Speakers

Ilisa B.G. Bernstein

Senior Vice President, Pharmacy Practice & Government Affairs

American Pharmacists Association - APHA
- The Big Picture from Pharmacy Trade Associations
  Thursday, August 31, 2023 | 10:45—12:00 PM
  
  M4 - Liberty Ballroom (I-P)
Ilisa B.G. Bernstein

Senior Vice President, Pharmacy Practice & Government Affairs

American Pharmacists Association - APHA
- The Big Picture from Pharmacy Trade Associations
  Thursday, August 31, 2023 | 10:45—12:00 PM
  
  M4 - Liberty Ballroom (I-P)
Ilisa Bernstein, PharmD, JD, FAPhA, is Senior Vice President for Pharmacy Practice and Government Affairs at the American Pharmacists Association (APhA). She is responsible for responsible for leading the development and implementation of APhA’s strategies, policies, and programs related to pharmacy practice, advocacy, and government affairs, and guiding APhA as the voice of pharmacists in all practice settings. She joined APhA in 2019. From June 2022 to July 2023, Dr. Bernstein was Interim CEO and Executive Vice President at APhA, the first female to lead as CEO in the 170-year history of APhA.

She has over 30 years of experience advocating for pharmacy and patients at the U.S. Food and Drug Administration (FDA), where she has held several senior leadership positions. Prior to joining APhA, Dr. Bernstein was deputy director of FDA’s Office of Compliance in the Center for Drug Evaluation & Research, leading policies, compliance, and enforcement in areas including drug compounding, supply chain security, drug manufacturing and quality, drug shortages, and post-market drug safety. Dr. Bernstein also served as director of pharmacy affairs for FDA and senior advisor for regulatory policy in the Office of the Commissioner. She started at FDA as clinical pharmacology reviewer of investigational and new drug applications.

Previously, Dr. Bernstein was senior associate director of worldwide regulatory affairs for Pfizer and completed a post-doctoral clinical residency at the National Institutes of Health. She earned her Doctor of Pharmacy from the University of Michigan College of Pharmacy and her Juris Doctor from American University Washington College of Law.
Alexandra Blasi

Executive Secretary

Kansas Board of Pharmacy
- Board of Pharmacy Perspectives on DSCSA Implementation and Enforcement
  Wednesday, August 30, 2023 | 3:30—4:30 PM
  
  M4 - Liberty Ballroom (I-P)
Alexandra Blasi

Executive Secretary

Kansas Board of Pharmacy
- Board of Pharmacy Perspectives on DSCSA Implementation and Enforcement
  Wednesday, August 30, 2023 | 3:30—4:30 PM
  
  M4 - Liberty Ballroom (I-P)
Josh M. Bolin

Associate Executive Director for Government Affairs and Innovation

National Association of Boards of Pharmacy®
- Board of Pharmacy Perspectives on DSCSA Implementation and Enforcement
  Wednesday, August 30, 2023 | 3:30—4:30 PM
  
  M4 - Liberty Ballroom (I-P)
Josh M. Bolin

Associate Executive Director for Government Affairs and Innovation

National Association of Boards of Pharmacy®
- Board of Pharmacy Perspectives on DSCSA Implementation and Enforcement
  Wednesday, August 30, 2023 | 3:30—4:30 PM
  
  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.
Riya Cao

CEO

LSPedia
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Riya Cao

CEO

LSPedia
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
William Carney

Vice President, Operations

Genetco, Inc.
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
William Carney

Vice President, Operations

Genetco, Inc.
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Robert Celeste

Founder

Center for Supply Chain Studies
- DSCSA Roundtable Discussions
  Wednesday, August 30, 2023 | 1:30—3:00 PM
  
  M4 - Liberty Ballroom (I-P)
Robert Celeste

Founder

Center for Supply Chain Studies
- DSCSA Roundtable Discussions
  Wednesday, August 30, 2023 | 1:30—3:00 PM
  
  M4 - Liberty Ballroom (I-P)
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.
Perry L. Fri

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

Healthcare Distribution Alliance
- Opening Remarks
  Wednesday, August 30, 2023 | 8:30—8:45 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
  Wednesday, August 30, 2023 | 8:30—8:45 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.
Elizabeth A. Gallenagh

General Counsel and Senior Vice President, Supply Chain Integrity

Healthcare Distribution Alliance
Elizabeth A. Gallenagh

General Counsel and Senior Vice President, Supply Chain Integrity

Healthcare Distribution Alliance
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.
Gregg A. Gorniak

VP - Manufacturer Operations & Data Services | Secure Supply Chain Lead

Cencora, Inc.
- Navigating the DSCSA Crossroads: A Case for Phased Implementation and Other Industry Recommendations
- DSCSA Roundtable Discussions
Gregg A. Gorniak

VP - Manufacturer Operations & Data Services | Secure Supply Chain Lead

Cencora, Inc.
- Navigating the DSCSA Crossroads: A Case for Phased Implementation and Other Industry Recommendations
- DSCSA Roundtable Discussions
Gregg is currently Vice President – Manufacturer Operations & Data Services and Secure Supply Chain Lead for Cencora (formerly AmerisourceBergen). The SSC project team is delivering the Track & Trace and serialization requirements of the DSCSA. Gregg’s focus is currently on Manufacturer & Customer onboarding activities as well as DC activation for inbound scanning at receiving, returns, and exception handling while also sending outbound EPCIS messages to downstream trading partners.

Prior to AB, Gregg was the US Serialisation Lead at GSK leading the work on the DSCSA saleable returns project and developing GSK’s long-term solution for the DSCSA requirements in 2023. At GSK, Gregg held positions ranging from Analytics Reporting Manager in R&D Clinical Operations, Data Lead for the US SAP implementation, and Director of Data Quality in the Transparency Data Operations & Reporting team in Pharma Finance. Prior to GSK, Gregg worked for 6 years at Pfizer in Global Logistics & Supply in the Enterprise Data Management group focused on SAP Material Master.

Gregg has almost 25 years of experience in multiple Leadership & Senior Data roles in both the Pharmaceutical, Finance, and Software industries. Gregg holds an MBA in Management from Saint Joseph’s University’s Haub School of Business and a BS in Business Administration from Rider University. Gregg has a passion for data, systems, & business processes and strives to work towards solutions that benefit all.
Bruce Harold

Director of EDI

KeySource
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
  Wednesday, August 30, 2023 | 4:30—5:30 PM
  
  M4 - Liberty Ballroom (I-P)
Bruce Harold

Director of EDI

KeySource
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
  Wednesday, August 30, 2023 | 4:30—5:30 PM
  
  M4 - Liberty Ballroom (I-P)
Bruce Harold is the Director of EDI at KeySource Acquisition, LLC. He has been the DSCSA technical lead since he started this position in January, 2022.

He has several years of previous experience with a lead role in DSCSA implementation at The Harvard Drug Group, including working with both wholesale distribution and repackaging requirements.
Connie Jung

Senior Advisor for Policy

U.S. Food and Drug Administration
- FDA DSCSA Overview and Update
  Wednesday, August 30, 2023 | 8:45—9:45 AM
  
  M4 - Liberty Ballroom (I-P)
Connie Jung

Senior Advisor for Policy

U.S. Food and Drug Administration
- FDA DSCSA Overview and Update
  Wednesday, August 30, 2023 | 8:45—9:45 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.
Caroline Juran

Executive Director

Virginia Board of Pharmacy
- Board of Pharmacy Perspectives on DSCSA Implementation and Enforcement
  Wednesday, August 30, 2023 | 3:30—4:30 PM
  
  M4 - Liberty Ballroom (I-P)
Caroline Juran

Executive Director

Virginia Board of Pharmacy
- Board of Pharmacy Perspectives on DSCSA Implementation and Enforcement
  Wednesday, August 30, 2023 | 3:30—4:30 PM
  
  M4 - Liberty Ballroom (I-P)
Blair Korman

Sr. Director, Digital Identification & Traceability

Johnson & Johnson Supply Chain
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Blair Korman

Sr. Director, Digital Identification & Traceability

Johnson & Johnson Supply Chain
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Blair Korman is the Senior Director of Digital Identification & Traceability for Johnson & Johnson. She leads the delivery of critical enterprise capabilities in the areas of regulatory compliance, customer compliance, standards and emerging digital technologies. She focuses her efforts on uniting the digital thread with the physical product and providing easier access to more accurate and more timely product data. Blair has more than two decades of supply chain expertise spanning operations, customer engagement and interactions with regulatory agencies and industry associations. She holds a Bachelor of Science in industrial and systems engineering from Virginia Tech and a Master of Science in engineering management from the University of South Florida.
David G. Mason

Supply Chain Compliance and Serialization Lead

Sandoz
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
David G. Mason

Supply Chain Compliance and Serialization Lead

Sandoz
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Dave Mason is currently the AD North America Serialization – Supply Chain, supporting the implementation of DSCSA for the Novartis group. He is leading the efforts for setting up systems and processes for ESO, supply chain and commercial operations. Dave represents Novartis in trade association, PDSA 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 a global master validation and TPO rollout plan.
Scott A. Mooney

Vice President Distribution Operations, Traceability

McKesson Corporation
- GS1 Updates on Implementation Guides
  Thursday, August 31, 2023 | 9:35—10:35 AM
  
  M4 - Liberty Ballroom (I-P)
Scott A. Mooney

Vice President Distribution Operations, Traceability

McKesson Corporation
- GS1 Updates on Implementation Guides
  Thursday, August 31, 2023 | 9:35—10:35 AM
  
  M4 - Liberty Ballroom (I-P)
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.
Arthi Nagaraj

Head of Analytics, Strategic Projects and Serialization

Sanofi US
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
  Wednesday, August 30, 2023 | 4:30—5:30 PM
  
  M4 - Liberty Ballroom (I-P)
Arthi Nagaraj

Head of Analytics, Strategic Projects and Serialization

Sanofi US
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
  Wednesday, August 30, 2023 | 4:30—5:30 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.
- DSCSA Roundtable Discussions
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
Maryann Nelson

Regulatory Manager

Cardinal Health, Inc.
- DSCSA Roundtable Discussions
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
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.
Tish E. Pahl

Principal

Olsson Frank Weeda Terman Matz PC
Tish E. Pahl

Principal

Olsson Frank Weeda Terman Matz PC
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).
Jeff Primeau

VP of Business Solutions

Cencora - Integrated Commercialization Solutions (ICS)
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
  Wednesday, August 30, 2023 | 4:30—5:30 PM
  
  M4 - Liberty Ballroom (I-P)
Jeff Primeau

VP of Business Solutions

Cencora - Integrated Commercialization Solutions (ICS)
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
  Wednesday, August 30, 2023 | 4:30—5:30 PM
  
  M4 - Liberty Ballroom (I-P)
Jeff Primeau is Vice President of Business Solutions for ICS, a leading provider of third-party logistics and turnkey pharmaceutical distribution services for specialty drugs. He is an accomplished supply chain executive with more than 25 years of experience in the industry. As a member of the executive lead team for ICS, he leads the long-term strategy and manages execution and delivery of key initiatives to efficiently scale while continuing to provide unsurpassed service levels to our clients. For the past five years, he has led the design, development, and execution of a cross functional strategy to deploy a new distribution model to support the Drug Supply Chain Security Act (DSCSA).
Jaidalyn Rand

Director, Industry Relations

Healthcare Distribution Alliance
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Jaidalyn Rand

Director, Industry Relations

Healthcare Distribution Alliance
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Michael Rowe

Director, DSCSA/Serialization Services

Two Labs Pharma Services
- DSCSA Roundtable Discussions
  Wednesday, August 30, 2023 | 1:30—3:00 PM
  
  M4 - Liberty Ballroom (I-P)
Michael Rowe

Director, DSCSA/Serialization Services

Two Labs Pharma Services
- DSCSA Roundtable Discussions
  Wednesday, August 30, 2023 | 1:30—3:00 PM
  
  M4 - Liberty Ballroom (I-P)
Matt Sample

SVP, Manufacturer and Replenishment Operations

Cencora, Inc.
- Opening Remarks
  Wednesday, August 30, 2023 | 8:30—8:45 AM
  
  M4 - Liberty Ballroom (I-P)
Matt Sample

SVP, Manufacturer and Replenishment Operations

Cencora, Inc.
- Opening Remarks
  Wednesday, August 30, 2023 | 8:30—8:45 AM
  
  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.
Jillanne Schulte Wall

Senior Director, Health and Regulatory Policy

American Society of Health-System Pharmacists (ASHP)
- The Big Picture from Pharmacy Trade Associations
  Thursday, August 31, 2023 | 10:45—12:00 PM
  
  M4 - Liberty Ballroom (I-P)
Jillanne Schulte Wall

Senior Director, Health and Regulatory Policy

American Society of Health-System Pharmacists (ASHP)
- The Big Picture from Pharmacy Trade Associations
  Thursday, August 31, 2023 | 10:45—12:00 PM
  
  M4 - Liberty Ballroom (I-P)
Lisa Schwartz

Senior Director, Professional Affairs

National Community Pharmacists Association
- The Big Picture from Pharmacy Trade Associations
  Thursday, August 31, 2023 | 10:45—12:00 PM
  
  M4 - Liberty Ballroom (I-P)
Lisa Schwartz

Senior Director, Professional Affairs

National Community Pharmacists Association
- The Big Picture from Pharmacy Trade Associations
  Thursday, August 31, 2023 | 10:45—12:00 PM
  
  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.
Tim Stearns

Senior Director, Industry Relations

Healthcare Distribution Alliance
- DSCSA Roundtable Discussions
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
Tim Stearns

Senior Director, Industry Relations

Healthcare Distribution Alliance
- DSCSA Roundtable Discussions
- Exceptions Handling: Mitigating Data Errors to Keep Products Moving
Tim Stearns is a Senior E-Commerce Analyst with Baxter HealthCare, focusing primarily on the distributor customer base. With over 22 years of experience in information systems, he has integrated back–end systems and implemented numerous EDI transaction sets focused on contract/chargeback administration, customer credit and invoicing, returns processing, order management and shipping notices, track–and–trace /pedigree systems design, customer–to–HIN alignment with HIBCC and distributor Fee for Service/inventory management agreements. Tim has served twice as co–chair of the HDMA Business Technology Committee, member of the HDMA eCommerce Task Force, member of the CSOS Working Group and the Health Industry Business Communications Council E-Business Council.
Anil Suresh

Product Management

SAP SE (NYSE: SAP)
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Anil Suresh

Product Management

SAP SE (NYSE: SAP)
- Onboarding the Industry: A Status Update and Call to Keep Moving!
  Thursday, August 31, 2023 | 8:30—9:30 AM
  
  M4 - Liberty Ballroom (I-P)
Leigh Verbois

Director of the Office of Drug, Security, Integrity and Response

Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
- FDA DSCSA Overview and Update
  Wednesday, August 30, 2023 | 8:45—9:45 AM
  
  M4 - Liberty Ballroom (I-P)
Leigh Verbois

Director of the Office of Drug, Security, Integrity and Response

Office of Compliance, Center for Drug Evaluation and Research, U.S. Food and Drug Administration
- FDA DSCSA Overview and Update
  Wednesday, August 30, 2023 | 8:45—9:45 AM
  
  M4 - Liberty Ballroom (I-P)
S. Leigh Verbois, Ph.D. currently serves as Director of the Office of Drug Security, Integrity and Response within CDER’s Office of Compliance, where she provides strategic leadership of pharmaceutical import, export, recall, and supply chain compliance and enforcement programs for the U.S. Food and Drug Administration.

Dr. Verbois previously served as the Director of the Office of Global Operations in the Office of Global Policy and Strategy and Acting Assistant Commissioner for International Programs, where she provided strategic direction and leadership for operations, policy and engagement of FDA’s diplomatic missions to protect and promote public health. She also served in Beijing as FDA Country Director for the People’s Republic of China where she led FDA’s efforts in China. Before posting to China, she oversaw FDA regulatory engagement with countries in the Asia-Pacific (excepting China and India), Middle East, Africa and Canada as Director of the Office of Regional and Country Affairs within FDA’s Office of International Programs.

Dr. Verbois began her FDA career as a reviewer in CDER’s Office of New Drugs. Subsequently, she developed and directed strategies, activities, and policies to reduce threats to the global drug supply chain through increased transparency and accountability, effective enforcement, and promotion of proactive industry vigilance and voluntary compliance in CDER’s Office of Compliance. Dr. Verbois previously served in the Office of Global Regulatory Operations and Policy as Senior Advisor, Acting Assistant Commissioner for Compliance Policy in the Office of Regulatory Affairs and Acting Deputy Director of FDA’s China Office. In these capacities, she guided multidisciplinary teams to facilitate strategic decisions, manage resources, and develop policy that is data driven and risk-based for all FDA- regulated commodities.

Dr. Verbois received her undergraduate degree from Tulane University, her Ph.D. in Pharmaceutical Sciences from the College of Pharmacy at the University of Kentucky and completed her postdoctoral training at the National Institutes of Health.
Jenni Wai

Chief Pharmacist

The State of Ohio Board of Pharmacy
- Board of Pharmacy Perspectives on DSCSA Implementation and Enforcement
  Wednesday, August 30, 2023 | 3:30—4:30 PM
  
  M4 - Liberty Ballroom (I-P)
Jenni Wai

Chief Pharmacist

The State of Ohio Board of Pharmacy
- Board of Pharmacy Perspectives on DSCSA Implementation and Enforcement
  Wednesday, August 30, 2023 | 3:30—4:30 PM
  
  M4 - Liberty Ballroom (I-P)
Brian P. Waldman

Partner

ArentFox Schiff LLP
Brian P. Waldman

Partner

ArentFox Schiff LLP
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.
- GS1 Updates on Implementation Guides
  Thursday, August 31, 2023 | 9:35—10:35 AM
  
  M4 - Liberty Ballroom (I-P)
Elizabeth Waldorf

Director, Global Traceability and Standards

TraceLink Inc.
- GS1 Updates on Implementation Guides
  Thursday, August 31, 2023 | 9:35—10:35 AM
  
  M4 - Liberty Ballroom (I-P)
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 Roundtable Discussions
  Wednesday, August 30, 2023 | 1:30—3:00 PM
  
  M4 - Liberty Ballroom (I-P)
Herbert Wong

SVP Product & Strategy

Antares Vision Group
- DSCSA Roundtable Discussions
  Wednesday, August 30, 2023 | 1:30—3:00 PM
  
  M4 - Liberty Ballroom (I-P)

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

2023 Traceability Seminar

August 29-31, 2023 | Marriott Marquis, Washington, D.C.

Speakers

Ilisa B.G. Bernstein

Ilisa B.G. Bernstein

Alexandra Blasi

Alexandra Blasi

Josh M. Bolin

Josh M. Bolin

Riya Cao

Riya Cao

William Carney

William Carney

Robert Celeste

Robert Celeste

Perry L. Fri

Perry L. Fri

Elizabeth A. Gallenagh

Elizabeth A. Gallenagh

Gregg A. Gorniak

Gregg A. Gorniak

Bruce Harold

Bruce Harold

Connie Jung

Connie Jung

Caroline Juran

Caroline Juran

Blair Korman

Blair Korman

David G. Mason

David G. Mason

Scott A. Mooney

Scott A. Mooney

Arthi Nagaraj

Arthi Nagaraj

Tracy Nasarenko

Tracy Nasarenko

Maryann Nelson

Maryann Nelson

Tish E. Pahl

Tish E. Pahl

Jeff Primeau

Jeff Primeau

Jaidalyn Rand

Jaidalyn Rand

Michael Rowe

Michael Rowe

Matt Sample

Matt Sample

Jillanne Schulte Wall

Jillanne Schulte Wall

Lisa Schwartz

Lisa Schwartz

Tim Stearns

Tim Stearns

Anil Suresh

Anil Suresh

Leigh Verbois

Leigh Verbois

Jenni Wai

Jenni Wai

Brian P. Waldman

Brian P. Waldman

Elizabeth Waldorf

Elizabeth Waldorf

Herbert Wong

Herbert Wong

Event Contacts