Skip navigation
Agenda

Emerging Trends, Best Practices and Benchmarking for Managing Risks Associated with Complex, High-Touch Therapies

September 12-13, 2019
  • Cambridge, MA

Agenda

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, SEPTEMBER 12, 2019

7:15

Registration and Continental Breakfast

8:15

Co-Chairs’ Welcome and Opening Remarks

Heather Golding
Vice President, Head of Legal and Compliance, North America
Sobi

Meenakshi Datta
Partner
Sidley Austin LLP

8:30

KEYNOTE PANEL Focal Points and Top Enforcement Trends for Specialty Pharma and Biotech Companies and Priorities for 2020

Moderator:

Brian French
Partner
Nixon Peabody LLP

Panelists:

Gregg Shapiro
Assistant U.S. Attorney, Chief of Affirmative Civil Enforcement Unit
U.S. Attorney’s Office, District of Massachusetts

Amanda Strachan
Acting Chief, Criminal Health Care Fraud Unit
U.S. Attorney’s Office, District of Massachusetts

Li Yu
Assistant U.S. Attorney
U.S. Attorney’s Office, Southern District of New York

Rachael A. Honig
First Assistant U.S. Attorney
U.S. Attorney’s Office, District of New Jersey

9:30

Weaving a Culture of Ethics and Compliance into the Business

Adam Oakley
Director
Potomac River Partners

Latarsha Stewart
Vice President, Head of Compliance U.S.
Servier Pharmaceuticals

10:15

Networking and Refreshment Break

10:45

Fast, Cheap and Under Control — Risk Identification and Mitigation in an Era of Stretched Resources and Short Attention Spans

Rusty Lewis
Chief Digital and Chief Information Officer
AppianRx

11:30

Creative Training Techniques for Out-of-the-Box Engagement

Moderator:

Daniel O’Connor
Senior Vice President
PharmaCertify™

Panelists:

Laura Gamel
Senior Director, Ethics and Business Integrity
Sanofi Genzyme

Katrina Cahill
Senior Director, Global Compliance Operations
Sarepta Therapeutics

Erica Powers
Compliance Officer, Head of Compliance Operations
Sage Therapeutics

10:45

LEGAL AND COMPLIANCE
LEADERSHIP SUMMIT INVITATION-ONLY*

This summit is designed to encourage an open exchange of ideas and strategies surrounding some of the most critical issues facing heads of compliance across the life sciences industry. The host facilitates discussions surrounding key questions, challenges and issues. Participants benefit from exclusive networking with peers, sharing concerns and acquiring additional best practices for enriching their compliance programs.

I. Diversity, Inclusion and Compliance as a Role Model for the Organization

II. Demonstrating Compliance Effectiveness Going Beyond KPIs

III. Emerging Risks for Specialty Pharma and Biotech —
A Response to the Keynote Panel

Summit Leaders:

Joe Philipose
Vice President, US and Enterprise Compliance
Alexion Pharmaceuticals

Jane Yoon
Of Counsel
Paul Hastings LLP

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

12:15

Close of Leadership Summit and Start of Networking Luncheon

1:15

Where Is the Line? Tackling the Overlap in Medical and Commercial Activities

Moderator:

Michelle Axelrod
Principal, Porzio, Bromberg & Newman P.C.;
Vice President, Porzio Life Sciences, LLC

Panelists:

Averi Price
Vice President, Chief Compliance Officer
Radius Health

Daina Selvig
former Deputy General Counsel, Legal Affairs, Sunovion;
President, Selvig Legal Consultants LLC

Maria Ostrovsky
Chief Compliance Officer, Associate General Counsel
Deciphera Pharmaceuticals, Inc

Sarah Whipple
Vice President, Legal and Chief Compliance Officer
Akebia Therapeutics

2:15

Aggregate Spend — Addressing the Challenges of Vendor Spend Reporting

Russ West
Senior Vice President, Data, Integrations and Insights
HealthSTAR Strategic Engagements

2:50

Networking and Refreshment Break

AFTERNOON FOCUS | Driving Compliant
Patient Interactions and Copay Assistance

3:20

How Far is Too Far?
Navigate the Risks While Maintaining the Merits of Patient Support Activities

MODERATOR:

Stefanie Doebler
Of Counsel
Covington & Burling

PANELISTS:

Gregory L. Shiferman
Senior Corporate Counsel
Sage Therapeutics, Inc.

Jacqueline Mantica
Corporate Counsel, Rare Blood Disorders
Sanofi Genzyme

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

4:05

Ensuring Transparency and Integrity in Patient Interactions and Foundation Relationships

MODERATOR:

Ben Carmel
Global Head of Business Development, Commercial Compliance
IQVIA

PANELISTS:

Francisco Ribeiro
Senior Director, U.S. Compliance Lead
TESARO, Inc.

Patricia W. Cone, PhD, Esq.
Director, Ethics & Compliance Innovation Unit,
CDMA Primary and Specialty Respiratory
Boehringer Ingelheim

Tiffany Tang
Engagement Manager
IQVIA Commercial Compliance

4:50

Strategies for Training and Maintaining a Compliant Nurse Educator Field Team

MODERATOR:

Emily F. Hodge
Partner
Choate, Hall & Stewart LLP

PANELISTS:

Alison Benincasa
Senior Associate Director, Specialty Markets
Boehringer Ingelheim

Jerald Korn
General Counsel
Kaleido Biosciences, Inc.

5:35

Close of Day One

Networking Wine and
Cheese Reception
immediately following the conclusion of day one

DAY TWO FRIDAY, SEPTEMBER 13, 2019

7:45

Continental Breakfast

8:15

Co-Chairs’ Review of Day One

Heather Golding
Vice President, Head of Legal and Compliance, North America
Sobi

Meenakshi Datta
Partner
Sidley Austin LLP

8:30

The Impact of Recent FDA Guidance on Product Communications —
Dramatic Change in Operations or Business as Usual?

Hannah Bornstein
Partner
Nixon Peabody LLP

9:15

Legal and Compliance Issues for Companies Exploring Value-Based Models

Meenakshi Datta
Partner
Sidley Austin LLP

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO COMPREHENSIVE BREAKOUTS (A-B)

A

Evaluate the Risks in Payer Contracting and Specialty Pharmacy Distribution

Co-Presentation

John Knighton
Chief Compliance Officer
TherapeuticsMD

Jesse C. Dresser, Esq
Partner
Frier Levitt, LLC

LIVE POLLING B

Best Practices for Maintaining Data Privacy Domestically
and Internationally

Heidy Abreu
Vice President, Legal and Corporate Secretary
Axcella Health, Inc.

Michelle Axelrod
Principal
Porzio, Bromberg & Newman P.C.
Vice President
Porzio Life Sciences, LLC

Stephanie Garfield
Associate
Porzio, Bromberg & Newman P.C.
Director of Compliance Services
Porzio Life Sciences, LLC

11:15

CHOOSE BETWEEN TWO COMPREHENSIVE BREAKOUTS (C-D)

ROUNDTABLE DISCUSSION C

Cell and Gene Therapies Learning Lab —
Compliance Considerations for Highly Complex,
Potentially Curative Treatments

Roundtable Leaders:

Elizabeth Jobes
Chief Compliance Officer
EMD Serono

Darren Jones
Senior Principal, Commercial Compliance Global Consulting Practice Leader
IQVIA

PANEL DISCUSSION D

Ramp Up Resources for Clinical and R&D Oversight to Achieve Compliance Excellence Throughout the Product Lifecycle

Moderator:

Sara Frank
Associate
Choate, Hall & Stewart LLP

Panelists:

Andrea L. Kocharyan
Vice President, Legal Affairs
Boston Biomedical

Patricia W. Cone, PhD, Esq.
Director, Ethics & Compliance Innovation Unit,
CDMA Primary and Specialty Respiratory
Boehringer Ingelheim

Masha Chestukhin
Associate Director, Compliance Officer R&D, IA, FMV
Sanofi Genzyme

12:00

Networking Luncheon

1:00

Optimize Field Force Design and Monitoring for Reimbursement Teams

Moderator:

Katherine Chaurette
Vice President, Healthcare Law and Compliance
Blueprint Medicines

Panelists:

Kelly Pitt
Senior Counsel, North America
Sobi

Lisa Shrayer
Head Therapeutics Counsel, North America
Vertex Pharmaceuticals

Jeremy Lutsky
Counsel
Manatt, Phelps & Phillips, LLP

1:45

FIRESIDE CHAT What You Need to Know and What You Wish You Had Known —
Compliance for the Beginner and the Expert

During this interview-style session, gain insights into some of the failures and successes of building a compliance program from scratch and the lessons learned along the way.

Intverview with:

Daryl Kreml
Chief Compliance Officer, Vice President
Sage Therapeutics

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

Intverview by:

Meenakshi Datta
Partner
Sidley Austin LLP

2:30

Final Thoughts and Close of Conference

Heather Golding
Vice President, Head of Legal and Compliance, North America
Sobi

Meenakshi Datta
Partner
Sidley Austin LLP

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE THURSDAY, SEPTEMBER 12, 2019

7:15

Registration and Continental Breakfast

8:15

Co-Chairs’ Welcome and Opening Remarks

Heather Golding
Vice President, Head of Legal and Compliance, North America
Sobi

Meenakshi Datta
Partner
Sidley Austin LLP

8:30

KEYNOTE PANEL Focal Points and Top Enforcement Trends for Specialty Pharma and Biotech Companies and Priorities for 2020

Moderator:

Brian French
Partner
Nixon Peabody LLP

Panelists:

Gregg Shapiro
Assistant U.S. Attorney, Chief of Affirmative Civil Enforcement Unit
U.S. Attorney’s Office, District of Massachusetts

Amanda Strachan
Acting Chief, Criminal Health Care Fraud Unit
U.S. Attorney’s Office, District of Massachusetts

Li Yu
Assistant U.S. Attorney
U.S. Attorney’s Office, Southern District of New York

Rachael A. Honig
First Assistant U.S. Attorney
U.S. Attorney’s Office, District of New Jersey

9:30

Weaving a Culture of Ethics and Compliance into the Business

Adam Oakley
Director
Potomac River Partners

Latarsha Stewart
Vice President, Head of Compliance U.S.
Servier Pharmaceuticals

10:15

Networking and Refreshment Break

10:45

Fast, Cheap and Under Control — Risk Identification and Mitigation in an Era of Stretched Resources and Short Attention Spans

Rusty Lewis
Chief Digital and Chief Information Officer
AppianRx

11:30

Creative Training Techniques for Out-of-the-Box Engagement

Moderator:

Daniel O’Connor
Senior Vice President
PharmaCertify™

Panelists:

Laura Gamel
Senior Director, Ethics and Business Integrity
Sanofi Genzyme

Katrina Cahill
Senior Director, Global Compliance Operations
Sarepta Therapeutics

Erica Powers
Compliance Officer, Head of Compliance Operations
Sage Therapeutics

10:45

LEGAL AND COMPLIANCE
LEADERSHIP SUMMIT INVITATION-ONLY*

This summit is designed to encourage an open exchange of ideas and strategies surrounding some of the most critical issues facing heads of compliance across the life sciences industry. The host facilitates discussions surrounding key questions, challenges and issues. Participants benefit from exclusive networking with peers, sharing concerns and acquiring additional best practices for enriching their compliance programs.

I. Diversity, Inclusion and Compliance as a Role Model for the Organization

II. Demonstrating Compliance Effectiveness Going Beyond KPIs

III. Emerging Risks for Specialty Pharma and Biotech —
A Response to the Keynote Panel

Summit Leaders:

Joe Philipose
Vice President, US and Enterprise Compliance
Alexion Pharmaceuticals

Jane Yoon
Of Counsel
Paul Hastings LLP

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

12:15

Close of Leadership Summit and Start of Networking Luncheon

1:15

Where Is the Line? Tackling the Overlap in Medical and Commercial Activities

Moderator:

Michelle Axelrod
Principal, Porzio, Bromberg & Newman P.C.;
Vice President, Porzio Life Sciences, LLC

Panelists:

Averi Price
Vice President, Chief Compliance Officer
Radius Health

Daina Selvig
former Deputy General Counsel, Legal Affairs, Sunovion;
President, Selvig Legal Consultants LLC

Maria Ostrovsky
Chief Compliance Officer, Associate General Counsel
Deciphera Pharmaceuticals, Inc

Sarah Whipple
Vice President, Legal and Chief Compliance Officer
Akebia Therapeutics

2:15

Aggregate Spend — Addressing the Challenges of Vendor Spend Reporting

Russ West
Senior Vice President, Data, Integrations and Insights
HealthSTAR Strategic Engagements

2:50

Networking and Refreshment Break

AFTERNOON FOCUS | Driving Compliant
Patient Interactions and Copay Assistance

3:20

How Far is Too Far?
Navigate the Risks While Maintaining the Merits of Patient Support Activities

MODERATOR:

Stefanie Doebler
Of Counsel
Covington & Burling

PANELISTS:

Gregory L. Shiferman
Senior Corporate Counsel
Sage Therapeutics, Inc.

Jacqueline Mantica
Corporate Counsel, Rare Blood Disorders
Sanofi Genzyme

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

4:05

Ensuring Transparency and Integrity in Patient Interactions and Foundation Relationships

MODERATOR:

Ben Carmel
Global Head of Business Development, Commercial Compliance
IQVIA

PANELISTS:

Francisco Ribeiro
Senior Director, U.S. Compliance Lead
TESARO, Inc.

Patricia W. Cone, PhD, Esq.
Director, Ethics & Compliance Innovation Unit,
CDMA Primary and Specialty Respiratory
Boehringer Ingelheim

Tiffany Tang
Engagement Manager
IQVIA Commercial Compliance

4:50

Strategies for Training and Maintaining a Compliant Nurse Educator Field Team

MODERATOR:

Emily F. Hodge
Partner
Choate, Hall & Stewart LLP

PANELISTS:

Alison Benincasa
Senior Associate Director, Specialty Markets
Boehringer Ingelheim

Jerald Korn
General Counsel
Kaleido Biosciences, Inc.

5:35

Close of Day One

Networking Wine and
Cheese Reception
immediately following the conclusion of day one

DAY TWO FRIDAY, SEPTEMBER 13, 2019

7:45

Continental Breakfast

8:15

Co-Chairs’ Review of Day One

Heather Golding
Vice President, Head of Legal and Compliance, North America
Sobi

Meenakshi Datta
Partner
Sidley Austin LLP

8:30

The Impact of Recent FDA Guidance on Product Communications —
Dramatic Change in Operations or Business as Usual?

Hannah Bornstein
Partner
Nixon Peabody LLP

9:15

Legal and Compliance Issues for Companies Exploring Value-Based Models

Meenakshi Datta
Partner
Sidley Austin LLP

10:00

Networking and Refreshment Break

10:30

CHOOSE BETWEEN TWO COMPREHENSIVE BREAKOUTS (A-B)

A

Evaluate the Risks in Payer Contracting and Specialty Pharmacy Distribution

Co-Presentation

John Knighton
Chief Compliance Officer
TherapeuticsMD

Jesse C. Dresser, Esq
Partner
Frier Levitt, LLC

LIVE POLLING B

Best Practices for Maintaining Data Privacy Domestically
and Internationally

Heidy Abreu
Vice President, Legal and Corporate Secretary
Axcella Health, Inc.

Michelle Axelrod
Principal
Porzio, Bromberg & Newman P.C.
Vice President
Porzio Life Sciences, LLC

Stephanie Garfield
Associate
Porzio, Bromberg & Newman P.C.
Director of Compliance Services
Porzio Life Sciences, LLC

11:15

CHOOSE BETWEEN TWO COMPREHENSIVE BREAKOUTS (C-D)

ROUNDTABLE DISCUSSION C

Cell and Gene Therapies Learning Lab —
Compliance Considerations for Highly Complex,
Potentially Curative Treatments

Roundtable Leaders:

Elizabeth Jobes
Chief Compliance Officer
EMD Serono

Darren Jones
Senior Principal, Commercial Compliance Global Consulting Practice Leader
IQVIA

PANEL DISCUSSION D

Ramp Up Resources for Clinical and R&D Oversight to Achieve Compliance Excellence Throughout the Product Lifecycle

Moderator:

Sara Frank
Associate
Choate, Hall & Stewart LLP

Panelists:

Andrea L. Kocharyan
Vice President, Legal Affairs
Boston Biomedical

Patricia W. Cone, PhD, Esq.
Director, Ethics & Compliance Innovation Unit,
CDMA Primary and Specialty Respiratory
Boehringer Ingelheim

Masha Chestukhin
Associate Director, Compliance Officer R&D, IA, FMV
Sanofi Genzyme

12:00

Networking Luncheon

1:00

Optimize Field Force Design and Monitoring for Reimbursement Teams

Moderator:

Katherine Chaurette
Vice President, Healthcare Law and Compliance
Blueprint Medicines

Panelists:

Kelly Pitt
Senior Counsel, North America
Sobi

Lisa Shrayer
Head Therapeutics Counsel, North America
Vertex Pharmaceuticals

Jeremy Lutsky
Counsel
Manatt, Phelps & Phillips, LLP

1:45

FIRESIDE CHAT What You Need to Know and What You Wish You Had Known —
Compliance for the Beginner and the Expert

During this interview-style session, gain insights into some of the failures and successes of building a compliance program from scratch and the lessons learned along the way.

Intverview with:

Daryl Kreml
Chief Compliance Officer, Vice President
Sage Therapeutics

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

Intverview by:

Meenakshi Datta
Partner
Sidley Austin LLP

2:30

Final Thoughts and Close of Conference

Heather Golding
Vice President, Head of Legal and Compliance, North America
Sobi

Meenakshi Datta
Partner
Sidley Austin LLP