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
Bernadette Johnson-Williams, MEd, Senior Advisor for STEM, OCS
8:40 – 8:50 AM
9:05 - 9:45 AM
Frontiers in Biomedical and Regulatory Science
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Keynote Speaker: Eric Lander, PhD
President and Founding Director of the Broad Institute
Massachusetts Institute of Technology
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Keynote Speaker: Eric Lander, PhDPresident and Founding Director of the Broad Institute
Massachusetts Institute of Technology
9:45 – 10:55 AM
Poster Session 1 and Break
Topics:
Topics:
- Identification and Evaluation of New Biomarkers
- 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 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
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
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
(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
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
Daniel Krainak, PhD, Biomedical Engineer, Center for Diagnostics and Radiological Health
1:24:15-1:35:19
Hisani Madison, PhD, MPH, Scientific Reviewer, Center for Devices and Radiological Health
1:35:30-1:53:11
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 Outbreaks
CDR Kari Irvin, MS, CORE Response Manager, Center for Food Safety and Nutrition
CDR Kari Irvin, MS, CORE Response Manager, Center for Food Safety and Nutrition
23:21 – 37:49
Characterization and Analysis of Multidrug Resistant Foodborne PathogensHeather Tate, PhD, MS, Epidemiologist, Center for Veterinary Medicine
38:15 – 53:11
Forensic Analysis of a Mass Poisoning in Mozambique Associated with Homebrewed Beverage
Travis Falconer, PhD, Chemist, Office of Regulatory Affairs
Travis Falconer, PhD, Chemist, Office of Regulatory Affairs
53:20 – 1:11:00
Use of an FDA Real-time Mobile Communication Platform System during Medical Countermeasure Events: RAPIDHenry "Skip" Francis, MD, Director for Data Mining and Informatics Evaluation and Research, Center for Drug Evaluation and Research
1:11:20-1:28:50
Development of Total and Neutralizing Anti-Ebola Virus Antibody Assays for Deployment in West Africa to Evaluate Clinical Trials of MCM, including Vaccines and ImmunotherapiesGeraldo Kaplan, PhD, Principal Investigator, Center for Biologics Evaluation and Research
1:29:00-1:47:46
Development 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
12:40 – 1:30 PM
Lunch
1:30 – 3:30 PM
Concurrent Sessions 3 & 4 (Click link below to expand and view Webcasts)
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
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
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
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
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
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
Odile Engel, PhD, Researcher, Center for Drug Evaluation and Research
1:39:23-2:05:52
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
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
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
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
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
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
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
Maureen Dreher, PhD, MS, Research Biomedical Engineer, Center for Devices and Radiological Health
1:50:32-2:08:16
3:30 – 4:30 PM
Poster Session 2
- Microbiome and Human Health
- Additive Manufacturing and 3D Printing
- 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:
Topics:
- Omics Technologies at FDA
- Patient and Consumer Engagement and Communication
- 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 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
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
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
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
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
John Cipollo, PhD, Principal Investigator, Center for Biologics Evaluation and Research
1:47:50-1:57:29
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
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
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
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
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
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
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
Paula Rausch, PhD, RN, Associate Director, Research and Risk Communications, Center for Drug Evaluation and Research
11:50 – 12:00 PM
12:00 – 1:00 PM
Lunch
1:00 – 2:00 PM
Poster Session 4 and Break
Topics:
Topics:
- Computational Modeling and Simulation at FDA
- 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 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
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
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
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
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
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
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
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
Antonio Paredes, MA, MS, Lead Mathematical Statistician, Center for Tobacco Products
1:29:25-1:39:40
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
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
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
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
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
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
Timothy Duncan, PhD, Research Chemist, Center for Foods Safety and Nutrition
1:10:20-1:26:30
3:40 – 4:00 PM
Closing Remarks and Adjourn, Carol Linden, Ph.D., Director, Office of Regulatory Science and Innovation