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Tuesday, May 07, 2019 - 8:00 am to Wednesday, May 08, 2019 - 3:30 pm
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Course Description / Needs Statement

There are growing challenges to accurately predict drug-induced liver injury (DILI) risk tied to evolving immunotherapies and in patients with underlying chronic liver disease. This international academic-industry-government conference sponsored by the FDA and AASLD, will hear expert presentations on new treatments with hepatotoxic liability and discuss study populations of growing concern as well as many state-of-the-art scientific tools and methods that are now becoming available for the assessment of DILI risk. There will also be a robust exchange of ideas and debate towards establishing consensus among participants in the meeting as a prelude for a planned comprehensive revision of the seminal FDA guidance on the pre-marketing evaluation of DILI, issued 10 years ago.

Program Chairs

  • Mark I. Avigan, MD, CM
  • Robert J. Fontana, MD, FAASLD

Co-Organizers

  • Arie Regev, MD
  • Paul B. Watkins, MD, FAASLD
  • Frank A. Anania, MD, FAASLD
  • Gyongyi Szabo, MD, PhD, FAASLD

Location

  • College Park Marriott Hotel and Convention Center
    3501 University Blvd E
    Hyattsville, MD 20783
    Phone: 301-985-7300

Poster Abstract Submission

The abstract submission period closed Monday, April 1.

Continuing Medical Education

  • CME – 11.75 AMA PRA Category 1 Credits™

Travel Note

US residents: Please review the Real ID Act regarding boarding federally regulated commercial aircrafts. Depending on your state of residence, you may need to provide a second form of identification at the airport.

Schedule Note

Breakfast is served at 7 am ET both days.

Registration Pricing Early Bird: On or Before April 9

  • Member $325
  • Trainee & Assoc. Members $185
  • Non-Member $540
    Any physician, scientist, or researcher with doctoral-level training
    who is not employed by Industry (pharma/device/etc.)
  • Trainee & Assoc. Non-Member $235
    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.
  • Industry $775
    Any Industry (pharma/device/etc.) employee with or without medical training.
  • Student $90
  • Student Non-Member $115
  • Government $270
    (Lunch fees are not included)

Registration Pricing: On or After April 10

  • Member $425
  • Trainee & Assoc. Members $210
  • Non-Member $640
    Any physician, scientist, or researcher with doctoral-level training
    who is not employed by Industry (pharma/device/etc.)
  • Trainee & Assoc. Non-Member $260
    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.
  • Industry $875
    Any Industry (pharma/device/etc.) employee with or without medical training.
  • Student $105
  • Student Non-Member $130
  • Government $370
    (Lunch fees are not included)

Registration Cancellation Policy

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

Cancellations received on or before April 9, 2019 will be eligible for a full refund.

Cancellations received between April 10 – April 23, 2019 will be subject to a $50.00 cancellation fee.

Cancellations received on or after April 24, 2019 are not eligible for a refund.

Tuesday, May 7 -- Session I

Session I: Treatment of Liver Diseases: A) When Does DILI Get in the Way? B) Analysis of Hepatotoxicity Connected to Drugs Cleared by the Liver
Moderators: Arun J. Sanyal, MD, FAASLD and Frank A. Anania, MD, FAASLD

  • 8:00 am – 8:10 am
    Meeting Introduction and Reflections on Key Challenges
    Mark I. Avigan, MD, CM and Robert J. Fontana, MD, FAASLD
  • 8:10 am – 8:30 am
    Drug Development in Patients with Liver Disease: What Populations Are of Concern?
    Lara L. Dimick-Santos, MD
  • 8:30 am – 8:50 am
    Which Liver Diseases May Predispose to Hepatotoxicity: The NIH Experience
    Jay H. Hoofnagle, MD, FAASLD
  • 8:50 am – 9:10 am
    Blood and Liver Cell PK & PD Measures in the Treatment of Liver Disease: Do They Inform Dosing?
    Insook Kim, PhD
  • 9:10 am – 9:30 am
    Altered Hepatic Transporters in Liver Disease: Are These a Prelude to DILI?
    Kim L.R. Brouwer, PharmD, PhD
  • 9:30 am – 9:50 am
    When Can Complications of Underlying Liver Disease Become Confused with DILI?
    Arun J. Sanyal, MD, FAASLD
  • 9:50 am – 10:10 am
    Panel Discussion
  • 10:10 am – 10:30 am
    Break

Tuesday, May 7 -- Session II

Session II: Tools for Pre-marketing Assessment of DILI Liability: What Do We Need?
Moderators: Paul B. Watkins, MD, FAASLD and Gyongyi Szabo, MD, PhD, FAASLD

  • 10:30 am – 10:50 am
    How Good Are We at Predicting Drugs That Are Hepatotoxic from Chemical Structure?
    Amit S. Kalgutkar, PhD
  • 10:50 am – 11:10 am
    Liver Cell Cocultures: Do These Discriminate Between Toxic and Non-Toxic Drugs?
    Salman Khetani, PhD
  • 11:10 am – 11:30 am
    Assessing Hepatotoxicity Risk Profiles in Drug Discovery: Can New Strategies Improve Lead Optimization?
    William Proctor, PhD, DABT
  • 11:30 am – 11:50 am
    New Markers of ALD From NIH Networks
    Gyongyi Szabo, MD, PhD, FAASLD
  • 11:50 am – 12:10 pm
    In Silico and in Vitro Simulations to Predict Idiosyncratic DILI: What is on the Horizon?
    Brett A. Howell, PhD
  • 12:10 pm – 12:30 pm
    Panel Discussion
  • 12:30 pm – 2:00 pm
    Lunch and Poster Session

Tuesday, May 7 -- Session III

Session III: Immunotherapy and Liver Toxicity: Is this a Growing Challenge?
Moderators: Michael Merz, MD and Jack Uetrecht, MD, PhD

  • 2:00 pm – 2:20 pm
    What is Immunotherapy and What Are its Unintended Hepatotoxic Consequences?
    Amy Rosenberg, MD
  • 2:20 pm – 2:40 pm
    What Animal Models Can We Use to Characterize Risk with New Agents?
    Jack Uetrecht, MD, PhD
  • 2:40 pm – 3:00 pm
    DILI Pathways that Are Immune-Mediated: Are They Overlapping or Drug-Specific?
    Hartmut Jaeschke, PhD, FAASLD
  • 3:00 pm – 3:15 pm
    Break
  • 3:15 pm – 3:45 pm
    Immune-mediated Hepatitis and Clinical Histopathology: What Are We Learning?
    Matthew M. Yeh, MD, PhD
  • 3:45 pm – 4:00 pm
    Are the Molecular Targets Associated with DILI on Immune Cells or Liver Cells?
    Tao Wang, MD
  • 4:00 pm – 4:30 pm
    Panel Discussion
  • 5:00 pm – 6:00 pm
    Reception

Wednesday, May 8 -- Session III continued

Session III Continued: Immunotherapy and Liver Toxicity: Is this a Growing Challenge?
Moderators: Robert J. Fontana, MD, FAASLD and Lorraine Pelosof, MD

  • 8:00 am – 8:20 am
    Emerging Toxicity Profiles in Clinical Trials of Immune Checkpoint Inhibitors?
    Lorraine Pelosof, MD
  • 8:20 am – 8:50 am
    Immune-mediated Hepatitis in a Tertiary Referral Center – Phenotypes and Management
    Robert J. Fontana, MD, FAASLD
  • 8:50 am – 9:15 am
    Debate: Will We Reliably Predict Patient-level Therapeutic and Adverse Responses to Treatment in the Future?
    Moderator: Amy Rosenberg, MD
    Presenter: Elad Sharon, MD, MPH
  • 9:15 am – 9:45 am
    Rebuttal and Panel Discussion
    Jack Uetrecht, PhD
    Hartmut Jaeschke, PhD, FAASLD
    Robert J. Fontana, MD, FAASLD
    Lorraine Pelosof, MD
  • 9:45 am – 10:15 am
    Audience Discussion
  • 10:15 am – 10:30 am
    Coffee Break

Wednesday, May 8 -- Session IV

Session IV: The FDA Guidance on the Premarketing Assessment of DILI: Where Are the Gaps?
Moderators: John R. Senior, MD, FAASLD and James W. Freston, MD, PhD

  • 10:30 am – 10:50 am
    DILI Guidance: Goals, Challenges and Current Status
    Mark I. Avigan, MD, CM
  • 10:50 am – 11:10 am
    Industry Perspectives and Initiatives to Fill Key Gaps in the Guidance
    Arie Regev, MD
  • 11:10 am – 11:30 am
    How Should We Assess Deteriorated Liver Function in DILI Patients with Cirrhosis?
    Patrick S. Kamath, MD
  • 11:30 am – Noon
    Panel Discussion and Questions
  • Noon – 1:00 pm
    Lunch
  • 1:00 pm – 1:10 pm
    Presentation of Outstanding DILI Poster Award
    John R. Senior, MD, FAASLD

Wednesday, May 8 -- Session IV continued

Session IV continued: Further Considerations for Revising the FDA Guidance on DILI
Moderators: Mark I. Avigan, MD, CM and Arie Regev, MD

  • 1:10 pm – 1:30 pm
    Can We Do Better in Collecting Study Subject Data and Graphic Tools for Analysis of DILI?
    Ted Guo, PhD and John R. Senior, MD, FAASLD
  • 1:30 pm – 1:50 pm
    The Value of Collecting Bio-samples in Clinical Trials
    Gerd Achim Kullak-Ublick, MD
  • 1:50 pm – 2:10 pm
    Assessing and Managing DILI Risk in Trials: A Consultant’s Perspective
    Paul B. Watkins, MD, FAASLD
  • 2:10 pm – 2:30 pm
    CDER Perspective: DILI Guidance for New Patient Populations and Drug Classes
    Robert Temple, MD
  • 2:30 pm – 3:10 pm
    Interactive Structured Panel Discussion with Audience Participation
    All Session IV Faculty
  • 3:10 pm – 3:20 pm
    Wrap-Up
    Mark I. Avigan, MD, CM and Robert J. Fontana, MD, FAASLD
  • 3:20 pm
    Adjourn