Day One — Monday, August 12, 2019
12:30
Workshop Registration
1:30
CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS
A Industry Standards for Transparency Reporting for Medical Device, Dental Manufacturers
|
B Beginner’s Guide to Open Payments ReportingExpert leaders provide an essential overview of transparency reporting operations, serving as a primer on the fundamentals of aggregate spend and lay the foundation for the more in-depth conversations that will take place throughout the conference. I. Overview of Open Payments Federal Requirements II. State-By-State Breakdown — Specific Regulations to Know III. Effective Data Collection Processes and Trends There will be a 30-minute networking break at 3:00pm Conversation Contributors: Nicole Colapietro Susan Hibbard 5:00 Close of Workshop B |
3:00
Closed Door Open Payments Summit —
Pre Conference Prelude for Experts
This exclusive, senior-level pre-conference benchmarking summit serves as a great starting point to ignite the conversation. Eligible attendees must have at least 5 years of experience in transparency reporting in the bio/pharmaceutical or medical device industries. During this working session, meet fellow expert colleagues to share experiences and brainstorm solutions to common challenges together. The discussion points will be summarized and distributed after the conference concludes. Participants are surveyed prior to the meeting to help the facilitators prepare key topics of discussion.
Take part in this knowledge-exchange to connect on key issues facing transparency and aggregate spend professionals working in the life sciences industry.
Facilitators:
Melissa Blaco
Director, Compliance Reporting
Regeneron Pharmaceuticals, Inc.
Jennifer Parsons
Director, US Transparency & Compliance Operations
Biogen
5:00
Close of Workshops and Day One
Please Join Us for a Networking
Wine and Cheese Reception
Day Two — Tuesday, August 13, 2019
7:00
Main Conference Registration and Continental Breakfast
8:00
Chairperson’s Welcome and Opening Remarks
Sharon Muscato
Director, Transparency & Compliance Operations
Alexion Pharmaceuticals, Inc.
8:15
CMS KEYNOTE ADDRESS Open Payments Reporting
Robin Usi
Director, Division of Data & Informatics,
Center for Program Integrity, Data Sharing & Partnership Group
Centers for Medicare and Medicaid Services (CMS)
9:00
PANEL DISCUSSION Collaborate on the Impact of Preparing for Sunshine Act Expansion to NPs and PAs on Data Collection, Analytics and Monitoring Processes
MODERATOR:
Brian Bohnenkamp
Partner
King & Spalding LLP
PANELISTS:
Nicole Colapietro
Manager, Transparency Reporting Group
Olympus Corporation of the Americas
Margaret Rossini
Director, Corporate Compliance Monitoring and Risk
Sandoz Inc.
Melissa Cox
Data Compliance Officer
Spectrum Pharmaceuticals
9:45
Networking and Refreshment Break
10:15
PANEL DISCUSSION Address the Recent Trends in State-By-State/ City-By-City Reporting and How to Keep on the Pulse of Change
MODERATOR:
John Oroho
Executive Vice President & Chief Strategy Officer
Porzio Life Sciences, LLC
PANELISTS:
Sharon Muscato
Director, Transparency & Compliance Operations
Alexion Pharmaceuticals, Inc.
April Pierce
Associate Director, Global Spend Transparency
Sage Therapeutics
Cheryl Chamallas
Director, Ethics and Compliance
Alnylam Pharmaceuticals
11:00
ENFORCEMENT PANEL Discuss Current Government Oversight and High Risk Areas to Closely Monitor
MODERATOR:
Donna White
Vice President, Contracts & Compliance
Chiesi
PANELISTS:
Corey R. Amundson
Director and Chief Counsel, Office of Professional Responsibility
U.S. Department of Justice
Rachael Honig
First Assistant U.S. Attorney
U.S. Attorney’s Office District of New Jersey
Joseph Mack
Senior Compliance Counsel, U.S. Office of Compliance
Bayer U.S.
11:45
Overview of the DOJ’s 2019 Evaluation of Corporate Compliance Programs Guidance — How effective are your compliance program controls?
Diana Borges
Vice President of Compliance Solutions
MediSpend
12:30
Networking Luncheon
1:30
Reflect on HCP Engagement Trends, How Transparency has Evolved and How to Improve Global HCP Interactions
Kari Loeser
U.S. Healthcare Compliance Officer
Relypsa
Erik Gross
Consultant
NUI
2:10
Develop and Manage a Scalable Global Transparency Program
Michael O’Connor
Vice President of Compliance Technology
Porzio Life Sciences, LLP
Kiran Vuppala
Assistant Vice President, Compliance Technology
Porzio Life Sciences, LLC
2:50
Learn How to Apply A.I. and Enhance Tracking of HCP Spend
Wendy Sward
Senior Solution Consultant, Life Sciences
SAP Concur
Michael Pace
Senior Director, Enterprise Sales – Life Sciences Market, U.S.
SAP Concur
3:30
Networking and Refreshment Break
4:00
The True Value of An Integrated Transparency Program
Baris Goc
Director, Risk and Regulatory
PwC
Tim Canonico
Partner
PwC
4:40
The Art and Science of Deploying Key Risk Indicators (KRIs) in Compliance Monitoring
Mohammad Ovais
CEO
qordata
5:20
Transition to Working Group Sessions
5:30
Choose From Four Concurrent Working Groups (I-IV)
I Deep-Dive into Compliance Risk Measures of
Speaker Programs/Nurse Educator Programs
Kari Loeser
U.S. Healthcare Compliance Officer
Relypsa
Louie Karapanagiotides
Manager
Helio Health
II Discuss Recent Trends in Reporting for
Clinical Research
MODERATOR:
Tom Sullivan
President
Policy & Medicine
PANELISTS:
David Vulcano
Vice President, Research, Compliance, & Integrity
HCA Healthcare
Jeffrey Trull
Global Transparency/Financial Systems Manager
Covance, Inc.
Nicodemo Fiorentino
Senior Manager, Compliance Operations & Transparency
SUN PHARMA
III Updates on Pharmaceutical Global Transparency Reporting Landscape
Andrea Pucci
Senior Legal & Compliance Advisor
Medicines for Europe
Joel Norris
Director, Global Transparency
Amicus Therapeutics
IV Updates on Medical Device Global Transparency Reporting Landscape
Kelly Tope, Esq., MBA
Global Director, Compliance
Zimmer Biomet
Sean Collins
HCP Transparency Analyst
Smith & Nephew
Bryan Stefanski
Compliance Director
Siemens Medical Solutions USA, Inc.
6:25
Close of Day Two
Please Join Us for a Networking
Wine and Cheese Reception
Day Three — Wednesday, August 14, 2019
7:30
Continental Breakfast
8:15
CHOOSE BETWEEN EACH PAIR OF CONCURRENT SESSIONS
CHAIR’S OPENING REMARKS Joel Norris 8:15–9:15 A ADVANCED Deep-Dive into the Intricacies of State-By-State Reporting and Data Privacy Requirements Denise Jones Brian Sharkey |
CHAIR’S OPENING REMARKS Bryan Stefanski 8:15–9:15 B INTERMEDIATE Learn Effective Approaches for Capturing and Reporting Transfers Melissa Blaco Michael Grandison |
|
9:15–10:15 C ADVANCED Address Best Practices for Monitoring and Executing Price Transparency Reporting Susan Hibbard Mallory O'Connor |
9:15–10:15 D INTERMEDIATE Review Data Collection Processes and Implement Key Metrics to Ensure Compliance Kelly Tope, Esq., MBA |
10:15
Networking and Refreshment Break
10:45
CHOOSE BETWEEN EACH PAIR OF CONCURRENT SESSIONS
10:45–11:45 E ADVANCED Deep-Dive into Global Data Analytics Processes Margaret Rossini Shruti Anand Karkun |
10:45–11:45 F INTERMEDIATE Understand Best Practices to Structure an Assumptions Document Emily Cunningham Mark Scallon |
|
11:45–12:30 G ADVANCED Develop a Dedicated, Internal Task Group to Improve Cross-Functional Collaboration and Improve Business Efficiencies Kimi Gorman, CCEP, CFE |
11:45–12:30 H CMS REVIEW Helpful Tips for Reporting and Preparing for a Potential CMS Audit Robert Forcier |
12:30
Networking Luncheon
1:30
PANEL SESSION Third-Party Monitoring and Oversight to Manage Key Risks
MODERATOR:
Emily Singh
Director
PwC
PANELISTS:
Jennifer Parsons
Director, US Transparency & Compliance Operations
Biogen
Rhonda Sobral O'Toole, Esq.
Director, Compliance Reporting and Systems
Ferring Pharmaceuticals Inc.
2:15
Best Practices for Streamlining Dispute Management
April Pierce
Associate Director, Global Spend Transparency
Sage Therapeutics
3:00
Close of Conference
Day One — Monday, August 12, 2019
12:30
Workshop Registration
1:30
CHOOSE BETWEEN TWO PRE-CONFERENCE WORKSHOPS
A Industry Standards for Transparency Reporting for Medical Device, Dental Manufacturers
|
B Beginner’s Guide to Open Payments ReportingExpert leaders provide an essential overview of transparency reporting operations, serving as a primer on the fundamentals of aggregate spend and lay the foundation for the more in-depth conversations that will take place throughout the conference. I. Overview of Open Payments Federal Requirements II. State-By-State Breakdown — Specific Regulations to Know III. Effective Data Collection Processes and Trends There will be a 30-minute networking break at 3:00pm Conversation Contributors: Nicole Colapietro Susan Hibbard 5:00 Close of Workshop B |
3:00
Closed Door Open Payments Summit —
Pre Conference Prelude for Experts
This exclusive, senior-level pre-conference benchmarking summit serves as a great starting point to ignite the conversation. Eligible attendees must have at least 5 years of experience in transparency reporting in the bio/pharmaceutical or medical device industries. During this working session, meet fellow expert colleagues to share experiences and brainstorm solutions to common challenges together. The discussion points will be summarized and distributed after the conference concludes. Participants are surveyed prior to the meeting to help the facilitators prepare key topics of discussion.
Take part in this knowledge-exchange to connect on key issues facing transparency and aggregate spend professionals working in the life sciences industry.
Facilitators:
Melissa Blaco
Director, Compliance Reporting
Regeneron Pharmaceuticals, Inc.
Jennifer Parsons
Director, US Transparency & Compliance Operations
Biogen
5:00
Close of Workshops and Day One
Please Join Us for a Networking
Wine and Cheese Reception
Day Two — Tuesday, August 13, 2019
7:00
Main Conference Registration and Continental Breakfast
8:00
Chairperson’s Welcome and Opening Remarks
Sharon Muscato
Director, Transparency & Compliance Operations
Alexion Pharmaceuticals, Inc.
8:15
CMS KEYNOTE ADDRESS Open Payments Reporting
Robin Usi
Director, Division of Data & Informatics,
Center for Program Integrity, Data Sharing & Partnership Group
Centers for Medicare and Medicaid Services (CMS)
9:00
PANEL DISCUSSION Collaborate on the Impact of Preparing for Sunshine Act Expansion to NPs and PAs on Data Collection, Analytics and Monitoring Processes
MODERATOR:
Brian Bohnenkamp
Partner
King & Spalding LLP
PANELISTS:
Nicole Colapietro
Manager, Transparency Reporting Group
Olympus Corporation of the Americas
Margaret Rossini
Director, Corporate Compliance Monitoring and Risk
Sandoz Inc.
Melissa Cox
Data Compliance Officer
Spectrum Pharmaceuticals
9:45
Networking and Refreshment Break
10:15
PANEL DISCUSSION Address the Recent Trends in State-By-State/ City-By-City Reporting and How to Keep on the Pulse of Change
MODERATOR:
John Oroho
Executive Vice President & Chief Strategy Officer
Porzio Life Sciences, LLC
PANELISTS:
Sharon Muscato
Director, Transparency & Compliance Operations
Alexion Pharmaceuticals, Inc.
April Pierce
Associate Director, Global Spend Transparency
Sage Therapeutics
Cheryl Chamallas
Director, Ethics and Compliance
Alnylam Pharmaceuticals
11:00
ENFORCEMENT PANEL Discuss Current Government Oversight and High Risk Areas to Closely Monitor
MODERATOR:
Donna White
Vice President, Contracts & Compliance
Chiesi
PANELISTS:
Corey R. Amundson
Director and Chief Counsel, Office of Professional Responsibility
U.S. Department of Justice
Rachael Honig
First Assistant U.S. Attorney
U.S. Attorney’s Office District of New Jersey
Joseph Mack
Senior Compliance Counsel, U.S. Office of Compliance
Bayer U.S.
11:45
Overview of the DOJ’s 2019 Evaluation of Corporate Compliance Programs Guidance — How effective are your compliance program controls?
Diana Borges
Vice President of Compliance Solutions
MediSpend
12:30
Networking Luncheon
1:30
Reflect on HCP Engagement Trends, How Transparency has Evolved and How to Improve Global HCP Interactions
Kari Loeser
U.S. Healthcare Compliance Officer
Relypsa
Erik Gross
Consultant
NUI
2:10
Develop and Manage a Scalable Global Transparency Program
Michael O’Connor
Vice President of Compliance Technology
Porzio Life Sciences, LLP
Kiran Vuppala
Assistant Vice President, Compliance Technology
Porzio Life Sciences, LLC
2:50
Learn How to Apply A.I. and Enhance Tracking of HCP Spend
Wendy Sward
Senior Solution Consultant, Life Sciences
SAP Concur
Michael Pace
Senior Director, Enterprise Sales – Life Sciences Market, U.S.
SAP Concur
3:30
Networking and Refreshment Break
4:00
The True Value of An Integrated Transparency Program
Baris Goc
Director, Risk and Regulatory
PwC
Tim Canonico
Partner
PwC
4:40
The Art and Science of Deploying Key Risk Indicators (KRIs) in Compliance Monitoring
Mohammad Ovais
CEO
qordata
5:20
Transition to Working Group Sessions
5:30
Choose From Four Concurrent Working Groups (I-IV)
I Deep-Dive into Compliance Risk Measures of
Speaker Programs/Nurse Educator Programs
Kari Loeser
U.S. Healthcare Compliance Officer
Relypsa
Louie Karapanagiotides
Manager
Helio Health
II Discuss Recent Trends in Reporting for
Clinical Research
MODERATOR:
Tom Sullivan
President
Policy & Medicine
PANELISTS:
David Vulcano
Vice President, Research, Compliance, & Integrity
HCA Healthcare
Jeffrey Trull
Global Transparency/Financial Systems Manager
Covance, Inc.
Nicodemo Fiorentino
Senior Manager, Compliance Operations & Transparency
SUN PHARMA
III Updates on Pharmaceutical Global Transparency Reporting Landscape
Andrea Pucci
Senior Legal & Compliance Advisor
Medicines for Europe
Joel Norris
Director, Global Transparency
Amicus Therapeutics
IV Updates on Medical Device Global Transparency Reporting Landscape
Kelly Tope, Esq., MBA
Global Director, Compliance
Zimmer Biomet
Sean Collins
HCP Transparency Analyst
Smith & Nephew
Bryan Stefanski
Compliance Director
Siemens Medical Solutions USA, Inc.
6:25
Close of Day Two
Please Join Us for a Networking
Wine and Cheese Reception
Day Three — Wednesday, August 14, 2019
7:30
Continental Breakfast
8:15
CHOOSE BETWEEN EACH PAIR OF CONCURRENT SESSIONS
CHAIR’S OPENING REMARKS Joel Norris 8:15–9:15 A ADVANCED Deep-Dive into the Intricacies of State-By-State Reporting and Data Privacy Requirements Denise Jones Brian Sharkey |
CHAIR’S OPENING REMARKS Bryan Stefanski 8:15–9:15 B INTERMEDIATE Learn Effective Approaches for Capturing and Reporting Transfers Melissa Blaco Michael Grandison |
|
9:15–10:15 C ADVANCED Address Best Practices for Monitoring and Executing Price Transparency Reporting Susan Hibbard Mallory O'Connor |
9:15–10:15 D INTERMEDIATE Review Data Collection Processes and Implement Key Metrics to Ensure Compliance Kelly Tope, Esq., MBA |
10:15
Networking and Refreshment Break
10:45
CHOOSE BETWEEN EACH PAIR OF CONCURRENT SESSIONS
10:45–11:45 E ADVANCED Deep-Dive into Global Data Analytics Processes Margaret Rossini Shruti Anand Karkun |
10:45–11:45 F INTERMEDIATE Understand Best Practices to Structure an Assumptions Document Emily Cunningham Mark Scallon |
|
11:45–12:30 G ADVANCED Develop a Dedicated, Internal Task Group to Improve Cross-Functional Collaboration and Improve Business Efficiencies Kimi Gorman, CCEP, CFE |
11:45–12:30 H CMS REVIEW Helpful Tips for Reporting and Preparing for a Potential CMS Audit Robert Forcier |
12:30
Networking Luncheon
1:30
PANEL SESSION Third-Party Monitoring and Oversight to Manage Key Risks
MODERATOR:
Emily Singh
Director
PwC
PANELISTS:
Jennifer Parsons
Director, US Transparency & Compliance Operations
Biogen
Rhonda Sobral O'Toole, Esq.
Director, Compliance Reporting and Systems
Ferring Pharmaceuticals Inc.
2:15
Best Practices for Streamlining Dispute Management
April Pierce
Associate Director, Global Spend Transparency
Sage Therapeutics
3:00
Close of Conference