Agenda

NIH-FDA Workshop on Advancing Regulatory Science: Second Investigators’ Team Meeting
8:00 – 8:15	Registration
8:15 – 8:20	Orientation, Danilo Tagle, NINDS
8:20 – 8:40	Introductions by Invited Participants (PIs and main project lead/s)
8:40 – 8:50	Welcome Remarks James Anderson, Division of Program Coordination, Planning, and Strategic Initiatives, NIH
8:50 – 9:05	FDA comments on Regulatory Science Initiative and Current Priorities Carlos Pena, Office of the Commissioner, FDA
9:05 – 9:10	Comments on Final Products, Messaging, and Communicating the Info to the Public Kathy L. Kopnisky, NIH Office of Science Policy
Group Presentations:
9:15 – 9:45	Replacement Ocular Battery (ROBatt) Dan Cerven, MB Research Laboratories or George DeGeorge
9:45 – 10:15	Accelerating Drug & Device Evaluation through Innovative Clinical Trial Design William Barsan, University of Michigan Roger Lewis, Harbor-UCLA Medical Center Mike Fetters, University of Michigan
10:15 – 10:30	BREAK
10:30 – 11:00	Characterization/Bioinformatics-modeling of Nanoparticle, Complement Interactions Dennis Hourcade, Washington University
11:00 – 11:30	Heart-Lung Micromachine for Safety and Efficacy Testing Kevin ‘Kit” Parker, Harvard University
11:30 – 11:45	General Discussion - Regulatory Science Initiative, Final Year, Implementation and Adoption of Findings in Regulatory Practice.
11:45 – 2:00	Working Lunch – Breakout Sessions: AGENDA Grantees, NIH & FDA experts associated with each project to discuss technical and administrative challenges, needs, and milestones. Also, begin discussion on the final products of the research project and the means of communicating these advances. Breakout Group 1: Adaptive Clinical Trials Discussion leaders: Naomi Kleitman (NIH); Sue-Jang Wang (FDA) NSC Conference Room A1/A2 Breakout Group 2: Replacement Ocular Battery Discussion leaders: Jerry Wujek (NIH); Suzanne Fitzpatrick (FDA) NSC Conference Room 3288 Breakout Group 3: Nanoparticle Complement Interactions Discussion leaders: Lori Henderson (NIH); Carols Pena (FDA) NSC Conference Room 2220 Breakout Group 4: Heart-Lung Micromachine Discussion leaders: Rosemarie Hunziker (NIH); Brenton McCright (CBER/FDA) and Luqi Pei (CDER/FDA) NSC Conference Room 2120
2:00 – 2:10	BREAK
2:10 – 3:10	Report from Breakout Groups on challenges, needs, milestones (15 minutes each)
3:10 – 3:30	General Discussion on Reports
3:30 – 4:00	Discussion of Final Research Work Products, Talking Points, and Means of Communicating Research Advances
4:00 – 4:15	Summary
4:15	Adjourn