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Agenda

Benchmark Winning Frameworks for Compliant Operational Excellence

August 12-14, 2019
  • Washington, DC

Agenda

Want more agenda details? Download the brochure.

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
and Distributors

This workshop provides a detailed overview of the critical issues in transparency reporting for consideration by medical device, suppliers and dental manufacturers and distributors.

I. Discuss Updates and Trends on Open Payments Reporting

II. Global Transparency Requirements

III. Loaner Devices

There will be a 30-minute networking break at 3:00pm

Conversation Contributors:

Matt Wetzel
Senior Counsel,
Akin Gump Strauss Hauer & Feld LLP;
former Vice President & Deputy General Counsel, AdvaMed

Carol Seaman
Vice President and Global Chief Ethics & Compliance Officer
Cook Group

Kelly Tope, Esq., MBA
Global Director, Compliance
Zimmer Biomet

5:00

Close of Workshop A

 
B Beginner’s Guide to Open Payments Reporting

Expert 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
Manager, Transparency Reporting Group
Olympus Corporation of the Americas

Susan Hibbard
Associate Director, Office of Ethics and Compliance-Transparency and Compliance
Boehringer Ingelheim

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
Director, Global Transparency
Amicus Therapeutics

8:15–9:15

A ADVANCED Deep-Dive into the Intricacies of State-By-State Reporting and Data Privacy Requirements

Denise Jones
U.S. Ethics & Compliance Transparency Partner
UCB, Inc.

Brian Sharkey
Vice President
Porzio Life Sciences, LLP

 

CHAIR’S OPENING REMARKS

Bryan Stefanski
Compliance Director
Siemens Medical Solutions USA, Inc.

8:15–9:15

B INTERMEDIATE Learn Effective Approaches for Capturing and Reporting Transfers
of Value

Melissa Blaco
Director, Compliance Reporting
Regeneron Pharmaceuticals

Michael Grandison
Senior Manager, Transparency
Regeneron Pharmaceuticals

9:15–10:15

C ADVANCED Address Best Practices for Monitoring and Executing Price Transparency Reporting

Susan Hibbard
Associate Director, Office of Ethics and Compliance-Transparency and Compliance
Boehringer Ingelheim

Mallory O'Connor
Director Of Public Policy
Mallinckrodt Pharmaceuticals

 

9:15–10:15

D INTERMEDIATE Review Data Collection Processes and Implement Key Metrics to Ensure Compliance

Kelly Tope, Esq., MBA
Global Director, Compliance
Zimmer Biomet

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
Director,
Corporate Compliance Monitoring and Risk
Sandoz Inc.

Shruti Anand Karkun
Senior Associate,
Global Transparency Reporting
Covance, Inc.

 

10:45–11:45

F INTERMEDIATE Understand Best Practices to Structure an Assumptions Document

Emily Cunningham
Associate Principal
IQVIA Commercial Compliance

Mark Scallon
Senior Principal
IQVIA Global Compliance

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
Senior Director Ethics & Compliance
Novo Nordisk

 

11:45–12:30

H CMS REVIEW Helpful Tips for Reporting and Preparing for a Potential CMS Audit

Robert Forcier
HCP Aggregate Spend Director
Smith & Nephew

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

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

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
and Distributors

This workshop provides a detailed overview of the critical issues in transparency reporting for consideration by medical device, suppliers and dental manufacturers and distributors.

I. Discuss Updates and Trends on Open Payments Reporting

II. Global Transparency Requirements

III. Loaner Devices

There will be a 30-minute networking break at 3:00pm

Conversation Contributors:

Matt Wetzel
Senior Counsel,
Akin Gump Strauss Hauer & Feld LLP;
former Vice President & Deputy General Counsel, AdvaMed

Carol Seaman
Vice President and Global Chief Ethics & Compliance Officer
Cook Group

Kelly Tope, Esq., MBA
Global Director, Compliance
Zimmer Biomet

5:00

Close of Workshop A

 
B Beginner’s Guide to Open Payments Reporting

Expert 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
Manager, Transparency Reporting Group
Olympus Corporation of the Americas

Susan Hibbard
Associate Director, Office of Ethics and Compliance-Transparency and Compliance
Boehringer Ingelheim

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
Director, Global Transparency
Amicus Therapeutics

8:15–9:15

A ADVANCED Deep-Dive into the Intricacies of State-By-State Reporting and Data Privacy Requirements

Denise Jones
U.S. Ethics & Compliance Transparency Partner
UCB, Inc.

Brian Sharkey
Vice President
Porzio Life Sciences, LLP

 

CHAIR’S OPENING REMARKS

Bryan Stefanski
Compliance Director
Siemens Medical Solutions USA, Inc.

8:15–9:15

B INTERMEDIATE Learn Effective Approaches for Capturing and Reporting Transfers
of Value

Melissa Blaco
Director, Compliance Reporting
Regeneron Pharmaceuticals

Michael Grandison
Senior Manager, Transparency
Regeneron Pharmaceuticals

9:15–10:15

C ADVANCED Address Best Practices for Monitoring and Executing Price Transparency Reporting

Susan Hibbard
Associate Director, Office of Ethics and Compliance-Transparency and Compliance
Boehringer Ingelheim

Mallory O'Connor
Director Of Public Policy
Mallinckrodt Pharmaceuticals

 

9:15–10:15

D INTERMEDIATE Review Data Collection Processes and Implement Key Metrics to Ensure Compliance

Kelly Tope, Esq., MBA
Global Director, Compliance
Zimmer Biomet

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
Director,
Corporate Compliance Monitoring and Risk
Sandoz Inc.

Shruti Anand Karkun
Senior Associate,
Global Transparency Reporting
Covance, Inc.

 

10:45–11:45

F INTERMEDIATE Understand Best Practices to Structure an Assumptions Document

Emily Cunningham
Associate Principal
IQVIA Commercial Compliance

Mark Scallon
Senior Principal
IQVIA Global Compliance

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
Senior Director Ethics & Compliance
Novo Nordisk

 

11:45–12:30

H CMS REVIEW Helpful Tips for Reporting and Preparing for a Potential CMS Audit

Robert Forcier
HCP Aggregate Spend Director
Smith & Nephew

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