LEAPS Design Lab
June 13, 2023
Welcome to our Design Lab on June 13 in Boston!
Location
Courtyard Boston Downtown
5th Floor
275 Tremont Street
Boston, MA 02116
Overview
Special Morning Session: “How an RWE Infrastructure Could Enable Payment Innovation” co-hosted by NEWDIGS & IMI’s Health Outcomes Observatory (H2O)
- Evaluate trends, gaps, and opportunities in the evolution of outcomes tracking innovations in the U.S. and Europe through the lens of several case studies.
- Explore how an RWE infrastructure could enable payment innovation in the U.S. to ensure timely and appropriate access for patients to biomedical products.
- Elucidate priorities for collective action to accelerate the evolution of sustainable, patient-centered outcomes tracking to support payment innovation.
Afternoon Session: LEAPS Design Lab focusing on Payment Innovation
- Explore concerns around Accelerated Approval Program (AAP) products in the context of their value, appropriate patient access, and long-term performance.
- Investigate the potential for value-based contracts to address these concerns, while also contributing to the totality of AAP regulatory evidence and supporting Payer Value Assessment approaches.
Message from Gigi Hirsch
Hello NEWDIGS Community and H2O consortium members,
Welcome in advance to LEAPS Design Lab, which will include a special morning event co-hosted with the Innovative Medicines Initiative’s Health Outcomes Observatory (H2O). For those who are able to join us in person, we look forward to gathering with you for the full day’s program and evening reception at the Courtyard Boston Downtown at 275 Tremont Street, Boston, MA. We are also pleased to welcome those of you who are unable to travel to Boston to participate virtually over livestream in the special co-hosted morning event, “How an RWE Infrastructure Could Enable Payment Innovation”.
We are grateful to those of you who joined us for our recent LEAPS (November) and FoCUS (April) Design Labs, and we also want to extend a very warm welcome to new collaborators to our community who are joining us for the first time. We have much to catch up on and consider as we plan our next steps and explore future directions for NEWDIGS and the Center for Biomedical System Design at Tufts Medical Center.
As always, we greatly appreciate your ongoing support and commitment. Your input is critical for our success!
Looking forward to continuing our work together.
Best regards,
Gigi
Morning session, 9am–12pm
“How an RWE Infrastructure Could Enable Payment Innovation” co-hosted by NEWDIGS & IMI’s Health Outcomes Observatory (H2O)
- Evaluate trends, gaps, and opportunities in the evolution of outcomes tracking innovations in the U.S. and Europe through the lens of several case studies.
- Explore how an RWE infrastructure could enable payment innovation in the U.S. to ensure timely and appropriate access for patients to biomedical products.
- Elucidate priorities for collective action to accelerate the evolution of sustainable, patient-centered outcomes tracking to support payment innovation.
9am
In-person Registration
10am
Welcome/Event Overview
Introduction & Welcome
Moderator: Jane Barlow, Senior Advisor, NEWDIGS
Event Overview
Gigi Hirsch, Director, Center for Biomedical System Design & NEWDIGS
H2O Overview
Meni Styliadou, Takeda & H2O Co-lead
Tanja Stamm, Medical University of Vienna & H2O Co-lead
10:30am
Panel Talks: Opening Statements
Payer Perspective
Kate Wallis, Point32Health
Developer Perspective
Greg Daniel, Eli Lilly and Company
PCORnet: National infrastructure for patient-centered clinical research
Claudia Grossman, PCORI
Real Endpoints: Multi-product market access platform
Rob O’Brien, Real Endpoints
Beekeeper AI: Next generation secure data access platform
Michael Blum, BeeKeeperAI
10:55am
Panel & Group Discussion
11:55am
Closing remarks
Jane Barlow
Afternoon session, 12pm–6:30pm
LEAPS Design Lab focusing on Payment Innovation
- Explore concerns around Accelerated Approval Program (AAP) products in the context of their value, appropriate patient access, and long-term performance.
- Investigate the potential for value-based contracts to address these concerns, while also contributing to the totality of AAP regulatory evidence and supporting Payer Value Assessment approaches.
12:00pm
Networking Lunch & Registration
1:00pm
LEAPS Design Lab Introduction
Mark Trusheim, Strategic Director, NEWDIGS
1:10pm
Methods Innovation Update
Fotios Kokkotos, Director of Data Science, NEWDIGS
Christopher Stuetzle Associate Professor and Chair, Department of Computer and Data Sciences, Merrimack College
1:30pm
Payment Innovation Framework Overview
Jane Barlow, Senior Advisor, NEWDIGS
1:45pm
Payment Innovation Accelerated Approval Program (AAP) Case Study presentation and clarifying questions
Ron Potts, 6 Degrees Health
Jamie Foley, Takeda Oncology
Felipe Dolz, Sanofi
2:45pm
AAP Case Study Breakout Groups Discussion
All
4:00pm
Break
4:15pm
AAP Case Study Breakout Groups Report-out and Q&A
All
5:00pm
Forward Planning
Gigi Hirsch, Director, Center for Biomedical System Design & NEWDIGS
5:30pm
Reception
Both sessions
Payment Innovation Roundtable 2022 Proceedings
Article in Cell and Gene Therapy Insights
A payment innovation framework to meet the urgent need in advanced therapies
Morning session
Afternoon session
LocationCourtyard Boston Downtown |
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Parking |
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LEAPS Design Lab participants
Azrina Azhar
Program Director
NEWDIGS
Jane Barlow
Senior Advisor
NEWDIGS
Stella Blackburn
Vice President, Strategic Operations
IQVIA
Michael Blum
Chief Executive Officer
BeeKeeperAI
Brandon Boyle
Director, R&D Data Program Manager
Takeda
Mary Brophy
Director Maveric Core Laboratory
VA Boston Healthcare System
Sung Hee Choe
Senior Director
FasterCures
Elizabeth Cobbs
Content Writer
NEWDIGS
Michael Collins
Senior Director
Janssen Pharmaceuticals
Mark Cziraky
President
Carelon
Reid D’Amico
Principal, Regulatory Science & Strategy
IQVIA
Gregory Daniel
VP & Head of Global Public Policy
Eli Lilly
Nhan Do
Director, VA Boston CSP Informatics
VA Boston Healthcare System
Bridget Doherty
Director, Market Access Scientific
Janssen
Felipe Dolz
Vice President, Global Regulatory Science and Policy
Sanofi
Dorothy Dulko
Research Project Director- Tufts ICRHPS
Tufts Medical Center
Sarah Emond
Executive Vice President and Chief Operating Officer
ICER
Lauren Feldman
Group Director, Innovative Contracting
Janssen Pharmaceuticals
John Ferguson
Head Pharmacovigilance
Sanofi
Ryan Ferguson
Director, Cooperative Studies Program Coordinating Center
U.S. Department of Veterans Affairs
Girisha Fernando
CEO & Founder
Lyfegen
Jamie Foley
Global Director, Value-Based Innovation
Takeda Oncology
Diana Frame
Founder
Frame Research, LLC
Jennifer Goldsack
Senior Director, Value Access & Pricing Innovation
Janssen Pharmaceuticals
Jennifer Graff
Founder
Innov8 Health Policy, LLC
Claudia Grossmann
Associate Director, Research Infrastructure
PCORI
Nashadee Guerrier
Research Project Coordinator
NEWDIGS
Luis Hernandez
Head, Global Health Economics
Takeda Oncology
Gigi Hirsch
Director, Center for Biomedical System Design
NEWDIGS
Keileen Hopps
Program Manager
NEWDIGS
Annie Huang
Director, Market Access Strategy
Takeda
Hui Huang
Vice President, Head of Global Value & Access Oncology
Takeda Oncology
Tom Hubbard
Senior Vice President
NEHI
Burcu Kazazoglu Taylor
Executive Director, Global Value & Access
Novartis Gene Therapies
Nirmal Keshava
Vice President, Data Science & Innovation
Cerevel Therapeutics
Fotios Kokkotos
Director of Data Science
NEWDIGS
Kay Larholt
Senior Advisor
NEWDIGS
Georgia Lin
Program Manager, Data Sciences Institute
Takeda
Mark Lin
Head of Global Evidence and Outcomes Research, Solid Tumor
Takeda Oncology
Peter Loupos
Founder & General Manager, Princeton Healthcare Strategies, LLC
Princeton Healthcare Strategies, LLC
Jiainbin Mao
Director, Global Value and Access
Cerevel Therapeutics
Tsega Meshesha
Program Manager
NEWDIGS
Michel Mohler
Chief Financial Officer
Lyfegen
Nico Mros
Chief Customer Experience Officer
Lyfegen
Naresh Murthy
Data Acquisition Governance & Engagement Lead-Global Real World Data Strategy
Pfizer
Joseph Nemeczky
Student
Merrimack College
Trung Nguyen
Director, Contract Strategy & Operations
Novartis Gene Therapies
Sara Noonan
Director, Public Relations
Takeda Oncology
Rob O’Brien
Senior Vice President
Real Endpoints
Wayne Pan
Medical Director
San Francisco Health Plan
Ron Potts
Chief Medical Officer
6 Degrees Health
Mayank Raizada
Principal, Regulatory Science & Strategy
IQVIA
Eric Small
Senior Project Manager
NEWDIGS
Tanja Stamm
Professor & Head of the Institute for Outcomes Research/ Co-lead
Medical University of Vienna/ H2O
Chris Stuetzle
Associate Professor of Computer Science
Merrimack College
Meni Styliadou
Vice President, Global Program Leader/ Co-Lead
Takeda Oncology/ H2O
Ludovic Trinquart
Director, Center for Clinical Trials
Tufts Medical Center ICRHPS
Mark Trusheim
Strategic Director and Visiting Scientist
NEWDIGS
Kate Wallis
Vice President, Clinical Innovation
Point32Health
Julie Walz
Principal, Nation Network Contracting
Humana
Special Morning Session: “How an RWE Infrastructure Could Enable Payment Innovation” virtual participants
Devin Abrahami
Senior Manager
Pfizer
Renn Andrews
Researcher & PhD Student
Medical University of Vienna
Jesús Aparicio
Head of Evidence and Value Generation
Takeda
Nitzan Arad
Assistant Research Director
Duke-Margolis Center for Health Policy
Naomi Aronson
Executive Director
Blue Cross Blue Shield Association
Afroditi Avgerinou
Real World Data & Data Solutions- (AIDA)
Pfizer
Michelle Baglia
Director Epidemiology, RWE
Sanofi
Jillian Berry Jaeker
Head (Director) Data Connectivity Services
Takeda
Muna Bhanji
Founder & Principal
Tiba Global Access, LLC
Steven Boyles
Senior Clinical Pharmacy Specialist
Providence Health Plan
Mary Lynn Cala
Takeda
MaryBeth Chalk
Co-founder & Chief Commercial Officer
BeeKeeperAI
Kristina Chen
Director, Health Economics Outcomes Research
Pfizer
Gwenaelle Corre
Global Alliance Manager
Sanofi
Anthony Eccleston
Global Director, HEOR
Pfizer
Ashley Geiger
Associate Director Oncology Patient Centered Outcomes
Takeda
Steven Gerst
PayRx
Megan Golden
Co-Founder and CEO
Mission: Cure
Shahid Hanif
Managing Director
GetReal Institute
Daniel Hauberg
Senior Market Access Manager
Pfizer
Antje Hottgenroth
Associate Director Real World Data
Eli Lilly and Company
Carolin Hüttinger
Roche
Danielle Isaman
Sanofi
Nataliya Kemenyash
Director, Project Management, Health Outcomes Observatory
Takeda
Melissa Kirker
Global Health Economics and Outcomes Research Director
Pfizer
Zoi Kolitsi
EU Institute for Innovation
Marissa Konstadt
Global Pricing & Market Access Senior Manager
Vertex
Lauren Lee
Director
Pfizer
Cayley Lloyd
Lead, Global Corporate Communications
Takeda
Jakki Lynch
ELMC Sequoia
Aaron Masini
Pharmacy Director of Innovation, Pipeline, and Value Based Care
Providence Health plan
Elizabeth Masters
Oncology Value & Evidence Team Lead
Pfizer
Kevin Mayo
Partner
Value Genome LLC
Laura Mesana
Value & Access Strategy Lead
Pfizer
Gandarvaka Miles
Director, RWE Analytics
Sanofi
Borja Moll
Roche
David C. Norris, MD
Precision Methodologies, LLC
Casper Paardekooper
Partner
Vintura
Natalia Petruski-Ivleva
Senior Director, RWE Team Lead
Sanofi
Ann-Kristin Porth
PhD Student
Medical University of Vienna
Salena Preciado
Patient Centered Outcomes Research Scientist
Genentech
Teresa Ramos
Head of Personalized Medicine
Roche
Elise Rinzema
Healthcare Systems Partner
Roche
Andres Rodriguez
Director, Oncology Policy
GSK
Chloe Grace Rose
HEOR Fellow
Pfizer
Josh Roth
Director, Global Value & Evidence, Oncology/Hematology
Pfizer
Mahsa Salsab
University of Minnesota
Erika Schirghuber
Medical Manager Personalized Healthcare
Roche
Suz Schrandt
Founder, CEO & Chief Patient Advocate
ExPPect, LLC
Roshani Shah
PhD Candidate, Oncology and Vaccines Early Clinical
Pfizer
Jennifer Shumsky
Director, Payer Relations
Little Hercules Foundation
Rebecca Steele
Senior Consultant
Vintura
Stella Stergiopoulos
Director, Value and Evidence, US
Pfizer
Ulrike Talkenberg
Lead Patient Advocacy
Takeda
Diogo Telmo Neves
Berline Institute of Health
Rob Thwaites
Founder and Director
Albion House Consulting
Siddhi Umarje
RWE Epidemiologist
Sanofi
George Wang
Investor
AV8 Venture
Mary Witkowski
Fellow
Harvard Business School
Durhane Wong-Rieger
Advisory Board Member
CORD
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
Updated November 8, 2022
Tufts Medical Center's NEWDIGS initiative 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 NEWDIGS 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. NEWDIGS’s initiatives are designed to facilitate “procompetitive” processes.
This Statement provides antitrust guidance to Tufts Medical Center personnel and to the representatives of companies and other institutions who participate in NEWDIGS 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 NEWDIGS activities and reduce the risk of any inadvertent violation of the antitrust laws. NEWDIGS asks all participants in NEWDIGS 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 NEWDIGS 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 NEWDIGS’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 NEWDIGS 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 NEWDIGS'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 NEWDIGS’s work may affect the global marketplace, NEWDIGS 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 NEWDIGS 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 NEWDIGS'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 NEWDIGS’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 Tufts Medical Center participants. All non-Tufts Medical Center 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 NEWDIGS. A more detailed look at this complex area may be found in the United States’ Antitrust Guidelines for Collaborations among Competitors, found here.