FoCUS Design Lab
Reshaping the Future of FoCUS
April 13–14, 2022 at MIT
Objectives:
- Share expectations regarding the current status of Precision Financing and Reimbursement
- Review landscape of current needs, including anticipated Medicaid Best Price changes
- Advance solutions to align future FoCUS actions
Day 1: Portfolio Impact and Constraints
1 :00pm– 5:30pm
12 – 1pm
Registration and lunch
1 – 2pm
Welcome, Introductions and Frame the Day
Gigi Hirsch & Mark Trusheim
2 – 3:30pm
Crossfire: Precision Reimbursement Now & In the Future Mark Trusheim
Terry Cothran, Kollet Koulianos, Kristin Wolff
3:30 – 4:00pm
Networking break
4:00 – 4:45pm
CMS Value Based Purchasing Rule Update
Michael Ciarametaro
4:45 – 5:10pm
Payor and Developer Surveys
Jane Barlow
5:10-5:30 pm
Wrap Up and Next Day Overview
Mark Trusheim
5:30 – 7:30pm
Cocktail hour and Dinner at Samberg Center
Day 2: Resetting the Future of FoCUS
8:00am– 1:30pm
8:00 – 9:00am
Networking breakfast
9:00 – 9:15am
Welcome and Frame the Day
Mark Trusheim
9:15 – 9:55am
Quantifying the Burden of Disease to Tailor Precision Financing Payment Innovations for Sickle Cell Disease & Beyond
Tsega Meshesha, Diane Nugent, Lisa Nugent, and Tina Park
10:00 – 10:45am
Medicaid and Medicare analysis with recommended policy asks
Colin Young
10:50 – 11:30am
Toolkit Demonstration
Karen Geary
11:30 – 1:00pm
Shaping Precision Financing & Reimbursement to meet evolving needs
Gigi Hirsch & Mark Trusheim
1:00 – 2:00pm
Networking Lunch
(To-go available)
Raj Arora
Sr. Director, Horizon Scanning and Payer Innovation
Sanofi
Jane Barlow
Senior Advisor, NEWDIGS
MIT FoCUS Project
Amber Batata
Global head of Market Access & Strategic Pricing,
Sanofi
Kim Caldwell
Principal
Texas Star Healthcare Consulting, LLC
Brian Carey
Partner
Foley Hoag LLP
Sara Castegini
Associate Director, Government Affairs and Policy
bluebird bio
Sung Hee Choe
Senior Director
Milken Institute
Michael Ciarametaro
VP Research
National Pharmaceutical Council
Francesca Cook
VP, Pricing and Market Access
REGENXBIO
Terry Cothran
Senior Pharmacy Director
Oklahoma Health Care Authority
Lucas de Breed
Founder and Managing Director
August Care
Thomas Dow
VP Business Development
Emerging Therapy Solutions
Stephanie Farnia
Principal
Nimitt Consulting
Lauren Feldman
Group Director, Innovative Contracting
Janssen
Diana Frame
Founder
Frame Research, LLC
Karen Geary
Senior Consultant, MIT FoCUS
MIT
John Glasspool
Senior Advisor, FoCUS Project
MIT
Abhi Gupta
Senior Director, Global Gene Therapy
Pfizer
Michelle Harika
Chief Clinical Officer
Equity Healthcare, LLC
Brendan Hayes
Director of Education - Innovative Therapies
National Hemophilia Foundation - New York, NY
Gigi Hirsch
Executive Director, NEWDIGS
MIT
Dorothy Hoffman
External Engagement and Access Policy Lead
Pfizer
Tom Hubbard
Vice President of Policy Research
NEHI The Network for Excellence in Health Innovation
Ashley Hume
Vice President Strategic Partnerships
Emerging Therapy Solutions
Paul Jeffrey
Consultant
Jeffrey Consulting
Keith Kennerly
Founder and CEO
PayRx, Inc.
Kollet Koulianos
VP Payer Relations
National Hemophilia Foundation
Nan Li
Director, Global Market Access
Janssen
Tsega Meshesha
Program Manager, FoCUS Project
MIT
John Meyer
Director
Novartis Gene Therapies
Erin Muller
Associate Director, Market Acc Strategy & Policy
BioMarin
Julie Murray
Executive Director, North America Market Access
BioMarin
Deepna Nandiga
Associate Director, Policy and Alliances
Vertex Pharmaceuticals - Boston, MA
Trung Nguyen
Director, Contract Strategy and Operations
Novartis Gene Therapies
Eric Norman
Communications Consultant
Hopewell
Lisa Nugent
Design Director
Sickle Cell Disease Foundation
Awo Osei-Anto
Director
FasterCures
Tina Park
Partner
Diagram
Ed Pezella
CEO/Consultant
Enlightenment Bioconsult, LLC
Cindy Pigg
Senior Vice President, Commercial Market Leader
Aon
Casey Quinn
Senior Research Advisor, FoCUS Project
MIT
Brian Ragan
Director, Pharmaceutical Manufacturer Relations
Humana Pharmacy Solutions
Gail Ryan
Director, Pharmaceutical Transformation
Point32Health
Susan Serrano
Associate Director, US Market Access
bluebird bio
Eric Small
Senior Administrative Assistant, NEWDIGS
MIT
Sam Stolpe, PharmD, MPH
Senior Director, Healthcare Quality Strategy
Janssen
Katie Torrence
Project Coordinator, FoCUS Project
MIT
Mark Trusheim
Strategic Director, NEWDIGS
MIT
Claire White
Administrative Manager, Cell Therapy
The Children's Hospital of Philadelphia
Brooks Wildasin
AVP
CareMetx/OutcomeRx
Kristin Wolff
Vice President, Payer Engagement & Access
bluebird bio
Durhane Wong-Rieger
President & CEO
Canadian Organization for Rare Disorders
Yoojung Yang
Senior Director, Health Economics & Outcomes RSRCH
Vertex
Colin Young
Director, Drug Development Pipeline Research, FoCUS Project
MIT
Frank Zhang
Head Of Commercial
uniQure
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.”
Antitrust Compliance Statement
Issued March 9, 2017
MIT's Center for Biomedical Information (CBI) spearheads initiatives focused on re-engineering drug development and delivery processes to optimize access to new medicines for patients while ensuring the sustainability of pharmaceutical innovation. Many of these initiatives involve cooperation among various constituencies, including pharmaceutical companies and other industry stakeholders, patient advocates, healthcare payers, and academic and research institutions.
Because competitors or potential competitors in the marketplace are often participating in the same initiatives, participants in CBI activities must take care to stay within antitrust boundaries.
The antitrust laws prohibit firms from entering into agreements and engaging in arrangements with competitors that are “anticompetitive” -- meaning that they reduce competition more than they advance it. The antitrust laws, however, support and encourage “procompetitive” agreements and arrangements that increase efficiency, enable and improve innovation, and increase the availability of higher quality, lower cost goods and services. CBI’s initiatives are designed to facilitate “procompetitive” processes.
This Statement provides antitrust guidance to MIT personnel and to the representatives of companies and other institutions who participate in CBI activities with the goal of encouraging and ensuring antitrust compliance. Even for specially trained experts, it can sometimes be difficult to distinguish “anticompetitive” from “procompetitive” outcomes. This Statement articulates General Antitrust Principles that guide differentiation of various interactions and lists Specific Antitrust Guidelines to enhance the procompetitive nature of CBI activities and reduce the risk of any inadvertent violation of the antitrust laws. CBI asks all participants in CBI activities to follow the General Antitrust Principles and to adhere to the Specific Antitrust Guidelines. The Principles and the Guidelines are intended to be conservative – meaning that they will prohibit some conduct that the antitrust laws may allow – in order to provide a reasonable safety margin for everyone.
General Antitrust Principles
1. Be “antitrust aware”, including in your emails, documents, and conversations. This means remembering that no CBI activity is intended to reduce competition or create undesirable “anticompetitive” effects. These undesirable effects include increased market power, higher prices, lower quality goods or services, and the creation or strengthening of obstacles to innovation.
2. Part of being “antitrust aware” involves recognizing and memorializing, when appropriate, the desirable “procompetitive” effects that flow from cooperative exploration and innovation. These effects include faster rates of innovation, greater efficiency, increased output, lower prices, and higher quality goods and services. Documents and meeting agendas that identify those positive effects create a helpful contemporaneous record of the participants’ procompetitive vision, which can be consulted later.
3. Note that preserving a particular company’s or group of companies’ prices, profit margins, or position in an industry is not a legitimate goal, particularly in the dynamic industries involved in CBI’s activities. All companies are expected to succeed on their own merits and not because they have created obstacles to competition. The law establishes one important exception – patent holders possess a temporary, completely legal monopoly as their reward for innovation. A patent holder, acting alone, is entitled to use the legal system to exclude rivals from practicing the subject of the patent.
4. “Market power,” meaning the ability of a single company or group of companies to control the price or availability of goods and services, is rarely permissible under antitrust laws. The acquisition or use of market power is tolerated where it results from superior products, services, or business skill, but otherwise it is highly suspect. No CBI activity that makes economic sense only if it creates or intensifies market power for the participants (other than through the eventual assertion of patent rights) should be undertaken without first consulting CBI's compliance contact.
5. Other countries have their own competition regimes, and some of those regimes operate quite differently from the United States’ antitrust laws. Recognizing that much of CBI’s work may affect the global marketplace, CBI intends to comply with competition laws in all countries where its work has local effect. This Compliance Statement addresses the fundamental principles that are common to the competition regimes in the United States and the European Union. If you believe a CBI activity is likely to have a significant, negative economic effect on a company outside of the United States or European Union, please raise that issue with CBI's compliance contact.
Specific Antitrust Guidelines
1. Do not reach any of the following types of agreements with a competitor: agreements affecting the price at which goods or services are sold in competition; agreements allocating customers or markets among competitors; or agreements not to deal with any company or organization.
2. Do not discuss with a competitor information concerning any of the following: your company’s or your competitors’ prices, costs, discounts, terms of sale, or profit margins or anything else that might affect those prices; the resale prices your customers should charge for any products you sell them; markets, customers, territories, or products sold in competition; whether or not to deal with any other company or organization; or any other competitively sensitive information concerning your company or a competitor. In addition, do not share non-public data concerning these topics with a competitor.
3. Do prepare and follow an accurate agenda, even if only in summary form, for meetings attended by representatives of two or more direct competitors.
4. Do consult with CBI’s antitrust compliance contact before proceeding in any area of uncertainty. The compliance contact does not provide legal advice. When needed, the compliance contact will obtain legal advice for MIT participants from MIT’s Office of the General Counsel. All non-MIT participants must consult their own counsel for legal advice.
5. Do recognize that the antitrust laws encourage cooperation among competitors for the legitimate, procompetitive purposes envisioned by CBI. A more detailed look at this complex area may be found in the United States’ Antitrust Guidelines for Collaborations among Competitors, found here.