Understanding the Impact of Blockchain on Pharmaceutical Serialization and Track & Trace Requirements

Where we are today, and where we’re heading tomorrow.

Blockchain technology has the potential to greatly revolutionize many areas of our lives, including improving visibility into pharma value chains. Countries around the world have mandated that pharma products be serialized and tracked/traced through the full supply chain. One important aspect of the U.S. Food and Drug Administration’s (FDA) traceability legislation, the Drug Supply Chain Safety Act (DSCSA), is a requirement that by 2023, all prescription drugs be tracked and traced through the supply chain using an interoperable system. While existing serialization and traceability solutions meet the current DSCSA regulations, there is no system in place that is fully interoperable at this time.

The FDA is looking to the pharma industry to develop its own solution for complete interoperability. There is currently work underway to demonstrate the viability of various blockchain solutions for pharma supply chains that has broad participation from the pharma industry, solution providers and regulatory agencies.

The goal of this webinar is to get you up to speed on that work, as well as share how one global technology company envisions developing blockchain solutions for the pharma industry in the near future.

Bob Celeste from The Center for Supply Chain Studies (CSCS) will share information/progress about the center’s proof-of-concept pilot program, “DSCSA and blockchain, phase 2.” During this webinar, Bob will provide an update for people who aren’t able to be part of the April 30 – May 1 in-person meetings where teams will perform walkthroughs of their work studies. This webinar will also be helpful to those who attended that event and want a summary or refresher on what ground was covered and what will likely take place next.

OPTEL has long believed that incorporating blockchain into its serialization and traceability solutions for its pharma customers will offer them the greatest value. Steve Gélinas, Director of Strategy and Innovation at OPTEL, will outline the company’s vision and its core development beliefs for blockchain technology; namely, that future blockchain solutions should be industry-specific and vendor-agnostic. He will share the company’s overarching compatibility goals that aim to support blockchain efforts industry-wide, as well as provide insights into how OPTEL hopes to offer integration points and expanded services to all blockchains so that one blockchain can be adopted by the entire pharmaceutical industry.

There will be time for questions and answers following Bob and Steve’s presentations.

Speakers

Bob Celeste, Founder, Center for Supply Chain Studies

Bob Celeste has over 30 years of experience in the chemical, financial, pharmaceutical, medical device and retail industries with a focus on business process re-engineering, information management, standards development and usage. For the past 13 years, Bob was senior director, Healthcare with GS1, EPCglobal and GS1 US where he concentrated on working with regulators (FDA, DEA, California, Florida and Nevada Boards of Pharmacy) on the proper use of master data management and track and trace information and practice. In this capacity, he provided numerous presentations and talks on the subjects of drug traceability, in particular on the 2013 Drug Supply Chain Security Act (DSCSA, Title II of the DQSA) and product Unique Device Identification regulation (UDI). Bob continues to speak on a broad range of topics concerning pharmaceutical, medical device supply chain issues as well as healthcare provider, brand protection and security. The Center for Supply Chain Studies (www.C4SCS.org) is a nonprofit organization, created as a neutral place for group-funded projects to occur and to publish the white papers, reference models and educational material that result from those studies.

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Steve Gélinas, Director of Strategy and Innovation, OPTEL GROUP

Steve Gélinas is director of strategy and innovation at OPTEL Group. He holds a bachelor’s degree in electrical engineering as well as a project management professional (PMP) certification. For more than 20 years, he has worked in technology and consulting, particularly in operational excellence and the deployment of information solutions. Mr. Gélinas has extensive experience in quality management, environmental and product development systems, and  has managed several technology implementation projects for major organizations with a focus on continuous improvement. His role as strategy and innovation director is to promote OPTEL’s traceability solutions for sustainable development and a circular economy.

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