At a glance

8 – 9am
Networking Breakfast
Lobby and Salon I

9 – 10am
Session I
Introductions and Frame the Day
Salon I

10am – 12pm
Session II
Team meetings
—Methods Team: Salon T
—Join IO/Core Protocol: Salon I
—Precision Reimbursement: Salon M
—PR Lipids Pilot Subteam: Salon East

12 – 1pm
Networking Lunch
Lobby and Salon I

1 – 2:30pm
Session III
Team Reports and Group Discussions
Salon I

2:30 – 3:30pm
Session IV
Potential Workstream Discussions
—Fit-For-Purpose Criteria for Predictive Outcomes Models: Salon T
—Integrated Pilot Metrics: Salon M

3:30 – 3:40pm 
Break

3:40 – 5pm
Session V
Workstream Learnings, Wrap-up, and Next Steps
Salon I

Agenda in detail

MORNING SESSIONS (I-II)

After an introduction to the day’s proceedings, small groups will form around working teams from LEAPS who will meet (for the first time face-to-face!) to discuss the following:

Joint Meeting: Immuno-Oncology (Case Study) Team and Core Protocol Team

• Building on the initial Case Study (immune checkpoint inhibitors in metastatic non-small cell lung cancer), begin to populate the Core Protocol framework for the case-specific Predictive Outcomes Platform in the integrated pilot concept.
• Define additional specific inputs (e.g., other teams, other stakeholders, research) required to finalize the Core Protocol
• Finalize plan for afternoon presentation/readout
• Discuss the potential value proposition of the two proposed new workstreams to be discussed in the afternoon sessions.

Methods Team

• Review of progress to date on planning the pilot
• Identify the response variables of interest for the pilot
• List of all ML/statistical models for consideration in the FL pilot
• Define types of FL and logistics, including reliable client-server communications
• Identify the trusted centralized server and its key personnel
• Identify available datasets/computational capabilities for the FL pilot

Precision Reimbursement Team

• Refine the Precision Reimbursement framework, especially for use by the Payment Innovation Roundtable in September
• Begin developing a Precision Reimbursement case study portfolio

Precision Reimbursement/Lipid Management Pilot Team

• Review of progress to date on planning the pilot
• Define resources and buy-in needed to advance three specific components of the pilot design now under consideration
• Assess feasibility in order to inform go/no go decision for the pilot.
• Note: seeking additional expertise in Epidemiology and RWE study designs to explore opportunities for federated learning from a basket of lipid lowering Precision Reimbursement interventions

AFTERNOON SESSIONS (III-V)

After hearing from all of the teams on their progress-to-date and future plans (III), the afternoon will center around exploring two potential new teams that could launch after this Design Lab (IV-V).  Both of these teams would require inputs from all stakeholders as well as the other working teams:

Fit-for-Purpose Criteria for Predictive Outcomes Models
Background: Models generated by the Predictive Outcomes Platform deliver patient outcomes improvements only when accepted by patients, used by providers and reimbursed by payers.  Currently no generally conducted processes exist to determine the extent to which a predictive model is fit-for-purpose for wide deployment.

Background: Models generated by the Predictive Outcomes Platform deliver patient outcomes improvements only when accepted by patients, used by providers and reimbursed by payers. Currently no generally conducted processes exist to determine the extent to which a predictive model is fit-for-purpose for wide deployment.

Proposed Workstream: Develop fit-for-purpose criteria for clinical predictive models, and a process for assessing them, using immuno-oncology checkpoint inhibitor response prediction as the prototype area and health technology assessment cost-simulation as the foundation for process and criteria development.  The health technology assessment foundational framework and tools will include the full range of direct medical and indirect social impacts (e.g., lost employment and work productivity, caregiver, equity and other value elements) emphasizing patient-centric metrics, experiences and journeys.

Integrated Pilot Metrics
Background: The goal of the first case study in the LEAPS integrated pilot concept is to improve our ability to predict which patients with advanced NSCLS will respond to ICIs.  Measuring our success will require consideration of two types of metrics:

• Clinical outcome measures that are acceptable to all key stakeholders, and are technically feasible for predictive modeling
• Impact measures that are meaningful to all stakeholders - that is, the impact of the new system capability (connecting evolving predictive models with innovative, outcome-based payment models) on perceived benefits and risks for each stakeholder.

Proposed Workstream: Apply a modified Delphi consensus process to define outcome and impact metrics that will provide critical input into the Core Protocol for the Predictive Outcomes Platform (the target variable for predictive modeling for all sites in the federated learning network); the outcomes tracking platform for Precision Reimbursement; and the overall evaluation of pilot’s success for the ecosystem.

Benjamin Ackerman
Quantitative Scientist
Flatiron Health

Elizabeth Apgar
Epidemiologist
NEWDIGS        

Azrina Azhar
Program Operations Manager
NEWDIGS

Abbie Ba-Mancini
Head of Patient Value of Access, Hemato—oncology
Takeda Pharmaceuticals

Jane Barlow
Senior Advisor, FoCUS Project
NEWDIGS

Paul Beninger
Associate Professor
Tufts University School of Medicine      

Stella Blackburn
VP, Strategic Operations
IQVIA

Mary Brophy
Director, MAVERIC
VA Boston Healthcare System

Fiona Cai
Undergraduate Researcher
MIT     

Dawn Cardeiro
Director of Precision Medicine
Point32Health

Dasha Cherepanov
Director, Global Evidence and Outcomes, DSI, R&D
Takeda Pharmaceuticals

Michael Ciarametaro
VP, Research
National Pharmaceutical Council

Amita Dasmahapatra
President
AD Health Strategy, LLC

Lucas de Breed
Founder
August Care     

Felipe Dolz
VP, Regulatory Science & Policy
Sanofi    

John Ferguson
Head, Pharmacovigilance Sanofi SC
Sanofi

Ryan Ferguson
Director
VA Cooperative Studies Program Coordinating Center, Boston

Nathanael Fillmore
Associate Director for Machine Learning and Advanced Analytics
MAVERIC
VA Boston Healthcare System

Jamie Foley
Director of Value-Based Innovation
Takeda Oncology         

Diana Frame
Founder
Frame Research LLC

Karen Geary
Senior Consultant, FoCUS Project
NEWDIGS        

Ramon Hernandez Vecino
Global Head RWE Clinical Development
Sanofi  

Gigi Hirsch
Executive Director
MIT Center for Biomedical Innovation
NEWDIGS

Keileen Hopps
Project Manager
NEWDIGS

Nirmal Keshava
VP - Data Science and Innovation
Cerevel Therapeutics 

Fotios Kokkotos
Director of Data Science
NEWDIGS

Smita Kothari
Executive Director Outcomes Research
Merck & Co. Inc.          

Kay Larholt
Retired Director of Research
NEWDIGS        

Peter Loupos
Founder and General Manager
Princeton Healthcare Strategies

Mary McGowan
Chief Medical Officer
The Family Heart Foundation

Tsega Meshesha
Program Manager, FoCUS
NEWDIGS

Kelly D. Myers
Chief Technology Officer
The Family Heart Foundation

Megan O’Brien
Executive Director
Merck & Co., Inc.

Chris Pashos
Member, Board of Directors
Genesis Research

Ron Potts
Chief Medical Officer
6 Degrees Health         

Lauren Ritterhouse
Associate Director, Center for Integrated Diagnostics
Massachusetts General Hospital

Gail Ryan
Director, Pharmaceutical Transformation
Point32Health  

Eric Small
Senior Administrative Assistant
NEWDIGS

Asvin Srinivasan
Head of Product
Onc.AI 

David Strutton
VP CORE Global Pharmaceutical, Outcomes Research
Merck & Co., Inc.         

Katie Torrence
Project Coordinator, FoCUS Project
NEWDIGS        

Ludovic Trinquart
Director, Center for Clinical Trials
Tufts Clinical and Translational Science Institute (CTSI)

Mark Trusheim
Strategic Director
NEWDIGS

Priscilla Velentgas
Global Lead, Safety Evidence for Regulators
IQVIA

Kate Wallis
VP Clinical Innovation
Point32Health  

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.