Life Sciences Supply Chain Working Group Webinar
January 20, 2022 @ 12-1p ET

Join us for a webinar on serialization requirements for manufacturers.

The Drug Supply Chain Security Act (DSCSA) requires pharmaceutical trading partners to share data that tracks products and provides traceability through the supply chain. The sharing of data is dependent on the Electronic Product Code Information System (EPCIS).

There have been recent developments to business requirements to fulfill DSCSA obligations. Manufacturers need to start now to meet requirements for November 2022 and beyond.

This event will provide insights on:

  • The new regulatory requirements for November 2023 and why they are important for manufacturers.
  • How the latest announcements by the Big3 distributors are accelerating the timeline to November 2022 and how that impacts manufacturers.
  • How manufacturers can prepare to stay compliant.
  • The options available for companies using 3PL and how manufacturers can evaluate these options.

Speakers

Picture of Dean Caravoulias, Senior Director of Commercial Supply Chain at Apellis Pharmaceuticals

Dean Caravoulias
Senior Director of Commercial Supply Chain at Apellis Pharmaceuticals

Dean Caravoulias is an experienced pharmaceutical supply chain executive with nearly 20 years of experience in the industry. In his current role at Apellis, Dean was instrumental in driving many commercial supply chain workstreams to completion in preparation for Apellis’ first commercial launch in 2021. As the business owner for serialization at Apellis, he led the implementation of a serialization system and development of related processes to ensure compliance with the Drug Supply Chain Security Act (DSCSA), and he continues to direct serialization efforts to accommodate business growth along with evolving industry and regulatory requirements. Before joining Apellis, Dean was Director of Operations Planning & Strategy at Takeda where he was responsible for long-term vaccine network strategy & capacity planning. He has also held a variety of senior supply chain positions at Biogen and Merck encompassing global manufacturing and supply, inventory management, and sales & operations planning.  Dean has a BS in Chemical Engineering from the University of Delaware.

Nicole C. Costa from Alexion Pharmaceuticals will share perspective on building high-touch patient supply chains.

Stephanie Byrne
Serialization Lead ,Converge Consulting

Stephanie Byrne is a Serialization expert and Supply Chain Project Manager. She helps clients bridge the gap between sound strategy and reliable tactics by increasing the impact of process, technical, and configuration choices. Stephanie has more than 25 years of integration experience and a focus on implementing serialization for pharmaceutical track and trace. She helped nearly a dozen life sciences companies implement serialization for DSCSA and EUFMD compliance across brand owners, CPOs, 3PLs and serialization solutions.

Prior to Converge, she led new software implementation, B2B integration and enhancement projects from business case development through post go-live support with Maxiom Consulting Group and Coopers & Lybrand. Stephanie has managed multiple phases of ERP software implementations across order-to-cash, procure-to-pay, manufacturing, distribution, procurement, and inventory management. In roles with Momentive Specialty Chemicals and Waters Corporation, she managed integration projects across the sales, procurement, supply chain and finance functions, while also leading an eBusiness/B2B integration program linking electronic catalogs, purchase orders and invoices to exchange eProcurement systems transactions. Stephanie earned her MBA and BS in Management from Rensselaer Polytechnic Institute. She is a certified TraceLink Administrator and has obtained Smartsheet certification, PMI certification, and GS1 standards certification for DSCSA.

Todd Applebaum from Converge Consulting will provide his perspective on developing high-touch patient supply chains.

Todd Applebaum
Managing Director, Converge Consulting

Todd Applebaum has supported many clients transitioning from clinical development to commercial production of Biologics, Pharmaceuticals, and Cell Therapies. Todd consults on business strategy, manufacturing, technical operations, the quality system, process development, operational strategy & execution, supply chain management, business process/workflow automation and IT enterprise solutions. Prior to starting Converge Consulting, he served as VP, Technical Operations at Ovascience, Inc., helping transition the company from research to commercial operations. Todd also held the role of VP, Research for the Healthcare and Life Science industries at Gartner, Inc. where his research focused on building patient outcomes-focused operations, the impact of personalized and precision medicines, global operations and network planning, track & trace technologies and operational & performance excellence. He has a BS in Industrial Engineering from General Motors Institute and an MBA from Carnegie Mellon University.

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