Expanded Access 3.0 Agenda
The Expanded Access Summit has a new format! Day 1’s Policy and Practice Workshop leads off with a thorough primer of the space. Day 2 will continue the Expanded Access Summit’s annual discussion on the integration of treatment and research. That evening, guests will enjoy the on-site Grand Reception and hear the latest industry developments at the Innovators Showcase. Day 3 is an interactive forum aimed at delivering modern guidance to industry and policymakers.
WHERE
National Press Club
Washington D.C.
WHEN
Monday through Wednesday
January 27-29, 2020
DOWNLOAD THE AGENDA
Click here to download the EA 3.0 Conference Agenda in PDF form.
Browse sessions by day
* indicates a session moderator
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Monday, Jan. 27 - EVENING (Primer / Workshop)
Day 1 - Evening
6:00PM - 9:00PM
MODULE A: The Pre-Workshop
Global Regulation and Industry Best Practices
6:00 – 6:15PM
Evening Check-in and Networking
- Meet the event directors and speakers
- Hors d’oeuvres, beverages
6:15 - 6:30PM
Why we have pre-market access to medicines: An introduction
PRESENTED BY
Marjorie Speers, PhD Executive Director, Clinical Research Pathways
6:30 – 7:00pm
U.S. Expanded Access Regulation: 30+ years of regulation, plus recent updates including "Right to Try" and Project Facilitate
PRESENTED BY
Richard Klein Former Director, Patient Liaison Program, FDA
Amy Barone, MD Medical Officer, Oncology Center of Excellence, FDA
7:00 – 7:45pm
Global Regulatory Landscapes: Europe, Americas, Asia
PRESENTED BY
David Schwicker, PhD Principal and Founder, ORPHA Strategy Consulting
Connie Coulomb, MBA Managing Partner, Coulomb Strategy Consulting LLC
Georges van Baelen, MScPh Founder and President, Arctiryon, Inc.
7:45 – 7:55pm
Regulatory Q&A Review
PRESENTED BY
All Speakers
7:55– 8:10pm
BREAK
8:10 – 8:35pm
The Range of Uses for Expanded Access: Pharmaceuticals, devices, research-stage, post-research, new-use, new form, etc.
PRESENTED BY
Karen Frascello Director, Global Medical Affairs, Early Access Programs, Alnylam Pharmaceuticals
Kevin Weatherwax Managing Director, Michigan Institute for Clinical and Health Research, University of Michigan Health System
8:35 – 9:00pm
Business Agreements and IRB Coordination with Health Care Providers
PRESENTED BY
Erika Segear, PhD, RAC Associate Director of Regulatory Affairs, Duke University School of Medicine
Chris Beardmore CEO, Anova LLC
9:00PM
Workshop Adjourned
Tuesday, Jan. 28 - MORNING & AFTERNOON
Day 2 - Morning & Afternoon
8:00AM - 5:00PM
MODULE 1: The Global Stakeholder Forum
Integrating Expanded Access into the Clinical Development Process
8:20 – 8:30am
Opening Remarks
PRESENTED BY
Jess Rabourn, CFA Executive Producer, Expanded Access Summit | CEO, WideTrial, Inc.
8:30 – 9:30am
Session 1
Meeting the Original Promise of Expanded Access: How far have we come? Are we on the right track?
PRESENTED BY
Steve Usdin* Senior Editor, BioCentury
Anthony Fauci, MD Director, National Institute of Allergy and Infectious Diseases (NIAID) 1984-Present
Peter Barton Hutt, JD Senior Counsel, Covington & Burling LLP Marjorie Speers, PhD Executive Director, Clinical Research Pathways
9:30 – 10:05am
Session 2
Morning Keynote Address: Smarter, more inclusive drug development
PRESENTED BY
Janet Woodcock, MD Director, Center for Drug Evaluation and Research (CDER), FDA
10:05 – 10:30am
BREAK
10:30 – 11:30am
Session 3
Getting Past the Simple Narratives: Deeper looks at the opportunities, obstacles, politics, and competitive interests surrounding pre-market access
PRESENTED BY
Marc Boutin* Chief Executive Officer, National Health Council
Anne Cropp, PharmD Chief Science Officer, Early Access Care LLC
Jonathan Darrow, S.J.D. Faculty Member, Harvard Medical School
Richard Klein Former Director, Officer of Health and Constituent Affairs, FDA (1990-1997)
Tobias Polak PhD Candidate, Erasmus University
11:30am – 12:30pm
Session 4
Frameworks for Reimbursing Exploratory Treatment for Serious & Life-Threatening Health Conditions: Re-examining “Reasonable and Necessary” care options; coverage with evidence generation
PRESENTED BY
Jess Rabourn, CFA* Executive Producer, Expanded Access Summit | CEO, WideTrial, Inc.
Alexander Natz Secretary General, European Confederation of Pharmaceutical Entrepreneurs (EUCOPE)
Edmund Pezalla, MD, MPH Former National Medical Director and VP, Aetna (2007 – 2016)
Peter Pitts President, Center for Medicine in the Public Interest
12:30 – 1:15pm
Buffet Lunch
1:15 – 1:45pm
Session 5
Afternoon Keynote Address: Clinical discovery through treatment of wider ranges of patients
PRESENTED BY
Chris Austin, MD Director, National Center for Advancing Translational Sciences, NIH
1:45 – 3:00pm
Session 6
The Integration of Treatment and Clinical Research: Informing and strengthening the clinical development of novel regulated products through data-generating treatment programs
PRESENTED BY
Stuart Bell, PhD* Vice President, Real World Evidence, Inceptua Medicines Access
Paul Aliu, PharmD Global Head Medical Governance, Chief Medical Office, Novartis Pharmaceuticals
Amy Barone, MD Medical Officer, Oncology Center of Excellence, FDA
Suanna Bruinooge, MPH Director of Research Strategy, CENTRA, ASCO
Michael Kurilla, MD, PhD Director, Clinical and Translational Science Awards (CTSA) Program, NCATS, NIH
3:00 – 3:10pm
BREAK
3:10 – 4:10pm
Session 7
Health Care Providers and Life Science Companies Partnering for Wider Access: Identifying the beneficiaries of pre-market access, and designing appropriate, sustainable partnerships
PRESENTED BY
Chris Beardmore* CEO, Anova LLC
Georges van Baelen, MScPh Founder and President of Arctiryon, Inc.
Erika Segear, PhD, RAC Associate Director of Regulatory Affairs, Duke University School of Medicine
Kevin Weatherwax Managing Director, Michigan Institute for Clinical and Health Research, University of Michigan Health System
4:10 – 5:00pm
Session 8
Addressing Population Needs: Pre-market access -- including Emergency Use Authorization -- to address supply shortages, underserved markets, contagion preparedness, and national defense
PRESENTED BY
Amar Bhat, PhD* Interim Executive Director, Reagan-Udall Foundation, FDA
John Lagus Managing Director of Business Development, Tanner Pharma Group
Hilary Marston, MD Medical Officer, National Institute of Allergy and Infectious Diseases (NIAID), NIH
Robert Walker, MD Director, Division of Clinical Development, Biomedical Advanced Research and Development Authority (BARDA), HHS
5:00PM
Session Adjourned
Tuesday, Jan. 28 - EVENING
Day 2 - Evening
5:15PM - 8:00PM
The Grand Reception & The Innovators Showcase
5:15 - 8:00PM
THE GRAND RECEPTION
- Gourmet food and beverage
- Exhibitor Galleries and Poster Session
- Music, ping-pong tournament, and additional activities
6:00 - 8:00PM
MODULE B: The Innovators Showcase
Real Solutions Presented by Leaders in the Field
6:00 - 6:30PM
Set 1
- MyTomorrows | Dennis Akkaya, Director of Corporate Development
- Caligor Coghlan | Geoff Fatzinger, Director of Market Access
- Early Access Care | Anne Cropp, PharmD, Chief Scientific Officer
- Tanner Pharma Group | Paul Stanton, Global Commercial Director
6:30 – 6:45pm
BREAK
6:45 – 7:15pm
Set 2
- xCures | Mike Newton, CEO
- WideTrial | Jess Rabourn, CEO
- Anova | Martin Walsh, President and Co-founder
- CISCRP | Behtash Bahador, MSc, Associate Director
7:15 – 7:30pm
BREAK
7:30 – 8:00pm
Set 3
- The Global Guide to Compassionate Use Programs | Sean Turbeville, PhD, Director
- The Accreditation Council for Medical Affairs | William Soliman, PhD, BCMAS, Chairman
- EA, RTT, and Payer Policy | Jacob Hill, Franklin University, Supply Chain Management Program
8:00PM
Showcase Adjourned
Wednesday, Jan. 29 - MORNING & AFTERNOON
Day 3 - Morning & Afternoon
8:30AM - 3:00PM
MODULE 2: The Interactive Forum
Charting the Course for Modern Clinical Development
8:30 – 8:40am
Recap of Day 1
PRESENTED BY
Jess Rabourn, CFA Executive Producer, Expanded Access Summit | CEO, WideTrial, Inc.
8:40 – 9:45am
Session 1
Inclusivity in Clinical Development: Should all patients be provided the option to participate? If so, how? What are the barriers?
PRESENTED BY
Behtash Bahador, MSc* Associate Director, Center for Information and Study on Clinical Research Participation (CISCRP)
Christina Hartman, MPH Senior Director of Advocacy, The Assistance Fund
Naomi Lopez Bauman Director of Healthcare Policy, Goldwater Institute
Andrew Shuman, MD, FACS Chief of Clinical Ethics Services, University of Michigan Medical School
9:45 – 10:00am
BREAK
10:00 – 11:00am
Session 2
Expanded Access for Modern High-cost Therapeutics: New challenges with cutting edge biologics, including cell & gene therapies, nucleotide, and novel antibodies
PRESENTED BY
Khrystal K. Davis, JD* Founder & President of Texas Rare Alliance, Texas Newborn Screening Advisory Committee
Karen Frascello Director, Global Medical Affairs, Early Access Programs, Alnylam Pharmaceuticals
Jeff Leider President, X2, “Let Them Be Little” Foundation
Douglas Sproule, MD Vice President, Spinal Muscular Atrophy Therapeutic Area Head, AveXis
11:00am - 12:00pm
Session 3
Who Should Pay for Pre-Market Treatment Access Programs: If Cost Recovery is key to feasible access programs, then who should the costs be recovered from and under what circumstances?
PRESENTED BY
Marjorie Speers, PhD* Executive Director, Clinical Research Pathways
Marc Boutin Chief Executive Officer, National Health Council
David Farber, JD Senior Partner, King & Spalding
12:00 - 12:15pm
Introduction to the interactive challenge
Behtash Bahador, MSc Associate Director, Center for Information and Study on Clinical Research Participation (CISCRP)
William Hoos, MBA, MS Chief Commercial Officer, xCures
12:15 - 1:15PM
Box Lunch
1:15 - 2:30PM
Session 4
The Interactive Challenge; Breakout and Report
Assigned seating at tables representing model stakeholder organizations. Delegates present findings.
PRESENTED BY
Behtash Bahador, MSc Associate Director, Center for Information and Study on Clinical Research Participation (CISCRP) (Moderator)
William Hoos, MBA, MS Chief Commercial Officer, xCures (Moderator)
2:30 – 3:00pm
Session 5
Policy Recommendations / Resolutions: A moderated roundtable discussion with audience
PRESENTED BY
Steve Usdin Senior Editor, BioCentury
Peter Pitts President, Center for Medicine in the Public Interest
Pat Furlong Founding President and CEO, Parent Project Muscular Dystrophy (PPMD
Paul Aliu, PharmD Global Head Medical Governance, Chief Medical Office, Novartis Pharmaceuticals
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!
Register now to ensure best price admission and hotel room availability.