The Evolution of Biopharmaceutics: Risk Assessment and Clinical Relevance
This workshop is sponsored by the University of Maryland Center for Excellence in Regulatory Science and Innovation (M-CERSI) and the Food and Drug Administration (FDA).
Workshop Dates: April 30 - May 1, 2026
| Event Information | |
|---|---|
| Date: | April 30- May 1, 2026 |
| Time: | 8:30 a.m. - 5 p.m. |
| Location: | Universities at Shady Grove (Rockville, Md.), Building II |
About the Event
This two-day public workshop represents a transformative approach towards the role of dissolution testing in regulatory decision making, moving beyond traditional quality control paradigms toward a predictive, patient-centric science. The workshop will explore the importance of dissolution testing and its shift from a quality control test to strategic tool that ensures adequate clinical performance throughout changes in the drug product’s lifecycle.
The workshop centers on a comprehensive risk assessment framework that examines the interplay between API physicochemical properties, drug product attributes, and gastrointestinal physiological conditions. This framework ranks drug products from very low to very high risk based on how material attributes and formulation and manufacturing variables, along with gastrointestinal physiological conditions, influence in vivo drug dissolution and absorption into the systemic circulation. In this context, the risk level determines the appropriate dissolution testing strategy and regulatory requirements.
Participants will explore how this paradigm shift can improve product understanding, reduce regulatory burden, and assure consistent clinical performance of moderate- to high-risk drug products by aligning dissolution testing with actual patient outcomes rather than arbitrary specifications or process capabilities.
Agenda - The Evolution of Biopharmaceutics
Speaker Bios: The Evolution of Biopharmaceutics
Videos
- Video - Session 1, Day 1: Biopharmaceutics Risk Assessment Framework
- Video - Session 2, Day 1: High Risk Drug Products-IVIVC and IVIVR
- Video - Session 3, Day 1: Medium Risk Drug Products-How to Use Biopharmaceutics Tool to Understand and Mitigate Risk
- Video - Session 4, Day 2: Low and Very Low Risk Products-What is Needed and What is Not
- Video - Session 5, Day 2: The Future of Dissolution - Beyond Quality Control
- Video - Breakout Session 3 Summary, Day 2: Low to Very Low Risk, Future
- Video - Closing Remarks for Workshop, Day 2
Presentations - Day 1
Welcome-Evolution of Biopharmaceutics: Risk Assessment and Clinical Relevance
L. Yu-Evolution of Dissolution Testing: Toward Prediction of In Vivo Performance
Kesisoglou-Biopharmaceutics Risk Assessment in Product Development
Polli-Underutilized and recent laboratory and data analysis approaches
Rege-Predictive Biopharmaceutics: A Deep Dive into the Risk Assessment Framework
Engman-The Evolution of Biopharmaceutics: Risk Assessment and Clinical Relevance
Savkur-High-Risk Drug Products and In Vivo Release: Defining the BE Safe Space
Qiu-Linking In Vitro Dissolution to In Vivo Performance of Extended Release
Patel-Understanding In Vitro Dissolution and Clinical Performance for High-Risk
Session 3 Speaker Introductions
Mann-The Tale of Truqap Dissolution: The Apex of Science vs Compliance
Danielak-Capturing Fasting Gastric Motility and pH Variability In Vitro
Fredro-Kumbaradzi-Biopharmaceutic Risk Assessment of a Neutral BCS Class IV Drug
Zhang-Defining and Managing Medium-Risk Drug Products Within the Risk-Based Bio
Ahmed_Zidan-Using Biopharmaceutics Tools to Understand, Manage and Mitigate Risk
Engman-Concluding Remarks Day 1
Presentations - Day 2
Randazzo-Evolution of Biopharmaceutics Day 2
Karlsson-The role of dissolution in dev of very low and low risk compounds
Jankovic-From Solubility to In-Vivo Predictability
Ju-Fundamental Determinants for Justifying Low & Very Low Biopharmaceutics Risk
H Patel-Risk-Based Release Testing for Low-Risk Products
Govada-Summary of Session 4 Low-Risk and Very Low Risk Products
Session 5 Speaker Introductions
Moes-The Future of Dissolution - An Industry Perspective
Raines-Future of Dissolution Testing-FDA Policy Perspective
Moody-From Policy Direction to Evidence Path
Schwabe-How TIM Systems are routinely replacing in-vivo assessments in industry
Gaines-Evolution of Biopharmaceutics Day 2 Recap
Funding Statement
This workshop is supported by the Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services (HHS) as part of a financial assistance award to the Center of Excellence in Regulatory Science and Innovation, U01FD005946 totaling $5,000 funded by FDA/HHS. The contents are those of the author(s) and do not necessarily represent the official views of, nor an endorsement, by FDA/HHS, or the U.S. government.