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

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.