2022 Traceability Webinar Series Speakers | Healthcare Distribution Alliance | HDA

Speakers

Robert Celeste

Founder

Center for Supply Chain Studies
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM
Robert Celeste

Founder

Center for Supply Chain Studies
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM
Bob Celeste’s deep understanding and knowledge of the healthcare supply chain, including current standards and technologies, along with his ability to harness his expertise and innovate around the complexities of track-and-trace implementation, serialization and regulatory compliance, has made him a trusted industry partner.

Along with his work with both state and federal regulators, Bob often serves as an advisor to the FDA, State Boards of Pharmacy and other governing organizations. Most recently he was tapped as an advisor to the USAID and international regulators on the identification and tracking of drugs and medical supplies.

Bob launched the Center for Supply Chain Studies in 2015 to continue his practice of utilizing strategic simulations to address the challenges and demands of the supply chain. His expertise extends across many industries, including pharmaceutical, consumer goods, fresh foods, aerospace, automotive, specialty chemicals and others.

Prior to founding the Center, Bob was Senior Director at GS1 US, where he worked with industry on standards-based, item-level traceability and was the lead in developing the first DSCSA implementation guideline.
Dwight De Vera

Vice President, Product Strategy

Inmar Intelligence
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM
Dwight De Vera

Vice President, Product Strategy

Inmar Intelligence
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM
Perry L. Fri

Executive Vice President, Industry Relations & Member Services and COO, HDA Research Foundation

Healthcare Distribution Alliance
- "Myths versus Realities" & "Legal and Business Requirements Across the Supply Chain"
  Thursday, September 15, 2022 | 2:00—3:00 PM
Perry L. Fri

Executive Vice President, Industry Relations & Member Services and COO, HDA Research Foundation

Healthcare Distribution Alliance
- "Myths versus Realities" & "Legal and Business Requirements Across the Supply Chain"
  Thursday, September 15, 2022 | 2:00—3:00 PM
Perry L. Fri is HDA’s Executive Vice President of Industry Relations, Membership & Education and Chief Operating Officer of the HDA Research Foundation. At HDA, Fri is responsible for the direction, supervision and development of industry initiatives that facilitate improved business processes and operational efficiencies in the healthcare supply chain. Fri currently serves on the Board of Directors for Healthcare Ready, a 501(c)(3) organization established to help public and private sector stakeholders across the pharmaceutical supply chain prepare for (and maintain operations during) disasters.

Fri previously served as Vice President of Industry Relations and Program Development for the Health Industry Distributors Association (HIDA). Prior to joining HIDA, Fri held positions with The Hale Group and Instill Corporation. He holds a BA in History from the University of Maryland.
Elizabeth A. Gallenagh

General Counsel and Senior Vice President, Supply Chain Integrity

Healthcare Distribution Alliance
- "Myths versus Realities" & "Legal and Business Requirements Across the Supply Chain"
  Thursday, September 15, 2022 | 2:00—3:00 PM
Elizabeth A. Gallenagh

General Counsel and Senior Vice President, Supply Chain Integrity

Healthcare Distribution Alliance
- "Myths versus Realities" & "Legal and Business Requirements Across the Supply Chain"
  Thursday, September 15, 2022 | 2:00—3:00 PM
Elizabeth A. Gallenagh is the General Counsel and Senior Vice President, Supply Chain Integrity at the Healthcare Distribution Alliance (HDA). She is the organization’s chief legal officer, overseeing all legal matters for HDA. Gallenagh also serves as HDA’s primary expert on prescription drug traceability, supply chain safety and integrity, distributor licensure and tax issues.

Since joining HDA, Ms. Gallenagh led the Alliance's industry-wide efforts to replace a 50-state patchwork of pedigree laws with one national traceability solution, which became a reality through the enactment of the Drug Supply Chain Security Act (DSCSA) in November 2014. In 2014, she was honored by the industry with the Distribution Management Award for Industry Leadership, which honors an individual who has exhibited the highest standards of honesty and integrity, working to enhance industry relations and knowledge, as well as supply chain efficiency and security.

Gallenagh is a graduate of the George Mason University School of Law and The George Washington University.
Ilir Ivezaj

Product Engineer

LSPedia
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM
Ilir Ivezaj

Product Engineer

LSPedia
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM
Julie Malone

Regulatory Affairs Manager

Value Drug Company
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
  Thursday, August 11, 2022 | 2:00—3:00 PM
Julie Malone

Regulatory Affairs Manager

Value Drug Company
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
  Thursday, August 11, 2022 | 2:00—3:00 PM
Julie Malone is the Regulatory Affairs Manager for Value Drug Company where she has been a part of the DSCSA team for the past seven years. In her role at VDC, she developed a regulatory affairs program across departments and additionally developed the DSCSA suspect and illegitimate product investigation system. A proven risk manager and ethical strategist, Julie has maintained VDC’s accreditation status through the NABP Drug Distributor program. With the ability to synthesize complex policy and high velocity issues Julie has contributed to compliant business operations and profitability. She has been an active member at HDA serving on several committees including the Technology Implementation Work Group. With over 20 years of experience in both the private and public sectors, she served on the budget and policy staff for former Florida Governor Jeb Bush, as well as an Executive Director for several state licensing boards within the Florida Department of Business and Professional Regulation. Julie holds a Master’s degree in Journalism from Regent University and a Bachelor of Science degree in Political Science from Carnegie Mellon University.
Scott A. Mooney

Vice President Distribution Operations, Traceability

McKesson Corporation
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
- "DSCSA 101 and Timeline" & "EPCIS Onboarding Checklist"
Scott A. Mooney

Vice President Distribution Operations, Traceability

McKesson Corporation
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
- "DSCSA 101 and Timeline" & "EPCIS Onboarding Checklist"
Scott Mooney is Vice President of Distribution Operations at McKesson Corporation. His primary responsibilities are assuring product integrity through regulatory compliance and traceability. Scott leads McKesson’s Traceability Team working on implementation across McKesson’s various business units.

Scott joined McKesson in 1987 and had previous roles in Finance, Distribution Center Management and as a Regional Vice President of Distribution Operations. Scott has participated in McKesson’s integration of acquisitions over the last 16 years.

Scott has been active in HDA’s Traceability Workgroup, the HDA Industry Relations Council and participates in several committees including the FGAC, RAC and SGAC. He is tri-chair of GS1 Global Healthcare Leadership Team and is a member of the GS1 US Healthcare Executive Leadership Committee.

Scott has a BA in Accountancy and a MBA from the University of Wisconsin – La Crosse.
Tracy Nasarenko

Vice President of Community Engagement, Healthcare

GS1 US
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
- "DSCSA 101 and Timeline" & "EPCIS Onboarding Checklist"
Tracy Nasarenko

Vice President of Community Engagement, Healthcare

GS1 US
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
- "DSCSA 101 and Timeline" & "EPCIS Onboarding Checklist"
Tracy Nasarenko, vice president of Community Engagement at GS1 US for Healthcare, is an accomplished leader with more than 20 years of experience in healthcare and pharmaceutical supply chain, finance, product management, marketing, and operations.

In her current role, Ms. Nasarenko leads a collaborative healthcare industry group focused on addressing supply chain challenges and meeting the requirements of regulations like the Drug Supply Chain Security Act (DSCSA). Using GS1 Standards, the most widely used supply chain standards in the world, Ms. Nasarenko guides the implementation of these standards to help the pharmaceutical industry deliver safe products to patients.

Prior to joining GS1 US, Ms. Nasarenko held several leadership positions with SPI Pharma Inc. Most recently, she served as a site general manager, overseeing end-to-end operations and performance of the entire team, where she built a culture of engagement, innovation, and collaboration.

Ms. Nasarenko earned her bachelor’s degree from Villanova University and received her Master of Business Administration from West Chester University.
Bradley T. Pine

Smith Drug Company, Div. J M Smith Corporation
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
  Thursday, August 11, 2022 | 2:00—3:00 PM
Bradley T. Pine

Smith Drug Company, Div. J M Smith Corporation
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
  Thursday, August 11, 2022 | 2:00—3:00 PM
Brad Pine is currently Vice President, Brand Pharma & Regulatory for Smith Drug Company; he has over 30 years of experience in the pharmaceutical wholesale industry. Brad's industry experience includes working for national and regional wholesalers; his breadth of knowledge comprises regulatory compliance, branded pharmaceuticals, consumer goods, marketing and overall business operations.

Brad is responsible for oversight of Branded Manufacturer Agreements, regulatory implementation, Distribution Center SOPs, and business strategies. He has been involved in implementing the Drug Supply Chain Security Act (DSCSA) at Smith Drug Company and is an active member on HDA's Traceability Implementation Work Group since its inception in November 2013.

He is an active member on HDA committees, including the Federal Government Affairs, Regulatory Affairs, and State Government Affairs Committees.

Brad holds a BS degree in Finance from Indiana University.
Matt Sample

SVP, Manufacturer and Replenishment Operations

Cencora, Inc.
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
  Thursday, August 11, 2022 | 2:00—3:00 PM
Matt Sample

SVP, Manufacturer and Replenishment Operations

Cencora, Inc.
- "DSCSA Dispenser Preparedness: What Your Distributor Can Do for You" & "DSCSA Compliance for the Dispenser"
  Thursday, August 11, 2022 | 2:00—3:00 PM
Matt Sample is the Vice President of Manufacturer Operations at AmerisourceBergen. He is responsible for the maintenance of vendor and item master data, driving the adoption of supply chain standards internally and with manufacturer trading partners, and leading the implementation of DSCSA across all AmerisourceBergen business units. In addition to the core drug distribution business responsibilities, Matt is responsible for the DSCSA serialization efforts within their pharmaceutical manufacturing and repackaging businesses and leads our Covid19 Therapies operations efforts with the United States Government.

He has over 17 years of experience in the medical device, pharmaceutical and life sciences industry, working both for manufacturers, wholesalers and for a large consulting firm. He has held various roles in the areas of product development, lean six sigma, business system implementation and operational leadership. Prior to joining AmerisourceBergen, Matt was the serialization program lead at a mid-size pharmaceutical company, and the UDI program manager a large medical device manufacturer.
Jillanne Schulte Wall

Senior Director, Health and Regulatory Policy

American Society of Health-System Pharmacists (ASHP)
- "DSCSA 101 and Timeline" & "EPCIS Onboarding Checklist"
  Thursday, September 29, 2022 | 2:00—3:00 PM
Jillanne Schulte Wall

Senior Director, Health and Regulatory Policy

American Society of Health-System Pharmacists (ASHP)
- "DSCSA 101 and Timeline" & "EPCIS Onboarding Checklist"
  Thursday, September 29, 2022 | 2:00—3:00 PM
Elizabeth Waldorf

Director, Global Traceability and Standards

TraceLink Inc.
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM
Elizabeth Waldorf

Director, Global Traceability and Standards

TraceLink Inc.
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM
Elizabeth Waldorf is Director of Global Traceability and Standards at TraceLink. She is responsible for transforming global regulatory serialization and traceability regulations into product requirements for TraceLink’s portfolio of track and trace solutions. Elizabeth is a key contributor to TraceLink’s delivery of US, Brazil, China, South Korea, EU, Russia, India, Bahrain, Indonesia, Uzbekistan, and Kazakhstan government compliance modules. Elizabeth is focused on transforming country regulations into standardized models for traceability implementations.

Starting before the US DSCSA regulation was passed, Elizabeth has been driving pharmaceutical compliance at the state level. Her effort has continued through the passing of the US DSCSA regulation to the present day. A believer in achieving interoperability and operational efficiency through standards, Elizabeth’s editorial contributions include the following guidelines: “GS1 US Implementation Guideline for Applying GS1 Standards for DSCSA and Traceability (release 1.2)”, “GS1 US Implementation Guideline for the GS1 Lightweight Messaging Standard for Verification of Product Identifiers (releases 1.0, 1.1 and 1.2)”, and “GS1 US Applying GS1 System of Standards to Pharmaceutical Chain of Custody (releases 1.0 and 1.1)”. With a vigilant eye towards accelerating onboarding of trading partners for DSCSA message exchanges using EPCIS, Elizabeth collaborated to develop the GS1 US Rx EPCIS Conformance Testing Program. Committed to industry pharmaceutical compliance readiness, she is working towards the development of future releases of implementation guidelines to reflect evolved requirements and learnings.

With a passion for thought leadership, Elizabeth joined the GS1 US Healthcare Executive Leadership team and has taken on various leadership roles spanning GS1 US and GS1 Global. She currently co-chairs the GS1 US Rx Secure Supply Chain workgroup and GS1 EPICS/CBV 2.0 MWSG. As a member of GS1 Architecture team, Elizabeth serves as the GS1 Architecture liaison to GS1 Mission Specific Workgroups for EPICS/CBV 2.0, Pharmaceutical Clinical Trial Processes and Biological Samples. Elizabeth previously co-chaired the GS1 Brazil Traceability, Global Traceability Standard, and the GS1 Lightweight Messaging Standard workgroups.

Elizabeth is also an active leader in other industry and standards organizations including Partnership for DSCSA Governance (PDG), Healthcare Distribution Alliance (HDA) and serves as tri-chair of the Open Credentialing Initiative (OCI)’s Policy and Architecture team. She brings together her multi-discipline experience to advance and accelerate the delivery of specifications and adoption of interoperable standards. Before joining TraceLink, Elizabeth led Amgen’s global serialization and traceability initiatives, and drove adoption of GS1 standards across the company. In her 20-year tenure at Amgen, Elizabeth held numerous senior leadership roles managing cross functional teams in Global Supply Chain, Sales & Marketing, Enterprise Architecture, and Finance. Her leadership style and operational excellence mindset combined with business and information systems background have resulted in many successful implementations of process re-engineering and automation initiatives.
Herbert Wong

SVP Product & Strategy

Antares Vision Group
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM
Herbert Wong

SVP Product & Strategy

Antares Vision Group
- "DSCSA 2023: How a Service Provider Can Help You Prepare" & "All About the VRS"
  Thursday, August 25, 2022 | 2:00—3:00 PM