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Agenda

The World’s Largest Bio/Pharma Event for Compliance and Legal Professionals

April 16-18, 2019
  • Washington, DC

Agenda

Want more agenda details? Download the brochure.

CONGRESS PRELUDES Tuesday, April 16, 2019

2:30 – 3:00PM

Prelude Registration

3:00 – 5:00PM

BENEFIT FROM ONE OF THREE TAILORED COMPLIANCE PRELUDES

PRELUDE A Healthcare Compliance and Policy Course

Designed for those new to compliance or new to the bio/pharma industry, this session acts as a primer for the conference as the main program is built off of the key elements discussed. Benefit from foundational knowledge in healthcare compliance basics before you embark on two content rich days covering emerging, high-risk areas.

Russell Rose
Senior Manager
Deloitte

Brian Miller, Ph.D.
Senior Director Training and Documentation,
Ethics and Compliance
Otsuka America Pharmaceutical Inc.

Jennifer Santos
Head of Global Corporate Compliance Operations
Vertex Pharmaceuticals

PRELUDE B Compliant Nurse Educator Programs

As scrutiny of nurse educator programs heats up, industry must ensure the proper guardrails are in place to maintain compliance for these critical patient support programs. During this session, gain foundational and operational knowledge needed to structure and maintain compliant programs.

Manny Tzavlakis
Managing Partner
Helio Health Group

Christine O’Connor-Fiore
Executive Director, Commercial Compliance
Boehringer Ingelheim

PRELUDE C Women’s Executive Leadership Forum
powered by:

This highly-acclaimed Forum showcases women in leadership within the compliance and life sciences community. Hear compelling stories of personal career success, reflect on professional development paths, discover flashpoint moments and ways to inspire and elevate the compliance team. Attendees discover meaningful mentorships and insights into optimal job placement and professional pathways.

Laura Skinner
Senior Manager
Deloitte

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

Margaret Feltz
Vice President, Ethics and Compliance,
Purdue Pharma L.P.

Veleka Peeples-Dyer
Partner
McDermott Will & Emery LLP

Adam Dubow
Chief Compliance and Ethics Officer
Bristol-Myers Squibb

IQVIA logo
Choate logo 5:00 – 6:00PM
PCC WELCOME RECEPTION
HOSTED BY:

DAY ONE Tuesday, April 17, 2019

7:00

Main Congress Registration and Continental Breakfast

7:50

CBI Welcome

8:00

Chairman’s Welcome and Opening Remarks

Bryant Aaron
Vice President, Chief Compliance, Officer, U.S. Country Head, Ethics and Compliance
Novartis Pharmaceuticals Corporation

8:10

“Compliance Year in Review” Video Reveal

8:15

Good Morning, PCC! Industry News Update and Policy Briefing

8:45

LUMINARY SHOWCASE
A Spotlight on Partnerships, Integration and Advancements Transforming the Industry y

Angela Rodin
Principal, Risk Advisory
KPMG LLP

10:00

CCO EXCHANGE Top of Mind Topics for Life Science Leaders

MODERATOR:

Regina Cavaliere
Principal
KPMG LLP

PANELISTS:

Jill Fallows Macaluso
Chief Compliance Officer and Vice President
Novo Nordisk Inc.

Beth Levine
Senior Vice President, Associate General Counsel
and Chief Compliance Officer
Regeneron Pharmaceuticals, Inc.

Michael Clarke
Vice President, Corporate Compliance
Indivior, Inc.

David Ryan
Vice President and Chief Compliance Officer
Epizyme

10:45

Networking and Refreshment Break
Hosted by:

11:15

HIGHLY-ACCLAIMED U.S. HEALTHCARE
FRAUD AND ENFORCEMENT PANEL

11:15

Past and Present Prosecutor Parley

PARLEY MODERATOR:

Kathleen Meriwether
Americas Life Sciences Leader, Principal,
Fraud Investigation & Dispute Services
Ernst & Young LLP

Current Prosecutors Panel

I.  Top Enforcement Trends and Focal Points for 2019 and Beyond

Nathaniel Mendell
First Assistant U.S. Attorney
U.S. Attorney’s Office for the District of Massachusetts

Vikas Khanna
Deputy Chief, Criminal Division
U.S. Attorney’s Office for the District of New Jersey

Former Prosecutors Panel

II.  New Developments on High-Profile Cases and Settlements Uncovering Healthcare Fraud

Terra Reynolds
Partner, White Collar and Investigations
Latham and Watkins LLP; Former Deputy Chief and Assistant U.S. Attorney
U.S. Attorney’s Office for the Northern District of Illinois

John Richter
Partner, King & Spalding LLP;
Former Deputy Chief and Assistant U.S. Attorney,
U.S. Attorney’s Office for the Western District of Oklahoma

12:30

Networking Luncheon

CLOSED-DOOR AND INVITATION-ONLY* CHIEF COMPLIANCE OFFICER SUMMIT

ABOUT OUR SUMMIT HOST - Porzio, Bromberg & Newman P.C. (“Porzio”) was founded in 1962 as a three-attorney firm and has grown to its present size of over 90 attorneys and 50 paraprofessionals with three office locations. Porzio has served the life sciences industry for over 30 years . In 2004, Porzio formed Porzio Life Sciences, LLC (“PorzioLS”) to provide the life sciences industry with web-based products, enabling companies to comply with state laws and regulations. Together, the companies provide regulatory compliance and legal services related to the Prescription Drug Marketing Act (PDMA), anti-kickback statutes, False Claims Act, US and ex-US transparency requirements, FDA regulations and OIG and CMS guidances.

*Invited participants hold the title of Chief Compliance Officer, Vice President of Compliance, General Counsel or an equivalent compliance leadership position at a life sciences company (at the time of the congress). Final eligibility approval is at the discretion of CBI.

HOSTED BY:

12:30

Private Networking Luncheon

1:30

Summit Host Welcome and Anti-Trust Guideline Reminders

John Oroho
Executive Vice President, Chief Strategy Officer
Porzio Life Sciences, LLC

I. Keynote Address

II. Candid Conversations on Key Business and Industry Topics

III. Reactionary Insights, Knowledge Sharing and Advanced Application

SUMMIT LEADER:

Jerald Korn
Senior Vice President, Deputy General Counsel
and Global Chief Compliance Officer
TESARO, Inc.

4:25

Close of CCO Summit

1:45 CHOOSE FROM 5 CONCURRENT MASTER CLASSES (A-E)

A Patient Assistance (PAPs) and A Support Programs (PSPs)

Track Chair’s Opening Remarks

BJ D'Avella
Senior Manager
Deloitte

1:50

Navigate the Complex Legal Landscape of PAPs

Meena Datta
Partner
Sidley Austin LLP

Jennifer McGee
Chief Compliance Officer, Vice President, Ethics and Compliance
Otsuka America Pharmaceutical, Inc.

2:30

Examine PSP Enforcement Trends as Scrutiny Heats Up

David Tolley
Partner, White Collar and Investigations
Latham and Watkins LLP

Francisco Ribeiro Filho
Senior Director, Head of U.S. Compliance
TESARO, Inc

Ann-Marie Tejcek
Senior Director, North American Ethics and Compliance Officer
Eli Lilly and Company

B Medical Affairs and B MSL Oversight

1:45

Track Chair’s Opening Remarks

1:50

Key Issues in Medical Affairs Compliance

Jon Wilkenfeld
President
Potomac River Partners

2:30

Demonstrate the Impact of MSL Interactions with Value and Access Stakeholders within a Controlled Framework

Brad Glazer
Head, Medical Governance and Compliance (MGC), U.S. Medical Affairs
GSK

Gary Del Vecchio
Healthcare Compliance Officer Cardiovascular, Metabolism and Puerto Rico
Janssen Pharmaceuticals

Mark DeWyngaert
Managing Director
Deloitte

C Transparency and C Aggregate Spend

1:45

Track Chair’s Opening Remarks

1:50

CMS ADDRESS CMS Transparency and Open Payments Update

Robin Usi
Director, Division of Data and Informatics
CMS

2:30

Prepare for Sunshine Expansion — Reporting Payments Made to Advance Practice Nurse and PAs

Gus Papandrikos
Senior Director Compliance
Daiichi Sankyo, Inc

D Promotional Compliance

1:45

Track Chair’s Opening Remarks

Scott Liebman
Partner & Co-Chair of Life Sciences
Loeb & Loeb LLP

1:50

FDA/OPDP ADDRESS OPDP Hot Topics, Guidances, Enforcement Trends and Warning Letter Review

Thomas W. Abrams, R.Ph., MBA
Director, Office of Prescription Drug Promotion
FDA

2:30

Industry Update — Evolution of Manufacturer Communication

MODERATOR:

Elizabeth Kim
Partner
Loeb & Loeb LLP

PANELISTS:

Sheetal Patel
Head, Regulatory Advertising and Promotion
Johnson & Johnson

Gina Vestea
Senior Director, Regulatory Affairs, Advertising and Promotion
Sanofi

Alessandra Ravetti
Vice President, Associate General Counsel
Regeneron Pharmaceuticals, Inc.

E Auditing, Monitoring and E Data Analytics

1:45

Track Chair’s Opening Remarks

1:50

INTERACTIVE BENCHMARKING Industry’s Bucket List — Key Areas for Oversight Amidst an Evolving Ecosystem

MODERATOR:

Stephanie Lewko, CFE
Director of Governance, Risk Management and Compliance
Navigant

PANELISTS:

Kelly Pitt
Director, Legal and Compliance, North America
Sobi, Inc.

Joyce Hsu
Lead Mandated Monitoring
Sanofi US

Jim Knepp
Director, Oversight and Monitoring
Johnson & Johnson

2:30

Collaboration Corner — Harmonize Data Sources and Business Partners for Advanced Analytics

Kathryn Pryze
Senior Manager, Compliance, Monitoring, Corporate Compliance andBusiness Practices
Endo Pharmaceuticals

Corey Dunbar
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

3:10

 NETWORKING AND REFRESHMENT BREAK HOSTED BY:

2:25

3:40 CHOOSE FROM 5 INTERACTIVE WORKSHOPS (1-5)

1 HCP/HEE Interactions and Contracting

WORKSHOP LEADERS:

Rahul Khara, Pharm.D.
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Brian P. Sharkey
Principal
Porzio Compliance Services, LLC

Michael O’Connor
Vice President, Compliance Technology
Porzio Compliance Services, LLC

2 Beyond Due Diligence — Auditing and Monitoring Third-Parties

WORKSHOP LEADERS:

Kris Curry
Principal, Forensic & Integrity Services
Ernst & Young LLP

Chris Matteson
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

3 Drug Pricing — From State Transparency Reporting to DTC Ads

WORKSHOP LEADERS:

Sheea Sybblis
Senior Counsel
Boehringer Ingelheim

Jennifer A. Romanski
Principal
Porzio Life Sciences

4 Risks Associated with the Hub and Field Reimbursement Teams

WORKSHOP LEADERS:

Jack Tanselle
Managing Director
Deloitte

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

Richard Konzelmann
Lead U.S. Risk Assessment and Compliance Audit
Sanofi US

Joe Philipose
Vice President, US and Enterprise Compliance
Alexion Pharmaceuticals

Meena Datta
Partner
Sidley Austin LLP

5 HCP Engagement Strategies and Contracting

WORKSHOP LEADERS:

Gregory Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

Angela Wood
Senior Director, Consumer Health Care Compliance North America and Global Functions Leader
Johnson & Johnson

T. Reed Stephens
Partner
McDermott Will & Emery LLP

4:25

Networking and Refreshment Break

4:55 CHOOSE FROM 5 THINK TANK SESSIONS (6-10)

6 Speaker Programs — Best Practice Benchmarking

MODERATOR:

Mark Scallon
Senior Principal
IQVIA Commercial Compliance

PANELISTS:

Jennifer McGee
Chief Compliance Officer, Vice President, Ethics and Compliance
Otsuka America Pharmaceutical, Inc.

Margaret Feltz
Vice President, Ethics and Compliance
Purdue Pharma L.P.

Peter J. Agnoletto, CPA
Senior Director, US Ethics and Business Integrity
Sanofi US

Rebecca Spitler
Director, Health Care Compliance
Johnson & Johnson

7 Investigations and Internal Audits

Daniel Font
Director, Compliance Investigations, Policy and Training
Daiichi Sankyo, Inc

Michael Hercz
Senior Vice President, General Counsel, Chief Compliance Officer
Sentynl Therapeutics, Inc.

Mark Pearson
Partner
Deloitte

8 Clinical and R&D Compliance

Patricia Cone
Head, Global R&D Compliance
Takeda

9 Social Media — Practical and Pragmatic Guidance

Nikki Reeves
Partner,
King & Spalding

Deborah Penza
Senior Vice President, Chief Compliance Officer
Melinta Therapeutics, Inc

Jennifer Sanfilippo
General Counsel
Melinta Therapeutics, Inc.

10 PAP and PSP Benchmarking — How Is Industry Adapting?

Casey J. Horton, CFE
Director of Governance, Risk Management and Compliance
Navigant

5:40

Close of Day One

Cocktail Reception Commences at the Close of Day One

DAY TWO Thursday, April 18, 2019

7:15

Continental Breakfast

8:00

Chairman's Review of Day One

Bryant Aaron
Vice President, Chief Compliance, Officer, U.S. Country Head, Ethics and Compliance
Novartis Pharmaceuticals Corporation

8:05

From the Trenches An Inside Look at the Forces and Pressures that Drive People to Violate the Law

KEYNOTE SPEAKER:

J. Kevin Foster
Founder and CEO
Business Ethics Advisors, LLC;
Former Executive Vice President, Finance
Peerless Real Estate Services, Inc.

MODERATOR:

Vito A. Gagliardi
President and CEO
Porzio Life Sciences

8:45

Enforcement Spotlight — Recent Trends and High-Priority
Risk Areas Impacting the Life Sciences Sector

PANELISTS:

Eric Rubenstein
Former Special Agent, U.S. Department of Health and Human Services
Office of Inspector General

Heather Johnson
Attorney, Health Care Division, Bureau of Competition
Federal Trade Commission

9:30

Brain Teaser
Rethinking the Compliance Profession — Where Should We Go from Here?

MODERATOR:

Patrik Florencio
Senior Vice President, Global Chief Compliance and Risk Officer
Amicus Therapeutics

PANELISTS:

James Accumanno
Director, Ethics and Compliance Strategy, Risk and Education
Novo Nordisk Inc.

Melissa Tearney
Department Chair
Choate Hall & Stewart LLP

Donna Boehme
Partner
Compliance Strategists LLC

10:30

Networking and Refreshment Break

11:00 CHOOSE FROM FIVE IN-DEPTH SUMMITS (I-V)

I Small to Mid-Sized Company Resource Center

MODERATOR:

Jeff Rosenbaum
Co-Founder and Partner
Dovetail Consulting Group LLC

PANELISTS:

Rahul Khara, Pharm.D.
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Leslie Zacks
General Counsel and Chief Compliance Officer
Clearside Biomedical, Inc.

David Ryan
Vice President and Chief Compliance Officer
Epizyme

II Market Access Compliance

Donna White
Vice President, Contracts and Compliance
Chiesi USA, Inc.

Debbie Walters
Vice President and Assistant General Counsel
Pfizer

Darren Jones
Senior Principal
IQVIA Commercial Compliance

Amy Greenstein
Engagement Manager
IQVIA Commercial Compliance

III Compliant Patient Interactions

MODERATOR:

Michelle Axelrod
Vice President
Porzio Life Sciences, LLC

PANELISTS:

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

Aida L. Gonzalez
Director, Health Care Compliance Officer
Johnson & Johnson

IV Global Compliance — Spotlight on High-Risk Markets

Ryan Lenz
Vice President and Head of Europe,
Middle East, Africa and Asia Audit and Assurance
GSK

Tiffany Moseley
Partnere
Loeb & Loeb LLP

V Data Privacy and Cybersecurity — What Every Compliance Professional Needs to Know

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

12:15

Networking Luncheon

1:30

2:00

Close of Congress

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

CONGRESS PRELUDES Tuesday, April 16, 2019

2:30 – 3:00PM

Prelude Registration

3:00 – 5:00PM

BENEFIT FROM ONE OF THREE TAILORED COMPLIANCE PRELUDES

PRELUDE A Healthcare Compliance and Policy Course

Designed for those new to compliance or new to the bio/pharma industry, this session acts as a primer for the conference as the main program is built off of the key elements discussed. Benefit from foundational knowledge in healthcare compliance basics before you embark on two content rich days covering emerging, high-risk areas.

Russell Rose
Senior Manager
Deloitte

Brian Miller, Ph.D.
Senior Director Training and Documentation,
Ethics and Compliance
Otsuka America Pharmaceutical Inc.

Jennifer Santos
Head of Global Corporate Compliance Operations
Vertex Pharmaceuticals

PRELUDE B Compliant Nurse Educator Programs

As scrutiny of nurse educator programs heats up, industry must ensure the proper guardrails are in place to maintain compliance for these critical patient support programs. During this session, gain foundational and operational knowledge needed to structure and maintain compliant programs.

Manny Tzavlakis
Managing Partner
Helio Health Group

Christine O’Connor-Fiore
Executive Director, Commercial Compliance
Boehringer Ingelheim

PRELUDE C Women’s Executive Leadership Forum
powered by:

This highly-acclaimed Forum showcases women in leadership within the compliance and life sciences community. Hear compelling stories of personal career success, reflect on professional development paths, discover flashpoint moments and ways to inspire and elevate the compliance team. Attendees discover meaningful mentorships and insights into optimal job placement and professional pathways.

Laura Skinner
Senior Manager
Deloitte

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

Margaret Feltz
Vice President, Ethics and Compliance,
Purdue Pharma L.P.

Veleka Peeples-Dyer
Partner
McDermott Will & Emery LLP

Adam Dubow
Chief Compliance and Ethics Officer
Bristol-Myers Squibb

IQVIA logo
Choate logo 5:00 – 6:00PM
PCC WELCOME RECEPTION
HOSTED BY:

DAY ONE Tuesday, April 17, 2019

7:00

Main Congress Registration and Continental Breakfast

7:50

CBI Welcome

8:00

Chairman’s Welcome and Opening Remarks

Bryant Aaron
Vice President, Chief Compliance, Officer, U.S. Country Head, Ethics and Compliance
Novartis Pharmaceuticals Corporation

8:10

“Compliance Year in Review” Video Reveal

8:15

Good Morning, PCC! Industry News Update and Policy Briefing

8:45

LUMINARY SHOWCASE
A Spotlight on Partnerships, Integration and Advancements Transforming the Industry y

Angela Rodin
Principal, Risk Advisory
KPMG LLP

10:00

CCO EXCHANGE Top of Mind Topics for Life Science Leaders

MODERATOR:

Regina Cavaliere
Principal
KPMG LLP

PANELISTS:

Jill Fallows Macaluso
Chief Compliance Officer and Vice President
Novo Nordisk Inc.

Beth Levine
Senior Vice President, Associate General Counsel
and Chief Compliance Officer
Regeneron Pharmaceuticals, Inc.

Michael Clarke
Vice President, Corporate Compliance
Indivior, Inc.

David Ryan
Vice President and Chief Compliance Officer
Epizyme

10:45

Networking and Refreshment Break
Hosted by:

11:15

HIGHLY-ACCLAIMED U.S. HEALTHCARE
FRAUD AND ENFORCEMENT PANEL

11:15

Past and Present Prosecutor Parley

PARLEY MODERATOR:

Kathleen Meriwether
Americas Life Sciences Leader, Principal,
Fraud Investigation & Dispute Services
Ernst & Young LLP

Current Prosecutors Panel

I.  Top Enforcement Trends and Focal Points for 2019 and Beyond

Nathaniel Mendell
First Assistant U.S. Attorney
U.S. Attorney’s Office for the District of Massachusetts

Vikas Khanna
Deputy Chief, Criminal Division
U.S. Attorney’s Office for the District of New Jersey

Former Prosecutors Panel

II.  New Developments on High-Profile Cases and Settlements Uncovering Healthcare Fraud

Terra Reynolds
Partner, White Collar and Investigations
Latham and Watkins LLP; Former Deputy Chief and Assistant U.S. Attorney
U.S. Attorney’s Office for the Northern District of Illinois

John Richter
Partner, King & Spalding LLP;
Former Deputy Chief and Assistant U.S. Attorney,
U.S. Attorney’s Office for the Western District of Oklahoma

12:30

Networking Luncheon

CLOSED-DOOR AND INVITATION-ONLY* CHIEF COMPLIANCE OFFICER SUMMIT

ABOUT OUR SUMMIT HOST - Porzio, Bromberg & Newman P.C. (“Porzio”) was founded in 1962 as a three-attorney firm and has grown to its present size of over 90 attorneys and 50 paraprofessionals with three office locations. Porzio has served the life sciences industry for over 30 years . In 2004, Porzio formed Porzio Life Sciences, LLC (“PorzioLS”) to provide the life sciences industry with web-based products, enabling companies to comply with state laws and regulations. Together, the companies provide regulatory compliance and legal services related to the Prescription Drug Marketing Act (PDMA), anti-kickback statutes, False Claims Act, US and ex-US transparency requirements, FDA regulations and OIG and CMS guidances.

*Invited participants hold the title of Chief Compliance Officer, Vice President of Compliance, General Counsel or an equivalent compliance leadership position at a life sciences company (at the time of the congress). Final eligibility approval is at the discretion of CBI.

HOSTED BY:

12:30

Private Networking Luncheon

1:30

Summit Host Welcome and Anti-Trust Guideline Reminders

John Oroho
Executive Vice President, Chief Strategy Officer
Porzio Life Sciences, LLC

I. Keynote Address

II. Candid Conversations on Key Business and Industry Topics

III. Reactionary Insights, Knowledge Sharing and Advanced Application

SUMMIT LEADER:

Jerald Korn
Senior Vice President, Deputy General Counsel
and Global Chief Compliance Officer
TESARO, Inc.

4:25

Close of CCO Summit

1:45 CHOOSE FROM 5 CONCURRENT MASTER CLASSES (A-E)

A Patient Assistance (PAPs) and A Support Programs (PSPs)

Track Chair’s Opening Remarks

BJ D'Avella
Senior Manager
Deloitte

1:50

Navigate the Complex Legal Landscape of PAPs

Meena Datta
Partner
Sidley Austin LLP

Jennifer McGee
Chief Compliance Officer, Vice President, Ethics and Compliance
Otsuka America Pharmaceutical, Inc.

2:30

Examine PSP Enforcement Trends as Scrutiny Heats Up

David Tolley
Partner, White Collar and Investigations
Latham and Watkins LLP

Francisco Ribeiro Filho
Senior Director, Head of U.S. Compliance
TESARO, Inc

Ann-Marie Tejcek
Senior Director, North American Ethics and Compliance Officer
Eli Lilly and Company

B Medical Affairs and B MSL Oversight

1:45

Track Chair’s Opening Remarks

1:50

Key Issues in Medical Affairs Compliance

Jon Wilkenfeld
President
Potomac River Partners

2:30

Demonstrate the Impact of MSL Interactions with Value and Access Stakeholders within a Controlled Framework

Brad Glazer
Head, Medical Governance and Compliance (MGC), U.S. Medical Affairs
GSK

Gary Del Vecchio
Healthcare Compliance Officer Cardiovascular, Metabolism and Puerto Rico
Janssen Pharmaceuticals

Mark DeWyngaert
Managing Director
Deloitte

C Transparency and C Aggregate Spend

1:45

Track Chair’s Opening Remarks

1:50

CMS ADDRESS CMS Transparency and Open Payments Update

Robin Usi
Director, Division of Data and Informatics
CMS

2:30

Prepare for Sunshine Expansion — Reporting Payments Made to Advance Practice Nurse and PAs

Gus Papandrikos
Senior Director Compliance
Daiichi Sankyo, Inc

D Promotional Compliance

1:45

Track Chair’s Opening Remarks

Scott Liebman
Partner & Co-Chair of Life Sciences
Loeb & Loeb LLP

1:50

FDA/OPDP ADDRESS OPDP Hot Topics, Guidances, Enforcement Trends and Warning Letter Review

Thomas W. Abrams, R.Ph., MBA
Director, Office of Prescription Drug Promotion
FDA

2:30

Industry Update — Evolution of Manufacturer Communication

MODERATOR:

Elizabeth Kim
Partner
Loeb & Loeb LLP

PANELISTS:

Sheetal Patel
Head, Regulatory Advertising and Promotion
Johnson & Johnson

Gina Vestea
Senior Director, Regulatory Affairs, Advertising and Promotion
Sanofi

Alessandra Ravetti
Vice President, Associate General Counsel
Regeneron Pharmaceuticals, Inc.

E Auditing, Monitoring and E Data Analytics

1:45

Track Chair’s Opening Remarks

1:50

INTERACTIVE BENCHMARKING Industry’s Bucket List — Key Areas for Oversight Amidst an Evolving Ecosystem

MODERATOR:

Stephanie Lewko, CFE
Director of Governance, Risk Management and Compliance
Navigant

PANELISTS:

Kelly Pitt
Director, Legal and Compliance, North America
Sobi, Inc.

Joyce Hsu
Lead Mandated Monitoring
Sanofi US

Jim Knepp
Director, Oversight and Monitoring
Johnson & Johnson

2:30

Collaboration Corner — Harmonize Data Sources and Business Partners for Advanced Analytics

Kathryn Pryze
Senior Manager, Compliance, Monitoring, Corporate Compliance andBusiness Practices
Endo Pharmaceuticals

Corey Dunbar
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

3:10

 NETWORKING AND REFRESHMENT BREAK HOSTED BY:

2:25

3:40 CHOOSE FROM 5 INTERACTIVE WORKSHOPS (1-5)

1 HCP/HEE Interactions and Contracting

WORKSHOP LEADERS:

Rahul Khara, Pharm.D.
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Brian P. Sharkey
Principal
Porzio Compliance Services, LLC

Michael O’Connor
Vice President, Compliance Technology
Porzio Compliance Services, LLC

2 Beyond Due Diligence — Auditing and Monitoring Third-Parties

WORKSHOP LEADERS:

Kris Curry
Principal, Forensic & Integrity Services
Ernst & Young LLP

Chris Matteson
Senior Manager, Forensic & Integrity Services
Ernst & Young LLP

3 Drug Pricing — From State Transparency Reporting to DTC Ads

WORKSHOP LEADERS:

Sheea Sybblis
Senior Counsel
Boehringer Ingelheim

Jennifer A. Romanski
Principal
Porzio Life Sciences

4 Risks Associated with the Hub and Field Reimbursement Teams

WORKSHOP LEADERS:

Jack Tanselle
Managing Director
Deloitte

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

Richard Konzelmann
Lead U.S. Risk Assessment and Compliance Audit
Sanofi US

Joe Philipose
Vice President, US and Enterprise Compliance
Alexion Pharmaceuticals

Meena Datta
Partner
Sidley Austin LLP

5 HCP Engagement Strategies and Contracting

WORKSHOP LEADERS:

Gregory Moss
Senior Vice President, Deputy General Counsel
Kadmon Holdings, Inc.

Angela Wood
Senior Director, Consumer Health Care Compliance North America and Global Functions Leader
Johnson & Johnson

T. Reed Stephens
Partner
McDermott Will & Emery LLP

4:25

Networking and Refreshment Break

4:55 CHOOSE FROM 5 THINK TANK SESSIONS (6-10)

6 Speaker Programs — Best Practice Benchmarking

MODERATOR:

Mark Scallon
Senior Principal
IQVIA Commercial Compliance

PANELISTS:

Jennifer McGee
Chief Compliance Officer, Vice President, Ethics and Compliance
Otsuka America Pharmaceutical, Inc.

Margaret Feltz
Vice President, Ethics and Compliance
Purdue Pharma L.P.

Peter J. Agnoletto, CPA
Senior Director, US Ethics and Business Integrity
Sanofi US

Rebecca Spitler
Director, Health Care Compliance
Johnson & Johnson

7 Investigations and Internal Audits

Daniel Font
Director, Compliance Investigations, Policy and Training
Daiichi Sankyo, Inc

Michael Hercz
Senior Vice President, General Counsel, Chief Compliance Officer
Sentynl Therapeutics, Inc.

Mark Pearson
Partner
Deloitte

8 Clinical and R&D Compliance

Patricia Cone
Head, Global R&D Compliance
Takeda

9 Social Media — Practical and Pragmatic Guidance

Nikki Reeves
Partner,
King & Spalding

Deborah Penza
Senior Vice President, Chief Compliance Officer
Melinta Therapeutics, Inc

Jennifer Sanfilippo
General Counsel
Melinta Therapeutics, Inc.

10 PAP and PSP Benchmarking — How Is Industry Adapting?

Casey J. Horton, CFE
Director of Governance, Risk Management and Compliance
Navigant

5:40

Close of Day One

Cocktail Reception Commences at the Close of Day One

DAY TWO Thursday, April 18, 2019

7:15

Continental Breakfast

8:00

Chairman's Review of Day One

Bryant Aaron
Vice President, Chief Compliance, Officer, U.S. Country Head, Ethics and Compliance
Novartis Pharmaceuticals Corporation

8:05

From the Trenches An Inside Look at the Forces and Pressures that Drive People to Violate the Law

KEYNOTE SPEAKER:

J. Kevin Foster
Founder and CEO
Business Ethics Advisors, LLC;
Former Executive Vice President, Finance
Peerless Real Estate Services, Inc.

MODERATOR:

Vito A. Gagliardi
President and CEO
Porzio Life Sciences

8:45

Enforcement Spotlight — Recent Trends and High-Priority
Risk Areas Impacting the Life Sciences Sector

PANELISTS:

Eric Rubenstein
Former Special Agent, U.S. Department of Health and Human Services
Office of Inspector General

Heather Johnson
Attorney, Health Care Division, Bureau of Competition
Federal Trade Commission

9:30

Brain Teaser
Rethinking the Compliance Profession — Where Should We Go from Here?

MODERATOR:

Patrik Florencio
Senior Vice President, Global Chief Compliance and Risk Officer
Amicus Therapeutics

PANELISTS:

James Accumanno
Director, Ethics and Compliance Strategy, Risk and Education
Novo Nordisk Inc.

Melissa Tearney
Department Chair
Choate Hall & Stewart LLP

Donna Boehme
Partner
Compliance Strategists LLC

10:30

Networking and Refreshment Break

11:00 CHOOSE FROM FIVE IN-DEPTH SUMMITS (I-V)

I Small to Mid-Sized Company Resource Center

MODERATOR:

Jeff Rosenbaum
Co-Founder and Partner
Dovetail Consulting Group LLC

PANELISTS:

Rahul Khara, Pharm.D.
Senior Director, Compliance and Commercial Counsel
Acceleron Pharma Inc.

Leslie Zacks
General Counsel and Chief Compliance Officer
Clearside Biomedical, Inc.

David Ryan
Vice President and Chief Compliance Officer
Epizyme

II Market Access Compliance

Donna White
Vice President, Contracts and Compliance
Chiesi USA, Inc.

Debbie Walters
Vice President and Assistant General Counsel
Pfizer

Darren Jones
Senior Principal
IQVIA Commercial Compliance

Amy Greenstein
Engagement Manager
IQVIA Commercial Compliance

III Compliant Patient Interactions

MODERATOR:

Michelle Axelrod
Vice President
Porzio Life Sciences, LLC

PANELISTS:

Sarah Whipple
Senior Corporate and Compliance Counsel
Akebia Therapeutics, Inc.

Aida L. Gonzalez
Director, Health Care Compliance Officer
Johnson & Johnson

IV Global Compliance — Spotlight on High-Risk Markets

Ryan Lenz
Vice President and Head of Europe,
Middle East, Africa and Asia Audit and Assurance
GSK

Tiffany Moseley
Partnere
Loeb & Loeb LLP

V Data Privacy and Cybersecurity — What Every Compliance Professional Needs to Know

Sujata Dayal
Vice President, Health Care Compliance and Privacy
Johnson & Johnson

12:15

Networking Luncheon

1:30

2:00

Close of Congress