Sunday, March 12, 2023
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1:00 PM - 7:30 PM
Registration
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1:00 PM - 5:00 PM
Exhibitor Setup
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5:00 PM - 6:00 PM
VIP Reception (Invitation Only)
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Sponsors
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Monday, March 13, 2023
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7:00 AM - 6:30 PM
Registration
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Sponsors
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8:00 AM - 8:20 AM
Opening General Session: Welcome Address
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8:20 AM - 8:30 AM
Opening General Session: Distribution Management Award Presentation
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Description
On February 18, 2021, Dr. Moogega “Moo” Cooper helped make history when the Mars Perseverance Rover successfully landed on the Red Planet. Part of the famed Jet Propulsion Laboratory (JPL) team, Moo is blazing a trail as a real-life “Guardian of the Galaxy,” holding the awesome responsibility of keeping the Red Planet safe from Earth’s contaminants. Now she will share leadership lessons learned from her inspirational journey to the top of a male-dominated field — space exploration — with insights on how perseverance pays off and how diversity makes the JPL team even stronger.
Speakers
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Moogega Cooper
Planetary Protection Engineer
National Aeronautics and Space Administration (NASA)
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9:30 AM - 10:00 AM
Expo Grand Opening and Morning Break
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Description
FDA has had another active year on DSCSA implementation: issuing rewritten draft guidance documents, proposing a critical licensure rule and holding an important meeting on the 2023 requirements. As the final DSCSA deadline approaches, FDA guidance documents are more critical than ever, not only for implementation by supply chain members, but also by individual state regulatory authorities. This session will provide an opportunity to hear directly from the agency on its activities, current implementation efforts, and expectations for the pharmaceutical supply chain and other stakeholders as the November 27, 2023 milestone nears.
Sponsors
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10:00 AM - 11:00 AM
Breakout Session A: Sustainability & De-carbonization Session
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Speakers
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Charles H. Forsaith
Vice President, PCSC
Healthcare Distribution Alliance
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11:00 AM - 11:30 AM
Networking Break
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Description
GS1 will be on site to review the EPCIS standard and implementation guideline. This standard is critical in understanding how to successfully exchange DSCSA-related transaction data, and is an FDA-endorsed standard for compliance. Following the overview, a service provider panel will share insights on EPCIS implementation progress and lessons learned to date from their customers’ experiences.
Sponsors
Speakers
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Craig Little
Senior Systems Developer
Value Drug Company
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Scott A. Mooney
Vice President, Distribution Operations
McKesson Corporation
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Tracy Nasarenko
Sr. Director, Community Engagement
GS1 US
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Senthil S. Rajaratnam
Director, Global Serialization and UDI
Lilly USA, LLC
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Tim Stearns
Senior Director, Industry Relations
Healthcare Distribution Alliance
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Elizabeth Waldorf
Director, Global Traceability and Standards
TraceLink Inc.
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Description
Learn about how the results of the 2022 congressional elections are playing a role in the policies legislators are addressing on issues related to: pandemic preparedness, drug shortages and prescription drug pricing.
Speakers
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Kristen L. Freitas
SVP, Federal Government Affairs and Alliance Development
Healthcare Distribution Alliance
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Description
This session will provide an update on current guidance and initiatives related to the 340B Drug Pricing Program as well as top-of-mind operational issues for distributors and manufacturers.
Speakers
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Heather Easterling
Senior Managing Consultant, 340B Solutions, Health Systems
McKesson Corporation
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Andrew L. Wilson
Vice President, 340B Solutions
McKesson Corporation
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11:30 AM - 12:30 PM
Breakout Session B: Supply Chain Security Session
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12:30 PM - 1:30 PM
General Luncheon
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1:30 PM - 2:00 PM
Expo and Dessert Break
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Description
The last DSCSA milestone is just months away, and trading partners are in the final throes of preparing for implementation. This session will cover progress, key learnings and outstanding challenges as industry works towards the rapidly approaching November 27 deadline. An expert panel will explore the state of readiness among trading partners while discussing implementation progress (including key impediments, risks and successes). Panelists will also provide recommendations to supply chain colleagues as the sector prepares for the final milestone. Come prepared with questions — audience participation is encouraged.
Sponsors
Speakers
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Anita T. Ducca
Senior Vice President, Regulatory Affairs
Healthcare Distribution Alliance
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Gregg Gorniak
Sr. Director - Manufacturer Operations & Secure Supply Chain Lead
AmerisourceBergen Corporation
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Daniel Jackson
Manager - EMPM - Serialization
Regeneron Healthcare Solutions
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Julie Malone
Regulatory Affairs Manager
Value Drug Company
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Michael J. Mazur
Director, Trade Operations
Pfizer Inc.
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Speakers
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Leah D. Lindahl
Vice President, State Government Affairs
Healthcare Distribution Alliance
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Description
This session will overview and highlight best practices used to successfully implement 340B as a pharmaceutical distributor.
Speakers
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Christopher Clement
Director, Distribution Services
Apexus, LLC
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Jennifer K Harrison
Portfolio Executive
Apexus, LLC
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Sponsors
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3:15 PM - 3:30 PM
Networking Break
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Description
This session will explore recent changes in state and federal reimbursement policy and what impact they have on the pharmaceutical supply chain.
Speakers
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Stephanie Trunk
Partner
Arent Fox LLP
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Description
Distributor teams will outline their specific plans for DSCSA implementation. Presenters will discuss their approach to several topics and answer questions from the audience. Topics highlighted will include:
- Aggregation and inference;
- Data standards and the use of identifiers;
- Verification requests;
- Trace requests;
- Master data complexities;
- Grandfathering: product arrived in warehouse with lot-level TI, (on and after November 27, 2023); and,
- Communications and expectations for trading partners.
Sponsors
Speakers
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Omid Ghobadi
Sr. Director, Finance & Technology
HyGen Pharmaceuticals, Inc.
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Scott A. Mooney
Vice President, Distribution Operations
McKesson Corporation
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Maryann Nelson
Regulatory Manager
Cardinal Health, Inc.
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Bradley T. Pine
Vice President, Brand Pharma & Regulatory
Smith Drug Company, Div. J M Smith Corporation
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Matt Sample
SVP, Manufacturer and Replenishment Operations
AmerisourceBergen Corporation
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Description
Work is under way to update HDA’s Return Request/Authorization Response EDI 180 guideline and EDI 812 Credit Memo to address DSCSA business requirements. Hear about these forthcoming updates, as well as the potential changes to the association’s entire set of EDI and barcode guidelines stemming from FDA’s proposed change for the NDC and barcode rules.
Speakers
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Tim Stearns
Senior Director, Industry Relations
Healthcare Distribution Alliance
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Sponsors
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4:30 PM - 6:30 PM
Expo Reception and Raffle
Tuesday, March 14, 2023
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7:00 AM - 6:00 PM
Registration
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7:00 AM - 8:00 AM
General Breakfast
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Description
Chess is known as a thinking game. To beat your opponent, you must step into their shoes and consider how they will think. In this compelling speech, chess grandmaster Maurice Ashley will show how to transfer the chess move thought process and adapt that same way of thinking to the critical decisions you make in business and life. This fascinating session will help you shift your decision-making perspective and adapt your thinking in ways you never expected.
Speakers
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Maurice Ashley
First African-American Chess Grandmaster, Analyst
Commentator and Emcee
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9:30 AM - 10:00 AM
Expo and Morning Break
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Description
Pharmacy community panelists will share their current thinking, approaches and challenges regarding DSCSA implementation. Topics to be addressed will include the structure of and planning toward a 2023 system; cost concerns; scanning and hardware upgrades across the dispensing community; communication strategies regarding packaging and bar code changes; and how dispensers might carry out verification and trace requests as well as report suspect product to FDA and upstream to suppliers.
Sponsors
Speakers
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Christopher Antypas
President & Chief Operating Officer
Asti’s South Hills Pharmacy
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Jon Brown
Manager-Pharmacy Purchasing and Logistics
Indiana University Health
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Ian Cannell
Consultant VI
Kaiser Permanente
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Leon Nevers
Director, Procurement and Business Development
H-E-B
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Description
Interact with DEA and discuss current topics in controlled substances regulation.
Sponsors
Speakers
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Thomas W. Prevoznik
Deputy Assistant Administrator, Diversion Control Division
U.S. Drug Enforcement Administration (DEA)
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Matthew Strait
Deputy Assistant Administrator
U.S. Drug Enforcement Administration (DEA)
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Description
Three leaders driving diversity, equity and inclusion (DE&I) efforts within the healthcare supply chain will provide practical insights and advice for building and enhancing organization-wide DE&I initiatives. Hearing firsthand experience of how these leaders worked to foster “belonging” among their teams, participants will leave the conversation with actionable ideas to help establish or refine a DE&I program within their own companies.
Sponsors
Speakers
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Jesse Cortez
Vice President - Diversity, Equity and Inclusion
McKesson Corporation
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Devray Kirkland
Chief Diversity, Equity and Inclusion Officer
Cardinal Health, Inc.
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11:00 AM - 11:15 AM
Networking Break
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Sponsors
Speakers
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Tish E. Pahl
Principal
Olsson Frank Weeda Terman Matz PC
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Description
A panel of experts will discuss "suspicious orders" monitoring and other legal issues in the evolving controlled substances regulatory environment.
Speakers
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Larry P. Cote
Founding Partner
Cote Law PLLC
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John A. Gilbert
Director
Hyman, Phelps, and McNamara, P.C.
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Speakers
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Tom Cotter
Executive Director
Healthcare Ready
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12:15 PM - 1:15 PM
General Luncheon
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1:15 PM - 2:00 PM
Expo and Dessert Break
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Sponsors
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2:00 PM - 3:00 PM
Breakout Session G: Health Delivered
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Sponsors
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3:00 PM - 3:15 PM
Networking Break
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Description
Specializing in analyzing information from IQVIA’s premier sales, prescription, promotional and medical databases, Doug Long will take a first look at the latest industry data and emerging market trends for branded and generic pharmaceutical and specialty product sales. Long will offer his perspective on a range of vital pharmaceutical topics, including global market trends, industry forecasts, research and development, marketing practices, blockbuster drugs, patent expirations and generic trends, biotechnology and more. He also will analyze how emerging trends will affect strategic business plans in the coming year and beyond.
Speakers
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Douglas M. Long
Vice President, Industry Relations
IQVIA
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4:15 PM - 6:15 PM
Networking Reception and Expo Raffle
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6:15 PM - 8:00 PM
Exhibitor Move-out
Wednesday, March 15, 2023
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7:30 AM - 9:00 AM
Registration
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8:00 AM - 9:00 AM
General Breakfast
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9:00 AM - 11:00 AM
Closing General Session
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11:00 AM - 12:00 AM
Conference Adjournment
Event Contacts
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Registration and Hotel Information
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Exhibit and Sponsorship Opportunities
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Membership
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Conference Schedule, Speaker Information, and Education Content