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Agenda

Innovative Models for Elevating Ethics and Integrity Programs

October 22-24, 2019
  • San Francisco, CA

Agenda

Want more agenda details? Download the brochure.

PRE-CONFERENCE SUMMITS TUESDAY, OCTOBER 22, 2019

12:30

Pre-Conference Summit Registration

1:30

CHOOSE BETWEEN TWO PRE-CONFERENCE SUMMITS (A-B)

A Patient Assistance and Support Programs — Ensuring Patient Centricity Through Compliant Frameworks

As scrutiny continues to increase around patient services and interactions, it is more important than ever that compliance teams ensure that plans are in place to reduce risk. This summit explores risks and compliance considerations associated with patient assistance programs, hub services, nurse educator programs and reimbursement services. During this session, attendees uncover emerging enforcement trends and risks, and collaborate with peers to benchmark leading frameworks to establish best practices for compliant patient interactions.

I. Critical Updates on PAPs, Foundation Support, Coupons and Copay Programs

II. Compliant Nurse Educator Program Design and Oversight

III. Build Compliant Hub Services to Enhance Patient Access

IV. Enhance Oversight of Field Reimbursement Teams

Summit Leaders:

Kari Loeser
US Healthcare Compliance Officer
Relypsa

Terra Buckley
Executive Director, Healthcare Compliance
Celgene

Daryl Kreml
Chief Compliance Officer, Vice President
Sage Therapeutics

*There will be a 30-minute networking and refreshment break at 3:15

5:00

Close of Summit

B Third-Party Risk and Oversight —
Innovative Models Driving Compliance

As innovative and emerging life sciences companies continue to outsource services within their organization, scrutiny from enforcement bodies has increased as a result, leaving life sciences organizations vulnerable. It is imperative that life sciences companies invest resources in the proper oversight of third-party relationships. This summit goes beyond the normal due diligence to bridge the gap between companies and vendors. During this session, attendees share best practices, uncover red flags and set a tactical plan to enhance third-party oversight.

I. Optimize Third-Party Contracting Due Diligence

II. Uncover Current and Emerging HighRisk Areas When Collaborating with Third-Parties

III. Conduct a Robust Risk Assessment to Foster Optimal Auditing and Monitoring Programs

IV. Global Spotlight on FCPA and ABAC

Summit Leaders:

Valorie Ciechanowski
Compliance and Privacy Officer
Advanced Bionics

Blair J. Shaw, Esq.
Director, Global Procurement Compliance & Third-Party Risk Management
Merck & Co., Inc.

John E. Kelly
Member
Bass, Berry & Sims PLC

*There will be a 30-minute networking and refreshment break at 3:15

5:00

Close of Summit

Networking, Wine and
Cheese Reception
immediately following the pre-conference summits

DAY ONE WEDNESDAY, OCTOBER 23, 2019

7:00

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Erik Atkisson
Chief Compliance Officer and Legal Counsel
Cytokinetics

8:15

Trailblazer Talk Adapt and Evolve Compliance Programs in Support of Innovation

Moderator:

Rujul H. Desai
Of Counsel
Covington & Burling LLP

Panelists:

Averi Price
Vice President, Chief Compliance Officer
Radius Health Inc.

Sharon Delshad
Compliance Counsel
Neurocrine Biosciences, Inc.

Daryl Kreml
Chief Compliance Officer, Vice President
Sage Therapeutics

9:00

Current and Former Prosecutor Panel Fraud and Enforcement Trends for 2020 and Beyond

Moderator:

Ernie Hernandez
Chief Compliance Officer
Global Blood Therapeutics

Panelists:

Tiffany Moseley
Partner
Loeb & Loeb LLP

Jose Vela Jr., JD, LLM
Assistant U.S. Attorney
Bass Berry & Sims

Adam A. Reeves
First Assistant United States Attorney
The United States Attorney’s Office, Northern District of California

9:45

Policy Update Drug Pricing Transparency and Federal/ State Level Legislation

Allison Frisbee
Senior Corporate Counsel, Market Access
Jazz Pharmaceuticals

10:30

Networking and Refreshment Break

11:00

New Guidance Walk Through the Evaluation of Corporate Compliance Programs —
Foundational Understanding and Future Impact

MODERATOR:

Casey Horton, CFE
Director, Life Sciences Governance, Risk Management and Compliance
Navigant

PANELISTS:

J. Mark Farrar, MSJ, CPA, CFE, CFF
Managing Director, Life Sciences Governance, Risk Management and Compliance
Navigant

Kate Godfrey, JD, CCEP
Vice President, Chief Compliance and Privacy Officer
Adaptive Biotechnologies

Gina Nese
Chief Compliance Officer
Advanced Sterilization Products (ASP)

11:45

The Value of Operational Controls Surrounding High Risks Engagements

Diana Borges
Vice President, Compliance Solutions
MediSpend

Neha Agarwal
Director, Internal Audit and Compliance
Corcept

12:30

Networking Luncheon

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

12:30

Private Networking Luncheon

About Our Summit Host

Loeb & Loeb is a premier law firm focused on helping organizations and individuals innovate, grow and evolve in a changing world. Their market leading practice and industry teams deliver practical insight and strategic solutions in complex deals, high-profile disputes, cutting-edge regulatory issues and other matters critical to their clients’ success. The firm has nearly 400 lawyers across seven offices in the United States and Asia.

Summit Overview:

The CCO Summit provides world-class thought-leadership and is designed to deliver high-quality information that C-suite leaders can develop into an action plan. Collaborate with your distinguished colleagues to gain valuable insights through a blend of innovative, thought-provoking keynotes coupled with an interactive and engaging working group.

Summit Leaders:

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

Averi Price
Vice President, Chief Compliance Officer
Radius Health Inc.

Fabiana Lacerca-Allen
Senior Vice President, Compliance
Aimmune

3:00

Close of Summit

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

1:30

CHOOSE BETWEEN TWO CONCURRENT MASTER CLASSES (1-2)

1. Transparency and Aggregate Spend

Elaine Golangco
Associate Director, Compliance
Avanir Pharmaceuticals, Inc.

Darya Khankin
Aggregate Spend Manager,
Ethical Compliance
Varian Medical Systems

 
2. Data Privacy and Cybersecurity

Valorie Ciechanowski
Compliance and Privacy Officer
Advanced Bionics

Michael “Chip” Sanders Esq.
Associate Compliance Officer
NuVasive

2:15

CHOOSE BETWEEN TWO CONCURRENT MASTER CLASSES (3-4)

3. Promotional Compliance

Bethany Fox
Executive Director,
Commercial Legal Affairs
Exelixis

Krista Cosner
Assistant General Counsel
Myovant Health

Sharon Delshad
Compliance Counsel
Neurocrine Biosciences, Inc.

 
4. Non-Promotional Activities Compliance

Adrienne Thompson
Senior Director, Compliance and Legal
Halozyme Therapeutics

Jeremy A. Lutsky
Counsel
Manatt, Phelps & Phillips, LLP

Kavita Aggarwall
Vice President, Medical Affairs
Dova Pharmaceuticals

3:00

Networking and Refreshment Break

3:30

Compliance for Innovative Therapies —
Spotlight on Rare Disease and Cell and Gene Therapies

Gary Giampetruzzi
Partner, Litigation Department
Paul Hastings LLP

Angelique Lee-Rowley
Vice President, Global Chief Ethics & Compliance Officer,
R&D Legal Lead
Greenwich Biosciences, Inc., a GW Pharmaceuticals plc company

4:15

Training and Communications — Make the Most of Limited Resources

Adam Oakley
Director
Potomac River Partners

5:00

Close of Day One

Networking, Wine
and Cheese Reception
immediately following the final session on day one

DAY TWO THURSDAY, OCTOBER 24, 2019

7:30

Women in Compliance Breakfast Forum

L. Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

8:30

CHOOSE BETWEEN TWO CONCURRENT MASTER CLASSES (5-6)

5. Optimize Market Access Compliance and Zero In on Outcomes-Based Contracting

Renee Reimonenq Watson
Senior Counsel, US Pricing,
Access and Commercial Legal
Gilead

 
6. Achieve Compliant Frameworks within Patient Interactions from Clinical to Commercial

Gary Thompson
Vice President, Compliance Officer
Dermira

9:30

CHOOSE BETWEEN TWO CONCURRENT MASTER CLASSES (7-8)

7. Clinical and R&D Compliance — Furthering the Disseminationof Scientific Information

Angelique Lee-Rowley
Vice President, Global Chief Ethics & Compliance Officer, R&D Legal Lead
Greenwich Biosciences, Inc.,
a GW Pharmaceuticals plc company

 
8. HCP Engagement and Contracting — Mitigate Compliance Risk and Improve Operational Efficiency

Eric Jen
Director, Compliance
Heron Therapeutics, Inc

10:15

Networking and Refreshment Break

10:45

IN-CONFERENCE WORKSHOP Strengthen Speaker Program Compliance Through Innovative Initiatives and
Best Practices

Erik Atkisson
Chief Compliance Officer and Legal Counsel
Cytokinetics

Rebecca Spitler
Director, Health Care Compliance
Johnson & Johnson

Russ West
Sr VP Data Integration & Analytics
HealthSTAR Strategic Engagements

12:30

Networking Luncheon

1:30

PANEL DISCUSSION Governance Best Practices and Working with the Board

Moderator:

John E. Kelly
Member
Bass, Berry & Sims PLC

Panelists:

Fabiana Lacerca-Allen
Senior Vice President, Compliance
Aimmune

L. Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

2:15

Exclusive Benchmarking Think-Tank

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

PRE-CONFERENCE SUMMITS TUESDAY, OCTOBER 22, 2019

12:30

Pre-Conference Summit Registration

1:30

CHOOSE BETWEEN TWO PRE-CONFERENCE SUMMITS (A-B)

A Patient Assistance and Support Programs — Ensuring Patient Centricity Through Compliant Frameworks

As scrutiny continues to increase around patient services and interactions, it is more important than ever that compliance teams ensure that plans are in place to reduce risk. This summit explores risks and compliance considerations associated with patient assistance programs, hub services, nurse educator programs and reimbursement services. During this session, attendees uncover emerging enforcement trends and risks, and collaborate with peers to benchmark leading frameworks to establish best practices for compliant patient interactions.

I. Critical Updates on PAPs, Foundation Support, Coupons and Copay Programs

II. Compliant Nurse Educator Program Design and Oversight

III. Build Compliant Hub Services to Enhance Patient Access

IV. Enhance Oversight of Field Reimbursement Teams

Summit Leaders:

Kari Loeser
US Healthcare Compliance Officer
Relypsa

Terra Buckley
Executive Director, Healthcare Compliance
Celgene

Daryl Kreml
Chief Compliance Officer, Vice President
Sage Therapeutics

*There will be a 30-minute networking and refreshment break at 3:15

5:00

Close of Summit

B Third-Party Risk and Oversight —
Innovative Models Driving Compliance

As innovative and emerging life sciences companies continue to outsource services within their organization, scrutiny from enforcement bodies has increased as a result, leaving life sciences organizations vulnerable. It is imperative that life sciences companies invest resources in the proper oversight of third-party relationships. This summit goes beyond the normal due diligence to bridge the gap between companies and vendors. During this session, attendees share best practices, uncover red flags and set a tactical plan to enhance third-party oversight.

I. Optimize Third-Party Contracting Due Diligence

II. Uncover Current and Emerging HighRisk Areas When Collaborating with Third-Parties

III. Conduct a Robust Risk Assessment to Foster Optimal Auditing and Monitoring Programs

IV. Global Spotlight on FCPA and ABAC

Summit Leaders:

Valorie Ciechanowski
Compliance and Privacy Officer
Advanced Bionics

Blair J. Shaw, Esq.
Director, Global Procurement Compliance & Third-Party Risk Management
Merck & Co., Inc.

John E. Kelly
Member
Bass, Berry & Sims PLC

*There will be a 30-minute networking and refreshment break at 3:15

5:00

Close of Summit

Networking, Wine and
Cheese Reception
immediately following the pre-conference summits

DAY ONE WEDNESDAY, OCTOBER 23, 2019

7:00

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Erik Atkisson
Chief Compliance Officer and Legal Counsel
Cytokinetics

8:15

Trailblazer Talk Adapt and Evolve Compliance Programs in Support of Innovation

Moderator:

Rujul H. Desai
Of Counsel
Covington & Burling LLP

Panelists:

Averi Price
Vice President, Chief Compliance Officer
Radius Health Inc.

Sharon Delshad
Compliance Counsel
Neurocrine Biosciences, Inc.

Daryl Kreml
Chief Compliance Officer, Vice President
Sage Therapeutics

9:00

Current and Former Prosecutor Panel Fraud and Enforcement Trends for 2020 and Beyond

Moderator:

Ernie Hernandez
Chief Compliance Officer
Global Blood Therapeutics

Panelists:

Tiffany Moseley
Partner
Loeb & Loeb LLP

Jose Vela Jr., JD, LLM
Assistant U.S. Attorney
Bass Berry & Sims

Adam A. Reeves
First Assistant United States Attorney
The United States Attorney’s Office, Northern District of California

9:45

Policy Update Drug Pricing Transparency and Federal/ State Level Legislation

Allison Frisbee
Senior Corporate Counsel, Market Access
Jazz Pharmaceuticals

10:30

Networking and Refreshment Break

11:00

New Guidance Walk Through the Evaluation of Corporate Compliance Programs —
Foundational Understanding and Future Impact

MODERATOR:

Casey Horton, CFE
Director, Life Sciences Governance, Risk Management and Compliance
Navigant

PANELISTS:

J. Mark Farrar, MSJ, CPA, CFE, CFF
Managing Director, Life Sciences Governance, Risk Management and Compliance
Navigant

Kate Godfrey, JD, CCEP
Vice President, Chief Compliance and Privacy Officer
Adaptive Biotechnologies

Gina Nese
Chief Compliance Officer
Advanced Sterilization Products (ASP)

11:45

The Value of Operational Controls Surrounding High Risks Engagements

Diana Borges
Vice President, Compliance Solutions
MediSpend

Neha Agarwal
Director, Internal Audit and Compliance
Corcept

12:30

Networking Luncheon

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

12:30

Private Networking Luncheon

About Our Summit Host

Loeb & Loeb is a premier law firm focused on helping organizations and individuals innovate, grow and evolve in a changing world. Their market leading practice and industry teams deliver practical insight and strategic solutions in complex deals, high-profile disputes, cutting-edge regulatory issues and other matters critical to their clients’ success. The firm has nearly 400 lawyers across seven offices in the United States and Asia.

Summit Overview:

The CCO Summit provides world-class thought-leadership and is designed to deliver high-quality information that C-suite leaders can develop into an action plan. Collaborate with your distinguished colleagues to gain valuable insights through a blend of innovative, thought-provoking keynotes coupled with an interactive and engaging working group.

Summit Leaders:

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

Averi Price
Vice President, Chief Compliance Officer
Radius Health Inc.

Fabiana Lacerca-Allen
Senior Vice President, Compliance
Aimmune

3:00

Close of Summit

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

1:30

CHOOSE BETWEEN TWO CONCURRENT MASTER CLASSES (1-2)

1. Transparency and Aggregate Spend

Elaine Golangco
Associate Director, Compliance
Avanir Pharmaceuticals, Inc.

Darya Khankin
Aggregate Spend Manager,
Ethical Compliance
Varian Medical Systems

 
2. Data Privacy and Cybersecurity

Valorie Ciechanowski
Compliance and Privacy Officer
Advanced Bionics

Michael “Chip” Sanders Esq.
Associate Compliance Officer
NuVasive

2:15

CHOOSE BETWEEN TWO CONCURRENT MASTER CLASSES (3-4)

3. Promotional Compliance

Bethany Fox
Executive Director,
Commercial Legal Affairs
Exelixis

Krista Cosner
Assistant General Counsel
Myovant Health

Sharon Delshad
Compliance Counsel
Neurocrine Biosciences, Inc.

 
4. Non-Promotional Activities Compliance

Adrienne Thompson
Senior Director, Compliance and Legal
Halozyme Therapeutics

Jeremy A. Lutsky
Counsel
Manatt, Phelps & Phillips, LLP

Kavita Aggarwall
Vice President, Medical Affairs
Dova Pharmaceuticals

3:00

Networking and Refreshment Break

3:30

Compliance for Innovative Therapies —
Spotlight on Rare Disease and Cell and Gene Therapies

Gary Giampetruzzi
Partner, Litigation Department
Paul Hastings LLP

Angelique Lee-Rowley
Vice President, Global Chief Ethics & Compliance Officer,
R&D Legal Lead
Greenwich Biosciences, Inc., a GW Pharmaceuticals plc company

4:15

Training and Communications — Make the Most of Limited Resources

Adam Oakley
Director
Potomac River Partners

5:00

Close of Day One

Networking, Wine
and Cheese Reception
immediately following the final session on day one

DAY TWO THURSDAY, OCTOBER 24, 2019

7:30

Women in Compliance Breakfast Forum

L. Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

8:30

CHOOSE BETWEEN TWO CONCURRENT MASTER CLASSES (5-6)

5. Optimize Market Access Compliance and Zero In on Outcomes-Based Contracting

Renee Reimonenq Watson
Senior Counsel, US Pricing,
Access and Commercial Legal
Gilead

 
6. Achieve Compliant Frameworks within Patient Interactions from Clinical to Commercial

Gary Thompson
Vice President, Compliance Officer
Dermira

9:30

CHOOSE BETWEEN TWO CONCURRENT MASTER CLASSES (7-8)

7. Clinical and R&D Compliance — Furthering the Disseminationof Scientific Information

Angelique Lee-Rowley
Vice President, Global Chief Ethics & Compliance Officer, R&D Legal Lead
Greenwich Biosciences, Inc.,
a GW Pharmaceuticals plc company

 
8. HCP Engagement and Contracting — Mitigate Compliance Risk and Improve Operational Efficiency

Eric Jen
Director, Compliance
Heron Therapeutics, Inc

10:15

Networking and Refreshment Break

10:45

IN-CONFERENCE WORKSHOP Strengthen Speaker Program Compliance Through Innovative Initiatives and
Best Practices

Erik Atkisson
Chief Compliance Officer and Legal Counsel
Cytokinetics

Rebecca Spitler
Director, Health Care Compliance
Johnson & Johnson

Russ West
Sr VP Data Integration & Analytics
HealthSTAR Strategic Engagements

12:30

Networking Luncheon

1:30

PANEL DISCUSSION Governance Best Practices and Working with the Board

Moderator:

John E. Kelly
Member
Bass, Berry & Sims PLC

Panelists:

Fabiana Lacerca-Allen
Senior Vice President, Compliance
Aimmune

L. Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

2:15

Exclusive Benchmarking Think-Tank

3:00

Close of Conference