Biomarker Validation: A Roadmap from Discovery to the Clinic

Needs Statement

Gastroenterologists, hepatologists, transplant surgeons, internists, advanced practice providers, fellows, residents, and medical students need to receive regular updates on recent advances in the field of Hepatology and Liver Transplantation. The series will highlight new developments in all areas related to liver diseases, changing selection criteria for transplantation, emerging transplantation techniques, and improved immunosuppressive therapies to minimize graft loss and other complications. The series aims to expand the knowledge of learners, promote current clinical and surgical best practices, enhance the quality of hepatology care, improve patient outcomes, and direct future research.

Educational Objectives

At the conclusion of the session, the participants should be able to:

• Recognize practice gaps in liver cancer screening.
• Evaluate candidate biomarkers and their stage of validation.
• Apply appropriate validation before bringing biomarkers to clinical use.

Target Audience

Activity Evaluation

Evaluation by questionnaire will address program content, presentation, and possible bias.

Educational Methods

• Lectures

Accreditation/Credit Designation

Baylor College of Medicine is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education for physicians.

Baylor College of Medicine designates this enduring material activity for a maximum of 1.0 AMA PRA Category 1 Credit™. Physicians should claim only the credit commensurate with the extent of their participation in the activity.

Term of Approval

April 1, 2024 through April 30, 2026. Original release date: April 1, 2024.

Disclosure Policy

Baylor College of Medicine (BCM) is accredited by the Accreditation Council for Continuing Medical Education (ACCME) to provide continuing medical education (CME) for physicians. BCM is committed to sponsoring CE activities that are scientifically based, accurate, current, and objectively presented.

In accordance with the ACCME Standards for Commercial Support, BCM has implemented a mechanism requiring everyone in a position to control the content of an educational activity (i.e., directors, planning committee members, faculty) to disclose any relevant financial relationships with commercial interests (drug/device companies) and manage/resolve any conflicts of interest prior to the activity. Individuals must disclose to participants the existence or non-existence of financial relationships at the time of the activity or within 24 months prior.

In addition, BCM has requested activity faculty/presenters to disclose to participants any unlabeled use or investigational use of pharmaceutical/device products; to use scientific or generic names (not trade names) in referring to products; and, if necessary to use a trade name, to use the names of similar products or those within a class. Faculty/presenters have also been requested to adhere to the ACCME's validation of clinical content statements.

BCM does not view the existence of financial relationships with commercial interests as implying bias or decreasing the value of a presentation. It is up to participants to determine whether the relationships influence the activity faculty with regard to exposition or conclusions. If at any time during this activity you feel that there has been commercial/promotional bias, notify the Activity Director or Activity Coordinator. Please answer the questions about balance and objectivity in the activity evaluation candidly.

All of the relevant financial relationships listed for these individuals have been mitigated.