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Agenda

Clarity, Guiding Strategies and Industry Benchmarking Amid Program Change and Policy Uncertainty

May 20-22, 2019
  • Orlando, FL

Agenda

Want more agenda details? Download the brochure.

PRE-CONFERENCE — MONDAY, MAY 20, 2019

12:00   Pre-Conference Registration

1:00   CHOOSE FROM TWO SUMMITS (1-2)

1 GOVERNMENT PRICING AND REPORTING 101

For newcomers and seasoned pricing, contracting and reporting professionals looking for a refresher course, this 101 Boot Camp is designed to lay the groundwork and instill a fundamental understanding on the key components of government programs, pricing and reporting.

Jennifer Crosswell
Manager,
Government Pricing and Reimbursement
Arbor Pharmaceuticals

Miree Lee, MS, MBA
Bio/Pharma Pricing Consultant
M. Lee Consulting, LLC

Stephanie Kupski
Director,
U.S. Pricing and Government Reporting
CSL Behring

Josephine Hawkins
Associate Director, Medicaid
Astrazeneca

Phillip Scott
Senior Vice President, Business Development
NCPDP

2 SENIOR EXECUTIVE THINK TANK

Technological advances, outsourcing vendors and new ways of thinking have created unprecedented opportunity to increase value, enhance business effectiveness and lower operating costs. This Summit is an engaging and dynamic discussion that delves it certain developments and explores their application in key business areas such as audit readiness, class of trade, bona fide service fees, bundled arrangements, government contracting and rebate adjudication.

Rick Zimmerer
Partner
KPMG LLP

Jennifer Lospinoso
Managing Director
KPMG LLP

Lynn Buhl
Director
KPMG LLP

Greg Wiefel
Director
KPMG LLP

Janice Matasi
Manager
KPMG LLP

*The Senior Executive Think Tank is targeted for managementlevel and above professionals with pricing, reporting and contracting responsibilities.

3:00   Networking and Refreshment Break

3:30   CHOOSE FROM TWO SUMMITS (3-4)

3 FEDERAL CONTRACTING AND FSS FUNDAMENTALS DEEP DIVE

This Summit addresses the basics of the Veteran’s Health Care Act (VHCA) and FSS pricing requirements. Gain an understanding of key concepts and requirements to benchmark government pricing processes against.

Jeffrey Clayton
Principal
Baker Tilly Virchow Krause, LLP

Jennifer Woodruff McElhenny
Manager
Baker Tilly Virchow Krause, LLP

Cathy Zhang
Associate Director, Government Contracts
Eisai Inc.

Allison Pugsley
Partner
Hogan Lovells

Marci Anderson
Auditor
VA Office of Inspector General,
Office of Contract Review

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General,
Office of Contract Review

4 340B PROGRAM EVOLUTION AND OVERSIGHT MASTER CLASS

As regulations evolve impacting the 340B Drug Discount Program, most recently the 340B Ceiling Price and Civil Monetary Penalties Final Rule, pharmaceutical companies are faced with uncertainty on how to ensure price reporting compliance. This Summit breaks down current regulations and guidance, and discusses potential operational implications and srategies.

Kathleen Peterson
Counsel
Hogan Lovells

Lenis De León
Senior Manager,
Government Pricing and Compliance
Apotex

5:30   CLOSE OF SUMMITS

HOSTED BY: WELCOME RECEPTION immediately following the close of summits

DAY ONE — TUESDAY, MAY 21, 2019

7:15

Networking Breakfast and Main Conference Registration

8:15

CBI Welcome

Elise Guerin Saas
Senior Program Director
CBI, a division of UBM Americas

8:20

Chairman’s Welcome and Opening Remarks

Rajeev Devgan
Director, Government Rebate Operations
Johnson & Johnson Health Care Systems Inc.

8:30

OPENING KEYNOTE ADDRESS Political and Legislative Trends in an Evolving Healthcare Landscape

Naomi Lopez Bauman
Director, Healthcare Policy
Goldwater Institute

9:10

PANEL DISCUSSION Current Environment of State Drug Pricing Transparency

MODERATOR:

Meena Datta
Partner
Sidley Austin

PANELISTS:

Brian Bohnenkamp
Partner
King & Spalding

Doug Helling
Associate General Counsel
UCB

9:50

The Fourth Industrial Revolution Is Here — Are You Ready?

Brenna Sniderman
Senior Manager
Deloitte Services LP

10:30

Networking and Refreshment Break

11:00

GP in the Upside-Down —
Unpack the Pricing Implications of a World Without PBM/Payor Rebates

John Shakow
Partner
King & Spalding

11:40

Novel Contracting Strategies with PBMs

Rujul Desai
Of Counsel
Covington & Burling LLP

12:20

Networking Luncheon

1:20

PANEL DISCUSSION Policy, Mechanics and Change within the Medicare Program

MODERATOR:

Jeffrey Baab
Vice President, Life Sciences
daVIZta

PANELISTS:

James Stansel
Executive Vice President and General Counsel
PhRMA

Mallory O’Connor
Director, Healthcare Policy and Federal Programs
BIO

Stephanie Trunk
Partner
Arent Fox LLP

2:00

PANEL DISCUSSIONManaging Refunds of 340B Overcharges and
Mitigating Compliance Risk

MODERATOR:

Mike Benedict
Vice President, Operations
Apexus

PANELISTS:

Marcy Imada
Principal
Deloitte & Touche LLP

Christopher Schott
Partner
Hogan Lovells

2:40

Networking and Refreshment Break

3:15   CHOOSE FROM THREE WORKSHOPS (A-C)

A Value-Based Frameworks and Government Pricing Considerations

Steve Benz
Partner
Arnold & Porter

Debbie Walters-Francique
Vice President and Assistant General Counsel
Pfizer Inc

B Forecast the Impact of Escalating Part D Coverage Gap Discounts on Gross-to-Net Sales

Murray Kay
former Senior VP and CFO, Solvay Pharmaceuticals;
former Commercial Controller, AbbVie & Abbott Laboratories

C Product Launch and Establishing a GP Strategy

William Sarraille
Partner
Sidley Austin

Trevor Wear
Partner
Sidley Austin

4:00   CHOOSE FROM THREE WORKSHOPS (D-F)

D Mergers and Acquisitions

David Berger
Vice President, Legal Affairs
Hikma Pharmaceuticals USA Inc.

Carmela Crimeni
Principal
Cumberland Consulting Group

E The Future of Health, Analytics and Technology — What Role Will You Play?

Simon Gisby
Managing Director
Deloitte Corporate Finance LLC

Ron Sandhu
Senior Manager, Deloitte Risk and Financial Advisory
Deloitte & Touche LLP

F State Invoicing and Dispute Resolution

Sandy Fischer
Government Pricing Senior Director
Ingenus Pharmaceuticals, LLC

Lynn Lewis
Director, Data Acquisition and Integrity
IQVIA

Dorine Rascoe
Fiscal Program Manager, Drug Rebates
Maryland Department of Health

Stacey Hale
Drug Rebate Manager
Oklahoma Health Care Authority

Tanuja Gohil
Associate Director, Government Contracts and Rebates
Novo Nordisk Inc.

4:45   CHOOSE FROM THREE WORKSHOPS (G-I)

G LARGE PHARMA

FACILITATORS:

Mike Borgia
Group Director, Government Channel
Johnson & Johnson

Mike Kurland
Vice President, Revenue Management & Compliance Solutions
EVERSANA

H EMERGING BIOTECH/NEW LAUNCH

FACILITATORS:

David Chan
Co-Founder and CEO
Riparian

Nicholas Torre
Manager
Riparian

I GENERICS

FACILITATORS:

JoAnn Bute
Director, Government Pricing and Compliance
Amneal Pharmaceuticals

Lisa Clayton
Director, Government Reporting
Granard Pharmaceuticals

5:30

Close of Workshops and Day One

NETWORKING, WINE AND CHEESE RECEPTION immediately following the final session on day one

DAY TWO — WEDNESDAY, MAY 22, 2019

7:30

Networking Breakfast

8:00

Day Two Chair’s Welcome and Review of Day One

Glen Huttar
Director, Government Pricing
Johnson & Johnson Health Care Systems Inc.

8:10

OIG UPDATE OIG Work Plan and 2019 Initiatives

David Tawes
Regional Inspector General, Department of Health and Human Services
OIG

Michael Kvassay
Social Science Research Analyst, Office of Evaluations and Inspections
OIG

8:50

CMS ADDRESS CMS Policy Initiatives and Operational Updates

Christine Hinds
Policy Analyst
CMS

9:30

Prevailing Trends and Key Factors Impacting State Policy

Gary Alexander
President and CEO, The Alexander Group;
former Head, Health and Human Services
Commonwealth of Pennsylvania and the State of Rhode Island

10:10

Cybersecurity Considerations for Pharmaceutical Manufacturers – Government Contract Requirements for Data Protection

Michael Tomaselli
Senior Manager
EY

10:50

Networking and Refreshment Break

CHOOSE FROM LEARNING STREAMS (I-III)

LEARNING STREAM I STRATEGIC PRICING AND TRANSPARENCY

11:20

Stream Chair’s Welcome

Ed McAdam
Director, Government Pricing, Contract Operations and Analytics
Indivior Inc.

11:25

PANEL Evolving State and Federal Transparency Regulations —
Implications to Medicaid and Government Programs

MODERATOR:

Aubrey Elmore
Engagement Manager
HighPoint Solutions, an IQVIA Company

PANELISTS:

Jill Page
Director, Government Pricing Strategy Analysis
Fresenius Medical Care

Funso Olufade, PhD, MBA
Director, U.S. Commercial Finance
Amicus Therapeutics Inc.

Lisa McNair
Senior Manager, Managed Care and Government Pricing
Alvogen

Jonathan Connell
Senior Counsel
Bristol-Myers Squibb

12:05

State Drug Pricing Initiatives

Lynn Buhl
Director
KPMG LLP

Andrew Parks
Director
KPMG LLP

LEARNING STREAM II STATUTORY REPORTING REQUIREMENTS

11:20

Stream Chair’s Welcome

Kathleen Black
Director, Government Strategy
Pfizer Inc

11:25

Addressing 340B Duplicate Medicaid and Commercial Rebates

Aaron Vandervelde
Managing Director
BRG

12:05

Bona Fide Service Fees and Fair Market Value Determination

Constance Wilkinson
Member of the Firm
Epstein Becker Green

LEARNING STREAM III FINANCE AND COMPLIANCE OPERATIONS

11:20

Stream Chair’s Welcome

Joseph Birdsall
Senior Vice President, Financial Services
EVERSANA

11:25

Gross-to-Net and Accruals for Medicaid

Josef Magpantay
Principal
Cumberland Consulting Group

12:05

PANEL Data Sharing and Insight Collaboration Between GP, Managed Markets and Finance

MODERATOR:

Susan Dunne
Managing Director
BDO

PANELISTS:

Donna White
Vice President, Contracts and Compliance
Chiesi USA, Inc.

Raquel Villanueva
Senior Manager, Contract Operations
Jazz Pharmaceuticals

Larry Breen
Director, Financial Planning and Analysis
Sunovion Pharmaceuticals

Jennifer English
Senior Director, Market Access,
Pricing and Gross-to-Net Financial Operations
Insmed Incorporated

12:45

Networking Luncheon

1:30

Operational Excellence and Process Efficiency Strategies for Government Pricing

Jesse Mendelsohn
Vice President, Centers of Excellence
Model N

2:10

FIRESIDE CHAT Legal and Compliance Closing Bell

MODERATOR:

Chris Cobourn
Managing Director
KPMG LLP

PANELISTS:

John Shakow
Partner
King & Spalding

Kristin Hicks
Partner
Arnold & Porter

Christopher Schott
Partner
Hogan Lovells

Stephanie Trunk
Partner
Arent Fox

Rujul Desai
Of Counsel
Covington & Burling LLP

William Sarraille
Partner
Sidley Austin

3:15

Chairman’s Closing Remarks and Key Takeaways

Glen Huttar
Director, Government Pricing
Johnson & Johnson Health Care Systems Inc.

3:30

Close of Conference

Agenda

Want more agenda details? Download the brochure.

Want more agenda details? Download the brochure.

PRE-CONFERENCE — MONDAY, MAY 20, 2019

12:00   Pre-Conference Registration

1:00   CHOOSE FROM TWO SUMMITS (1-2)

1 GOVERNMENT PRICING AND REPORTING 101

For newcomers and seasoned pricing, contracting and reporting professionals looking for a refresher course, this 101 Boot Camp is designed to lay the groundwork and instill a fundamental understanding on the key components of government programs, pricing and reporting.

Jennifer Crosswell
Manager,
Government Pricing and Reimbursement
Arbor Pharmaceuticals

Miree Lee, MS, MBA
Bio/Pharma Pricing Consultant
M. Lee Consulting, LLC

Stephanie Kupski
Director,
U.S. Pricing and Government Reporting
CSL Behring

Josephine Hawkins
Associate Director, Medicaid
Astrazeneca

Phillip Scott
Senior Vice President, Business Development
NCPDP

2 SENIOR EXECUTIVE THINK TANK

Technological advances, outsourcing vendors and new ways of thinking have created unprecedented opportunity to increase value, enhance business effectiveness and lower operating costs. This Summit is an engaging and dynamic discussion that delves it certain developments and explores their application in key business areas such as audit readiness, class of trade, bona fide service fees, bundled arrangements, government contracting and rebate adjudication.

Rick Zimmerer
Partner
KPMG LLP

Jennifer Lospinoso
Managing Director
KPMG LLP

Lynn Buhl
Director
KPMG LLP

Greg Wiefel
Director
KPMG LLP

Janice Matasi
Manager
KPMG LLP

*The Senior Executive Think Tank is targeted for managementlevel and above professionals with pricing, reporting and contracting responsibilities.

3:00   Networking and Refreshment Break

3:30   CHOOSE FROM TWO SUMMITS (3-4)

3 FEDERAL CONTRACTING AND FSS FUNDAMENTALS DEEP DIVE

This Summit addresses the basics of the Veteran’s Health Care Act (VHCA) and FSS pricing requirements. Gain an understanding of key concepts and requirements to benchmark government pricing processes against.

Jeffrey Clayton
Principal
Baker Tilly Virchow Krause, LLP

Jennifer Woodruff McElhenny
Manager
Baker Tilly Virchow Krause, LLP

Cathy Zhang
Associate Director, Government Contracts
Eisai Inc.

Allison Pugsley
Partner
Hogan Lovells

Marci Anderson
Auditor
VA Office of Inspector General,
Office of Contract Review

Mark Myers
Director, Healthcare Resources Division
VA Office of Inspector General,
Office of Contract Review

4 340B PROGRAM EVOLUTION AND OVERSIGHT MASTER CLASS

As regulations evolve impacting the 340B Drug Discount Program, most recently the 340B Ceiling Price and Civil Monetary Penalties Final Rule, pharmaceutical companies are faced with uncertainty on how to ensure price reporting compliance. This Summit breaks down current regulations and guidance, and discusses potential operational implications and srategies.

Kathleen Peterson
Counsel
Hogan Lovells

Lenis De León
Senior Manager,
Government Pricing and Compliance
Apotex

5:30   CLOSE OF SUMMITS

HOSTED BY: WELCOME RECEPTION immediately following the close of summits

DAY ONE — TUESDAY, MAY 21, 2019

7:15

Networking Breakfast and Main Conference Registration

8:15

CBI Welcome

Elise Guerin Saas
Senior Program Director
CBI, a division of UBM Americas

8:20

Chairman’s Welcome and Opening Remarks

Rajeev Devgan
Director, Government Rebate Operations
Johnson & Johnson Health Care Systems Inc.

8:30

OPENING KEYNOTE ADDRESS Political and Legislative Trends in an Evolving Healthcare Landscape

Naomi Lopez Bauman
Director, Healthcare Policy
Goldwater Institute

9:10

PANEL DISCUSSION Current Environment of State Drug Pricing Transparency

MODERATOR:

Meena Datta
Partner
Sidley Austin

PANELISTS:

Brian Bohnenkamp
Partner
King & Spalding

Doug Helling
Associate General Counsel
UCB

9:50

The Fourth Industrial Revolution Is Here — Are You Ready?

Brenna Sniderman
Senior Manager
Deloitte Services LP

10:30

Networking and Refreshment Break

11:00

GP in the Upside-Down —
Unpack the Pricing Implications of a World Without PBM/Payor Rebates

John Shakow
Partner
King & Spalding

11:40

Novel Contracting Strategies with PBMs

Rujul Desai
Of Counsel
Covington & Burling LLP

12:20

Networking Luncheon

1:20

PANEL DISCUSSION Policy, Mechanics and Change within the Medicare Program

MODERATOR:

Jeffrey Baab
Vice President, Life Sciences
daVIZta

PANELISTS:

James Stansel
Executive Vice President and General Counsel
PhRMA

Mallory O’Connor
Director, Healthcare Policy and Federal Programs
BIO

Stephanie Trunk
Partner
Arent Fox LLP

2:00

PANEL DISCUSSIONManaging Refunds of 340B Overcharges and
Mitigating Compliance Risk

MODERATOR:

Mike Benedict
Vice President, Operations
Apexus

PANELISTS:

Marcy Imada
Principal
Deloitte & Touche LLP

Christopher Schott
Partner
Hogan Lovells

2:40

Networking and Refreshment Break

3:15   CHOOSE FROM THREE WORKSHOPS (A-C)

A Value-Based Frameworks and Government Pricing Considerations

Steve Benz
Partner
Arnold & Porter

Debbie Walters-Francique
Vice President and Assistant General Counsel
Pfizer Inc

B Forecast the Impact of Escalating Part D Coverage Gap Discounts on Gross-to-Net Sales

Murray Kay
former Senior VP and CFO, Solvay Pharmaceuticals;
former Commercial Controller, AbbVie & Abbott Laboratories

C Product Launch and Establishing a GP Strategy

William Sarraille
Partner
Sidley Austin

Trevor Wear
Partner
Sidley Austin

4:00   CHOOSE FROM THREE WORKSHOPS (D-F)

D Mergers and Acquisitions

David Berger
Vice President, Legal Affairs
Hikma Pharmaceuticals USA Inc.

Carmela Crimeni
Principal
Cumberland Consulting Group

E The Future of Health, Analytics and Technology — What Role Will You Play?

Simon Gisby
Managing Director
Deloitte Corporate Finance LLC

Ron Sandhu
Senior Manager, Deloitte Risk and Financial Advisory
Deloitte & Touche LLP

F State Invoicing and Dispute Resolution

Sandy Fischer
Government Pricing Senior Director
Ingenus Pharmaceuticals, LLC

Lynn Lewis
Director, Data Acquisition and Integrity
IQVIA

Dorine Rascoe
Fiscal Program Manager, Drug Rebates
Maryland Department of Health

Stacey Hale
Drug Rebate Manager
Oklahoma Health Care Authority

Tanuja Gohil
Associate Director, Government Contracts and Rebates
Novo Nordisk Inc.

4:45   CHOOSE FROM THREE WORKSHOPS (G-I)

G LARGE PHARMA

FACILITATORS:

Mike Borgia
Group Director, Government Channel
Johnson & Johnson

Mike Kurland
Vice President, Revenue Management & Compliance Solutions
EVERSANA

H EMERGING BIOTECH/NEW LAUNCH

FACILITATORS:

David Chan
Co-Founder and CEO
Riparian

Nicholas Torre
Manager
Riparian

I GENERICS

FACILITATORS:

JoAnn Bute
Director, Government Pricing and Compliance
Amneal Pharmaceuticals

Lisa Clayton
Director, Government Reporting
Granard Pharmaceuticals

5:30

Close of Workshops and Day One

NETWORKING, WINE AND CHEESE RECEPTION immediately following the final session on day one

DAY TWO — WEDNESDAY, MAY 22, 2019

7:30

Networking Breakfast

8:00

Day Two Chair’s Welcome and Review of Day One

Glen Huttar
Director, Government Pricing
Johnson & Johnson Health Care Systems Inc.

8:10

OIG UPDATE OIG Work Plan and 2019 Initiatives

David Tawes
Regional Inspector General, Department of Health and Human Services
OIG

Michael Kvassay
Social Science Research Analyst, Office of Evaluations and Inspections
OIG

8:50

CMS ADDRESS CMS Policy Initiatives and Operational Updates

Christine Hinds
Policy Analyst
CMS

9:30

Prevailing Trends and Key Factors Impacting State Policy

Gary Alexander
President and CEO, The Alexander Group;
former Head, Health and Human Services
Commonwealth of Pennsylvania and the State of Rhode Island

10:10

Cybersecurity Considerations for Pharmaceutical Manufacturers – Government Contract Requirements for Data Protection

Michael Tomaselli
Senior Manager
EY

10:50

Networking and Refreshment Break

CHOOSE FROM LEARNING STREAMS (I-III)

LEARNING STREAM I STRATEGIC PRICING AND TRANSPARENCY

11:20

Stream Chair’s Welcome

Ed McAdam
Director, Government Pricing, Contract Operations and Analytics
Indivior Inc.

11:25

PANEL Evolving State and Federal Transparency Regulations —
Implications to Medicaid and Government Programs

MODERATOR:

Aubrey Elmore
Engagement Manager
HighPoint Solutions, an IQVIA Company

PANELISTS:

Jill Page
Director, Government Pricing Strategy Analysis
Fresenius Medical Care

Funso Olufade, PhD, MBA
Director, U.S. Commercial Finance
Amicus Therapeutics Inc.

Lisa McNair
Senior Manager, Managed Care and Government Pricing
Alvogen

Jonathan Connell
Senior Counsel
Bristol-Myers Squibb

12:05

State Drug Pricing Initiatives

Lynn Buhl
Director
KPMG LLP

Andrew Parks
Director
KPMG LLP

LEARNING STREAM II STATUTORY REPORTING REQUIREMENTS

11:20

Stream Chair’s Welcome

Kathleen Black
Director, Government Strategy
Pfizer Inc

11:25

Addressing 340B Duplicate Medicaid and Commercial Rebates

Aaron Vandervelde
Managing Director
BRG

12:05

Bona Fide Service Fees and Fair Market Value Determination

Constance Wilkinson
Member of the Firm
Epstein Becker Green

LEARNING STREAM III FINANCE AND COMPLIANCE OPERATIONS

11:20

Stream Chair’s Welcome

Joseph Birdsall
Senior Vice President, Financial Services
EVERSANA

11:25

Gross-to-Net and Accruals for Medicaid

Josef Magpantay
Principal
Cumberland Consulting Group

12:05

PANEL Data Sharing and Insight Collaboration Between GP, Managed Markets and Finance

MODERATOR:

Susan Dunne
Managing Director
BDO

PANELISTS:

Donna White
Vice President, Contracts and Compliance
Chiesi USA, Inc.

Raquel Villanueva
Senior Manager, Contract Operations
Jazz Pharmaceuticals

Larry Breen
Director, Financial Planning and Analysis
Sunovion Pharmaceuticals

Jennifer English
Senior Director, Market Access,
Pricing and Gross-to-Net Financial Operations
Insmed Incorporated

12:45

Networking Luncheon

1:30

Operational Excellence and Process Efficiency Strategies for Government Pricing

Jesse Mendelsohn
Vice President, Centers of Excellence
Model N

2:10

FIRESIDE CHAT Legal and Compliance Closing Bell

MODERATOR:

Chris Cobourn
Managing Director
KPMG LLP

PANELISTS:

John Shakow
Partner
King & Spalding

Kristin Hicks
Partner
Arnold & Porter

Christopher Schott
Partner
Hogan Lovells

Stephanie Trunk
Partner
Arent Fox

Rujul Desai
Of Counsel
Covington & Burling LLP

William Sarraille
Partner
Sidley Austin

3:15

Chairman’s Closing Remarks and Key Takeaways

Glen Huttar
Director, Government Pricing
Johnson & Johnson Health Care Systems Inc.

3:30

Close of Conference