Earlier this year, the FDA called on the life sciences and healthcare industry to design and deliver pilot projects for an electronic, interoperable system that can identify and trace prescription drugs as they are distributed across the United States in support of the Drug Supply Chain Security Act (DSCSA). Several industry innovators including Systech, RXTransparent, T-Systems, FarmaTrust, CryptoWerk, and CalQLogic responded to the FDA’s proposal and were recently notified that the proposal was approved by the Agency.
The proposed Pilot Project represents The Optimal Solution to the future of the Drug Supply Chain including new innovations e-Fingerprinting®, IOT Cold Chain data, Blockchain, and advanced supply chain analytics that will deliver significant value beyond simple compliance in addition to assuring that the US Drug Supply Chain is one the safest in the world. The Optimal Solutions pilot is a two-phase six-month engagement. The first phase of the project involves developing a detailed blueprint for the industry advisors and FDA to review. The second phase of the pilot involves simulating scenarios and summarizing the findings for final review by industry advisors and the agency. The following is the pilot program’s initial supply chain overview.
- Serialization of units, intermediates, shippers, and pallets using GS1 standards.
- Capture and creation of a unique fingerprint for unit serialized barcode.
- Aggregation of children to parents.
- Transmission and storage of manufacturing lot data including serialized, aggregated packaging data using GS1 messaging standards.
- Processing and storage of supply chain events including outbound shipping and inbound goods receipt from point of manufacture to downstream trade partners.
- Processing and storage of warehouse events including unpacking, picking, and packing.
- Processing and storage of supply chain events including outbound shipping and inbound goods receipt from distribution trade partners to points of dispensation.
- Capture and storage of in-transit IoT events and data in real time using sensors applied to shipments.
- Capture of dose dispensing data at health systems.
- Authentication of unique fingerprints at dispense location using mobile technologies.
- Connectivity to manufacturing and trade partners using a cloud-based Internet as a Service (IaaS) solution.
- Storage of full EPCIS payloads on a cloud-based IaaS solution, preferably individually encrypted by respective data owners and with non-encrypted metadata attached for cross-vendor, the interoperable discovery of provenance (“phone book”).
- Storage of anonymous digital fingerprints (hashes) of transaction data on any participating (vendor) blockchain for interoperable proof of transaction data authenticity and respective immutable timestamps.
- Optionally, storage of obfuscated transaction data and metadata on vendor blockchain(s) in parallel as required by the respective vendor solution(s).
- Mobile distributed app-based functionality to query blockchain data for brand inspectors.
- The ability of the FDA to audit information from the blockchain.
- Ability to feed AI/ML models for insight and analytics.
We are currently recruiting industry advisors from across the supply chain as stakeholders’ companies. Finally, we will be showcasing our initial plans via several online events including the Talk to Your Pharmacist Podcast and an introductory panel discussion webinar being held on:
Date | April 30, 2019
Time | 1pm EDT .
April 24th press release announcing this collaborative effort. Click here.