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:




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




This page last reviewed on May 6, 2014