Date of event
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Add to Calendar 2021-04-20 09:00:00 2021-04-22 14:00:00 AASLD / FDA DILI Conference AASLD alonzo.tolver@boldrstrategy.com America/New_York public

Course Description / Needs Statement

The AASLD/FDA DILI Conference — Drug-induced Liver Injury: New Developments and Innovations in Patients with Underlying Liver Disease, Cancer or COVID-19 — will connect international academic, industry and government participants who are dedicated to the study of DILI in chronic liver disease and cancer with topics spanning into innovative tools in the assessment of hepatotoxic risk and the growing number of best practice consensus reports by public-private partnerships management of DILI in different study populations. Additionally, the meeting will have planned sessions on the impact of COVID-19 in the evaluation and management of liver disease. With virtual communication tools, the conference will promote interactivity between faculty and the audience by with panel discussions and a live poster session.

Program Chairs

  • Mark I. Avigan, MD, CM, FAASLD
  • Victor J. Navarro, MD, MHCM, FAASLD

Co-organizers

  • Robert J. Fontana, MD, FAASLD
  • Arie Regev, MD, FAASLD
  • Paul H. Hayashi, MD, MPH, FAASLD
  • Lorraine Pelosof, MD
  • Frank A. Anania, MD, FAASLD
  • Paul B. Watkins, MD, FAASLD

Conference Format

The online live-streaming conference will have pre-recorded presentations for viewing along with live elements such as panel discussions, a poster session, and the opportunity to get your faculty questions answered in real time with both Chat and Q&A features available throughout the event.

Poster Abstract Submission

Those interested in drug-induced hepatotoxicity are encouraged to submit poster abstracts for this conference starting Monday, February 1, 2021. To learn more, visit our Abstract Submission and Policies section.

Continuing Education

  • Continuing Medical Education (CME): 14.00 AMA PRA Category 1 Credits™
  • MOC Points: 14.00 ABIM MOC Points

Registration will open Wednesday, March 10, 2021 at 9:00 am ET. Early bird registration pricing ends on or before Tuesday, April 6, 2021 at 11:59 pm ET.

Registration Pricing: Early Bird / Regular

  • Member — $350 / $400
  • Non-Member/Government — $450 / $550
  • Associate Member — $200 / $250
  • Associate Non-Member — $300 / $400
  • Student Member — $100 / $100
  • Student Non-Member — $150 / $150
  • Trainee Member — $200 / $250
  • Trainee Non-Member — $300 / $400
  • Industry — $900 / $1000

Note: Government employees will register under the Non-member category, unless they are AASLD members.

Cancellation Policy

Requests for cancellations must be submitted in writing to meetings@aasld.org.

Cancellations received through April 19, 2021 at 11:59 pm ET are subject to a 20% cancellation fee.

Cancellations received on April 20, 2021 and after are non-refundable.

Session I: Strategies to Identify, Assess and Manage Hepatotoxicity in Clinical Trials for Treatment of CLD
Moderators: Frank A. Anania, MD, FAASLD and Mark I. Avigan, MD, CM, FAASLD

  • 9:00 am – 9:10 am ET
    Welcome and Opening Remarks
    Mark I. Avigan, MD, CM, FAASLD and Victor J. Navarro, MD, MHCM, FAASLD
  • 9:10 am – 9:30 am ET
    The Natural Progression of CLD and DILI Risk: Two Sides of the Same Coin or Two Coins?
    James H. Lewis, MD, FAASLD
  • 9:30 am – 9:50 am ET
    When Does Altered Hepatic Disposition of Drugs in NASH Patients Promote Hepatotoxicity?
    Nathan J. Cherrington, PhD
  • 9:50 am – 10:10 am ET
    Suppressing Bile Acids to Treat CLD: Can We Mitigate Risk for Unintended DILI and Gallstone Formation?
    James L. Boyer, MD, FAASLD
  • 10:10 am – 10:30 am ET
    Panel Discussion
  • 10:30 am – 10:50 am ET
    Break
  • 10:50 am – 11:10 am ET
    What Pathophysiological/Pharmacological Factors Determine Optimal Dosing of a Study Drug in CLD?
    Insook Kim, PhD
  • 11:10 am – 11:30 am ET
    DILI in NASH and PBC Clinical Trials: What Lessons Have We Learned for Patient Enrollment, Monitoring and Dose Interruption
    Naga P. Chalasani, MD, FAASLD
  • 11:30 am – 11:50 am ET
    Non-invasive Quantitative Liver Tests for Disease Activity and Fibrosis: Can They Reliably Guide Optimal Treatment Regimens During the Progression of CLD?
    Gregory T. Everson, MD, FAASLD
  • 11:50 am – 12:10 pm ET
    Non-invasive Imaging, Elastography and Liver Biopsy: How Can These Be Practically Applied to Track Liver Safety in Long-Term Treatment Trials of NASH And PBC?
    Theo Heller, MD, FAASLD
  • 12:10 pm – 12:30 pm ET
    Panel Discussion
  • 12:30 pm – 1:30 pm ET
    Lunch Break

Session II: Liver Injury Scenarios with COVID-19
Moderators: Robert J. Fontana, MD, FAASLD and Mark Russo, MD, FAASLD

  • 1:30 pm – 1:50 pm ET
    Hepatic Manifestations in COVID-19: Implications for Therapeutics and Clinical Trials
    Elizabeth C. Verna, MD, MS
  • 1:50 pm – 2:10 pm ET
    Recent Liver Transplant and Drug Management During COVID-19 Infection
    Alfred Sidney Barritt IV, MD, MSCR
  • 2:10 pm – 2:30 pm ET
    Underlying Chronic Liver Disease Treatment with COVID-19
    Mark W. Russo, MD, MPH, FAASLD
  • 2:30 pm – 3:00 pm ET
    Panel Discussion

Session III: Innovative Tools to Predict and Diagnose DILI
Moderators: William Proctor, PhD and Paul B. Watkins, MD, FAASLD

  • 9:00 am – 9:10 am ET
    Welcome Remarks
    Mark I. Avigan, MD, CM, FAASLD and Victor J. Navarro, MD, MHCM, FAASLD
  • 9:10 am – 9:30 am ET
    Quantitative Systems Modeling: Can it Predict Disease-Related DILI Risk?
    James J. Beaudoin, PhD
  • 9:30 am – 9:50 am ET
    Does the Innate Immune Response to a Drug Impact Risk for Idiosyncratic DILI?
    Jack Uetrecht, PhD
  • 9:50 am – 10:10 am ET
    New DILI Biomarkers: Where Are We?
    Rachel Church, PhD
  • 10:10 am – 10:30 am ET
    Leveraging Stem-cell Derived Liver Organoids to Predict DILI
    Keynote Speaker: Takanori Takebe, MD
  • 10:30 am – 10:50 am ET
    Panel Discussion
  • 10:50 am – 11:10 am ET
    Break

Session IV: Cancer Drugs and Hepatotoxicity
Moderators: K. Rajender Reddy, MD, FAASLD and Lorraine Pelosof, MD

  • 11:10 am – 11:30 am ET
    A Growing Diversity of Anticancer Agents: How Should We Classify Hepatotoxicity?
    K. Rajender Reddy, MD, FAASLD
  • 11:30 am – 11:50 am ET
    CTCAE Grading and Other Approaches to Measure DILI Severity: What Makes Sense?
    Paul B. Watkins, MD, FAASLD
  • 11:50 am – 12:10 pm ET
    The New Anticancer Therapies: What Have We Learned About Their Hepatoxicity?
    Hui-Talia Zhang, MD, PhD
  • 12:10 pm – 12:30 pm ET
    Panel Discussion
  • 12:30 pm – 1:30 pm ET
    Lunch Break
  • 1:30 pm – 1:50 pm ET
    DILI With a Combination of Anti-Cancer Treatments: How Can We Predict Risk?
    Lorraine Pelosof, MD
  • 1:50 pm – 2:10 pm ET
    HBV Reactivation Tied to Cancer Treatments: Lessons Learned
    T. Jake Liang, MD, FAASLD
  • 2:10 pm – 2:30 pm ET
    How Should We Communicate with Patients and Oncologists to Study and Manage DILI Risk?
    Abhilasha Nair, MD
  • 2:30 pm – 2:50 pm ET
    Banking Biospecimens to Study Liver Toxicity: Barriers and Opportunities
    Gerd Achim Kullak-Ublick, MD
  • 2:50 pm – 3:15 pm ET
    Panel Discussion
  • 3:15 pm – 3:30 pm ET
    Break
  • 3:30 pm – 4:30 pm ET
    Poster Session

Session V: Perspectives in the Development of Best Practices for Different DILI Scenarios
Moderators: Victor J. Navarro, MD, MHCM, FAASLD and Arie Regev, MD, FAASLD

  • 9:00 am – 9:10 am ET
    Welcome Remarks
    Mark I. Avigan, MD, CM, FAASLD and Victor J. Navarro, MD, MHCM, FAASLD
  • 9:10 am – 9:30 am ET
    LiverTox: Past, Present and Future
    Jay H. Hoofnagle, MD, FAASLD
  • 9:30 am – 9:50 am ET
    Liver Forum: HBV Treatment and DILI
    Nathaniel A. Brown, MD
  • 9:50 am – 10:10 am ET
    CIOMS DILI Report 2020: Challenges and Rationale
    Mark I. Avigan, MD, CM, FAASLD
  • 10:10 am – 10:30 am ET
    Detection, Characterization and Risk Assessment of DILI in Clinical Trials
    Arie Regev, MD, FAASLD
  • 10:30 am – 10:50 am ET
    Break
  • 10:50 am – 11:10 am ET
    Liver Safety Biomarkers and HDS Hepatotoxicity
    Robert J. Fontana, MD, FAASLD
  • 11:10 am – 11:30 am ET
    Post-market Risk Assessment, Minimization and Communication
    Walter L. Straus, MD
  • 11:30 am – 12:00 pm ET
    Panel Discussion
  • 12:00 pm – 1:00 pm ET
    Lunch Break

Session VI: DILI: One Four Letter Word, Multiple Phenotypes: Case Presentations and Discussion
Moderators: Paul H. Hayashi, MD, MPH, FAASLD and Laurie D. DeLeve, MD, PhD, FAASLD

  • 1:00 pm – 1:20 pm ET
    Causality Assessment: Improvements, Limitations and Keeping Pace with New Phenotypes
    Paul H. Hayashi, MD, MPH, FAASLD
  • 1:20 pm – 1:40 pm ET
    Case 1: Pexidartinib in Clinical Trials: Vanishing Bile Duct Syndrome
    Laurie D. DeLeve, MD, PhD, FAASLD
  • 1:40 pm – 2:00 pm ET
    Case 2: Green Tea Hepatitis
    Victor J. Navarro, MD, MHCM, FAASLD
  • 2:00 pm – 2:20 pm ET
    Case 3: Obeticholic Acid and Liver Failure in Advanced PBC: Chicken or Egg?
    Raj Vuppalanchi, MD, FAASLD
  • 2:20 pm – 2:40 pm ET
    Panel Discussion
  • 2:40 pm – 3:00 pm ET
    Meeting Wrap-up
    Mark I. Avigan, MD, CM, FAASLD and Victor J. Navarro, MD, MHCM, FAASLD

Needs Statement

The conference will connect international academic, industry and government participants who are dedicated to the study of DILI in chronic liver disease and cancer with topics spanning into innovative tools in the assessment of hepatotoxic risk and the growing number of best practice consensus reports by public-private partnerships management of DILI in different study populations. Additionally, the meeting will have planned sessions on the impact of COVID-19 in the evaluation and management of liver disease. With virtual communication tools, the conference will promote interactivity between faculty and the audience by with panel discussions and a live poster session.

Learning Objectives

Upon completion of this activity, learners will be able to:

  • Understand strategies to identify, assess, and manage hepatotoxicity in clinical trials
  • Recognize the presentation of drug induced liver injury in the setting of COVID-19 infection.
  • Apply innovative tools to predict and diagnose DILI, including quantitative modeling, biomarkers, and stem-cell derived liver organoids.
  • Understand the approach to hepatoxicity due to anti-cancer drugs.

Target Audience

  • Hepatologists
  • Gastroenterologists
  • Pharmacists
  • Surgeons
  • Fellows/Trainees
  • Pharmaceutical Developers
  • Pharmaceutical Regulators
  • Governmental Regulators

This activity was planned in the context of the following ACGME/IOM/IPEC competencies:

  • Patient Care and Procedural Skills
  • Medical Knowledge
  • Practice-based Learning and Improvement
  • Professionalism
  • Systems-based Practice
  • Provide Patient-centered Care
  • Work in Interdisciplinary Teams
  • Employ Evidence-based Practice
  • Utilize Informatics
  • Values/Ethics for Interprofessional Practice
  • Teams and Teamwork

Credits Offered

  • CME Hours: 14.00 AMA PRA Category 1 Credits™
  • MOC Points: 14.00 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 14.00 AMA PRA Category 1 Credits™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Successful completion of this CME activity, which includes participation in the evaluation component, enables the participant to earn up to 14.00 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 Saturday, May 15, 2021. The CME evaluation will be available to you upon completion of the on-demand course.

MOC Points
Physicians seeking ABIM MOC points must complete the electronic CME and MOC evaluation by Saturday, May 15, 2021. 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 May 2021 for attendees who successfully complete the MOC evaluation.

Abstract submissions will open soon.

  • Opens: Monday, February 1, 2021
  • Closes: Monday, March 15, 2021

Overview

Abstracts submitted will be reviewed by the Program Chairs for potential virtual poster and/or oral abstract presentation. If selected, the presenting author will be required to accept the invitation to present, register for the conference, and provide current financial disclosure information.

Abstract notification will be sent to presenting authors by late March.

Title
The title should be brief, but long enough to identify the nature of the study. Omit author names and medical degrees and institutional appointments in the title. The maximum for the title character count is 300.

Abstract Body
The body of the abstract needs to include:

  • A background
  • Description of methods
  • Summary of results obtained
  • Statement of conclusion reached

There is a set 3,000 maximum character count for the abstract body.

Attachments
You may include any supporting images/tables. Images and tables are not a part of the overall character count. Accepted files: pdf, jpg, jpeg, png, csv, doc(x), and ppt under 5MB.

Author Types
Only one presenting and corresponding author may be selected – see author definitions below.

  • Co-Author – One of several authors who provided a significant contribution to the abstract.
  • Corresponding Author – This author will receive all notifications regarding the abstract, and will be expected to make any changes requested by the abstract reviewers.
  • Presenting Author – The author who will be presenting the poster at the meeting.

The maximum number of authors on an abstract is 30.

Questions
For questions about the abstract submission process, send an email to abstracts@aasld.org.

Ethics Policy
The initial responsibility for adherence to ethical guidelines lies with the responsible investigators submitting their research findings to AASLD meetings or journals.

  • For reports of research using human subjects, provide assurance that (a) informed consent in writing was obtained from each patient and (b) the study protocol conformed to the ethical guidelines of the 1975 Declaration of Helsinki as reflected in a prior approval by the appropriate institutional review committee. Refer to individual patients by number, not by initials.
  • HEPATOLOGY will only accept papers for review from liver transplant centers that explicitly state that no donor organs were obtained from executed prisoners or other institutionalized persons. Papers without such explicit statements will be returned without review.
  • In studies involving animal experimentation, provide assurance that all animals received humane care according to the criteria outlined in the Guide for the Care and Use of Laboratory Animals [PDF] prepared by the National Academy of Sciences and published by the National Institutes of Health (NIH publication 86-23 revised 1985).

Disclosure Policy
All faculty members (including Program Planners, Program Chairs, Moderators, Panelists, and Presenters) are expected to fully disclose all financial relationships with a commercial interest. By accepting our invitation, you agreed to comply with AASLD's Disclosure Policy and the ACCME Standards for Commercial Support in the planning, development, and presentation of educational activities.

Presentations may be recorded for printed and electronic distribution by AASLD. This includes posting on the eLearning portal LiverLearning®, and any AASLD affiliated websites and printed communications. If a course is selected for recording, presenters will have the ability to accept or decline this policy prior to the meeting.

Off-Label, Investigational Use
When an unlabeled use of a commercial product or an investigational use not yet approved for any purpose is included in the content of the educational activity, you are required to verbally disclose that the product is not labeled for the use under discussion or that the product is still investigational, in accordance with the ACCME standards and the Food and Drug Administration requirements.