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Agenda

Ensure Compliance, Strengthen Customized Services and Drive Operational Efficiencies

June 19-20, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

Day One Wednesday, June 19, 2019

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Joanne de Vries
Director, Patient Services
Takeda

Plenary Sessions — Jumpstart the Day with
Powerful Perspectives from Key Stakeholders

8:45

Defining Key Terms and Congress Level-Setting

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

Kate Holland
Vice President, Patient Engagement & Digital Marketing
Harmony Biosciences, LLC

9:30

PATIENT STORY
Turn the Volume Up — How One Patient Made Her Voice Heard in the Industry

Candace Heline Lerman, Esq.
Board Member, Of Counsel, Lerman Law Firm;
Board Member, Bridge the GapSYNGAP Education and Research Foundation

10:15

Networking and Refreshment Break

10:45

ENFORCEMENT FORUM
Government Perspectives on High-Priority Risks for Patient Support Services

MODERATOR:

Jane Yoon
Of Counsel, Litigation Department
Paul Hastings

PANELISTS:

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

Eric Rubenstein
Independent Consultant, Confidential Investigative Associates, LLC;
former Special Agent, U.S. Department of Health and Human Services, Office of Inspector General

Andrew A. Caffrey, III
Assistant U.S. Attorney, Civil Healthcare Fraud Coordinator
U.S. Attorney’s Office, District of New Jersey

11:45

DYNAMIC CO-PRESENTATION
Put Your Patient Support Program Under the Magnifying Glass

Manny Tzavlakis
Managing Partner
Helio Health Group

Chapman Richardson
Global Head, Data Consumerization
Sanofi

12:30

Networking Luncheon

1:35

CHOOSE BETWEEN TWO COMPREHENSIVE TRACKS (1 or 2)

TRACK 1 Legal and Compliance
Critical Regulatory Updates and Effective Strategies for Monitoring and Oversight

1:35

Legal and Compliance Chairperson Welcome

Amy Wilson
Director, Enterprise Compliance Lead
Alexion Pharmaceuticals, Inc.

1:45

Ensure Transparency in Contributions to 501(C)(3) Organizations

MODERATOR:

John E. Kelly
Member
Bass, Berry & Sims PLC

PANEL:

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

Candace Heline Lerman, Esq.
Board Member, Of Counsel,
Lerman Law Firm;
Board Member, Bridge the GapSYNGAP Education and Research Foundation

2:45

Compliance Considerations for Specialty Pharmacy Contracting and Distribution

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

3:30

Networking and Refreshment Break

4:00

COMPLIANCE OFFICER PANEL
Reboot Your Approach to Patient Assistance and Reimbursement Support

MODERATOR:

Jane Yoon
Of Counsel, Litigation Department
Paul Hastings

PANELISTS:

Peter Agnoletto
Senior Director, U.S. Ethics & Business Integrity – Puerto Rico, Monitoring, Auditing and IRO
Sanofi

Stefanie L. Hill, Esq.
Associate Director, Associate Compliance Counsel
Otsuka America Pharmaceutical, Inc.

Jill Dailey
Vice President, Chief Compliance Officer
Incyte

4:45

Best Practices for Launching a Successful and Compliant Clinical Nurse Educator Program

Abby Mallon
Senior Vice President,
Innovation and Chief Compliance Officer
VMS Biomarketing

 
TRACK 2 Innovation and Operations
Novel Approaches to Services, Operational Management
and Launch Planning

1:35

Innovation and Operations Chairperson Welcome

Kelley Allison
Vice President, Patient Access
Horizon Pharma plc

1:45

PANEL DISCUSSION
Examine the Pros and Cons of Different Support Service Models

MODERATOR:

Gregory Leighton, PharmD
Senior Director of Patient Support Operations and Compliance
Asembia

PANELISTS:

Brian Haenni
Director, Reimbursement and Patient Services
Dova Pharmaceuticals

Desiree Priestley
Director, Otsuka Patient Support,
Strategy & Insights
Otsuka America Pharmaceutical, Inc.

Mohamed Datoo
Senior Manager, Patient Access Servicesd
Kyowa Kirin Co., Ltd.

2:45

Leverage Data Science to Improve Patient Adherence

Joshua Halpern
Co-Founder and EVP, Product & Strategy
IntegriChain

3:30

Networking and Refreshment Break

4:00

The Devil is in the Details —
An Overview of Selecting and Contracting with Third-Party Providers to Ensure High-Quality Service

Kimberly Golyinsky
Manager, Patient Support Services,
Market Access
Neurocrine Biosciences

Amy Greenstein, Esq.
Associate Principal
IQVIA

4:45

CASE STUDY
Customized Support for Unique Patient Populations

Kelley Allison
Vice President, Patient Access
Horizon Pharma plc

5:30

Close of Day One

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

Day Two Thursday, June 20, 2019

7:30

Registration and Continental Breakfast

8:00

CHOOSE BETWEEN TWO COMPREHENSIVE TRACKS (1 or 2)

TRACK 1 Legal and Compliance
Critical Regulatory Updates and Effective Strategies for Monitoring and Oversight

8:00

Chairperson Review of Day One

Amy Wilson
Director, Enterprise Compliance Lead
Alexion Pharmaceuticals, Inc.

8:15

Navigate the Differences in Providing Assistance for Government Versus Commercial Patients

Stephanie Wisdo
General Counsel, Compliance Officer
Harmony Biosciences, LLC

9:00

Evolving State Copay Card Legislations and the Effects on Patient Assistance

Katherine Chaurette
Vice President, Healthcare Law and Compliance
Blueprint Medicines

Angela Newsom
Associate Director, Access Services-Operational Effectiveness
Regeneron Pharmaceuticals, Inc.

 
TRACK 2 Innovation and Operations
Novel Approaches to Services, Operational Management
and Launch Planning

8:00

Chairperson Review of Day One

Kelley Allison
Vice President, Patient Access
Horizon Pharma plc

8:15

Strategies for Training and Maintaining a Compliant Nurse Educator Field Team

Speaker TBD

9:00

Optimize Advocate-Pharma Relations to Enrich the Patient Experience

Michael Mittelman
Chairman American Living Organ Donor Fund; Ambassador, Patient-Centered Outcomes Research Institute (PCORI)

9:45

Networking and Refreshment Break

Plenary Sessions
Idea Exchange and Trends to Watch

10:15

Artificial Intelligence (AI) — Based Automated Compliance Monitoring and Patient Services Quality Reporting

Rusty Lewis
Chief Digital and Chief Information Officer
AppianRx

11:00

Knowing Where to Invest – Understanding Experience Drivers’ Impact on HCP Satisfaction

Greg Christianson
Principal
Nuvera Life Science Consulting

11:45

Networking Luncheon

12:45

CAMPFIRE SESSION
What it Takes to Design a Patient Services Program that Drives Better Outcomes

Joanne de Vries
Director of Patient Services
Takeda

1:30

HOT TOPICS PANEL
What’s On Tap for Patient Services Going Forward

MODERATOR:

Candace Heline Lerman, Esq.
Board Member, Of Counsel, Lerman Law Firm;
Board Member, Bridge the GapSYNGAP Education and Research Foundation

PANELISTS:

Desiree Priestley
Director, Otsuka Patient Support, Strategy & Insights
Otsuka America Pharmaceutical, Inc.

Stephanie Wisdo
General Counsel, Compliance Officer
Harmony Biosciences, LLC

Kimberly Golyinsky
Manager, Patient Support Services, Market Access
Neurocrine Biosciences

Candace Heline Lerman, Esq.
Of Counsel
Lerman Law Firm
Board Member
Bridge the Gap- SYNGAP Education and Research Foundation

2:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

Day One Wednesday, June 19, 2019

7:30

Registration and Continental Breakfast

8:30

Chairperson’s Welcome and Opening Remarks

Joanne de Vries
Director, Patient Services
Takeda

Plenary Sessions — Jumpstart the Day with
Powerful Perspectives from Key Stakeholders

8:45

Defining Key Terms and Congress Level-Setting

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

Kate Holland
Vice President, Patient Engagement & Digital Marketing
Harmony Biosciences, LLC

9:30

PATIENT STORY
Turn the Volume Up — How One Patient Made Her Voice Heard in the Industry

Candace Heline Lerman, Esq.
Board Member, Of Counsel, Lerman Law Firm;
Board Member, Bridge the GapSYNGAP Education and Research Foundation

10:15

Networking and Refreshment Break

10:45

ENFORCEMENT FORUM
Government Perspectives on High-Priority Risks for Patient Support Services

MODERATOR:

Jane Yoon
Of Counsel, Litigation Department
Paul Hastings

PANELISTS:

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

Eric Rubenstein
Independent Consultant, Confidential Investigative Associates, LLC;
former Special Agent, U.S. Department of Health and Human Services, Office of Inspector General

Andrew A. Caffrey, III
Assistant U.S. Attorney, Civil Healthcare Fraud Coordinator
U.S. Attorney’s Office, District of New Jersey

11:45

DYNAMIC CO-PRESENTATION
Put Your Patient Support Program Under the Magnifying Glass

Manny Tzavlakis
Managing Partner
Helio Health Group

Chapman Richardson
Global Head, Data Consumerization
Sanofi

12:30

Networking Luncheon

1:35

CHOOSE BETWEEN TWO COMPREHENSIVE TRACKS (1 or 2)

TRACK 1 Legal and Compliance
Critical Regulatory Updates and Effective Strategies for Monitoring and Oversight

1:35

Legal and Compliance Chairperson Welcome

Amy Wilson
Director, Enterprise Compliance Lead
Alexion Pharmaceuticals, Inc.

1:45

Ensure Transparency in Contributions to 501(C)(3) Organizations

MODERATOR:

John E. Kelly
Member
Bass, Berry & Sims PLC

PANEL:

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

Candace Heline Lerman, Esq.
Board Member, Of Counsel,
Lerman Law Firm;
Board Member, Bridge the GapSYNGAP Education and Research Foundation

2:45

Compliance Considerations for Specialty Pharmacy Contracting and Distribution

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

3:30

Networking and Refreshment Break

4:00

COMPLIANCE OFFICER PANEL
Reboot Your Approach to Patient Assistance and Reimbursement Support

MODERATOR:

Jane Yoon
Of Counsel, Litigation Department
Paul Hastings

PANELISTS:

Peter Agnoletto
Senior Director, U.S. Ethics & Business Integrity – Puerto Rico, Monitoring, Auditing and IRO
Sanofi

Stefanie L. Hill, Esq.
Associate Director, Associate Compliance Counsel
Otsuka America Pharmaceutical, Inc.

Jill Dailey
Vice President, Chief Compliance Officer
Incyte

4:45

Best Practices for Launching a Successful and Compliant Clinical Nurse Educator Program

Abby Mallon
Senior Vice President,
Innovation and Chief Compliance Officer
VMS Biomarketing

 
TRACK 2 Innovation and Operations
Novel Approaches to Services, Operational Management
and Launch Planning

1:35

Innovation and Operations Chairperson Welcome

Kelley Allison
Vice President, Patient Access
Horizon Pharma plc

1:45

PANEL DISCUSSION
Examine the Pros and Cons of Different Support Service Models

MODERATOR:

Gregory Leighton, PharmD
Senior Director of Patient Support Operations and Compliance
Asembia

PANELISTS:

Brian Haenni
Director, Reimbursement and Patient Services
Dova Pharmaceuticals

Desiree Priestley
Director, Otsuka Patient Support,
Strategy & Insights
Otsuka America Pharmaceutical, Inc.

Mohamed Datoo
Senior Manager, Patient Access Servicesd
Kyowa Kirin Co., Ltd.

2:45

Leverage Data Science to Improve Patient Adherence

Joshua Halpern
Co-Founder and EVP, Product & Strategy
IntegriChain

3:30

Networking and Refreshment Break

4:00

The Devil is in the Details —
An Overview of Selecting and Contracting with Third-Party Providers to Ensure High-Quality Service

Kimberly Golyinsky
Manager, Patient Support Services,
Market Access
Neurocrine Biosciences

Amy Greenstein, Esq.
Associate Principal
IQVIA

4:45

CASE STUDY
Customized Support for Unique Patient Populations

Kelley Allison
Vice President, Patient Access
Horizon Pharma plc

5:30

Close of Day One

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

Day Two Thursday, June 20, 2019

7:30

Registration and Continental Breakfast

8:00

CHOOSE BETWEEN TWO COMPREHENSIVE TRACKS (1 or 2)

TRACK 1 Legal and Compliance
Critical Regulatory Updates and Effective Strategies for Monitoring and Oversight

8:00

Chairperson Review of Day One

Amy Wilson
Director, Enterprise Compliance Lead
Alexion Pharmaceuticals, Inc.

8:15

Navigate the Differences in Providing Assistance for Government Versus Commercial Patients

Stephanie Wisdo
General Counsel, Compliance Officer
Harmony Biosciences, LLC

9:00

Evolving State Copay Card Legislations and the Effects on Patient Assistance

Katherine Chaurette
Vice President, Healthcare Law and Compliance
Blueprint Medicines

Angela Newsom
Associate Director, Access Services-Operational Effectiveness
Regeneron Pharmaceuticals, Inc.

 
TRACK 2 Innovation and Operations
Novel Approaches to Services, Operational Management
and Launch Planning

8:00

Chairperson Review of Day One

Kelley Allison
Vice President, Patient Access
Horizon Pharma plc

8:15

Strategies for Training and Maintaining a Compliant Nurse Educator Field Team

Speaker TBD

9:00

Optimize Advocate-Pharma Relations to Enrich the Patient Experience

Michael Mittelman
Chairman American Living Organ Donor Fund; Ambassador, Patient-Centered Outcomes Research Institute (PCORI)

9:45

Networking and Refreshment Break

Plenary Sessions
Idea Exchange and Trends to Watch

10:15

Artificial Intelligence (AI) — Based Automated Compliance Monitoring and Patient Services Quality Reporting

Rusty Lewis
Chief Digital and Chief Information Officer
AppianRx

11:00

Knowing Where to Invest – Understanding Experience Drivers’ Impact on HCP Satisfaction

Greg Christianson
Principal
Nuvera Life Science Consulting

11:45

Networking Luncheon

12:45

CAMPFIRE SESSION
What it Takes to Design a Patient Services Program that Drives Better Outcomes

Joanne de Vries
Director of Patient Services
Takeda

1:30

HOT TOPICS PANEL
What’s On Tap for Patient Services Going Forward

MODERATOR:

Candace Heline Lerman, Esq.
Board Member, Of Counsel, Lerman Law Firm;
Board Member, Bridge the GapSYNGAP Education and Research Foundation

PANELISTS:

Desiree Priestley
Director, Otsuka Patient Support, Strategy & Insights
Otsuka America Pharmaceutical, Inc.

Stephanie Wisdo
General Counsel, Compliance Officer
Harmony Biosciences, LLC

Kimberly Golyinsky
Manager, Patient Support Services, Market Access
Neurocrine Biosciences

Candace Heline Lerman, Esq.
Of Counsel
Lerman Law Firm
Board Member
Bridge the Gap- SYNGAP Education and Research Foundation

2:15

Close of Conference