9:30
Welcome 
David Goldston, Director, MIT Washington D.C. Office
Krystyn Van Vliet, PhD, Associate Provost and Professor of Materials Science & Engineering & Biological Engineering, MIT

Opening Remarks
Gigi Hirsch, MD, Executive Director, Center for Biomedical Innovation and Executive Director, NEWDIGS

9:40 Panel Session
Why Are We Here? The Science, Patients and System Readiness for Curative Therapies
This panel will bring together the science, patient and systems perspectives on the advent of durable/curative therapies. Where can the science go from here? How does it impact the hopes, dreams and daily lives of patients and what is the state of operational readiness for the system to deal with this paradigm shift in healthcare.

Moderator:
Janet Lynch Lambert, MBA, CEO, Alliance for Regenerative Medicine (ARM)

Panelists:
Science
Usman “Oz” Azam, MD, President & CEO, Tmunity Therapeutics

Patients
Marc Boutin, JD, CEO, National Health Council
Anish Goel, PhD, Beta-Thalassemia patient

System
Murray Ross, PhD, Vice President, Kaiser Foundation Health Plan and Director of the Kaiser Permanente Institute for Health Policy

10:20
Cell & Gene Therapies Drug Development Pipeline
Colin M. Young, PhD, Director, Drug Development Pipeline Research, MIT FoCUS Project

10:55 Panel Session
Financial Challenges Imposed by Curative Therapies: Real or Imagined
Panelists will react to the previous panel session on the Science, Patient and Systems dynamics as they relate to the advent of cell and gene therapy rollouts and what they meant to the future of healthcare, as well as predications of the drug development pipeline. Panelists will discuss the many challenges beyond price, presented by the durable/curative therapies from each stakeholder perspective.

Moderator:
Steve Usdin, Senior Editor (Washington), Head Policy & Regulation, BioCentury and BioCentury Innovations

Panelists:
Provider
Joseph Alvarnas, MD, Vice President, Government Affairs & Senior Medical Director, Employer Strategy, City of Hope

Patient Advocacy
Tim Brent, Senior Director, Business Development, National Hemophilia Foundation

Self-Insured Employer
Robert Galvin, MD, Operating Partner, Equity Healthcare (former Executive Director, Health Services & Chief Medical Officer, General Electric)

Public Payer
Darin Gordon, President & CEO, Gordon & Associates (former Director, Tennessee Medicaid program-TennCare)

National Payer
TBA

Government/Regulatory
John O’Brien, PharmD, MPH, Senior Advisor for Drug Pricing Reform, Health and Human Services (Invited)

12:10 Lunch

12:35 Keynote Speaker: Senator Bill Cassidy
How medicine is changing, what it means to improved health and why there is a need to create alternative financing mechanisms.

Introduction:
Jonathan Gruber, PhD, Ford Professor of Economics, MIT and Director, Health Care Program, National Bureau of Economic Research.

Keynote:
Senator Bill Cassidy (R) U.S. Senator for Louisiana

1:00 Panel Session
The FoCUS Project: Precision Financing Solutions
Go behind the scenes with this panel on the creation of financing and reimbursement solutions to the myriad of challenges brought by the upfront cost of the durable/curative therapies. Stakeholder representatives will highlight and review the case studies utilized in the development of precision financing ideas.

Moderator:
Mark Trusheim, MSc, Strategic Director, NEWDIGS

Panelists:
FoCUS Project Development & Goals
Edmund Pezalla, MD, MPH, CEO Enlightenment Bio-consulting (former Vice President, National Medical Director, Pharmaceutical Policy and Strategy, Aetna)

Blood Disorders Case study/Performance-based Annuities
Chuck Bucklar, Group Vice President, Commercial Operations, North America, BioMarin Pharmaceutical Inc.

CAR-T Case Study/Milestone-based Rebates
Krishna Komanduri, MD, Kalish Family Chair in Stem Cell Transplantation; Professor of Medicine and Associate Director, Clinical Innovation, Sylvester Comprehensive Cancer Center, University of Miami Miller School of Medicine

Ultra-Orphans Case Study/Orphan Reinsurer Benefit Manager
Mike Ciarametaro, MBA, Vice President Research, National Pharmaceutical Council

1:50 Panel Session
Putting Theory into Practice
This panel will describe the pilots FoCUS is designing, including plans for a Massachusetts pilot on performance-based annuities (PAP), and milestone-based contracts with public payers (MCP3).

Moderator:
Rena Conti, PhD, Associate Professor, Markets, Public Policy, and Law; Associate Research Director, Biopharma and Public Policy, Institute for Health System Innovation and Policy, Boston University Questrom School of Business

Panelists:
PAP
Lovena Chaput, Vice President, Managed Markets & Reimbursement, AveXis
Michael Sherman, MD, Chief Medical Officer, Harvard Pilgrim Health Care

MCP3
John Glasspool- Board Member, DalCore Pharmaceuticals, Senior Advisor, FoCUS Project
Jeff Myers- EVP Strategy and External Relations- CareSource (former president and CEO of Medicaid Health Plans of America (MHPA)

2:30
Identifying Opportunities for Enabling Precision Financing
All precision financing solutions, including those proposed by the FoCUS Consortium, will require improvements to existing financial systems. This panel will explore what those challenges are, how they might be overcome and what you can do to aid in this endeavor.

Moderator:
Gregory Daniel, PhD, MPH, RPh, Deputy Director & Clinical Professor, Fuqua School of Business, Duke Margolis Center for Health Policy, Washington D.C. Office

Panelists:

State Regulatory and Medicaid
Kim Caldwell, RPh, Principal, Texas Star Healthcare Consulting, LLC (former Division Director, Medicare Drug Benefit Group, CMS; Vice President of Pharmacy Professional Affairs & Comprehensive Health, Humana Inc.)

Regulatory
Brian Carey, JD, Partner, Co-Chair, Administrative Law Department, Foley-Hoag LLP

Stop-Loss/Reinsurance
Mehb Khoja, FSA, MAAA, President, Medical Risk Managers Inc. (MRM)

Patient Advocacy
Peter Saltonstall, President and CEO, National Organization for Rare Diseases (NORD)

3:20 Keynote Speaker: Senator Sheldon Whitehouse
The current climate on Capitol Hill around payment reform and opportunities for innovation in pricing arrangements.

Introduction
Mark Trusheim, MSc, Strategic Director, NEWDIGS

Keynote
Senator Sheldon Whitehouse (D), U.S. Senator for Rhode Island

3:40 Wrap Up and Adjourn