Makary, MD, MPH, wrote that any new COVID-19 vaccine must now be evaluated in placebo-controlled studies.