Science & Research

FDA's 2015 Office of Regulatory Science and Innovation Science Symposium

Photo of panel at ORSI Science Symposium

FDA's Office of Regulatory Science and Innovation (ORSI) held a one-day Science Symposium on April 27, 2015 to highlight research underway in its extramural programs to advance FDA's Regulatory Science Initiative. For web casts of the presentations on leading-edge science being conducted and for speaker biographies see the agenda below.

See the Symposium's Poster Presentations of:

  1. FDA's Centers of Excellence in Regulatory Science & Innovation (CERSI) collaborations
  2. Extramural collaborative research projects funded by Broad Agency Announcements (BAA)
  3. FDA Intramural cross-agency research programs
  4. FDA’s Technology Transfer Program

For biographies of the ORSI Science Symposium speakers see the Symposium's Speaker Information.

Speaker Topic Presentation Start Time

Stephen M. Ostroff, M.D.

FDA Acting Commissioner Dr. Stephen Ostroff, Opening Remarks 1:10
Carol Linden, Ph.D. Opening Remarks of Director, Dr. Carol Linden, Office of Regulatory Science & Innovation 14:00
Frank Weichold, M.D., Ph.D. Opening Remarks, Director, Critical Path and Regulatory Science Initiatives Dr. Frank Weichold 17:40
Taha Kass-Hout, M.D. Update on ‘openFDA’, Chief Health Informatics Officer Dr. Taha Kass-Hout 19:25
Centers of Excellence in Regulatory Science and Innovation (CERSI) Presentations 33:50
University of Maryland CERSI Presentations 34:50
William E. Bentley, Ph.D. Science That Speeds Health Innovation 35:15
Yu Chen, Ph.D. 3D Printed Biomimetic Phantoms for Assessment of Biophotoinics Imaging Systems 46:05
Bruce Yu, Ph.D. Noninvasive Detection of Protein Aggregation using Water Proton NMR 55:20
Johns Hopkins University CERSI Presentations 01:11:35
G. Caleb Alexander Regulatory Science and Innovation: Optimizing the Evidentiary Basis for Decision-Making at FDA 01:11:50
John F. P. Bridges, Ph.D. Partnership to Advance Stated-Preferences Methods in Regulatory Science 01:21:24
Georgetown Unviersity CERSI Presentation 00:00
Ira Shoulson, M.D. Overcoming Challenges to Medical Product Innovation 00:00
Peter McGarvey, Ph.D. Genetics of Vaccine Safety signal Detection Supporting FDA's Data Mission Through Informatics 09:36
University of California at San Francisco/Stanford University CERSI Presentations 33:00
Russ B. Altman, M.D., Ph.D. Innovative Regulatory Science on the West Coast 34:50
Kathy M. Giacomini, Ph.D. Renal Impairment in New Drug Development 43:30
Nigam H. Shah, M.B.B.S., Ph.D. Improving ADR Signal Detection by Combining Signals from Spontaneous Reports and Electronic Helath Records 53:40
Talent Competition Agenda Regulatory Science Student Competition Winner Presentations 00:00
ORSI Initiatives Panel Discussion
FDA Product Center Representatives and Audience Discuss Value and Future of ORSI Programs and Initiatives
Broad Agency Announcement (BAA) Research Contract Program Presentations
William Murray, CEO MDIC: Patient-Centered Benefit/Risk Assessment: Developing a Useful Methodology for Integrating Patient-Centerd Perspectives into Regulatory Decisions 03:30
Dr. John Brownstein Epidemico - Social Media Listening for Adverse Event Surveillance 15:27
Dr. Gary Hill Manila Consulting: The National Medical Device Curriculum: Supporting Innovation by Enhancing Academic Regulatory Knowledge 33:33
Dr. Joseph Pergolizzi Jr., COO NEMA Research Inc: Nurse Pain Educator Pilot Program (NPE): A Method for Improving Communication About Pain Treatment 41:56
Dr. Garry Nolan Stanford University: Cross-Species Immune System Reference (Human Immune Atlas) 55:20
Chief Scientist Intramural Grant Annual Presentations 00:00
Rapid & Sensitive Detection of Crutzfeldt-Jakob Disease Agents in Tissue and Blood Donations 1:55
Lauren Jackson, Ph.D. Optimal Allergen Biomarkers for Effective Assays and Labeling: A Collaborative Project between FDA, IFSH and General Mills 18:48
Qiang Shi, Ph.D. Urine microRNAs as Novel Biomarkers for Acute Liver Failure Patients 41:06
CORES Scientific Intramural Grant Presentations 01:01:26
Peng Zou, Ph.D. Physiologically Based Pharmacokinetic (PBPK) Modeling of Nanomedicine: Building Clinically Relevant Standards for FDA-Regulated Nanoparticulate Drug 01:02:00
Julian Leakey, Ph.D. Complement Assays for Detection of Immune-Sensitizing Activity of Nanomaterials 01:20:24
Closing Remarks 1:39:14

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