2022 Traceability Seminar Speakers | Healthcare Distribution Alliance

Speakers

Ameer Ali

Sr. Director, Manufacturer Operations

Cencora, Inc.
- Roundtable Discussions
- Roundtable Discussions
Ameer Ali

Sr. Director, Manufacturer Operations

Cencora, Inc.
- Roundtable Discussions
- Roundtable Discussions
Ameer Ali is Sr. Director of Manufacturer Operations at Cencora. He joined Cencora in 2015 to support DSCSA related process implementations with responsibilities spanning both data exchange and barcode compliance as well as other non-DSCSA EDI and packaging functions. He participates regularly in industry groups to support process efficiency and best practices across the supply chain. These groups include HDA DSCSA exceptions, HDA Research Foundation, GS1 Rx Secure Supply Chain and GS1 GLN workgroups among others. He also took part in many industry pilots and FDA public meetings in preparation for phased implementation of DSCSA.
Josh M. Bolin

Associate Executive Director for Government Affairs and Innovation

National Association of Boards of Pharmacy®
- State Regulators and the DSCSA; Enforcement Approaches and Outstanding Gaps in Product Tracing
  Thursday, October 13, 2022 | 10:30—11:00 AM
  
  M4 - Liberty Ballroom (I-P)
Josh M. Bolin

Associate Executive Director for Government Affairs and Innovation

National Association of Boards of Pharmacy®
- State Regulators and the DSCSA; Enforcement Approaches and Outstanding Gaps in Product Tracing
  Thursday, October 13, 2022 | 10:30—11:00 AM
  
  M4 - Liberty Ballroom (I-P)
Josh Bolin serves as the Associate Executive Director for Federal Affairs and Strategy for the National Association of Boards of Pharmacy (NABP). Since joining NABP in 2005, Josh has worked on development of PMP InterConnect, multiple pharmacy accreditation and inspection programs, including accreditation programs for durable medical equipment and specialty pharmacy, and inspection programs for the prescription drug supply chain, sterile and nonsterile compounding and nuclear pharmacy. Josh also worked with NABP’s member boards of pharmacy to develop NABP’s Universal Inspection form and Multistate Inspection Blueprint, which are tools to assist the boards of pharmacy in conducting uniform inspections of sterile compounding facilities. Josh is currently working with NABP member boards of pharmacy on uniform processes and tools with respect to the DSCSA.
Ronald N. Bone

HDA Consultant

Ronald N. Bone Consulting LLC
- Moving Downstream: The Dispenser Community on Data-Flow Endpoints
  Friday, October 14, 2022 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Ronald N. Bone

HDA Consultant

Ronald N. Bone Consulting LLC
- Moving Downstream: The Dispenser Community on Data-Flow Endpoints
  Friday, October 14, 2022 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Ron Bone is a consultant in the area of Pharmaceutical Traceability and is currently focusing on the implementation of the U.S. 2013 Drug Quality and Security Act. Ron retired from McKesson Corporation where he held the position of Senior Vice President, Distribution Support. His responsibilities included Regulatory Affairs and leading McKesson's product security initiatives through the use of electronic track and trace.

Ron spent 41 years with McKesson Corporation in various operations, sales and financial management positions. He was a member of the of the GS1 Process Oversight Committee, a member of the Leadership Teams of GS1 Global Healthcare and GS1 US Healthcare, and was a member of the Industry Relations Council for the Healthcare Distribution Management Association (HDMA). In 2008, Bone testified before the U.S. House of Representatives, Energy and Commerce Committee as an industry expert on anti-counterfeiting. In 2007, he was the recipient of HDMA’s Nexus Award, which is the industry’s highest honor recognizing leadership, exemplary service and professional excellence.

Ron received his BS and MBA degrees from San Jose State University.
Ian Cannell

Business Process Consultant / DSCSA National Project Sponsor

Kaiser Permanente
- Roundtable Discussions
- Moving Downstream: The Dispenser Community on Data-Flow Endpoints
Ian Cannell

Business Process Consultant / DSCSA National Project Sponsor

Kaiser Permanente
- Roundtable Discussions
- Moving Downstream: The Dispenser Community on Data-Flow Endpoints
Robert Celeste

Founder

Center for Supply Chain Studies
- Roundtable Discussions
- Roundtable Discussions
Robert Celeste

Founder

Center for Supply Chain Studies
- Roundtable Discussions
- Roundtable Discussions
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.
Jeffery W. Denton

Cencora, Inc.
- EPCIS Onboarding Across the Supply Chain
  Thursday, October 13, 2022 | 1:30—2:30 PM
  
  M4 - Liberty Ballroom (I-P)
Jeffery W. Denton

Cencora, Inc.
- EPCIS Onboarding Across the Supply Chain
  Thursday, October 13, 2022 | 1:30—2:30 PM
  
  M4 - Liberty Ballroom (I-P)
Jeff Denton is currently Senior Director, IT Global Secure Supply Chain at AmerisourceBergen. With over 30 years of experience in the wholesale distribution business, Jeff has held positions of increasing responsibility in finance, procurement, contracts and chargebacks as well as Information Technology.

Over the last 13 years, Jeff has been very involved in a variety of aspects around the supply chain security initiative. In addition, he has participated in numerous standards-activities within HDA and GS1-US/Global.

His current responsibilities include Enterprise IT solutions for AmerisourceBergen’s Global Secure Supply Chain program. Jeff serves at the IT lead and is the key liaison across all of the various business units – aligning implementation with standardization.
Anita T. Ducca

Healthcare Distribution Alliance
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
Anita T. Ducca

Healthcare Distribution Alliance
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
Anita T. Ducca is HDA’s Senior Vice President of Regulatory Affairs. She serves as the chief liaison and advocate on behalf of HDA with federal regulatory agencies, including FDA and DEA. She has been with the organization since 2002. Prior to joining HDA, Ducca was the Director of Regulatory Affairs for the American Red Cross Biomedical Services (ARC), where she was responsible for internal and external regulatory, compliance and health and safety. Anita also served in a regulatory advocacy capacity for the American Petroleum Institute. Earlier, she has also served on the staff of several federal regulatory agencies, including the Food and Drug Administration, the Office of Management and Budget and the Environmental Protection Agency. Ducca has a BA in Mathematics from Boston College and a MS in Biostatistics from Georgetown University.
Perry L. Fri

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

Healthcare Distribution Alliance
- Opening Remarks
  Thursday, October 13, 2022 | 8:30—9:00 AM
  
  M4 - Liberty Ballroom (I-P)
Perry L. Fri

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

Healthcare Distribution Alliance
- Opening Remarks
  Thursday, October 13, 2022 | 8:30—9:00 AM
  
  M4 - Liberty Ballroom (I-P)
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.
Connie Jung

Senior Advisor for Policy

U.S. Food and Drug Administration
- FDA DSCSA Overview and Update
  Thursday, October 13, 2022 | 9:00—10:00 AM
  
  M4 - Liberty Ballroom (I-P)
Connie Jung

Senior Advisor for Policy

U.S. Food and Drug Administration
- FDA DSCSA Overview and Update
  Thursday, October 13, 2022 | 9:00—10:00 AM
  
  M4 - Liberty Ballroom (I-P)
Dr. Jung is currently Senior Advisor for Policy in the Office of Drug Security, Integrity, and Response (ODSIR) in FDA’s Center for Drug Evaluation and Research, Office of Compliance. Her work focuses on development of policy and regulatory strategies to improve the security and integrity of the U.S. drug supply to protect patients from counterfeit or stolen product. She received her B.S. in Pharmacy from The Ohio State University and her Ph. D. in Pharmaceutical Sciences from the University of Cincinnati. Dr. Jung joined the FDA in 1999 as a toxicology researcher in the Center for Food Safety and Applied Nutrition, and later served as a Regulatory Reviewer of bioequivalence studies in the Office of Generic Drug before working on supply chain issues.
Georg Jürgens

Manager Industry Solutions & OCI Co-Chair

Spherity, Inc.
- Roundtable Discussions
- Roundtable Discussions
Georg Jürgens

Manager Industry Solutions & OCI Co-Chair

Spherity, Inc.
- Roundtable Discussions
- Roundtable Discussions
After graduating in Business Administration from Technical University of Munich, Georg worked as manager for a large German retailer and as product owner for a software house for supply chain management services. Joining Spherity as first employee in 2018, he is today responsible for industry solutions built on top of the Spherity Cloud Identity Wallet. Currently, Georg is rolling out the Credentialing Service for authorized trading partners to enable compliance with the US Drug Supply Chain Security Act. He represents Spherity on OCI, HDA and PDG tasks forces for DSCSA.
Mark Karhoff

Principal Consultant

Ten Count Consulting
- Roundtable Discussions
  Thursday, October 13, 2022 | 2:35—3:50 PM
  
  M4 - Liberty Ballroom (I-P)
Mark Karhoff

Principal Consultant

Ten Count Consulting
- Roundtable Discussions
  Thursday, October 13, 2022 | 2:35—3:50 PM
  
  M4 - Liberty Ballroom (I-P)
Mark Karhoff is the Program Manager for the U.S. Serialization Program at Genentech. The Serialization Program has been formed to ensure compliance of DSCSA guidelines for manufactures for 2017 while also supporting distributors and dispensers similar efforts. Mark previously served as Program Test Manager in NASCAR project including the internal testing of labels from all plants supplying the U.S.
Julie Malone

Regulatory Affairs Manager

Value Drug Company
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
Julie Malone

Regulatory Affairs Manager

Value Drug Company
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
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.
David G. Mason

Supply Chain Compliance and Serialization Lead

Novartis Pharmaceuticals Corporation
- EPCIS Onboarding Across the Supply Chain
  Thursday, October 13, 2022 | 1:30—2:30 PM
  
  M4 - Liberty Ballroom (I-P)
David G. Mason

Supply Chain Compliance and Serialization Lead

Novartis Pharmaceuticals Corporation
- EPCIS Onboarding Across the Supply Chain
  Thursday, October 13, 2022 | 1:30—2:30 PM
  
  M4 - Liberty Ballroom (I-P)
Dave Mason is currently the Director of Supply Chain compliance and Serialization – Dave supports the Commercial Trade and Supply Chain teams, supporting the implementation of DSCSA for the Novartis group. Leading efforts to assure Novartis error rates are six sigman or less by assuring procedures are in place for serialization data quality and integrity, improving existing serialization processes and systems as information is provided by supply chain partners on the DSCSA processes. Dave represents Novartis in trade association, PDG and FDA public meetings. He communicates to the NTO Global Serialization team with new and existing requirements for other countries, and he assures that the validation approach is consistent within the organization and execution at the sites. Dave also supports the team to develop to support serialization as it is integrated into the normal business processes. Dave has worked on serialization since 2003 in California and helped implement global solutions.
Michael J. Mazur

Director, Trade Operations

Pfizer Inc.
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
Michael J. Mazur

Director, Trade Operations

Pfizer Inc.
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
Mike’s responsibilities include developing and implementing strategies to enhance patient safety and further secure the U.S. pharmaceutical supply chain. He represents Pfizer externally on various customer engagements and industry interactions relative to channel security and works closely with internal Pfizer colleagues to implement approved strategies. Mike has been directly involved with Pfizer’s global projects to implement serialization and is responsible for ensuring compliance with the U.S. Drug Supply Chain Security Act (DSCSA) requirements. He also works closely with Pfizer’s Global Security organization as it relates to investigations of suspected counterfeit or adulterated Pfizer products and is a member of the GS1 Healthcare US. Mike has 22 years of operational experience within the pharmaceutical industry.
Scott A. Mooney

Vice President Distribution Operations, Traceability

McKesson Corporation
- EPCIS Onboarding Across the Supply Chain
- Roundtable Discussions
Scott A. Mooney

Vice President Distribution Operations, Traceability

McKesson Corporation
- EPCIS Onboarding Across the Supply Chain
- Roundtable Discussions
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 is serving as a member of the Board of Directors of the Partnership for DSCSA Governance as well.

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

Head of Analytics, Strategic Projects and Serialization

Sanofi US
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
Arthi Nagaraj

Head of Analytics, Strategic Projects and Serialization

Sanofi US
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
Arthi Nagaraj is part of the North America Supply Chain team at Sanofi and leads their analytics and serialization efforts. She supports all 3 Business units within Sanofi: General Medicine, Specialty Care and Vaccines, in their efforts to be ready for DSCSA. She also serves on the Board of PDG (Partnership for DSCSA Governance) and co-chairs the TI/TS workgroup under PDG. She is actively involved in the industry forums for DSCSA including participating in the Pilot project program with the FDA. Arthi is a vocal proponent of Diversity, Equity, and Inclusion (DEI) and serves as part of the leadership team for DEI in North America Supply Chain and the CAN (Capable and Able Network) ERG at Sanofi..

Prior to Sanofi, Arthi has worked in both Manufacturing and Supply Chain at Agfa Corporation leading the Regional S&OPs for the US Business. Prior to her experience in Supply Chain, she has over 7 years of experience working in the IT industry developing, leading, and coordinating projects in diverse sectors such as Finance, Telecom and Energy.

Arthi has a bachelor's degree in Computer Science Engineering and an MBA in Supply Chain Management from Lehigh University.
Tracy Nasarenko

Vice President of Community Engagement, Healthcare

GS1 US
Tracy Nasarenko

Vice President of Community Engagement, Healthcare

GS1 US
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.
Maryann Nelson

Regulatory Manager

Cardinal Health, Inc.
- Roundtable Discussions
  Friday, October 14, 2022 | 9:35—10:50 AM
  
  M4 - Liberty Ballroom (I-P)
Maryann Nelson

Regulatory Manager

Cardinal Health, Inc.
- Roundtable Discussions
  Friday, October 14, 2022 | 9:35—10:50 AM
  
  M4 - Liberty Ballroom (I-P)
Maryann Nelson is a Regulatory Manager with Cardinal Health, Inc. responsible for developing strategies to insure supply chain integrity, preventing prescription drug diversion and complying with state and federal legislative requirements. She has over 30 years of experience in Pharmaceutical Distribution. She is actively involved with industry organizations, including HDA and GS1, focused on implementing the Track and Trace requirements of the Drug Supply Chain Security Act (DSCSA).

Ms. Nelson is a graduate of The Pennsylvania State University where she received a BS degree in Business Logistics.
Leon Nevers

Senior Director, Procurement and Business Development

H-E-B
- Moving Downstream: The Dispenser Community on Data-Flow Endpoints
- Roundtable Discussions
Leon Nevers

Senior Director, Procurement and Business Development

H-E-B
- Moving Downstream: The Dispenser Community on Data-Flow Endpoints
- Roundtable Discussions
Leon Nevers is the Director of Procurement and Business Development with H-E-B Pharmacy. Leon has been engaged in retail buying and selling for a lifetime. He actively works with suppliers, employers, state and U.S. political leaders, and a variety of health care providers to provide lifestyle changes that keep Texans healthy at H-E-B.

Leon has managed direct relationships with hundreds of H-E-B suppliers of Rx, OTC, and Home Diagnostics controlling an annual budget of over $2 billion per year. He currently is Chairman of The Buyers Consortium, LLC, representing 1200 retail stores and $1 billion in Generics Purchasing opportunity with group contracting. He directs, trains, and coaches business development experts to support all aspects of procurement, immunizations, store communications, third party reimbursement, specialty pharmacy, medication therapy management and helps form strategies for business development and buying.

With extensive experience in both the pharmacy and retail industries, Leon looks for simple solutions that can make life long health improvements in a value market. He believes in serving others as a formula for personal success.
Tish E. Pahl

Principal

Olsson Frank Weeda Terman Matz PC
- HDA Perspectives on FDA Activities
  Thursday, October 13, 2022 | 4:30—5:30 PM
  
  M4 - Liberty Ballroom (I-P)
Tish E. Pahl

Principal

Olsson Frank Weeda Terman Matz PC
- HDA Perspectives on FDA Activities
  Thursday, October 13, 2022 | 4:30—5:30 PM
  
  M4 - Liberty Ballroom (I-P)
Tish Eggleston Pahl is a principal at Olsson Frank Weeda Terman Matz PC. She is regulatory counsel to drug, cosmetic, dietary supplement and food clients with concerns before the Food and Drug Administration, the Federal Trade Commission, and other federal agencies. Her work has encompassed representation of companies making and marketing human and animal prescription and over-the-counter (OTC) drugs, dietary supplements, and cosmetics. She has particular expertise in the areas of health care communications, advertising and labeling of FDA-regulated products. Further, she advises trade association clients on a range of antitrust and trade regulation issues.

Since November 2013, Tish has been heavily involved with implementation of the Drug Quality and Security Act (DQSA). She has advised pharmacy compounders and outsourcing facilities on their new FDA responsibilities under Title I of the DQSA. She has worked closely with pharmaceutical supply chain stakeholders, including manufacturers, repackagers, and wholesale distributors, on implementation of Title II of the DQSA, the Drug Supply Chain Security Act (DSCSA).

Tish is a regular participant in HDA activities, providing FDA regulatory and antitrust counsel to the Public Policy Council, the Traceability Implementation Work Group, the Regulatory Affairs Committee, the Returns Task Force, and other committees.

Tish graduated from Northwestern University and earned her Juris Doctor from Northwestern University (cum laude).
Senthil S. Rajaratnam

Senior Director, Global Serialization and UDI

Lilly USA, LLC
- Roundtable Discussions
  Thursday, October 13, 2022 | 2:35—3:50 PM
  
  M4 - Liberty Ballroom (I-P)
Senthil S. Rajaratnam

Senior Director, Global Serialization and UDI

Lilly USA, LLC
- Roundtable Discussions
  Thursday, October 13, 2022 | 2:35—3:50 PM
  
  M4 - Liberty Ballroom (I-P)
Senthil Rajaratnam is the Director for Global Serialization and UDI implementation. In his role, Senthil leads the global strategy and implementation for serialization and product traceability for pharmaceutical products and Unique Device Identification implementation for medical devices. Senthil coordinates with the Lilly’s affiliate offices, packaging sites, engineering and IT teams to implement the right solutions to ensure compliance with serialization/UDI marking and reporting requirements.

Senthil has been with Eli Lilly and Company for 20 years. Senthil’s key expertise includes packaging line equipment and systems, warehousing, distribution and logistics area of the supply chain and has deep knowledge in the business processes and solutions in this space. He is also the subject matter expert on GS1 standards and is part of various industry workgroups that work towards a common goal of providing advocacy to influence the adoption of global standards, harmonizing requirements and help governments achieve their goals leveraging serialization. He is currently on the Board of Directors for Partnership for DSCSA Governance (PDG) and also part of the Healthcare Leadership team of GS1 Healthcare Global organization.
Jaidalyn Rand

Director, Industry Relations

Healthcare Distribution Alliance
- EPCIS Onboarding Across the Supply Chain
  Thursday, October 13, 2022 | 1:30—2:30 PM
  
  M4 - Liberty Ballroom (I-P)
Jaidalyn Rand

Director, Industry Relations

Healthcare Distribution Alliance
- EPCIS Onboarding Across the Supply Chain
  Thursday, October 13, 2022 | 1:30—2:30 PM
  
  M4 - Liberty Ballroom (I-P)
Michael Rowe

Director, DSCSA/Serialization Services

Two Labs Pharma Services
- Roundtable Discussions
  Thursday, October 13, 2022 | 2:35—3:50 PM
  
  M4 - Liberty Ballroom (I-P)
Michael Rowe

Director, DSCSA/Serialization Services

Two Labs Pharma Services
- Roundtable Discussions
  Thursday, October 13, 2022 | 2:35—3:50 PM
  
  M4 - Liberty Ballroom (I-P)
Michael Rowe (Sr. Director of DSCSA/Serialization Services) is renowned within the DSCSA circles as an expert in this arena with a passion for education. At Two Labs, he leads a team of DSCSA experts and has supported ~60 pharmaceutical companies in their DSCSA compliance efforts. Prior to Two Labs, he came from a major wholesaler
(Cardinal Health), where he has worked on complex DSCSA projects related to all sectors of the pharmaceutical distribution models. He is also a certified Lean Six Sigma Black Belt.
Matt Sample

SVP, Manufacturer and Replenishment Operations

Cencora, Inc.
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
Matt Sample

SVP, Manufacturer and Replenishment Operations

Cencora, Inc.
- Countdown to 2023
  Thursday, October 13, 2022 | 11:05—12:05 PM
  
  M4 - Liberty Ballroom (I-P)
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.
Lisa Schwartz

Senior Director, Professional Affairs

National Community Pharmacists Association
- Moving Downstream: The Dispenser Community on Data-Flow Endpoints
  Friday, October 14, 2022 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Lisa Schwartz

Senior Director, Professional Affairs

National Community Pharmacists Association
- Moving Downstream: The Dispenser Community on Data-Flow Endpoints
  Friday, October 14, 2022 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Lisa is knowledgeable on pharmacy practice issues including pharmacy operations, pharmacy quality measurement, DSCSA, pharmacy automation, and health IT. She utilizes her unique skills to support pharmacy owners nationwide on a variety of practice transformation and business issues.
Brian P. Waldman

Partner

ArentFox Schiff LLP
- HDA Perspectives on FDA Activities
  Thursday, October 13, 2022 | 4:30—5:30 PM
  
  M4 - Liberty Ballroom (I-P)
Brian P. Waldman

Partner

ArentFox Schiff LLP
- HDA Perspectives on FDA Activities
  Thursday, October 13, 2022 | 4:30—5:30 PM
  
  M4 - Liberty Ballroom (I-P)
Brian Waldman concentrates his practice in the area of food and drug law and advertising law, counseling clients primarily on pharmaceutical, medical device, food, dietary supplement and cosmetic issues, with particular emphasis on developing effective strategies for introducing and distributing new products. Brian advises clients on a broad range of legal and regulatory issues in all phases of a product’s life cycle, including (i) developing appropriate strategies for the introduction of new ingredients and finished products, (ii) coordinating pre-market safety, efficacy, and claims evaluations, (iii) preparing FDA-related applications and notifications, (iv) designing compliant and effective labeling, advertising, and promotional materials, as well as educational materials, (v) ensuring post-marketing regulatory compliance, including compliance with adverse event reporting requirements and limitations on off-label promotion, and (vi) responding to threatened enforcement action. Brian has been advising clients including HDA on drug distribution issues since 1995.
Elizabeth Waldorf

Director, Global Traceability and Standards

TraceLink Inc.
Elizabeth Waldorf

Director, Global Traceability and Standards

TraceLink Inc.
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

Chief Customer Officer

Antares Vision Group
- EPCIS Onboarding Across the Supply Chain
- Roundtable Discussions
Herbert Wong

Chief Customer Officer

Antares Vision Group
- EPCIS Onboarding Across the Supply Chain
- Roundtable Discussions

Registration and Hotel Information

Genesis Argueta
Sponsorship Opportunities

Lisa Kanfer
Exhibit Opportunities

Michelle Leslie
Membership

Lisa Gallagher
Conference Schedule, Speaker Information, and Education Content

Subrina Ghorashi

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2022 Traceability Seminar

October 12-14, 2022 | Marriott Marquis, Washington, D.C.

2022 Traceability Seminar

October 12-14, 2022 | Marriott Marquis, Washington, D.C.

Speakers

Ameer Ali

Ameer Ali

Josh M. Bolin

Josh M. Bolin

Ronald N. Bone

Ronald N. Bone

Ian Cannell

Ian Cannell

Robert Celeste

Robert Celeste

Jeffery W. Denton

Jeffery W. Denton

Anita T. Ducca

Anita T. Ducca

Perry L. Fri

Perry L. Fri

Connie Jung

Connie Jung

Georg Jürgens

Georg Jürgens

Mark Karhoff

Mark Karhoff

Julie Malone

Julie Malone

David G. Mason

David G. Mason

Michael J. Mazur

Michael J. Mazur

Scott A. Mooney

Scott A. Mooney

Arthi Nagaraj

Arthi Nagaraj

Tracy Nasarenko

Tracy Nasarenko

Maryann Nelson

Maryann Nelson

Leon Nevers

Leon Nevers

Tish E. Pahl

Tish E. Pahl

Senthil S. Rajaratnam

Senthil S. Rajaratnam

Jaidalyn Rand

Jaidalyn Rand

Michael Rowe

Michael Rowe

Matt Sample

Matt Sample

Lisa Schwartz

Lisa Schwartz

Brian P. Waldman

Brian P. Waldman

Elizabeth Waldorf

Elizabeth Waldorf

Herbert Wong

Herbert Wong

Event Contacts