议程

  PRE-CONFERENCE SUMMITS
2019年10月22日(二)

12:30

Pre-Conference Summit Registration and Continental Breakfast

1:30 CHOOSE BETWEEN TWO PRE-CONFERENCE SUMMITS (A-B)

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

Summit Objective:

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.

Summit Outline:

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

BThird-Party Risk and Oversight — Innovative Models Driving Compliance

Summit Objective:

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.

Summit Outline:

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.

Darya Khankin
Aggregate Spend Manager, Ethical Compliance
Varian Medical Systems

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

第1天 2019年10月23日(三)

7:30

Registration and Continental Breakfast

8:30

Chairman’s Welcome and Opening Remarks

Erik Atkisson
Vice President, Legal and Compliance
Acer Therapeutics Inc.

8:45

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
Director, Compliance & Legal Affairs
Nalpropion Pharmaceuticals, Inc

Daryl Kreml
Chief Compliance Officer, Vice President
Sage Therapeutics

9:30

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., J.D., LL.M.
Assistant U.S. Attorney
Bass Berry & Sims

Adam A. Reeves
First Assistant United States Attorney
Dinsmore & Shohl LLP

10:15

Networking and Refreshment Break

11:00

POLICY UPDATEDrug Pricing Transparency and Federal/ State Level Legislation

Allison Frisbee
Senior Corporate Counsel, Market Access
Jazz Pharmaceuticals

11:45

NEW GUIDANCE Walk Through the Evaluation of Corporate Compliance Programs — Foundational Understanding and Future Impact

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

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

12:30

Networking Luncheon

CLOSED-DOOR AND INVITATION-ONLY*

CHIEF COMPLIANCE OFFICER SUMMIT

12:30

Private Networking Luncheon

Hosted By:

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.

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
Compliance Manager, Aggregate Spend
Avanir Pharmaceuticals

 
2. Data Privacy and Cybersecurity

Valorie Ciechanowski
Compliance and Privacy Officer
Advanced Bionics

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
Director, Compliance & Legal Affairs
Nalpropion Pharmaceuticals, Inc

 
4. Non-Promotional Activities Compliance

Adrienne Thompson
Senior Director, Compliance and Legal
Halozyme Therapeutics

Sunita Ramamurthy
Head of Compliance and Privacy Officer
Loxo Oncology

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

4:15

Leverage Data Analytics to Drive Auditing, Monitoring and Risk Identification

Jon Wilkenfeld
President
Potomac River Partners

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

第2天 2019年10月24日(四)

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 Watson
Senior Counsel, US Pricing, Access and Commercial Lega
Gilead

Thomas Felton
Executive Director, Head Market Access Counsel
Celgene

 
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

Darya Khankin
Aggregate Spend Manager, Ethical Compliance
Varian Medical Systems

10:15

Networking and Refreshment Break

10:45

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

Erik Atkisson
Vice President, Legal and Compliance
Acer Therapeutics Inc.

Rebecca Spitler
Director, Health Care Compliance
Johnson & Johnson

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:

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

Sunita Ramamurthy
Head of Compliance and Privacy Officer
Loxo Oncology

L. Kathleen Durousseau
Chief Compliance Officer
Rigel Pharmaceuticals

2:15

Exclusive Benchmarking Think-Tank

3:00

Close of Conference

* 活动内容有可能不事先告知作更动及调整。