I hope everyone had a great holiday season and found time to spend with family and friends. I am looking forward to a great 2019.
Towards that end I wanted to offer a few of my own personal insights for the pharma serialization space in 2019 followed by an update on new consulting, solution and service offerings from Jennason.
Predictions for pharma serialization in 2019
With the Nov 2018 DSCSA serialization milestone having passed the industry is in a unique position. As more and more companies enter a fully serialized world, we will experience the first true test of how well implementations are performing.
Some bumps have already been experienced- the question is whether it will become a trend?
Some bold predictions for 2019
1. As the industry starts to tackle aggregation and integration with distribution/3PL operations (on a mass scale) the robustness of enterprise serialization platforms will be tested- and many will recognize their solutions are not up to par.
2. The major players in the enterprise serialization space will see some shakeup- with both current players losing steam and new players entering the mix
3. The progression towards "value beyond compliance" will be slowed by efforts to resolve issues with current implementations
Jennason Consulting in 2019
As always Jennason continues to provide the pharmaceutical industry with expert consulting support and purpose-built solutions based on over 10 years of serialization and commercial supply chain experience.
At the end of 2018 Jennason consulting engagements could generally be put into 3 categories:
1. Emerging biotech/pharma manufacturers looking to launch products in the next 12-24 months and needing to be serialization compliant.
2. Manufacturers who have had an ongoing serialization project/program for 1+ years but need additional support to resolve vendor issues to ensure compliance with DSCSA is achieved.
3. Manufacturers with an interest to extract further value out of their serialization investments- but to do so first need an assessment on the current state of their implementations.
Jennason looks forward to an intriguing 2019- the consistent goal remains the same- making sure pharmas are educated on serialization/traceability/compliance while promoting proper use of GS1 standards to ensure best, long-term implementations.
New/Updated Solution Offerings
Jennason Master Data and Workflow Manager- As a company's commercial supply chain demands grow so too does the importance of master data management. The Jennason MD&W Manager provides a cost-effective and robust alternative to spreadsheets and manual processes. More information
Jennason DSCSA Verification Manager- Last fall the FDA released guidance for Verification Systems under DSCSA. The Jennason DSCSA Verification Manager provides a workflow for companies to ensure compliance with all required tasks (verification, quarantine, investigations) as well as manages required FDA and trading partner notifications. More Information
EU FMD EMVO Gateway Translation Tool - Built in collaboration with Be4ward Consulting, the EMVO Gateway Translation Tool is geared towards companies needing an immediate EU FMD compliance solution. The Tool is capable of translating serialization data files from packaging sites/CMOs into the EMVS format which can then be manually uploaded via the EMVO Gateway web portal. More Information
Jennason Serialization Test Tool- Launched over 4 years ago the Serialization Test Tool continues to be the leading off-the-shelf testing solution specifically designed for pharma serialization implementations. The Tool is capable of simulating common serialization scenarios (commissioning, aggregation, shipping, end of life) and generating the corresponding EPCIS test data. All major L4/L5 serialization platform vendors are supported. More Information
New Service Offerings
In late 2018 Jennason launched Jennason Design Services. The purpose of Design Services is to support companies in need of building custom applications which supplement or enhance their serialization and commercial supply chain operations. Design Service engagements range from developing implementation tools to reporting dashboards to proof of concepts for companies looking to unlock additional value from their serialization investments. More information
Thank you again and look forward to hearing from you in 2019.