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Expanded Access 3.0 Agenda

WHERE

National Press Club
Washington D.C.

WHEN

Monday through Wednesday
January 27-29, 2020

h

DOWNLOAD THE AGENDA

Click here to download the EA 3.0 Conference Agenda in PDF form.

Jump to Session

  Day 1 – Evening
January 27, 2020


SESSION A: The Workshop

Global Regulation and Industry Best Practices

6:00 – 6:30pm

Evening Check-in and Networking
  • Meet the event directors and speakers
  • Hors d’oeuvres, beverages
}

6:30 – 6:40pm

Introduction: Why do we have pre-market access? What are the legal, ethical, and practical underpinnings?

PRESENTED BY

Marjorie Speers, PhD Executive Director, Clinical Research Pathways

}

6:40 – 7:10pm

US Regulation: Project Facilitate and government initiatives to lower barriers

PRESENTED BY

Richard Klein Former Director, Patient Liaison Program, FDA

Amy Barone, MD Medical Officer, Oncology Center of Excellence, FDA

}

7:10 – 7:40pm

Global Regulatory Landscapes, including reimbursement & data capture

PRESENTED BY

David Schwicker, PhD ORPHA Strategy Consulting

7:40 – 8:00pm

BREAK
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8:00 – 8:20pm

Named Patient EAPs and Cohort EAPs: What they’re each for

PRESENTED BY

David Farber Senior Partner, King & Spalding

}

8:20 – 8:40pm

Utilizing the Range of EA Channels: A strategy primer on where and when to undertake pre-market access programs

PRESENTED BY

Kevin Weatherwax Managing Director, Michigan Institute for Clinical and Health Research, University of Michigan Health System

}

8:40 – 9:00pm

Business Agreements with Health Care Providers: Traditional and non-traditional trial sites

PRESENTED BY

Erika Segear, PhD, RAC Associate Director of Regulatory Affairs, Duke University School of Medicine

Chris Beardmore CEO, Anova LLC

Z

9:00PM

Workshop Adjourned

  Day 2 – Morning
January 28, 2020


SESSION 1: The Global Stakeholder Forum

Integrating Expanded Access into the Clinical Development Process

7:30 – 8:15am

Morning Check-in and Networking

  • Meet the exhibitors
  • Hot breakfast

}

8:15 – 8:30am

Opening Remarks

PRESENTED BY

Jess Rabourn, CFA Executive Producer, Expanded Access Summit | CEO, WideTrial, Inc.

}

8:30 – 9:30am

The Founders: Are we meeting the original promise of Expanded Access?

PRESENTED BY

Frank Young, MD, PhD EVP Clinical & Reg Affairs, TissueTech Inc.; Former FDA Commissioner, 1984-1989

Tony Fauci, MD Director, National Institute of Allergy and Infectious Diseases (NIAID) 1984-Present

Stuart Nightingale, MD Consultant on Public Health and Regulatory Affairs, NIH Former FDA Associate Commissioner for Health Affairs

Steve Usdin Senior Editor, BioCentury

}

9:30 – 10:15am

A Smarter, More Inclusive Drug Development Process: FDA Outlook

PRESENTED BY

Janet Woodcock, MD Director, Center for Drug Evaluation and Research (CDER), FDA

10:15 – 10:30am

Break
}

10:30 – 11:30am

Seeing Past the Narratives: Stakeholder leaders examine the politics, misconceptions, and competitive interests that can hold back innovation in this space

PRESENTED BY

Mark Boutin Chief Executive Officer, National Health Council

Jeff Leider President, X2, “Let Them Be Little” Foundation

Marjorie Speers, PhD Executive Director, Clinical Research Pathways

Anne Cropp, PharmD Chief Science Officer, Early Access Care LLC

}

11:30am – 12:30pm

Strategies for Expanded Access Feasibility and Utility: Operational and scientific considerations for meaningful engagement of the intended patient population(s)

PRESENTED BY

Paul Aliu, PharmD Global Head of Medical Governance, Novartis Oncology

Marcel van Kuijck, PhD Vice President, Global Medical Affairs, Ultragenyx

  Day 2 – Afternoon
January 28, 2020


SESSION 1: The Global Stakeholder Forum

Integrating Expanded Access into the Clinical Development Process

12:30 – 1:15pm

BUFFET LUNCH

1:15 – 1:45pm

Lunch Keynote

PRESENTED BY

Chris Austin, MD Director, National Center for Advancing Translational Sciences, NIH

}

1:45 – 3:00pm

Designs for Integrating Treatment and Research: Pragmatic trials and virtual clinical trials under Expanded Access pathways

PRESENTED BY

Sean Khozin, MD, MPH* Founding Director, Information Exchange and Data Transformation (INFORMED), FDA

Suanna Bruinooge, MPH Director of Research Strategy, CENTRA, ASCO

Stuart Bell, PhD Vice President, Real World Evidence, Inceptua Medicines Access

Amy Barone, MD Medical Officer, Oncology Center of Excellence, FDA

*Pending Confirmation

}

3:00 – 4:00pm

HealthCare Delivery Systems as Partners for Access: The symbiosis of stakeholders

PRESENTED BY

Michael Kurilla, MD, PhD Director, Clinical and Translational Science Awards (CTSA) Program, NCATS, NIH

Andrew Shuman, MD, FACS Chief of Clinical Ethics Services, University of Michigan Medical School

Erika Segear, PhD, RACS Associate Director of Regulatory Affairs, Duke University School of Medicine

Jonathan Darrow, JD Faculty Member, Harvard Medical School

}

4:00 – 5:00pm

Frameworks for Cost Recovery: Sustainability at scale & stakeholder economics

PRESENTED BY

Jess Rabourn, CFA CEO, WideTrial Inc.

Peter Pitts President, Center for Medicine in the Public Interest (CMPI)

Alexander Natz Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)

National Director of U.S. HealthCare Delivery System Representative*

*TBA, pending confirmation

Z

5:00pm

Session Adjourned

  Day 2 – Evening
January 28, 2020

5:15 – 8:00pm

THE GRAND RECEPTION
  • Gourmet food and beverage
  • Exhibitor Galleries open
  • Music, ping-pong tournament, and additional activities
SESSION B: The Innovators Showcase

Real Solutions and Service Offerings Presented by Leaders in the Field

}

6:00 – 6:30pm

Set 1

  • Four presenters, schedule TBA
  • 6 minutes each, 1-minute turnaround

6:30 – 6:45pm

Break
}

6:45 – 7:15pm

Set 2
  • Four presenters, schedule TBA
  • 6 minutes each, 1-minute turnaround

7:15 – 7:30pm

Break
}

7:30 – 8:00pm

Set 2
  • Four presenters, schedule TBA
  • 6 minutes each, 1-minute turnaround
Z

8:00pm

SHOWCASE ADJOURNED

  Day 3 – Morning
January 29, 2020


SESSION 2: The Interactive Forum

Charting the Course for Modern Clinical Development

7:30 – 8:15am

Morning Check-in and Networking
  • Exhibitor galleries open
  • Continental breakfast
}

8:15 – 8:30am

Recap of Day 1

PRESENTED BY

Jess Rabourn, CFA Executive Producer, Expanded Access Summit | CEO, WideTrial, Inc.

}

8:30 – 9:30am

Empowering Patients Who Seek Treatment Options

PRESENTED BY

Behtash Bahador Director, Center for Information and Study on Clinical Research Participation (CISCRP)

Kelly Ranallo President, Turner Syndrome Global Alliance; Associate, Rare Diseases, Sanofi

Naomi Lopez Bauman Director of Healthcare Policy, Goldwater Institute

Andrew Shuman, MD, FACS Chief of Clinical Ethics Services, University of Michigan Medical School

}

9:30 – 10:00am

Adding “Big Data” Technology to EA Clinical Outcomes: Computational advancements for getting the most from large sets of secondary outcomes data

PRESENTED BY

Nationally Recognized “Precision Medicine” Expert, to be announced

10:00 – 10:30am

Break
}

10:30am – 12:00pm

Who Should Pay for Exploratory Treatment Access?

PRESENTED BY

Mark Boutin Chief Executive Officer, National Health Council

Jeff Leider President, X2, “Let Them Be Little” Foundation

National Director of Integrated Health Delivery System, to be announced

David Farber, JD Senior Partner, King & Spalding

}

12:00 – 12:15pm

Introduction to the Interactive Strategy Challenge

PRESENTED BY

Behtash Bahador Director, Center for Information and Study on Clinical Research Participation (CISCRP)

  Day 3 – Afternoon
January 29, 2020


SESSION 2: The Interactive Forum

Charting the Course for Modern Clinical Development

12:15 – 1:15pm

Box Lunch
}

1:15 – 2:30pm

Interactive Strategy Challenge: Breakout groups respond to challenge scenario(s)

PRESENTED BY

Behtash Bahador Director, Center for Information and Study on Clinical Research Participation (CISCRP)

Conference Attendees Representing Breakout Groups On-Stage

}

2:30 – 3:00pm

Policy Recommendations / Resolutions: Moderated round-table forum for publishable outcomes of the Summit

PRESENTED BY

Steve Usdin Senior Editor, BioCentury

Peter Pitts President, Center for Medicine in the Public Interest

Marjorie Speers, PhD Executive Director, Clinical Research Pathways

Open Floor for Round-table Input

Z

3:00PM

Expanded Access Summit Adjourned

DOWNLOAD THE AGENDA

Click here to download the EA 3.0 Conference Agenda in PDF form.

We look forward to seeing you in WASHINGTON!

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