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  1. The FDA Science Forum

2017 FDA Science Forum Webcast

FDA White Oak Building 31
Silver Spring, Maryland

May 31, 2017 – Day 1

8:30 – 8:40 AM
Introduction
Bernadette Johnson-Williams, MEd, Senior Advisor for STEM, OCS 
8:40 – 8:50 AM
Welcome by FDA Acting Chief Scientist, Luciana Borio, MD
8:50 – 9:05 AM
Remarks, Introduction of Keynote Speaker by FDA Commissioner, Scott Gottlieb, MDdisclaimer icon
9:05 - 9:45 AM
Frontiers in Biomedical and Regulatory Science
disclaimer iconKeynote Speaker: Eric Lander, PhD
President and Founding Director of the Broad Institute
Massachusetts Institute of Technology
9:45 – 10:55 AM
Poster Session 1 and Break
Topics: 
  1. Identification and Evaluation of New Biomarkers
  2. FDA Response to Urgent Public Health Needs
10:55 – 12:40 PM
Concurrent Sessions 1 & 2 (Click link below to expand and view Webcasts)
 

Concurrent Sessions 1 & 2

Concurrent Session 1: Identification and Evaluation of New Biomarkers
Great Room, Section B: 
Session Chair: Lisa Meier McShane, PhD, Chief, Biostatistics Branch, Biometric Research Program, National Institutes of Health /National Cancer Institute

0:00-32:54
Food and Drug Administration (FDA)/National Institutes of Health (NIH) Interactions and BEST
Lisa Meier McShane, PhD, Chief Biostatistics Branch, Biometric Research Program, National Institutes of Health/NCI
33:06-52:40
Biomarker Qualification Program with Update, Case Studies and Challenges
Christopher Leptak, MD, PhD, Associate Director of Biomarker Development Regulatory Science Team, Center for Drug Evaluation and Research
52:41-1:04:02
Biomarker Data in the Population Assessment of Tobacco and Health
(PATH) Study - Cindy Chang, PhD, MPH, Epidemiologist, Center for Tobacco Products
1:04:21-1:14:33
Transcript, Proteo, and Metabol-omics as Tools for Translational Biomarker Discovery and Evaluation
William B. Mattes, PhD, DABT, Director, Division of Systems Biology, National Center for Toxicological Research
1:14:47-1:23:56
CDRH Perspectives on Imaging Biomarkers-Analytical Validation Expectations
Daniel Krainak, PhD, Biomedical Engineer, Center for Diagnostics and Radiological Health
1:24:15-1:35:19
Next Generation Sequencing (NGS): FDA Approval of the 1st NGS Companion Diagnostic
Hisani Madison, PhD, MPH, Scientific Reviewer, Center for Devices and Radiological Health
1:35:30-1:53:11
Q&A Panel
 

Concurrent Session 2: FDA Response to Urgent Public Health Needs
Great Room, Section C:
Session Chair: RADM Palmer Orlandi, Jr., PhD, Chief Science Officer and Director of Research, FDA Office of Foods and Veterinary Medicine

0:00 - 23:12
FDA's Coordinated Response to Recent Foodborne Outbreaksdisclaimer icon
CDR Kari Irvin, MS, CORE Response Manager, Center for Food Safety and Nutrition
23:21 – 37:49
disclaimer iconCharacterization and Analysis of Multidrug Resistant Foodborne Pathogens
Heather Tate, PhD, MS, Epidemiologist, Center for Veterinary Medicine
38:15 – 53:11
Forensic Analysis of a Mass Poisoning in Mozambique Associated with Homebrewed Beveragedisclaimer icon
Travis Falconer, PhD, Chemist, Office of Regulatory Affairs
53:20 – 1:11:00
disclaimer iconUse of an FDA Real-time Mobile Communication Platform System during Medical Countermeasure Events: RAPID
Henry "Skip" Francis, MD, Director for Data Mining and Informatics Evaluation and Research, Center for Drug Evaluation and Research
1:11:20-1:28:50
disclaimer iconDevelopment of Total and Neutralizing Anti-Ebola Virus Antibody Assays for Deployment in West Africa to Evaluate Clinical Trials of MCM, including Vaccines and Immunotherapies
Geraldo Kaplan, PhD, Principal Investigator, Center for Biologics Evaluation and Research
1:29:00-1:47:46
disclaimer iconDevelopment of Mouse Models to Assess Efficacy and Potency of ZIKA Virus Therapeutics
Daniela Verthelyi, MD, PhD, Lab Chief, Center for Drug Evaluation and Research
1:48:00-2:07:00
Q&A Sessiondisclaimer icon
 
12:40 – 1:30 PM
Lunch
1:30 – 3:30 PM
Concurrent Sessions 3 & 4 (Click link below to expand and view Webcasts)
 

Concurrent Sessions 3 & 4

Concurrent Session 3: Microbiome and Human Health
Great Room Section B:
Session Chair: Ryan Ranallo, Program Officer, National Institutes of Health/National Institute of Allergy and Infectious Diseases

0:00-15:32
Overview
Ryan Ranallo, Program Officer, National Institutes of Health/National Institute of Allergy and Infectious Diseases
15:32-31:30
MetaGenomeTrakr and Food Safety Microbiome Research at FDA Center for Food Safety and Nutrition
Andrea Ottesen, PhD, Research Microbiologist, Center for Food Safety and Nutrition
31:31-44:39
MAIT Cells Alter the Murine Microbiome Reducing Colonization Resistance against Clostridium difficile
Paul Carlson, PhD, Senior Staff Fellow, Center for Biologics Evaluation and Research
44:45-1:05:222
The Effect of Chlortetracycline on Swine Fecal Microbiome and Resistome
Daniel A. Tadesse, PhD, Research Microbiologist, Center for Veterinary Medicine
1:05:30-1:22:12
Interaction of Silver Nanoparticles Beyond Intestinal Bacterial Microbiota: Effects of Intestinal Virome and Phages
Sangeeta Khare, PhD, Research Microbiologist, National Center for Toxicological Research
1:22:20-1:39:20
Impact of TNF Antagonist Treatment on the Gut Microbiome: an in vivo Pilot Study
Odile Engel, PhD, Researcher, Center for Drug Evaluation and Research
1:39:23-2:05:52
Q&A Session
 

Concurrent Session 4: Advanced Manufacturing and 3D Printing
Great Room Section C: Cut
Session Chair: Andy Christensen, President, Somaden, LLC

0:00-17:13
An Historical Perspective of 3D Printing in Clinical Medicine
Andy Christensen, President, Somaden, LLC
17:14-30:15
Techniques Performance and Process Evaluation of Advanced Manufacturing
LCDR James Coburn, MS, Sr. Research Engineer
Center for Devices and Radiological Health, FDA
30:22-46:52
Continuous Manufacturing Technologies
Celia Cruz, PhD, Division Director
Center for Drug Evaluation and Research, FDA
47:03-1:03:46
Manufacturing the Seasonal Flu Vaccine
Zhiping YE, MD, PhD, Senior Investigator, Center for Biologics Evaluation and Research
1:03:55-1:18:18
Practical Microscale Technologies in the Assessment of Advanced Therapeutic Products in the Center for Biologics Evaluation and Research
Kyung Sung, PhD, Principal Investigator, Center for Biologics Evaluation and Research FDA
1:18:31-1:35:45
Continuous Bio-Manufacturing Technologies
LCDR Cyrus Agarabi, PharmD, RPh, MBA, PhD, Regulatory Research Officer, Center for Drug Evaluation and Research
1:35:57-1:50:30
Advancing Characterization of 3D Printed Tissue Engineered Scaffolds
Maureen Dreher, PhD, MS, Research Biomedical Engineer, Center for Devices and Radiological Health
1:50:32-2:08:16
Q&A Session
 
3:30 – 4:30 PM
Poster Session 2
  1. Microbiome and Human Health
  2. Additive Manufacturing and 3D Printing
  3. FDA Response to Urgent Public Health Needs
4:30 PM
End of Day 1
 

June 1, 2017 – Day 2

9:15 – 10:15 AM
Poster Sessions 3 and Break
Topics:
  1. Omics Technologies at FDA
  2. Patient and Consumer Engagement and Communication
  3. FDA Response to Urgent Public Health Needs
10:15 – 12:00 PM
Concurrent Sessions 5 & 6 (Click link below to expand) and view webcasts)
 

Concurrent Sessions 5 & 6

Concurrent Session 5: Omics Technologies at FDA
Great Room Section B:
Session Chair: Minnie Sarwal, MD, FRCP, DCH, PhD, Professor of Surgery, Director Precision Transplant Medicine, University of California, San Francisco, FDA Science Board member

0:00-23:16
Opening Remarks: Minnie Sarwal, MD, DCH, Professor of Surgery, Director, Precision Transplant Medicine, University of California, San Francisco
23:20-37:09
FDA-led Community-wide Sequencing Quality Control Consortium-SEQC2
Weida Tong, PhD, Division Director, Bioinformatics and Biostatistics, National Center for Toxicological Research
37:20-51:48
FDA's Genome Trackr Program: Advancing Food Safety through Whole Genome Sequencing of Foodborne Bacteria
Errol Strain, PhD, Director, Biostatistics and Bioinformatics Staff, Center for Food Safety and Applied Nutrition
52:00-1:11:20
MicroRNA Biomarkers of Acute Pancreatic Injury Use
Rodney Rouse, DVM, MBA, PhD, Acting Associate Director, Division of Applied Regulatory Science, Office of Translational Science, Center for Drug Evaluation and Research
1:11:39-1:29:13
FDA-ARGOS Microbial Reference Genomes for Regulatory use: Zika and Ebola
Heike Sichtig, PhD, SME, Principal Investigator, Center for Devices and Radiological Health
1:29:22-1:47:43
Glycomics Work-Flows for the Characterization of Vaccine Glycoprotein Antigens
John Cipollo, PhD, Principal Investigator, Center for Biologics Evaluation and Research
1:47:50-1:57:29
Q&A Session
 

Concurrent Session 6: Patient and Consumer Engagement and Communication
Great Room Section C:
Session Chair: Brian J. Zikmund-Fisher, PhD, Associate Professor of Health Behavior and Health Education, University of Michigan

0:00-4:49
Overview
Brian J. Zikmund-Fisher, PhD, Associate Professor of Health Behavior and Health Education, University of Michigan
 
4:50-20:21
Use of Flavored Tobacco Products: Findings from the Population Assessment of Tobacco and Health (PATH) Study
Bridget Ambrose, PhD, MPH, Supervisory Epidemiologist, Center for Tobacco Products
20:30-36:41
Understanding Mothers' Attitudes and Motivations Regarding Menu Labeling: Testing Messaging Concepts and Treatments
Kathleen Yu, MPH, Social Scientist, Center for Food Safety and Applied Nutrition
36:50-51:37
Development of Tools to Capture the Patient Perspective with Implantable Minimally Invasive Glaucoma Surgical (MIGS) Devices
Michelle Tarver, MD, PhD, Medical Officer, Center for Devices and Radiological Health
51:44-1:04:25
Upper Limb Prostheses Patient Preference Study to Inform Clinical Trial Design and Regulatory Decisions
Heather Benz, PhD, Medical Device Fellow, Center for Devices and Radiological Health
1:04:29-1:21:07
Advancing the Science of Patient Input in a Regulatory Setting through Internal Capacity-Building and Research
Million Tegenge, PhD, RPh, Visiting Scientist, Center for Biologics Evaluation and Research
1:21:10-1:36:59
Communicating Risk Information about Drugs: the Effect of Quantitative Information Type on Risk Perceptions and Understanding
Paula Rausch, PhD, RN, Associate Director, Research and Risk Communications, Center for Drug Evaluation and Research
11:50 – 12:00 PM
Moderator's Comments and Closing Remarks
 
12:00 – 1:00 PM
Lunch
1:00 – 2:00 PM
Poster Session 4 and Break
Topics: 
  1. Computational Modeling and Simulation at FDA 
  2. Current Progress in Nanotechnology Research at FDA
2:00 – 3:45 PM
Concurrent Sessions 7 & 8 (Click link below to expand and view webcasts)
 

Concurrent Sessions 7 & 8 

Concurrent Session 7: Computational Modeling and Simulation Session for Science Forum
Great Room Section B:
Session Chair: Grace Peng, PhD, Director of Computational Modeling and Simulation, National Institutes of Health/National Institute of Biomedical Imaging and Bioengineering

0:00-9:23
Overview
Grace Peng, PhD, Director of Computational Modeling and Simulation, National Institutes Of Health/National Institute of Biomedical Imaging and Bioengineering
9:24-20:19
Advancing Regulatory Science at FDA with Modeling and Simulation
Tina Morrison, PhD, Chair, Modeling and Simulation Working Group, Center for Devices and Radiological Health
20:20-31:10
Computational Electromagnetic Modeling and Medical Devices
Leonardo Angelone, PhD, Research Biomedical Engineer, Center for Devices and Radiological Health
 
31:15-42:24
Using (Q)SAR Modeling to Inform Drug Safety Assessment
Naomi Kruhlak, PhD, Chemist, Center for Drug Evaluation and Research
42:25-53:00
Modeling the U.S. Blood Supply for Emergency Preparedness
Mark Walderhaug, PhD, Microbiologist, Center for Biologics Evaluation and Research
53:02-1:05:20
Potential Uses for Modeling and Simulation in Veterinary Medicine
Marilyn Martinez, PhD, Senior Scientist, Center for Veterinary Medicine
1:05:22-1:16:12
Contamination of Food by Radionuclides after a Nuclear Accident
Danielle Larese, PhD, ORISE Fellow, Office of Regulatory Affairs
1:16:15-1:29:23
Modeling and Simulation in Tobacco Regulatory Science
Antonio Paredes, MA, MS, Lead Mathematical Statistician, Center for Tobacco Products
1:29:25-1:39:40
Q&A Session
 

Concurrent Session 8: Current Progress in Nanotechnology Research at FDA
Great Room Section C:
Session Chair: Anil Patri, PhD, Director, Nanotechnology CORE, National Center for Toxicological Research

0:00-16:16
Current Progress in Nanotechnology Research at FDA (NTF, CORES, Research Infrastructure Facilities)
Anil Patri, PhD, Director, Nanotechnology CORE, National Center for Toxicological Research
16:22-31:23
The Safety of Nanomaterials Using Silver Nanoparticles as an Example
Mary Boudreau, PhD, Research Toxicologist, National Center for Toxicological Research
31:30-42:06
Drugs Products Containing Nanomaterials
Katherine Tyner, PhD, Acting Associate Director of Science, Center for Drug Evaluation and Research
42:12-57:10
Nanotechnology and Medical Devices
Peter Goering, PhD, Research Toxicologist, Center for Devices and Radiological Health
57:20-1:09:47
Nanomaterial-Based In Vitro Diagnostics for Pathogens
Indira Hewlett, PhD, Laboratory Chief, Center for Biologics Evaluation and Research
 
Potential Exposure to Nanoparticles from Nanotechnology-Enabled Food Contact Materials
Timothy Duncan, PhD, Research Chemist, Center for Foods Safety and Nutrition
1:10:20-1:26:30
Panel Discussion
 
3:40 – 4:00 PM
Closing Remarks and Adjourn, Carol Linden, Ph.D., Director, Office of Regulatory Science and Innovation
 

 

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