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Agenda

A Forum for Emerging and Innovative Pharma, Biotech and Device Companies

October 17-18, 2017
  • San Francisco, CA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, OCTOBER 17, 2017

7:30

Conference Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

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

8:45

LESSONS FROM THE FRONT LINES Anti-Kickback Violation Accusations and the Aftermath —
An Inside Look at Sales and Marketing Practices under Fire

Jonathan Roper
Former District Sales Director at a Specialty Pharmaceutical Company

9:30

ENFORCEMENT PERSPECTIVES Top Enforcement Trends and Focal Points for 2018 and Beyond

PANELISTS:

Sara Winslow
Chief, Civil Division
U.S. Attorney’s Office for the Northern District of California

Gregg Shapiro
Assistant United States Attorney, District of Massachusetts
U.S. Department of Justice

David Walk
Assistant United States Attorney, District of New Jersey
U.S. Department of Justice

10:15

Networking and Refreshment Break

10:45

CCO LUMINARY SHOWCASE

Gain insight into the industry’s foremost minds as influential Chief Compliance Officers sound off on the most pressing issues impacting the business.

PANELISTS:

Matt Werner
Vice President, Chief Compliance Officer
Bio-Rad Laboratories, Inc.

Sherry Schnell
Chief Compliance Officer, Associate General Counsel
Neurocrine Biosciences, Inc.

Dan Guggenheim
Chief Compliance Officer
Theranos

11:30

REGULATORY UPDATE Off-Label Communication —
Deep Dive into the New Regulatory Updates and Actions

Chrissy Bradshaw, JD
Vice President
Porzio Life Sciences

12:15

Networking Luncheon

1:30

Industry’s Guide to GDPR Compliance

Mark Farrar
Managing Director
Navigant

2:15

Navigate the Complexities of Patient Assistant Programs, Reimbursement Support and Patient Services Compliance in an Era of Ambiguity

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

Stefanie Doebler
Of Counsel
Covington & Burling LLP

Francisco Ribeiro Filho
Senior Director, Global Head of Compliance
Sarepta Therapeutics

3:00

Networking and Refreshment Break

3:30

CHOOSE BETWEEN TWO CONTENT STREAMS (A-B)

A Small to Mid-Sized Company Boot Camp

I. Early Compliance Governance Considerations

II. Key Elements of Compliance Program by Development Phase

III. Roundtable Discussion

FACILITATORS:

Jim Schneider
Associate Director
Seattle Genetics

Jane Wright-Mitchell
Chief Legal Officer
AcelRx Pharmaceuticals, Inc.

Daniel O'Connor
Senior Vice President
NXLevel Solutions

 
B Compliance Program Master Class —
How Does Your Program Stack Up to Effectiveness Benchmarks?

I. Analysis and Remediation of Underlying Conduct

II. Senior and Middle Management

III. Autonomy and Resources

IV. Policies and Procedures

V. Risk Assessment

VI. Training and Communications

VII. Confidential Reporting and Investigation

VIII. Incentives and Disciplinary Measures

IX. Continuous Improvement, Periodic Testing and Review

X. Third-Party Management

XI. Mergers and Acquisitions

FACILITATORS:

Jeremy Livianu
Director, Legal Affairs
Compliance and Privacy Officer
Nevro

Richard J. Ciamacca
Vice President
Secretary and General Counsel
Amring Pharmaceuticals

5:00

Close of Day One

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

WEDNESDAY, OCTOBER 18, 2017 INVITATION-ONLY* CHIEF COMPLIANCE OFFICER SUMMIT

An Exclusive Dialogue among Chief Compliance Officers in the Life Sciences Industry

HOSTED BY:

7:30

Summit Registration and Networking Breakfast

8:30

Summit Host Welcome and Anti-Trust Guideline Reminders

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

Summit Objective:

This Summit has been designed to encourage an open exchange of ideas and strategies surrounding some of the most critical issues facing compliance and legal departments in the life sciences industry. Participants can share their challenges in these areas, pose questions of their colleagues and come away with valuable insight into current and future compliance initiatives.

An antitrust attorney is present throughout the Summit to ensure appropriate and compliant discussion among participants.

Summit Facilitator:

Richard J. Ciamacca
Vice President, Secretary and General Counsel
Amring Pharmaceuticals

12:00

Close of CCO Summit

There will be a 30-minute networking and refreshment break at 10:00am

*Summit participants must hold the title of Chief Compliance Officer, General Counsel or an equivalent compliance leadership position in the pharmaceutical, biotech or medical device industry at the time of the conference to meet eligibility requirements. Final eligibility approval
is at the discretion of CBI.

DAY TWO — MAIN CONFERENCE WEDNESDAY, OCTOBER 18, 2017

7:30

Continental Breakfast

8:00

Chairperson’s Review of Day One

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

8:15

KEYNOTE ADDRESS A Journey to the Dark Side of International Business and Steps to Protect Your Organization

Richard Bistrong
CEO, Front-Line Anti-Bribery LLC;
former FCPA Violator and FBI/UK Cooperator

COMPLIANCE CIRCLES OF EXCELLENCE Elevate and Enhance Best Practices During Focused,
Small Group Discussions and Exchange

Following the presentation, attendees have the opportunity to participate in open discussion surrounding operational best practices surrounding each topic.
Sessions are designed to optimize your peer-to-peer networking and learning.

9:15

TOPIC #1
HCP Engagement and Contracting

Eric Jen
Associate Director, Compliance
Heron Therapeutics

10:00

Networking and Refreshment Break

10:30

TOPIC #2
Operations Management —
Align Compliance Strategy with Emerging Risks on the Horizon for 2018

Ben Carmel
Managing Director, San Francisco
Polaris

11:15

TOPIC #3
Speaker Programs — A Holistic Approach to Managing Risk

Jon Wilkenfeld
President
Potomac River Partners

Chris Hull
Consultant
Potomac River Partners

12:00

Networking Luncheon

1:15

TOPIC #4
Analyze the Involvement of Medical Affairs in Commercial Activities

Ben Carmel
Managing Director, San Francisco
Polaris

2:00

TOPIC #5
Utilize Monitoring Data and Analytics for Meaningful Metrics

Valorie Ciechanowski
Compliance and Privacy Officer
Advanced Bionics

3:00

Close of Conference

Agenda

Want more agenda details? Download the brochure.
Want more agenda details? Download the brochure.

DAY ONE TUESDAY, OCTOBER 17, 2017

7:30

Conference Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

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

8:45

LESSONS FROM THE FRONT LINES Anti-Kickback Violation Accusations and the Aftermath —
An Inside Look at Sales and Marketing Practices under Fire

Jonathan Roper
Former District Sales Director at a Specialty Pharmaceutical Company

9:30

ENFORCEMENT PERSPECTIVES Top Enforcement Trends and Focal Points for 2018 and Beyond

PANELISTS:

Sara Winslow
Chief, Civil Division
U.S. Attorney’s Office for the Northern District of California

Gregg Shapiro
Assistant United States Attorney, District of Massachusetts
U.S. Department of Justice

David Walk
Assistant United States Attorney, District of New Jersey
U.S. Department of Justice

10:15

Networking and Refreshment Break

10:45

CCO LUMINARY SHOWCASE

Gain insight into the industry’s foremost minds as influential Chief Compliance Officers sound off on the most pressing issues impacting the business.

PANELISTS:

Matt Werner
Vice President, Chief Compliance Officer
Bio-Rad Laboratories, Inc.

Sherry Schnell
Chief Compliance Officer, Associate General Counsel
Neurocrine Biosciences, Inc.

Dan Guggenheim
Chief Compliance Officer
Theranos

11:30

REGULATORY UPDATE Off-Label Communication —
Deep Dive into the New Regulatory Updates and Actions

Chrissy Bradshaw, JD
Vice President
Porzio Life Sciences

12:15

Networking Luncheon

1:30

Industry’s Guide to GDPR Compliance

Mark Farrar
Managing Director
Navigant

2:15

Navigate the Complexities of Patient Assistant Programs, Reimbursement Support and Patient Services Compliance in an Era of Ambiguity

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

Stefanie Doebler
Of Counsel
Covington & Burling LLP

Francisco Ribeiro Filho
Senior Director, Global Head of Compliance
Sarepta Therapeutics

3:00

Networking and Refreshment Break

3:30

CHOOSE BETWEEN TWO CONTENT STREAMS (A-B)

A Small to Mid-Sized Company Boot Camp

I. Early Compliance Governance Considerations

II. Key Elements of Compliance Program by Development Phase

III. Roundtable Discussion

FACILITATORS:

Jim Schneider
Associate Director
Seattle Genetics

Jane Wright-Mitchell
Chief Legal Officer
AcelRx Pharmaceuticals, Inc.

Daniel O'Connor
Senior Vice President
NXLevel Solutions

 
B Compliance Program Master Class —
How Does Your Program Stack Up to Effectiveness Benchmarks?

I. Analysis and Remediation of Underlying Conduct

II. Senior and Middle Management

III. Autonomy and Resources

IV. Policies and Procedures

V. Risk Assessment

VI. Training and Communications

VII. Confidential Reporting and Investigation

VIII. Incentives and Disciplinary Measures

IX. Continuous Improvement, Periodic Testing and Review

X. Third-Party Management

XI. Mergers and Acquisitions

FACILITATORS:

Jeremy Livianu
Director, Legal Affairs
Compliance and Privacy Officer
Nevro

Richard J. Ciamacca
Vice President
Secretary and General Counsel
Amring Pharmaceuticals

5:00

Close of Day One

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

WEDNESDAY, OCTOBER 18, 2017 INVITATION-ONLY* CHIEF COMPLIANCE OFFICER SUMMIT

An Exclusive Dialogue among Chief Compliance Officers in the Life Sciences Industry

HOSTED BY:

7:30

Summit Registration and Networking Breakfast

8:30

Summit Host Welcome and Anti-Trust Guideline Reminders

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

Summit Objective:

This Summit has been designed to encourage an open exchange of ideas and strategies surrounding some of the most critical issues facing compliance and legal departments in the life sciences industry. Participants can share their challenges in these areas, pose questions of their colleagues and come away with valuable insight into current and future compliance initiatives.

An antitrust attorney is present throughout the Summit to ensure appropriate and compliant discussion among participants.

Summit Facilitator:

Richard J. Ciamacca
Vice President, Secretary and General Counsel
Amring Pharmaceuticals

12:00

Close of CCO Summit

There will be a 30-minute networking and refreshment break at 10:00am

*Summit participants must hold the title of Chief Compliance Officer, General Counsel or an equivalent compliance leadership position in the pharmaceutical, biotech or medical device industry at the time of the conference to meet eligibility requirements. Final eligibility approval
is at the discretion of CBI.

DAY TWO — MAIN CONFERENCE WEDNESDAY, OCTOBER 18, 2017

7:30

Continental Breakfast

8:00

Chairperson’s Review of Day One

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

8:15

KEYNOTE ADDRESS A Journey to the Dark Side of International Business and Steps to Protect Your Organization

Richard Bistrong
CEO, Front-Line Anti-Bribery LLC;
former FCPA Violator and FBI/UK Cooperator

COMPLIANCE CIRCLES OF EXCELLENCE Elevate and Enhance Best Practices During Focused,
Small Group Discussions and Exchange

Following the presentation, attendees have the opportunity to participate in open discussion surrounding operational best practices surrounding each topic.
Sessions are designed to optimize your peer-to-peer networking and learning.

9:15

TOPIC #1
HCP Engagement and Contracting

Eric Jen
Associate Director, Compliance
Heron Therapeutics

10:00

Networking and Refreshment Break

10:30

TOPIC #2
Operations Management —
Align Compliance Strategy with Emerging Risks on the Horizon for 2018

Ben Carmel
Managing Director, San Francisco
Polaris

11:15

TOPIC #3
Speaker Programs — A Holistic Approach to Managing Risk

Jon Wilkenfeld
President
Potomac River Partners

Chris Hull
Consultant
Potomac River Partners

12:00

Networking Luncheon

1:15

TOPIC #4
Analyze the Involvement of Medical Affairs in Commercial Activities

Ben Carmel
Managing Director, San Francisco
Polaris

2:00

TOPIC #5
Utilize Monitoring Data and Analytics for Meaningful Metrics

Valorie Ciechanowski
Compliance and Privacy Officer
Advanced Bionics

3:00

Close of Conference