Date of event
Continuing Education Credits
Course Description
The purpose of the AASLD/EASL HBV Endpoints Conference is to bring together the academic, regulatory, pharmaceutical communities and patients’ advocacy groups to discuss therapeutic endpoints, trial designs appropriate patient populations and safety concerns with regards to novel therapeutic approaches for treatment of chronic hepatitis B and D. The HBV therapeutic field is at a crossroads with many different approaches being considered but numerous regulatory issues, trial design issues and safety issues need to be addressed. This meeting will be unique in that it will bring all the important and relevant parties to the table to discuss these critical issues that will need to be resolved before substantial progress can be made in delivering the next generation of therapeutic agents to affected individuals with chronic hepatitis B and D.
Program Chairs
- Marc G. Ghany, MD, MHSc, FAASLD
- Hannah Lee, MD
- Maria Buti, MD, PhD, FAASLD
- Pietro Lampertico, MD, PhD
Location
Washington Marriott Metro Center
775 12th St NW
Washington, D.C. 20005
USA
To secure your housing, please click here or contact the Washington Marriott Metro Center at (202) 737-2200.
The deadline to secure housing at the discounted group rate is May 6th.
Registration
Registration for the conference is now open! Register Now!
Continuing Education
- Continuing Medical Education (CME): 8.75 AMA PRA Category 1 Credits™
- ABIM MOC points: 8.75 MOC points
Health & Safety Information
AASLD is taking steps to protect the health and safety of all stakeholders participating in the AASLD/EASL Endpoints Conference. This will be happening in a public space and AASLD cannot guarantee that participants will not encounter members of the public who have not been fully vaccinated.
AASLD continues to ask all attendees, guests and AASLD staff to follow all applicable regulations and make informed choices about travel, onsite, and external engagement.
AASLD is monitoring the evolving public health guidance and AASLD will continue to update attendees as new information becomes available. AASLD asks all stakeholders to follow all applicable regulations and make informed choices about their participation in one or both in-person conferences offered.
The AASLD Governing Board has approved a “Vaccination Required” policy for all AASLD/EASL Endpoints Conference attendees, exhibitors and AASLD staff.
For more information, click here.
Travel Note
US residents:
Please review the Real ID Act regarding boarding federally regulated commercial aircrafts. Due to circumstances resulting from the COVID-19 pandemic, the Department of Homeland Security has extended the REAL ID enforcement deadline to May 3, 2023. Depending on your state of residence, you may need to provide a second form of identification at the airport.
International travelers:
Before You Travel to the United States
All non-U.S. citizen, non-U.S. immigrants traveling to the United States by air are required to show proof of being fully vaccinated against COVID-19. Learn more about this requirement.
Before boarding a flight to the United States, you are required to show a negative COVID-19 test result taken no more than 1 day before travel. There is also an option for people who have documented recovery from COVID-19 in the past 90 days. Learn more about these requirements.
All air passengers to the United States will also be required to provide contact information to airlines before boarding flights to the United States. This strengthens a travel process already in place to rapidly identify and contact people in the U.S. who may have been exposed to a communicable disease, such as COVID-19. Access to travelers’ contact information will allow U.S. federal, state, and local health departments, and agencies to share appropriate health and public health information necessary to help keep the public safe.
As a reminder, be sure to have your required documents, such as your passport and any visa or other entry/residency documentation. All Visa Waiver Program travelers must have a valid, approved Electronic System for Travel Authorization (ESTA) for travel to the United States. The United States Government recommends travelers log in and review their ESTA status in advance of travel. Visit https://esta.cbp.dhs.govexternal icon for more information.
Registration Pricing
Member - $450
Non-Member - $670
Any physician, scientist, or researcher with doctoral-level training who is not employed by Industry (pharma/device/etc.)
Trainee & Associate Member - $220
Trainee & Associate Non-Member - $275
Any physician, scientist or researcher in a training program as certified by the director of their training program. This category also includes, but is not limited to, the degrees of MS, NP, PA, RN, and other related or comparable degrees.
Student Member - $110
Student Non-Member - $135
Industry - $920
Any Industry (pharma/device/etc.) employee with or without medical training.
Patient Advocates: $25
Patients & Caregivers: $25
Registration scholarships are available by request for the Patient Advocates and Patients Caregivers categories. Please contact Michael Providence at mprovidence@aasld.org for further details.
Registration Cancellation Policy
Requests for cancellations must be submitted in writing to meetings@aasld.org.
Cancellations received by Monday, May 2, 2022 will be refunded in full.
Cancellations received between May 3 – May 18, 2022 will be subject to a $50.00 cancellation fee.
Cancellations received on or after May 19, 2022 are not eligible for a refund.
Credits Offered
Continuing Medical Education (CME): 8.75 AMA PRA Category 1 Credits™
ABIM Maintenance of Certification (MOC): 8.75 ABIM MOC Points
Accreditation and Designation Statements
Continuing Medical Education (CME)
The American Association for the Study of Liver Diseases (AASLD) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians. AASLD designates this live activity for a maximum of 8.75 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.
American Board of Internal Medicine Maintenance of Certification (MOC)
Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 8.75 MOC points in the American Board of Internal Medicine’s (ABIM) Maintenance of Certification (MOC) program. Participants will earn MOC points equivalent to the amount of CME credits claimed for the activity. It is the CME activity provider’s responsibility to submit participant completion information to ACCME for the purpose of granting ABIM MOC points.
Claiming CME Credits and ABIM MOC Points
CME Credits
Physicians and other health care professionals seeking AMA PRA Category 1 Credits™ for this live continuing medical education activity must complete an evaluation by Friday, July 15, 2022. A link to the CME evaluation will be emailed to attendees after the meeting.
MOC Points
Physicians seeking ABIM MOC points must complete the CME and MOC evaluation by Friday, July 15, 2022. Requests for MOC after this date will not be honored. The MOC evaluation is included in the CME evaluation.
MOC Points will be reported to the ABIM by the end of July 2022 for attendees who successfully complete the MOC evaluation.
COURSE DESCRIPTION/Needs Statement
The HBV therapeutic field is at a crossroads with many different approaches being considered but numerous regulatory issues, trial design issues and safety issues need to be addressed. This meeting will be unique in that it will bring the academic, regulatory, pharmaceutical communities and patients’ advocacy groups to discuss therapeutic endpoints, trial designs appropriate patient populations and safety concerns with regards to novel therapeutic approaches for treatment of chronic hepatitis B and D. These discussions of critical issues will be addressed and resolved before substantial progress can be made in delivering the next generation of therapeutic agents to affected individuals with chronic hepatitis B and D.
Learning Objectives
Upon completion of this activity, learners will be able to:
- To understand how ongoing and completed clinical studies may inform future clinical trial design and endpoints of therapy in development for chronic hepatitis B and D
- To understand the role of currently available biomarkers as surrogates of treatment response and clinical outcome and identify new monitoring tools for chronic hepatitis B and D
- Design appropriate phase II-III clinical trials with clinically relevant endpoints for chronic hepatitis B and D
- Evaluate unique safety concerns and appropriate stopping rules of clinical trials using novel, high risk approaches to therapy of patients with chronic hepatitis B and D
Target Audience
- Hepatologists
- Gastroenterologists
- Nurses
- Nurse Practitioners
- Pharmacists
- Physician Assistants
- Fellows/Trainees
- Drug Regulators
- Pharmaceutical Drug Developers
This activity was planned in the context of the following ACGME/IOM/IPEC competencies:
Patient Care and Procedural Skills, Medical Knowledge, Provide Patient-centered Care, Employ Evidence-based Practice, Interprofessional Communication, and Teams and Teamwork.
Friday, June 3, 2022
Session I: Current Treatment Landscape for HBV and HDV
ModeratorS: Harry L. A. Janssen, MD, PhD, FAASLD and TBD
- 7 am – 8 am
Breakfast - 7:55 am – 8 am
Welcome and Introductions
8 am – 8:20 am - Achieving the “Holy Grail”: The Quest for HBV and HDV Elimination
Hannah Lee, MD - 8:20 am – 8:40 am
Pros and Cons of Current Therapies for HBV
Geoffrey M. Dusheiko, MD - 8:40 am – 9 am
Pros and Cons of Stopping Therapy Before HBsAg Loss
Harry L. A. Janssen, MD, PhD, FAASLD - 9 am – 9:20 am
Pros and Cons of Current Therapy for HDV
Pietro Lampertico, MD, PhD - 9:20 am – 9:40 am
Current Therapies for HBV and HDV: The Patient Perspective
Marko Korenjak, MD - 9:40 am – 10:10 am
Panel Discussion - 10:10 am – 10:30 am
Break
Friday, June 3, 2022
Session II: Treatment Endpoints and Biomarkers
ModeratorS: Marc G. Ghany, MD, MHSc, FAASLD and Thomas Berg, MD, FAASLD
- 10:30 am – 10:50 am
What is the Optimal Treatment Endpoint for Hepatitis B?
Marc G. Ghany, MD, MHSc, FAASLD - 10:50 am – 11:10 am Biomarkers as Surrogates for Treatment Response and Clinical Outcome for Hepatitis B
Thomas Berg, MD, FAASLD - 11:10 am – 11:30 am
What’s Missing from our Monitoring Toolbox for Hepatitis B?
Markus Cornberg, MD - 11:30 am – 11:50 am
What is the Optimal Treatment Endpoint for Hepatitis D?
Francesco Negro, MD - 11:50 am – 12:10 pm
Optimization of HDV Biomarkers
Maurizia R. Brunetto, MD - 12:10 pm – 12:45 pm
Panel Discussion - 12:45 pm – 2 pm
Lunch
Friday, June 3, 2022
Session III: Lessons Learned from Studies with Novel Therapies
ModeratorS: Maria Buti, MD, PhD, FAASLD and TBD
- 2 pm – 2:20 pm
Targeting HBV Replication
T. Jake Liang, MD, FAASLD - 2:20 pm – 2:40 pm
Targeting HBV Antigenemia
Jorg Petersen, MD - 2:40 pm – 3 pm
Targeting Delta Hepatitis
Maria Buti, MD, PhD, FAASLD - 3 pm – 3:20 pm
Targeting cccDNA for HBV and HDV
Maura Dandri, PhD - 3:20 pm – 3:50 pm
Panel Discussion - 3:50 pm – 4:10 pm
Break
Friday, June 3, 2022
Session IV: Lessons Learned from Studies with Immunomodulatory and Combination Therapy for HBV
ModeratorS: Pietro Lampertico, MD, PhD and Anna S. Lok, MD, FAASLD
- 4:10 pm – 4:30 pm
Targeting Innate Immunity
Kyong-Mi Chang, MD, FAASLD - 4:30 pm – 4:50 pm
Targeting Adaptive Immunity
Barbara Rehermann, MD, FAASLD - 4:50 pm – 5:10 pm
Current Combination Strategies
Jordan J. Feld, MD, MPH, FAASLD - 5:10 pm – 5:30 pm
What Might Future Curative Therapy Look Like
Anna S. Lok, MD, FAASLD - 5:30 pm – 6 pm
Panel Discussion
Saturday, June 4, 2022
Session V: Trial Designs: Lessons Learned
ModeratorS: Jorg Petersen, MD and Norah Terrault, MD, MPH, FAASLD
- 7 am – 8 am
Breakfast - 8 am – 8:20 am
Lessons Learned from Ongoing Studies to Inform Safety Monitoring of Novel Antiviral and Immunomodulatory Therapies
Man-Fung Yuen, MD, PhD, DSc - 8:20 am – 8: 40 am
FDA Perspective on Patient Populations and Phase 3 Endpoints of Novel Therapies
Virginia Sheikh - 8:40 am – 9 am
EMA/CHMP Perspective on Optimal Trial Design for Phase 3 Trials of Novel Antiviral and Immunomodulatory Therapies
Stephanie Buchholz - 9 am – 9:20 am
Utilizing Current Trial Designs to Inform Phase 3 Trial
Norah Terrault, MD, MPH, FAASLD - 9:20 am – 9:40 am
Panel Discussion - 9:40 am – 10:00 am
Break
Saturday, June 4, 2022
Session VI: Drug Development: A Patient Focused Approach
ModeratorS: Hannah Lee, MD and George Papatheodoridis, MD, PhD, FAASLD
- 10 am – 10:20 am
Patient Reported Outcomes in Phase 3 Studies
Zobair M. Younossi, MD, MPH, FAASLD - 10:20 am – 10:40 am
Future Therapies and Treatment Endpoints: The Patient Perspective
Jacki Chen - 10:40 am – 11 am
WHO Lecture on Elimination Pathways and the Global Response
Philippa Easterbrook, MD, FRCP, MPH, DTM&H - 11 am – 11:50 am
Panel Discussion and Q&A with Academia, Pharma and Regulatory agencies - 11:50 am – Noon
Closing Remarks - Noon
Adjourn
Venue
Washington Marriott at Metro Center
775 12th St NW
Washington, DC 20005
Make your Online Reservations
Click here to secure your housing for the Endpoints Conference. The deadline to secure the group rate is May 6th.
Phone: (202) 737-2200
*If you are calling to make a reservation, please let the hotel representative know you are attending the AASLD meeting
Rates
Single/Double $199 per night plus taxes and fees.
Cancellation Policy
All hotel room reservations must be cancelled at least 72 hours prior to arrival in order to avoid a cancellation fee equal to (1) night room and tax.
Airports
• Ronald Reagan Washington National Airport (DCA)
• Washington Dulles International Airport (IAD)
• Baltimore/Washington International Thurgood Marshall Airport (BWI)
Ground Transportation
Shuttle Services
Shuttle services are not available from the DC metro area airports to the Marriott Metro Center.
Taxi
From DCA the taxi fare estimation is $15 -$19, IAD is $85 - $100 and BWI is 100 - $130. All taxi estimations are for one-way fares.
Metro/Subway/Public Transportation
The nearest WMATA metro station is Metro Center (Red, Blue, Orange & Silver Lines) using the G and 12th Street entrance from the metro station.
Parking
Valet parking fee is $54 daily.