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
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
