Virtual | Virtual

Event Title

BsUFA III Regulatory Science Pilot Program

October 16, 2023

Date:: October 16, 2023
Time:: 8:30 a.m. - 11:30 a.m. ET

Topics & Presentations	Speakers
BsUFA III Regulatory Science Pilot Program
Welcoming Remarks and Introduction.pdf	Darlese Solorzano, MS, MBA Manager BsUFA Regulatory Science Pilot Program Office of Biotechnology Products (OBP) Office of Pharmaceutical Quality (OPQ) Center for Drug Evaluation and Research (CDER) \| FDA
BsUFA III Overview: Putting the BsUFA Regulatory Science Program in Context.pdf	Sarah Yim, MD Director Office of Therapeutic Biologics and Biosimilar Office of New Drugs (OND) CDER \| FDA
Overview and Current Status of the BsUFA III Regulatory Science Program.pdf	Steven Kozlowski, MD Chair BsUFA III Regulatory Science Subcommittee Director OBP \| OPQ \| CDER \| FDA
Awardee Presentations New Frontiers in Immunogenicity Research for Biosimilars in CDER.pdf Real-World Research.pdf Assessment of the performance of the multi-attribute method (MAM) vs conventional QC methods for evaluation of Product Quality Attributes of adalimumab and etanercept.pdf Pharmacodynamic (PD) Biomarkers for Biosimilar Development & Approval.pdf	Susan Kirshner, MSc, PhD Director Division of Biotechnology Review & Research III OBP \| OPQ \| CDER \| FDA Cate Lockhart, PharmD, PhD Executive Director Biologics and Biosimilars Collective Intelligence Consortium Diane McCarthy, PhD Senior Scientific Director Global Biologics U.S. Pharmacopeia Yow-Ming Wang, PhD Associate Director for Biosimilars Office of Clinical Pharmacology (OCP) Office of Translational Sciences (OTS) CDER \| FDA
Q&A and Panel Discussion	Steven Kozlowski, Susan Kirshner, Cate Lockhart, Diane McCarthy, Yow-Ming Wang and Kimberly Maxfield, PhD Scientific Lead BsUFA Regulatory Science Pilot Program Office of Therapeutic Biologics and Biosimilars (OTBB) OND \| CDER \| FDA
Update on BsUFA III Regulatory Science Research Priorities in Roadmap 2.0.pdf	Kimberly Maxfield
Stakeholder Feedback and Discussion	Steven Kozlowski, Kimberly Maxfield, and Darlese Solorzano
Next Steps and Day One Closing Remarks	Steven Kozlowski, Kimberly Maxfield, and Darlese Solorzano

Agenda

Summary of In-Person Roundtable Discussion

Visit CDER Small Business and Industry Assistance Page

About This Event

The U.S. Food and Drug Administration (FDA) is hosting a two-part meeting on October 16 (virtual) and October 26 (in person), 2023.

The meeting agenda includes an overview of the regulatory science pilot program and discussion of the program’s current status as it relates to the BsUFA III commitments. The public component of the meeting on October 16 will also include presentations and panel discussions by FDA staff as well as internal and external awardees conducting research projects under the BsUFA III regulatory science program. In addition, FDA staff will present updates to the BsUFA III regulatory science program research priorities made in response to stakeholder feedback on the research roadmap.

The second day of the meeting will be held in person at the FDA White Oak Campus. During this section of the meeting, invitees will participate in round table discussions focused on progress, feedback, and recommendations to improve regulatory impact of the demonstration projects outlined under the program’s research priorities.

Due to capacity limits, participation in the in-person portion of the meeting will be first come-first served and requires attendance at the webinar component.

Intended Audience

Regulatory science and regulatory affairs professionals working on scientific, public health, or policy issues related to biosimilar biological products or who submit Biologics License Applications under the abbreviated 351(k) licensure pathway
Biosimilar product developers
Researchers working on methodologies to advance biosimilar development
Foreign regulators working in biosimilar and interchangeable product regulation
Pharmacists and clinicians
Patients or patient advocacy groups
Biological product manufacturers
Representatives from consortia or other organizations interested in improving access to biological products

Topics

BsUFA III regulatory science pilot program overview and status
BsUFA III regulatory science pilot program project vignettes
Updates to the BsUFA III regulatory science pilot program research priorities
Stakeholder feedback and discussion on regulatory impact of the BsUFA III regulatory science pilot program, ongoing projects, and updates to the regulatory science roadmap

About This Event

Intended Audience

Topics

FDA Resources