Patient and Health Advocacy Summit Agenda

October 30-31, 2019

Wednesday, October 30, 2019

Registration Open
8:00 AM – 4:30 PM 
Salon Foyer

Continental Breakfast
8:00 AM – 9:00 AM
Salon Foyer

Networking Lounge Open
8:00 AM – 3:00 PM
Salon Rooms

BIO One-on-One Partnering 
9:00 AM – 5:00 PM
Gallery Lounge

Opening Remarks
9:15 AM – 9:30 AM 
Gallery Ballroom

Julie Gerberding, MD, MPH, Executive Vice President and Chief Patient Officer, Strategic Communications, Global Public Policy and Population Health, Merck & Co., Inc.

Practices and Principles: Navigating the FDA
9:30 AM – 10:30 AM
Gallery Ballroom

Patients, their caregivers, and patient advocacy organizations engage with the FDA to impact the FDA’s thinking and to influence drug development. This session will address the kind of feedback and engagement the FDA and drug developers are looking for. This panel of patients, patient advocacy organizations, the FDA, and drug developers will discuss recent efforts underway, including the patient-focused drug development initiative, Patient Affairs Staff listening sessions, and PDUFA VII. Learn about opportunities for engagement and hear from patients, caregivers, and patient organizations about their experiences impacting the FDA’s thinking and drug development.

Moderator:

Cartier Esham, PhD, Executive Vice President, Emerging Company Section and Senior Vice
President, Science and Regulatory Affairs

Panelists:

Jeff Allen, PhD, President and CEO, Friends of Cancer Research
Captain Robyn Bent, Director, Patient Focus Drug Development Program, Center for Drug Evaluation and Research (CDER), US Food and Drug Administration (FDA)
Samir Shaikh, MBA, Deputy Director, Patient Affairs Staff, Office of the Commissioner, Office of Clinical Policy and Programs, U.S. Food and Drug Administration (FDA)
Pat Wildman, Vice President, Advocacy and Government Relations, Lupus Foundation of America

Closing the Gap: Partnering to Invest in Areas of Unmet Need
10:30 AM – 11:30 AM
Gallery Ballroom

As the drug development landscape evolves, nonprofit disease foundations are leading the charge to ensure that the patient perspective is integrated throughout the lifecycle of a medical product.  This panel will explore the heart of patient advocacy, how patient-led partnerships can drive therapeutic development particularly in areas of unmet need.  Panelists will share key learnings and best practices as well as obstacles and solutions from collaborations.

Moderator:
Bernie Zeiher, MD, FCCP, FACP, Chief Medical Officer, Medical & Development, Astellas

Panelists:
Alice Bast, Founder and President, Beyond Celiac
Mark Dant, Founder and Volunteer Executive Director, Ryan Foundation; Chairman, Everylife Foundation
Emily Kramer Golinkoff, Co-Founder, Emily’s Entourage
John Bardi, SVP, Market Access, Policy & Government Affairs​, Intra-Cellular Therapies

Lunch
11:30 PM - 12:00 PM
Salon Foyer, Gallery Ballroom

Keynote: 2020 Election: Impact on Patient Access
12:00 PM - 12:45 PM
Gallery Ballroom

This keynote will provide “insider political baseball” on the 2020 election and the various healthcare policy proposals of presidential candidates including Medicare for All. The affordable care act court case and significant state races will also be covered. Attendees will have the opportunity to ask questions during this session.

Speaker:
Amy Walter, National Editor, The Cook Political Report

Moderated and Audience Q&A
12:45 PM– 1:15 PM
Gallery Ballroom

Panelists:
James C. Greenwood, President & Chief Executive Officer, Biotechnology Innovation Organization (BIO)
Amy Walter, National Editor, The Cook Political Report

International Reference Pricing and the Impact on Patient Access and Future Innovation
1:15 PM – 2:30 PM
Gallery Ballroom

The U.S. is the global leader in ensuring patients have access to the newest therapies. As policymakers in Washington D.C. discuss various drug pricing reforms, one idea attracting greater attention would tie drug prices in the U.S. to prices paid in foreign countries. This approach would replace the current market-based system for determining the value of medicines with an approach determined by foreign governments with single-payer health care systems. Under a proposal (H.R. 3) released by Speaker Nancy Pelosi (D-CA), international reference pricing would be imposed on both government programs and the commercial market. The Trump administration has proposed applying international reference pricing to certain drugs reimbursed by Medicare Part B. This panel will explore the impact international reference pricing will have on patient access and innovation.

Moderator:
Kenneth I. Moch, President and Chief Executive Officer, Cognition Therapeutics

Panelists:
Cynthia Bens, Senior Vice President, Personalized Medicine Coalition
Alexander Hardy, MBA, Chief Executive Officer, Genentech
Andrew Spiegel, JD, Executive Director, Global Colon Cancer Association
Erin Trish, PhD, Associate Director, USC Schaeffer Center, Assistant Professor, Department of Pharmaceutical and
Health Economics USC School of Pharmacy

Congressional Keynote
2:30 PM - 3:00 PM
Gallery Ballroom

Speaker:
U.S. Senator Tim Scott (R-SC)

Networking Break 
3:00 PM – 3:30 PM
Salon Foyer

An Overview of Drug Pricing Proposals in Congress and the Administration
3:30 PM - 4:00 PM
Gallery Ballroom

This discussion will review the drug pricing proposals currently in Congress including the Prescription Drug Pricing Reduction Act (PDPRA) and the Lower Drug Costs Now Act of 2019, and the ultimate impact these proposals will have on the healthcare system and patients.

Moderator:
Mike Mattoon, Vice President, Federal Government Relations, Biotechnology Innovation Organization (BIO)

Panelists:
Brett Baker, Senior Advisor, Health Policy, Senate Committee on Finance
Wendell Primus, Senior Health & Budget Policy Advisor, Majority House Leadership, U.S. House of Representatives

Where Do We Go From Here?
4:00 PM - 5:00 PM
Gallery Ballroom

During this session, panelists will provide reactions to the previous panels on the 2020 election, patient access to innovative therapies, and drug pricing proposals in Congress and the administration.  Panelists will outline where there is alignment within the patient advocacy community, how to move forward, and calls to action.

Moderator:
Jeanne Haggerty, Executive Vice President, Government Affairs and External Relations, Biotechnology Innovation Organization (BIO)

Panelists:
Anna Hyde, Vice President of Advocacy and Access, Arthritis Foundation
Andrew Sperling, JD, Director of Legislative and Policy Advocacy, National Alliance on Mental Illness
Carl Schmid, MBA, Deputy Executive Director, The AIDS Institute
Pam Traxel, Senior Vice President, American Cancer Society Cancer Action Network (ACS CAN)

Networking Reception
5:00 PM – 7:00 PM
Salon Rooms/Salon Foyer

THURSDAY, OCTOBER 31, 2019

Registration Open
7:30 AM – 11:45 AM
Salon Foyer

Networking Lounge Open
7:30 AM – 11:45 AM
Salon Rooms

BIO One-on-One Partnering™
7:00 AM – 11:30 AM
Gallery Lounge

Networking Breakfast
7:30 AM – 8:30 AM
Salon Rooms and Foyer

The Art of Storytelling
8:30 AM - 10:00 AM
Gallery Ballroom

This session will explore storytelling methods that empower patients to tell the most meaningful and memorable stories possible.  Examples of successful engagements that have led to advancements in policy or clinical development will be provided.   This will be a discussion of skills and best practices including the science behind why stories can impact when statistics cannot, techniques for preparing patients to meet with legislators and regulators, ways to elevate the use of data among patient advocates, and challenges patients face in speaking publicly and how industry can move beyond asking patients to simply “tell us your story.”   

Moderator:
Gwen Mayes, JD, MMSc, Founder and Chief Concept Officer, GwenCo Health

Panelists:
Dena Battle, Co-founder and President, KCCure
Freda C. Lewis-Hall, MD, DFAPA, Chief Patient Officer and Executive Vice President, Pfizer, Inc.
Paul Hastings, Chief Executive Officer, Nkarta Therapeutics

Value Assessment Frameworks
10:15 AM – 11:30 AM
Gallery Ballroom

How does a patient advocacy group develop the skills needed for health economics—where do you start, where do you go? This panel will discuss how value assessments are used in the US and will provide best practices for patient advocates on how to engage with value assessment frameworks.

Moderator:
Elisabeth M. Oehrlein, PhD, MS, Senior Director, Research and Programs, National Health Council

Panelists:
Catherine Davis Ahmed, VP, Policy and Outreach, The FH Foundation
Annie Kennedy, Senior Vice President, Legislation & Public Policy, Parent Project Muscular Dystrophy
Ashley Valentine, Co-Founder and President, Sick Cells

Summit Adjourns
11:30 AM