American College of Clinical Pharmacy
      Search      Cart
         

SCHEDULE

Drug Information PRN Focus Session — 505(b)(2) FDA Pathway Products, Biosimilars, and Pharmacogenomics: Implications for Artificial Intelligence and Drug Information Services

Monday, October 19, 2026 from 1:45 p.m. to 3:15 p.m. MDT at Salt Palace Convention Center - Ballroom H

Available for 1.50 hours of CPE credit
Activity Number: 0217-0000-26-152-L04-P
Activity Type: A Knowledge-Based Activity

The Drug Information PRN presents an engaging session addressing contemporary challenges at the intersection of regulatory pathways, payer dynamics, and emerging technologies in drug information services. Healthcare professionals face unprecedented complexities navigating 505(b)(2) FDA pathway products, biosimilar adoption, pharmacogenomics implementation, and the integration of artificial intelligence into clinical decision-making. This session will equip clinicians with practical strategies to address operational challenges including Healthcare Common Procedure Coding System Codes (HCPCS) coding updates, claim denials, and formulary management while exploring responsible AI implementation in drug information practice. Participants will learn to leverage pharmacogenomics clinical decision support tools, including drug-gene interaction databases and alert systems to optimize medication selection and dosing based on patient-specific gene factors. This session will provide essential ethical knowledge to optimize patient care through evidence-based approaches to these evolving pharmaceutical and technological landscapes across all practice settings.

Learning Objectives

1. Identify operational and regulatory challenges associated with 505(b)(2) FDA pathway products, including HCPCS coding complexities, claim denial patterns, biosimilar distinctions, and formulary and reimbursement implications in health system settings.

2. Describe the current payer landscape for biosimilar adoption, including formulary management approaches, coverage variability across insurance plans, and economic considerations supporting institutional decision-making.

3. Describe Clinical Pharmacogenetics Implementation Consortium (CPIC) and FDA pharmacogenomic guidance for high‑impact drug–gene pairs and its application to medication selection in person‑centered care.

4. Discuss integration of pharmacogenomics clinical decision support tools into clinical workflows to prevent adverse drug reactions and optimize therapeutic outcomes.

5. Discuss artificial intelligence (AI) applications in drug information services, including ethical considerations, implementation barriers, and frameworks for responsible AI adoption while maintaining professional standards and patient safety.

Julie B. Sibbesen, Pharm.D.
Moderator:Julie B. Sibbesen, Pharm.D.
Clinical Pharmacy Specialist, Enterprise Medication Use
Hematology/Oncology and Ambulatory Care Services
West Virginia University (WVU) Medicine
Morgantown, West Virginia

Similar Stories, Different Paths: 505(b)(2) Products Meet Biosimilars

1:45 p.m. to 2:15 p.m.

Beyond the Test Result: Critical Role of Drug Information in Pharmacogenomics

2:15 p.m. to 2:45 p.m.
Amanda Massmann, Pharm.D.
Speaker:Amanda Massmann, Pharm.D.
Lead Clinical Pharmacogenomics Pharmacist
Sanford Health
Assistant Clinical Professor
University of South Dakota Sanford School of Medicine
Sioux Falls, South Dakota
  View Biography

Facilitated Panel Q&A

2:45 p.m. to 3:15 p.m.