The Evolution of Biopharmaceutics: Risk Assessment and Clinical Relevance

Agenda Speaker Bios

The U.S. Food and Drug Administration (FDA)- in collaboration with the University of Maryland Center of Excellence in Regulatory Science and Innovation (M-CERSI) hosted a two-day in-person workshop entitled “The Evolution of Biopharmaceutics: Risk Assessment and Clinical Relevance” on Tuesday, April 30 and Wednesday, May 1, 2026.

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 explored 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 centered 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 explored 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.

Day 1 Workshop Details | April 30, 2026

Session 1: Biopharmaceutics Risk Assessment Framework (Video) Session Leads: Dr. Helena Engman and Dr. Hailing Zhang Scope: This foundational session introduces a science- and risk-based framework for linking in vitro dissolution testing to in vivo clinical performance. It highlights the evolution of dissolution from a traditional quality control tool to a predictive, patient-centric measure of bioperformance that can inform regulatory and development decisions. The session will outline the scientific principles connecting API physicochemical properties, formulation factors, and gastrointestinal physiology to drug absorption. It will describe a structured Biopharmaceutics Risk Assessment Framework designed to systematically identify, rank, and mitigate biopharmaceutic risk, and to align the level of supporting evidence with the degree of potential clinical impact. Emerging laboratory and analytical approaches that enhance prediction of in vivo performance will also be discussed. Overall, the session establishes a strategic foundation for integrating predictive dissolution into modern drug product development, regulatory assessment, and lifecycle management to support consistent clinical performance and patient-centric quality standards
8:30 AM – 8:35 AM Welcome & Speaker Introductions	Speaker: Hailing Zhang, PhD Division Director, DPQA XII, OPQA II, OPQ, CDER, FDA	Presentation (PDF)
8:35 AM – 8:55 AM The Evolution of Dissolution Testing: Toward Prediction of In Vivo Performance	Keynote Speaker: Lawrence X. Yu, PhD Director, OPQA II, OPQ, CDER, FDA; Adjunct Professor, Univ. of Michigan	Presentation (PDF)
8:55 AM – 9:15 AM Current Biopharmaceutical Risk Assessment Practices in New Drug Product Development of Solid Oral Dosage Form	Speaker: Filippos Kesisoglou, PhD, FAAPS Scientific Associate VP, Pharmaceutical Sciences, Merck & Co,. Inc.	Presentation (PDF)
9:15 AM – 9:35 AM Underutilized and Recent Laboratory and Data Analysis Approaches to Assess Oral Biopharmaceutics Risk	Speakers: James Polli, PhD Professor and Ralph F. Shangraw/Noxell Endowed Chair in Industrial Pharmacy and Pharmaceutics, University of Maryland School of Pharmacy	Presentation (PDF)
9:35 AM – 9:55 AM Predictive Biopharmaceutics: A Deep Dive into the Risk Assessment Framework	Speaker: Bhagwant Rege, PhD Division Director, DPQA VI, OPQA I, OPQ, CDER, FDA	Presentation (PDF)
9:55 AM – 10:00 AM Session 1 Summary	Speaker: Helena Engman, MSc, PhD Senior Principal Scientist, ADME Sciences, Seda Pharmaceutical Development Services	Presentation (PDF)
10:00 AM – 10:15 AM	Break
Session 2: High Risk Drug Products-IVIVC and IVIVR (Video) Session Leads: Dr. James Polli, Dr. Filippos Kesisoglou, and Dr. Haritha Mandula Scope: This session focuses on products where rate and extent of drug absorption are dictated by in vivo drug release. Discussions will cover mitigation strategies including PK studies to establish IVIVRs, and when possible validated IVIVCs, the development of "Bioequivalence Safe Spaces," and the supplementary role of Physiologically Based Biopharmaceutics Modeling (PBBM).
10:15 AM – 10:20 AM Speaker Introductions	Speaker: Haritha Mandula, PhD Acting Supervisor, DPQA VI, OPQA I, OPQ, CDER, FDA	Presentation (PDF)
10:20 AM – 10:40 AM High-Risk Drug Products and In Vivo Release: Defining the BE Safe Space Through IVIVC/IVIVR Development	Speaker: Rajesh Savkur, PhD Senior Biologist, DPQA VI, OPQA I, OPQ, CDER, FDA	Presentation (PDF)
10:40 AM – 11:00 AM Linking In Vitro Dissolution to In Vivo Performance of Extended-Release Drug Products	Speaker: Yihong Qiu, PhD Chief Technical Director, QPD Solutions	Presentation (PDF)
11:00 AM – 11:20 AM Understanding In Vitro Dissolution and Clinical Performance for High-Risk IR Products	Speaker: Sanjaykumar Patel, PhD Senior Principal Scientist, Merck & Co., Inc.	Presentation (PDF)
11:20 AM – 11:40 AM Development of a Dissolution Control Strategy and BE Safe-Space for a Solid-Dispersion Drug Product	Speaker: David Sperry, PhD Executive Director, Synthetic Molecule Design & Development, Eli Lily
11:40 AM – 11:45 AM Session 2 Summary	Speaker: Haritha Mandula, PhD Acting Supervisor, DPQA VI, OPQA I, OPQ, CDER, FDA	Presentation (PDF)
11:45 AM – 12:45 PM	Lunch Break
Session 3: Medium Risk Drug Products-How to Use Biopharmaceutics Tool to Understand and Mitigate Risk? (Video) Session Leads: Dr. Emilija Fredro-Kumbaradzi, Dr. Duxin Sun, Dr. Hailing Zhang, Dr. Ahmed Zidan Scope: This session addresses products where in vivo dissolution and absorption are governed by drug substance properties and are likely impacted by GI physiological conditions. The focus will be on developing dissolution methods, including biorelevant methods that mimic and may therefore be, indicative of in vivo performance, the potential for these methods to exist separately from QC dissolution methods, and their use in mitigating BA/BE requirements for lifecycle management. Discussions will center on what data and scientific justifications are required to potentially downgrade, rather than just mitigate, the risk from medium to low from a regulatory perspective and therefore, reduce the dissolution testing requirements throughout the product’s lifecycle
12:45 PM – 12:50 PM Speaker Introductions	Speaker: Duxin Sun, PhD Associate Dean for Research, The Charles R. Walgreen Jr. Professor of Pharmacy & Pharmaceutical Sciences, College of Pharmacy, The University of Michigan	Presentation (PDF)
12:50 PM – 1:10 PM The Tale of Truqap Dissolution: The Apex of Science vs. Compliance	Speaker: James Mann, MSci, PhD Principal Scientist, In Vitro Product Performance, AstraZeneca	Presentation (PDF)
1:10 PM – 1:30 PM Capturing Fasting Gastric Motility and pH Variability In Vitro to De-Risk Development of Oral Medicines	Speaker: Dorota Danielak, PhD, dr hab Senior R&D Specialist, Physiolution	Presentation (PDF)
1:30 PM – 1:50 PM Biopharmaceutic Risk Assessment of a Neutral BCS Class IV Drug: A Generic Industry Perspective	Speaker: Emilija Fredro-Kumbaradzi, PhD Director, Biopharmaceutics & Statistics, R&D, Apotex, Inc	Presentation (PDF)
1:50 PM – 2:10 PM Defining and Managing Medium-Risk Drug Products Within the Risk-Based Biopharmaceutics Framework: An FDA Perspective	Speaker: Hailing Zhang, PhD Division Director, DPQA XII, OPQA II, OPQ, CDER, FDA	Presentation (PDF)
2:10 PM – 2:15 PM Session 3 Summary	Speaker: Ahmed Zidan, PhD Senior Pharmacologist, DPQR V, OPQR, OPQ, CDER, FDA	Presentation (PDF)
Breakout Sessions: Framework, High Risk, Medium Risk (Video)
2:15 PM – 2:20 PM	Transition to Breakout Session Rooms
2:20 PM – 2:30 PM Introduction to Breakout Sessions Topic A and B	Breakout Session by Moderators
2:30 PM – 3:30 PM	Breakout Session A: Implementing Biopharmaceutics Risk Assessment Framework: Practical Strategies for Drug Development and Regulatory Decision-Making. Breakout Session B: A Framework for Biopharmaceutics Risk Characterization and Mitigation Strategies for High-Risk Drug Products with Emphasis on Clinical Relevance
3:30 PM – 3:45 PM	Break
3:45 PM – 3:50 PM	Transition to Breakout Session Rooms
3:50 PM – 4:00 PM Introduction to Breakout Sessions Topic C and D	Breakout Session by Moderators
4:00 PM – 5:00 PM	Breakout Session C: What Biopharmaceutics Characteristics Differentiate a Medium Risk Product from a Low or High Risk Product? Breakout Session D: What Would be the Appropriate Control Strategy for Medium Risk Products to Ensure Bioperformance
5:00 PM – 5:15 PM Day 1 Closing Remarks	Speaker: Helena Engman, PhD Senior Principal Scientist, ADME Sciences, Seda Pharmaceutical Development Services	Presentation (PDF)

Day 2 Workshop Details | May 1, 2026

Session 4: Low and Very Low Risk Products-What is Needed and What is Not (Video) Session Leads: Dr. Biljana Jankovic and Dr. Hardikkumar Patel Scope: This session examines products where in vivo dissolution is minimally impacted by formulation variables or GI conditions. For very low-risk products, discussions will explore the potential for waiving dissolution testing for batch release. For low-risk products, the session will cover how simple dissolution tests are sufficient to ensure consistent PK performance and what minimal development data are required.
8:30 AM – 8:45 AM Day 2 Welcome and Day 1 Recap	Speaker: Giuseppe Randazzo, MS Senior VP, Sciences & Regulatory Affairs, Association for Accessible Medicines	Presentation (PDF)
8:45 AM – 8:50 AM Speaker Introductions	Speaker: Carrie Coutant, PhD Senior Director, Lilly Research Labs	Presentation (PDF)
8:50 AM – 9:10 AM The Role of Dissolution in Development of Very Low and Low Risk Compounds	Speaker: Eva Karlsson, PhD Associate Principal Biopharmaceutics, Global Product Development, AstraZeneca	Presentation (PDF)
9:10 AM – 9:30 AM From Solubility Challenges to In Vivo Predictability: Dissolution as a Low Risk Parameter in Oral Suspensions	Speaker: Biljana Janković, PhD Head of Pharmaceutical Research, Sandoz, Slovenia Development Centre	Presentation (PDF)
9:30 AM – 9:50 AM Fundamental Determinants for Justifying Low Biopharmaceutics Risk When Dissolution is Not Critical to Product Performance	Speaker: Tzuchi “Rob” Ju, PhD Director, AbbVie Inc	Presentation (PDF)
9:50 AM – 10:10 AM Risk-Based Release Testing for Low-Risk Products: Disintegration Substitution and Clinically Justified Use of Standard Dissolution Method	Speaker: Hardikkumar Patel, PhD Senior Biopharmaceutics Assessor, DPQA XII, OPQA II, OPQ, CDER, FDA	Presentation (PDF)
10:10 AM – 10:15 AM Session 4 Summary	Speaker: Anitha Govada, PhD Senior Pharmaceutical Quality Assessor, DPQA VI, OPQA I, OPQ, CDER, FDA	Presentation (PDF)
10:15 AM – 10:30 AM	Break
Session 5: The Future of Dissolution - Beyond Quality Control (Video) Session Leads: Dr. James Mann and Dr. Rebecca Moody Scope: This forward-looking session explores the evolution toward predictive, patient-centric standards including Clinically Relevant Dissolution Specifications (CRDS) and the concept of "safe space" dissolution ranges where bioequivalence is assured. Discussions will cover the totality-ofevidence approach, the vision for harmonized global regulatory frameworks where scrutiny is proportional to biopharmaceutical risk, and how enhanced biopharmaceutics understanding represents a strategic investment yielding cost savings and development efficiency.
10:30 AM – 10:35 AM Speaker Introductions	Speaker: James Mann, MSci, PhD Principal Scientist, In Vitro Product Performance, AstraZeneca	Presentation (PDF)
10:35 AM – 11:00 AM Future of Dissolution Testing: Industry Perspective	Speaker: Johannes Moes, PharmD, PhD Scientific Director, Dissolution Sciences, J&J Innovative Medicine	Presentation (PDF)
11:00 AM – 11:15 AM Future of Dissolution Testing: Policy Perspective from FDA	Speaker: Kimberly Raines, PhD Associate Director of Science, OPPQ, OPQ, CDER, FDA	Presentation (PDF)
11:15 AM – 11:25 AM Future of Dissolution Testing: Scientific Perspective from FDA	Speaker: Rebecca Moody, PhD Pharmaceutical Scientist, OPQA II, OPQ, CDER, FDA	Presentation (PDF)
11:25 AM – 11:50 AM From Established to Essential: How TIM Systems are Routinely Replacing In Vivo Assessments in Industry to Manage Biopharmaceutical Risk, and Accelerate Development	Speaker: Robert Schwabe, BS Senior Scientist, Boehringer Ingelheim Pharmaceuticals, Inc.	Presentation (PDF)
11:50 AM – 12:00 PM Session 5 Summary	Speaker: James Mann, MSci, PhD Principal Scientist, In Vitro Product Performance, AstraZeneca
12:00 PM – 1:00 PM	Lunch Break
Breakout Sessions: Low to Very Low Risk, Future
1:00 PM – 1:05 PM	Transition to Breakout Session Rooms
1:05 PM – 1:15 PM Introduction to Breakout Sessions Topic E and F	Breakout Session by Moderators
1:15 PM – 2:15 PM	Breakout Session E: Defining Low- and Very Low-Risk Products in Biopharmaceutics: A Framework Based on Physicochemical and Clinical Evidence Breakout Session F: Strategizing the Future: Implementing Advanced, Risk-Based Control Frameworks
2:15 PM – 2:35 PM	Break
2:35 PM – 2:45 PM Breakout Session 3 Summary	Speaker: Robert Gaines, Jr., PharmD, MBA Senior Director, Sciences and Regulatory Affairs, Association for Accessible Medicines	Presentation (PDF)
2:45 PM – 3:00 PM Closing Remarks	Speaker: CDR Geoffrey Wu,PhD, PMP, CPH Office Director, OPQA I, OPQ, CDER, FDA	Video

Top

Workshop Details: Day 1

Day 1 Workshop Details | April 30, 2026

Session 1: Biopharmaceutics Risk Assessment Framework (Video)

Session 2: High Risk Drug Products-IVIVC and IVIVR (Video)

Session 3: Medium Risk Drug Products-How to Use Biopharmaceutics Tool to Understand and Mitigate Risk? (Video)

Breakout Sessions: Framework, High Risk, Medium Risk (Video)

Workshop Details: Day 2

Day 2 Workshop Details | May 1, 2026

Session 4: Low and Very Low Risk Products-What is Needed and What is Not (Video)

Session 5: The Future of Dissolution - Beyond Quality Control (Video)

Breakout Sessions: Low to Very Low Risk, Future