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Team Remits

Current Remits Effective Until April 2023,
Subject to Review after Respective Team Calls

Download the remits in a PDF

Workstreams seeking new members

Precision Reimbursement Adoption Monitoring (PRAM) Project

Team Lead: Mark Trusheim

The team and database aim to increase transparency of value-based contracts in the market place. However, creating a new database is not easily feasible, so the team plans to contribute a research paper that will identify the value propositions and incentives of engaging in such an activity. By doing so, they hope to facilitate the creation of similar databases in the future, promoting transparency and better outcomes for all stakeholders involved in value-based contracts.

Exploring the Possibilities of Risk Pools for Chronic Therapies in Rare Diseases

Team Leads: Lisa Feng, Michelle Harika, Mukesh Sharma

September 2023 Design Lab Case study: Part 3

The October 2022 and April 2023 Design Labs fostered great momentum around exploring Precision Financing solutions in chronic rare disease. This team will be working with the Precision Reimbursement Team and other interested parties on a follow up case study in September 2023.

Analyze the Interactions of 340B and ASP with Value-Based Purchasing Arrangements

Team Lead: Mark Trusheim

The Federal 340B drug pricing program required discounts may disincentivize the use of Value-Based Purchasing arrangements (VBPs). The use of ASP-based “Buy & Bill” reimbursement may also inhibit VBP use. This team examines the interactions of these programs, describe scenarios (perhaps quantitatively) when these programs do and do not interfere with VBPs, and suggest possible reforms when they do. The team is fully dedicated to producing a comprehensive and influential white paper.

Policy Team

PDUFA VII Implications

Team Lead: John Glasspool

Our interest in The Prescription Drug User Fee Act (PDUFAVII) lies in the section, ‘Ensuring the effectiveness of the human drug review program’: Enhancing regulatory science and expediting drug development. The first half of 2023 investigated designing a pilot proposal for the FDA to include Precision Financing with effectiveness and post approval study requirements.

Pipeline Analysis and Modeling (PAM) Predictions and Understanding the Systems' Capacity for Cell and Gene Therapies

Team Leader: Mark Trusheim, Claire White, Colin Young

In partnership with healthcare providers and systems, Team will assess the current and future practices related to the infrastructure and administration of cell and gene therapies in both in- and out-patient settings. Aims to identify feasible and acceptable solutions to overcome barriers that impact patient access, such as provider availability, hospital capacity, and availability of necessary products. The goal is to highlight best practices, challenges, and issues that affect providers' capability and engage patients in a multi-stakeholder setting to suggest patient-centered solutions.

Paying For Cures Toolkit: Navigation and Design

Team Leader: Karen Geary

This team is responsible for maintaining the Toolkit website with industry updates and all relevant briefs and progress notes from FoCUS. With the move to Tufts Medical Center, we are using this opportunity to enhance the user experience, making improvements to the navigation and design. Other Toolkit activities will include the development of visual presentations of information as downloadable infographics and/or slides.

Day 1

11:30am – 1:00pm
Registration

11:35am – 12:20pm
Orientation to The FoCUS Project

12:00 – 1:00pm
Lunch

1:00 – 1:45pm
Welcome, Introductions and Frame the Day

1:45 – 2:30pm
Market Advancement and Opportunities, opening panel

2:30 – 5:35pm
Risk Pooling Strategies for Chronic and Durable Therapies: Part II Case study
Opening presentation & clarifying questions
Breakout sessions
Report out and Discussion

5:35 – 6:00pm
Daily Wrap Up and Next Day Overview

6:00 – 7:30pm
Cocktail hour

Day 2

8:00 – 8:45am
Networking breakfast

8:45 – 12:40pm
Precision Reimbursement Adoption Monitoring (PRAM) Project
Analysis of 340B and ASP Interactions for Precision Reimbursement & Value-based contracts
When could a managed entry agreement create a win-win-win situation — Exploring the window of opportunity
Payers’ Perspectives on Value-based contracts best practices, barriers and challenges, areas of improvement
Toolkit 2023 — Updates and demonstration
PAM 2023: Pipeline Updates and Expansion Opportunities
PDUFA VII Policy Implications on Real World Evidence

10:50 – 11:05am
Break

12:40 – 1:00pm
Wrap Up and Closing

1:00 – 1:30pm
Networking lunch (takeaway available)

Raj Arora
Senior Director, Payer Innovation
Sanofi

Azrina Azhar
Project Director
NEWDIGS

Tracy Baroni Allmon
Vice President, Global Access & Reimbursement
Policy Takeda

Jane Barlow
Senior Advisor
NEWDIGS

Laura Barry
Director
Sun Life

Amber Batata
Global Head of Market Access & Pricing, Rare & RBD
Sanofi

Andy Berg
Co-founder & Chief Executive Officer
Audaire Health

Marcelien Callenbach
PhD Candidate
Utrecht University

Brian Carey
Partner
Foley Hoag

Francesca Cook
Vice President, Pricing and Market Access
Regenxbio

Terry Cothran
Senior Pharmacy Director
Oklahoma Health Care Authority

Lucas de Breed
Founder
August Care

Caitlin Dixon
Clinical Pharmacist, Cell & Gene Therapy
BlueCross BlueShield Association

Joey Dizenhouse
Senior Vice President, Head of HealthTrust IHP
HealthTrust Coalition

Hana Do
Research Analyst
Tufts Center for the Study of Drug Development

Stephanie Farnia
Principal
Nimitt Consulting

Lauren Feldman
Group Director, Innovative Contracting
Janssen Pharmaceutical Companies of Johnson & Johnson

Lisa Feng
Senior Director, Health Policy
Alexion

Girisha Fernando
Chief Executive Officer & Founder
Lyfegen

Jamie Foley
Director, Global Oncology Value-Based Innovation
Takeda

Karen Geary
Senior Consultant, FoCUS Project
NEWDIGS

John Glasspool
Senior Advisor, FoCUS Project
NEWDIGS

Chester (Bernie) Good
Senior Medical Director Center for Value Based Pharmacy Initiatives
UPMC

Nashadee Guerrier
Research Project Coordinator
NEWDIGS

Michelle Harika
Chief Clinical Officer
Blackstone/Equity Healthcare

Brendan Hayes
Director, Senior Non-Profit Leader, Healthcare Advocacy & Policy
National Hemophilia Foundation

Carissa Heine
Senior Director, HCP & Payer Marketing
Novartis Gene Therapies

Erin Hertzog
Partner
Foley Hoag LLP

David Hinchcliffe
Market Access Strategy
CSL Behring

Gigi Hirsch
Director
NEWDIGS

Dorothy Hoffman
Market Access Policy Team Lead
Pfizer

Keileen Hopps
Program Manager, LEAPS Project
NEWDIGS

Tom Hubbard
Senior Vice President of Policy Research
Network for Excellence in Health Innovation

Ashley Hume
Senior Vice President, Strategic Growth & Client Engagement
Emerging Therapy Solutions

Lukasz Jarzyna
Vice President, Global Value Access and Pricing
Alexion

Paul Jeffrey
Principal Consultant
Paul Jeffrey Consulting

Maryanne Maliwat
Senior Director, Global Pricing, Reimbursement & Market Access
REGENXBIO

Kelly Maynard
President
Little Hercules Foundation

Scott McGoohan
Senior Director, Government Affairs & Public Policy
Vertex

Tsega Meshesha
Program Manager
FoCUS Project NEWDIGS

Julia Morawski
Senior Director Access and HEOR Strategy
Intellia Therapeutics

Nico Mros
CXO & Co-Founder
Lyfegen

Bibhash Mukhopadhyay
Managing Partner
August Care

Kelly Munger
President
PartnerRe Americas Insurance Company

Trung Nguyen
Director, Contract Strategy and Operations
Novartis Gene Therapies

Eric Norman
Principal
Hopewell Partners

Wayne Pan
Medical Director
Banner Health Plans & Networks

Chris Pashos
Member, Board of Directors
Genesis Research

Cindy Pigg
Senior Vice President
Elixir

Casey Quinn
Senior Advisor for Patient-Centered Economic Outcomes
PCORI

Robert Rouse
Head of Market Access
CSL Behring

Gail Ryan
Director, Pharmaceutical Transformation
Point32Health

Peter Rzewnicki
Senior Director, Access Ecosystem Strategy
Johnson & Johnson

Heather Schneider
Director of Prior Authorization Strategy
CVS Health

Carol Seidel
Research Administrative Director
ICRHPS Tufts Medical Center

Mukesh Sharma
Senior Director, GVAP, Pricing Excellence and New Product Strategy
Alexion

Michael Sherman
Venture Partner
RA Capital Management

Jennifer Shumsky
Director, Payer Relations
Little Hercules Foundation

Surya Singh
Chief Medical Officer
Emerging Therapy Solutions

Eric Small
Senior Project Manager
NEWDIGS

Mark Trusheim
Strategic Director
NEWDIGS

Alice Valder Curran
Partner
Hogan Lovells

Amanda Wagner Gee
Associate Director FasterCures,
Milken Institute

Julie Walz
Principal, National Network Contracting
Humana

Bonnie Weber
Executive Director, Specialty Product Innovation
CVS Health

Claire White
Administrative Manager
CHOP

Brooks Wildasin
Healthcare Strategist and Innovator, Chief Underwriter, Product Manager
CareMetx

Amy Wotring
Director
Vertex Pharmaceuticals

Colin Young
Director, Drug Development Pipeline Research
NEWDIGS

Qiaoyi Zhang
Global Market Access Leader, Retinal Gene Therapy
Janssen Pharmaceutical Companies of Johnson & Johnson

Design Lab Briefing Book

A payment innovation framework to meet the urgent need in advanced therapies

Value-based performance arrangements for chronic conditions: an economic simulation of Med- icaid Drug Rebate Program reforms (tandfonline.com)

Medicaid best price reforms to enable innovative payment models for cell and gene therapies (tandfonline.com)

Healthcare leaders convene: take next step towards developing and modeling new financing mechanisms for cures

Precision Reimbursement Roundtable Proceedings

Regenerative Medicine and Advanced Therapies, United States Government Accountability Office (GAO) Information on Workforce and Education report (March 2023)

Chatham House Rule

The Chatham House Rule is used in meetings where participants need a way to openly share information, but don't want to be identified as the source of that information in any meeting records or articles written afterward. The rule is invoked regularly in meetings dealing with sensitive topics. It reads:

“When a meeting, or part thereof, is held under the Chatham House Rule, participants are free to use the information received, but neither the identity nor the affiliation of the speaker(s), nor that of any other participant, may be revealed.”