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The third annual

Expanded Access Summit

The global forum on pre-market access to medicines

January 27 – 29, 2020 | National Press Club | Washington, D.C.

January 27 – 29, 2020
National Press Club
Washington, D.C.

The
Science

The
Regulation

The Most Relevant Innovations
The Best Paths Forward

Bringing together world leaders in integrating treatment-use trials into the clinical development of new therapeutics for serious diseases.

January 27-29, 2020
National Press Club
Washington, D.C.

Get on the alert list for the “Industry Best Practices” publication and for Expanded Access 3.0 program updates!

Inclusivity in Clinical Drug Development

2017 FDARA (PDUFA VI) calls for better patient representation in the clinical development process through a combination research trials and expanded access trials.  Join the discussion on optimizing these two channels for engaging more patients.

An Emerging Marketplace for Early Access?

Are we prepared for a marketplace for research-stage medicines? Who pays for exploratory treatment options?  There is demand, a capability to supply, and regulatory systems that accommodate informed choice. 

Get Past the Politics

The Summit is for unbiased, intellectual discussion on how early access works and how it can be put to better use.  Our all-star panelists will cut through the recent noise that has obscured the core issues of feasibility, ethics, and value.

The Real Opportunity for Real World Data

Expanded Access may be the largest source of consented patient outcomes information, from which to inform further research studies, strengthen regulatory claims, and improve provider care decisions.  Learn the history and latest approaches.

Collaborative Access Networks

Can we make Expanded Access more feasible for research centers and clinics?  See the latest innovative partnerships among doctors, health systems, pharmaceutical companies, and granting organizations.

PRECISION MEDICINE AND CLINICAL DISCOVERY

Discoveries gained from Expanded Access programs have given insight to who benefits from a new medicine and who does not.  Join the discussion about new paradigms for discovery and adaptive clinical research.

Featured Speakers

Biography

Michael Kurilla is the director of the Division of Clinical Innovation at NCATS (National Center for Advancing Translational Sciences (NCATS), National Institutes of Health (NIH)). In this capacity, he oversees the Clinical and Translational Science Awards (CTSA) Program, which supports innovative solutions to advance the efficiency, quality and impact of translational science, with the ultimate goal of getting more treatments to more patients more quickly.

Prior to joining NCATS, Kurilla served as the director of the Office of Biodefense Research Resources and Translational Research within the National Institute of Allergy and Infectious Diseases (NIAID), where he focused on translational efforts toward infectious disease product development, including vaccines, therapeutics and diagnostics, with emphasis on biodefense and emerging infectious disease threats.

Prior to joining NIAID in 2003, Kurilla was an associate director for infectious diseases at Wyeth. He also worked in antimicrobials at DuPont and on clinical microbiology and molecular pathology at the University of Virginia Health Sciences Center.

Kurilla received his M.D. and his Ph.D. in microbiology and immunology from Duke University. He was a postdoctoral research fellow at Harvard Medical School and completed a residency in pathology at Brigham and Women’s Hospital. He received a B.S. in chemistry from the California Institute of Technology.

Biography

Marc M. Boutin, JD, is the Chief Executive Officer of the National Health Council. He has been a leading voice for greater patient involvement at every stage of the health care continuum, starting with the development of new drugs, to regulatory oversight of health care delivery, to shared decision-making at the point of care.

Under his leadership, the National Health Council has convened a broad range of stakeholders to create and effectively implement pragmatic strategies and public policy that address diverse issues, such as enhancing patient engagement, advancing the development of new treatments, and developing a better health delivery system to meet the needs of people with chronic conditions.

Boutin has a long history of board and committee service. Currently, he serves as a member of the Patient-Centered Outcomes Research Institute (PCORI) Patient Engagement Advisory Panel, FasterCures Benefit-Risk Advisory Council, and the Medical Device Innovation Consortium (MDIC) Patient-Centered Benefit-Risk Steering Committee.

Boutin has been actively involved in patient advocacy organization management, health advocacy, and both federal and state policy throughout his career. He is a founding member of the international Patient-Focused Medicine Development consortium and has served on the Governing Board of the International Alliance of Patients’ Organizations as a member and treasurer. He is also a former member of the Partnership to Fight Chronic Disease Board of Directors, the Humana Cares Clinical Advisory Board, the eHealth Initiative Leadership Council, Community Health Charities Board of Directors, Healthcare Systems Research Collaboratory, and the North America Advisory Board to the Drug Information Association.

Biography
Janet Woodcock is Director of the Center for Drug Evaluation and Research (CDER), at the Food and Drug Administration (FDA). In 2015, Dr. Woodcock also assumed the role of Acting Director of CDER’s newly formed Office of Pharmaceutical Quality, (OPQ).

Dr. Woodcock first joined CDER in 1994. For three years, from 2005 until 2008, she served FDA’s Commissioner, holding several positions, including as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations, and Chief Operating Officer. Her responsibilities involved oversight of various aspects of scientific and medical regulatory operations.

Before joining CDER, Dr. Woodcock served as Director, Office of Therapeutics Research and Review, and Acting Deputy Director in FDA’s Center for Biologics Evaluation and Research. Dr. Woodcock received her M.D. from Northwestern Medical School and completed further training and held teaching appointments at the Pennsylvania State University and the University of California in San Francisco. She joined FDA in 1986.

Biography

Christopher P. Austin has served as director of the National Center for Advancing Translational Sciences at the National Institutes of Health since 2012. Prior to this role, he was NCATS’ scientific director, focusing on translating basic science discoveries into new treatments and technologies to improve the efficiency of therapeutic/diagnostic development. He founded several initiatives, including the NIH Chemical Genomics Center, the Therapeutics for Rare and Neglected Diseases program, and the Toxicology in the 21st Century program.

Before joining NIH in 2002, he led genomic-based target discovery, pharmacogenomic, and neuropsychiatric drug-development programs at Merck. From 2016 to 2018, he served as chair of the International Rare Disease Research Consortium (IRDiRC); Dr. Austin is also a member of National Academy of Medicine.

He earned an A.B. from Princeton University, an M.D. from Harvard Medical School, and completed training in internal medicine and neurology at Massachusetts General Hospital.

Biography

Anthony S. Fauci, M.D. is director of the National Institute of Allergy and Infectious Diseases (NIAID) at the U.S. National Institutes of Health, where he oversees an extensive research portfolio focused on infectious and immune-mediated diseases. He serves as one of the key advisors to the White House and Department of Health and Human Services on global HIV/AIDS issues, and on initiatives to bolster medical and public health preparedness against emerging infectious disease threats.

He is the winner of numerous prestigious awards including the Presidential Medal of Freedom, the National Medal of Science and the Lasker Award for Public Service.

Biography
Suanna Bruinooge, MPH, is the Division Director of Research Strategy and Operations in ASCO’s Center for Research and Analytics (CENTRA). CENTRA generates, integrates, analyzes, and shares oncology data to foster innovation in research and patient care and help develop and evaluate ASCO’s policy positions. CENTRA develops and implements ASCO’s research agenda, including the Targeted Agent Profiling and Utilization (TAPUR) clinical trial and projects to advance clinical trial design and methodology. CENTRA also staffs ASCO’s Cancer Research Committee, Research Community Forum, and Workforce Advisory Group.

Prior to joining ASCO, Suanna worked for seven and a half years in the U.S. House of Representatives, working for Congresswoman Nancy Johnson (R-CT) and Congressman Vernon Ehlers (R-MI). Ms. Bruinooge earned a Master’s of Public Health in Health Policy at The George Washington University’s Milken Institute School of Public Health in 2015.

Biography
Dr. Marjorie Speers is Executive Director of Clinical Research Pathways (formerly WCG Foundation), a public charity, since 2015. Clinical Research Pathways promotes compassion, inclusion and education in research. Clinical Research Pathways helps physicians and institutional review boards streamline the Food and Drug Administration's expanded access process to make it easier for desperately ill patients to try experimental medicines.

Previously, beginning in 2001, Dr. Speers was the inaugural president and CEO of the Association for the Accreditation of Human Research Protection Programs (AAHRPP) until her retirement in 2013. From 1999-2001, she was the Acting Executive Director of the National Bioethics Advisory Commission, where she oversaw the Commission’s work and report on the oversight system for research involving human participants.

Prior to that, she was the Deputy Associate Director for Science at the Centers for Disease Control and Prevention (CDC) where she oversaw all domestic and international research involving human participants. Dr. Speers was on the faculty at the University of Texas Medical Branch prior to joining CDC. As an epidemiologist, her research focused on risk factors for cardiovascular disease and cancer prevention.

What People Say about the Summit

Conference Location

National Press Club

The Expanded Access Summit will be held at the National Press Club Main Ballroom in the historic National Press Building.

Conference attendees can secure a special rate at the JW Marriott, which is located next to the National Press Building.

You can book online using this link.

If you prefer to book over the phone, please call (800) 393-2503

Join Attendees from world-class
companies and organizations

2017 companies included Pfizer, Takeda, Janssen, Bayer, Eli Lilly, Biogen, Alnylam, Vertex, Bluebird, Amicus, Ultragenyx, AmpliPhi, Wave Life Sciences, Neuralstem, Incyte, Asuragen, Astellas, Tesaro, Ovid, Spectrum, ALS Association, Parent Project Muscular Dystrophy, Kids V Cancer, BIO, FDA, NIH, Patient Advocate Foundation, the FNIH Biomakers Consortium, and more.

Past Attendees by Organization Type

  • Life Science Companies 60% 60%
  • Government & Non-Profits 22% 22%
  • Service Providers 18% 18%

Industry Attendees by Job Function

  • Clinical Development and Research 35% 35%
  • Medical Affairs 31% 31%
  • Central/Executive 18% 18%
  • Regulatory Affairs 16% 16%

OUR CURRENT PARTNERS

We look forward to seeing you in WASHINGTON!

Register now to ensure best price admission and hotel room availability.