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Agenda

Increase Transparency, Benchmark Risk and Reduce Disparity in Practice

April 30-May 1, 2019
  • Philadelphia, PA

Agenda

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, APRIL 30, 2019

7:00

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Adam Toronto
U.S. Commercial Compliance Lead, Specialty Therapeutics
Allergan

Successfully Structure
Optimal FMV Frameworks

8:15

Structure FMV Tier Schedules for Maximum Operational Efficiency

Richard Eschle
Compliance Officer
Taiho Oncology Inc.

9:00

Planes, Trains and Automobiles —
Develop HCP Travel Compensation Best Practices

Eric Bolesh
Chief Operating Officer
Cutting Edge Information

9:45

Networking and Refreshment Break

10:15

FMV in Outsourced Clinical Trials — Balancing Speed and Risk

Heather Kemp
Trial Capabilities Business Operations Consultant
Eli Lilly and Company

Determine FMV Best Practices for
Third-Parties and Other Service Providers

11:00

Key FMV Considerations for Niche and Complex CRO Relationships

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

11:45

Networking Luncheon

1:00

Determine FMV for HCOs and Niche HCP Scenarios

Heather Reavey
Senior Manager, HCP Consulting Management
Olympus Corporation of the Americas

Alissa Muffley
Senior Specialist, HCP Contracting
Olympus Corporation of the Americas

1:45

CHOOSE BETWEEN TWO BREAKOUT SESSIONS (A or B)

A. FMV Strategies for Bona Fide Fee-for-Service

Jen Perinotti
Government Contract Compliance
Janssen Pharmaceuticals, Inc.

Doris Chern
Senior Manager, Government Contract Pricing & Compliance
Johnson & Johnson

 
B. Explore the Challenges of FMV Compliance for Medical Device Manufacturers

Mark DeWyngaert Ph.D
Managing Director
Deloitte & Touche LLP

Laura Skinner
Senior Manager,
Life Sciences Advisory
Deloitte & Touche LLP

3:15

Networking and Refreshment Break

Best Practices for Globalizing
FMV Methodologies

3:45

Global FMV Compliance for Third-Party Service Providers

Darren Jones
Partner
IQVIA

Samantha Sutherland
Associate Principal
IQVIA

4:30

ROUNDTABLE DISCUSSION
Discuss Risk Assessment and Calculations for Global FMV Operations

Laura Skinner
Senior Manager, Life Sciences Advisory
Deloitte & Touche LLP

Leanne DiDomenico
Manager, Life Sciences Advisory
Deloitte & Touche LLP

5:15

Close of Day One

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

DAY TWO WEDNESDAY, MAY 1, 2019

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

Adam Toronto
U.S. Commercial Compliance Lead, Specialty Therapeutics
Allergan

Ensure FMV Compliance

8:15

Construct an Efficient FMV Framework to Ensure Compliance and Regulatory Adherence

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

9:00

ROUNDTABLE DISCUSSION
Management Strategies for “Exceptions” to FMV

Melanie Fagan
External Expert Engagement Lead,
Medical Governance & Compliance for Medical Affairs
GSK

9:45

Networking and Refreshment Break

10:15

Increase Transparency and Compliance Through Strong Documentation Practices

Adam Toronto
U.S. Commercial Compliance Lead, Specialty Therapeutics
Allergan

11:00

Design Strategies for Compliant HCP Interactions

Linda Stoeber
Senior, Compliance Program Manager
Medtronic

12:15

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

DAY ONE TUESDAY, APRIL 30, 2019

7:00

Registration and Continental Breakfast

8:00

Chairman’s Welcome and Opening Remarks

Adam Toronto
U.S. Commercial Compliance Lead, Specialty Therapeutics
Allergan

Successfully Structure
Optimal FMV Frameworks

8:15

Structure FMV Tier Schedules for Maximum Operational Efficiency

Richard Eschle
Compliance Officer
Taiho Oncology Inc.

9:00

Planes, Trains and Automobiles —
Develop HCP Travel Compensation Best Practices

Eric Bolesh
Chief Operating Officer
Cutting Edge Information

9:45

Networking and Refreshment Break

10:15

FMV in Outsourced Clinical Trials — Balancing Speed and Risk

Heather Kemp
Trial Capabilities Business Operations Consultant
Eli Lilly and Company

Determine FMV Best Practices for
Third-Parties and Other Service Providers

11:00

Key FMV Considerations for Niche and Complex CRO Relationships

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

11:45

Networking Luncheon

1:00

Determine FMV for HCOs and Niche HCP Scenarios

Heather Reavey
Senior Manager, HCP Consulting Management
Olympus Corporation of the Americas

Alissa Muffley
Senior Specialist, HCP Contracting
Olympus Corporation of the Americas

1:45

CHOOSE BETWEEN TWO BREAKOUT SESSIONS (A or B)

A. FMV Strategies for Bona Fide Fee-for-Service

Jen Perinotti
Government Contract Compliance
Janssen Pharmaceuticals, Inc.

Doris Chern
Senior Manager, Government Contract Pricing & Compliance
Johnson & Johnson

 
B. Explore the Challenges of FMV Compliance for Medical Device Manufacturers

Mark DeWyngaert Ph.D
Managing Director
Deloitte & Touche LLP

Laura Skinner
Senior Manager,
Life Sciences Advisory
Deloitte & Touche LLP

3:15

Networking and Refreshment Break

Best Practices for Globalizing
FMV Methodologies

3:45

Global FMV Compliance for Third-Party Service Providers

Darren Jones
Partner
IQVIA

Samantha Sutherland
Associate Principal
IQVIA

4:30

ROUNDTABLE DISCUSSION
Discuss Risk Assessment and Calculations for Global FMV Operations

Laura Skinner
Senior Manager, Life Sciences Advisory
Deloitte & Touche LLP

Leanne DiDomenico
Manager, Life Sciences Advisory
Deloitte & Touche LLP

5:15

Close of Day One

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

DAY TWO WEDNESDAY, MAY 1, 2019

7:30

Continental Breakfast

8:00

Chairman’s Review of Day One

Adam Toronto
U.S. Commercial Compliance Lead, Specialty Therapeutics
Allergan

Ensure FMV Compliance

8:15

Construct an Efficient FMV Framework to Ensure Compliance and Regulatory Adherence

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

9:00

ROUNDTABLE DISCUSSION
Management Strategies for “Exceptions” to FMV

Melanie Fagan
External Expert Engagement Lead,
Medical Governance & Compliance for Medical Affairs
GSK

9:45

Networking and Refreshment Break

10:15

Increase Transparency and Compliance Through Strong Documentation Practices

Adam Toronto
U.S. Commercial Compliance Lead, Specialty Therapeutics
Allergan

11:00

Design Strategies for Compliant HCP Interactions

Linda Stoeber
Senior, Compliance Program Manager
Medtronic

12:15

Close of Conference