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  1. The FDA Science Forum

2021 FDA Science Forum Agenda

The 2021 FDA Science Forum virtual poster sessions will be exhibited on FDA's Science Forum website on May 26, 2021. The posters will be published and available for download to all FDA Science Forum registrants. The audience will have the opportunity to e-mail their questions directly to the designated authors of the posters for their response from May 26 through June 9, 2021.

View 2021 FDA Science Forum Posters


Day 1: May 26, 2021

Keynote Session

Time:
9:00 am - 10:15 am ET
Keynote Speaker:
NIAID Director Dr. Anthony Fauci
Mediasite Webcast:    
https://fda.yorkcast.com/webcast/Play/b62823fe42f740dda1b386a401f08d061d
YouTube:
https://youtu.be/G3mS-3pNWJo
Keynote Session
Time Topics

9:00 am - 9:05 am

Introduction
Sharron Watson - OSPD
9:05 am - 9:15 am Welcome
FDA Chief Scientist, RADM Denise Hinton
9:15 am - 9:45 am Opening Remarks and Introduction of Keynote Speaker
Acting FDA Commissioner, Janet Woodcock, MD
9:45 am - 10:15 am Keynote Speaker
Anthony S. Fauci, MD, NIAID Director
National Institutes of Health (NIH)
COVID-19 in 2021: Lessons Learned and Remaining Challenges
10:15 am - 10:30 am ET:
Break
10:30 am - 12:30 pm ET:
Concurrent Sessions 1 & 2

Concurrent Session 1: Improving Clinical and Post-market Evaluation

Time:
10:30 am - 12:30 pm ET
Chairs / Moderators:
Julie Schneider, PhD, and Steven Berman, MPH
Mediasite Webcast:
https://fda.yorkcast.com/webcast/Play/b62823fe42f740dda1b386a401f08d061d
YouTube:
https://youtu.be/G3mS-3pNWJo
Concurrent Session 1: Improving Clinical and Post-market Evaluation
Time Presentation Speaker
10:30 am - 11:05 am Between Marketing Approval and Appropriate Use of Medical Products -- Time to Transform the System Robert M. Califf, MD, MACC
Head of Clinical Policy and Strategy for Verily and Google Health
Adjunct Professor, Duke University and Stanford University
11:05 am - 11:20 am Applications for Surveillance: Interrogating Whole-Genome Sequence and CAERS Data James Pettengill, PhD
CFSAN/FDA
11:20 am - 11:35 am
Regulatory Science/Research Needs Related to Digital Health
Bakul Patel, MSEE, MBA
CDRH/FDA
11:35 am - 11:50 pm Regulatory Applications and Research of Model-Informed Drug Development (MIDD) Yaning Wang, PhD
CDER/FDA
11:50 pm - 12:05 pm Including Non-Concurrent Control Data in Bayesian Adaptive Platform Trials When Temporal Changes Exist Min (Annie) Lin, PhD
Statistical Science Director
Astra Zeneca
12:05 pm - 12:30 pm Q&A/ Discussion Robert M. Califf, MD, MACC
James Pettengill, PhD
Min (Annie) Lin, PhD 
Yaning Wang, PhD
Bakul Patel, MSEE, MBA 

Concurrent Session 2: Tools to Effectively Use Big Data

Time:
10:30 am - 12:30 pm ET
Chair / Moderator:
Donna Mendrick, PhD
Mediasite Webcast:
https://fda.yorkcast.com/webcast/Play/cca6a93ebb15402d93438b11c79ed2381d
YouTube:
https://youtu.be/v9z0iVfMaBQ
Concurrent Session 2: Tools to Effectively Use Big Data
Time Presentation Speaker
10:30 am - 11:00 am Democratizing Screening & Diagnostics with AI Lily Peng, MD, PhD
Product Manager
Google Health
11:00 am - 11:15 am Developing a Deep Learning MedDRA encoder (MedDRA-DeepCoder) for Patient Narratives Qais Hatim, PhD
CDER/FDA
11:15 am -11:30 am CBER BEST: Leveraging AI to Build an Automated Adverse Events Reporting System Hussein Ezzeldin, PhD
CBER/FDA
11:30 am -11:45 am BE ASSESSMENT MATE (BEAM) - A Data Analytics Tool to Enhance Efficiency, Quality, and Consistency of Bioequivalence Assessment Meng Hu, PhD
CDER/FDA
11:45 am - 12:00 pm Trade-off Between Explainability and Predictivity in Toxicity Assessment with AI   Leihong Wu, PhD
NCTR/FDA
12:00 pm - 12:15 pm Use of Machine Learning to Improve Food Safety Quantitative Microbial Risk Assessment Hao Pang, PhD
CFSAN/FDA
12:15 pm - 12:30 pm Role of AI in Medical Imaging Berkman Sahiner, PhD
CDRH/FDA
12:30 pm - 1:30 pm ET:
Lunch
1:30 pm - 3:30 pm ET:
Concurrent Sessions 3 & 4

Concurrent Session 3: Empowering Patients and Consumers

Time:
1:30 pm - 3:30 pm ET
Chairs / Moderators:
Christine Lee, PharmD, PhD, and Andrea Furia Helms, MPH
Mediasite Webcast:
https://fda.yorkcast.com/webcast/Play/b62823fe42f740dda1b386a401f08d061d
YouTube:
https://youtu.be/G3mS-3pNWJo
Concurrent Session 3: Empowering Patients and Consumers
Time Presentation Speaker
1:30 pm - 1:40 pm Introduction Andrea Furia Helms, MPH
OC/FDA
1:40 pm - 1:55 pm Listening Sessions to Uncover Patient Questions: The COVID-19 Vaccine Confidence Project Susan Winckler, JD
Chief Executive Officer of
Reagan Udall Foundation (RUF)
1:55 pm - 2:05 pm Understanding Perceptions and Attitudes About COVID-19 Testing in Under-represented Populations Jessica Weinberg, MPP
CDRH/FDA
2:05 pm - 2:15 pm COVID-19 and Tobacco Use: The Latest from the Population Assessment of Tobacco and Health Study Yu-Ching Cheng, PhD
CTP/FDA
2:15 pm - 2:25 pm Impact of COVID-19 on FDA Orphan Products Grants Christine Mueller, DO
OC/FDA
2:25 pm - 2:35 pm COVID-19 Pandemic: Adjustments to Ongoing Clinical Trials   Wilson Bryan, MD
CBER/FDA
2:35 pm - 2:45 pm FDALabel – An FDA Product Labeling Tool Enabling Patients and Consumers Safety in Combating COVID-19 Hong Fang, PhD
NCTR/FDA
2:45 pm - 2:55 pm Patient Focus Groups to Enhance Communications Addressing Biosimilar Drug Products   Brian Lappin, MA
CDER/FDA
2:55 pm - 3:05 pm 2019 FDA Food Safety and Nutrition Survey – Making Food Safety and Nutrition Accessible to Public Health Professionals Amy Lando, MPP
CFSAN/FDA
3:05 pm - 3:15 pm Addressing Demographic Subgroup Underrepresentation in Oncology   Lola Fashoyin-Aje, MD, MPH
OCE/FDA
3:15 pm - 3:25 pm Advancing Health Equity through Outreach and Communications Jovonni Spinner, DrPH, MPH, CHES  
OMHHE/FDA
3:25 pm - 3:30 pm Closing Remarks / Discussion Christine Lee, PharmD, PhD
OMHHE/FDA

Concurrent Session 4: Product Development and Manufacturing

Time:
1:30 pm - 3:30 pm ET
Chair / Moderator:
Suzanne Fitzpatrick, PhD
Mediasite Webcast:
https://fda.yorkcast.com/webcast/Play/cca6a93ebb15402d93438b11c79ed2381d
YouTube:
https://youtu.be/v9z0iVfMaBQ
Concurrent Session 4: Product Development and Manufacturing
Time Presentation Speaker
1:30 pm - 2:00 pm 21st Century Solutions for 21st Century Problems   Geoffrey Ling, MD, PhD
Chief Executive Officer
On Demand Pharmaceuticals
2:00 pm - 2:15 pm MALDI Imaging Mass Spectrometry: A New Imaging Modality for Use in Toxicological Studies Elizabeth Jones, PhD
NCTR/FDA
2:15 pm - 2:30 pm Advancing New Alternative Methodologies at FDA: The Expanded Decision Tree   Szabina Stice, PhD
CFSAN/FDA
2:30 pm - 2:45 pm ISTAND: A Pilot Program to Address Novel Technologies as Drug Development Tools (DDTs) Christopher Leptak, MD, PhD
CDER/FDA
2:45 pm - 3:00 pm Medical Device Cybersecurity   Kevin Fu, PhD
CDRH/FDA
3:00 pm - 3:15 pm FDA’s Advanced Manufacturing Journey Sau Lee, PhD
CDER/FDA
3:15 pm - 3:30 pm Understanding Ex Vivo Manufacturing of HSC-Based Therapeutics   Pankaj Mandal, PhD
CBER/FDA

Day 2: May 27, 2021

Opening Remarks

Time:
8:55 am - 9:00 am ET
Mediasite Webcast:    
https://fda.yorkcast.com/webcast/Play/4f169c55537f4e17b17dde8c2b2986f21d
YouTube:
https://youtu.be/GT2dN870hgY
Opening Remarks
Time Topic
8:55 am - 9:00 am Opening Remarks
Rokhsareh Shahidzadeh
9:00 am - 11:00 am ET:
Concurrent Sessions 5 & 6

Concurrent Session 5: Advancing Products Based on Novel Technologies

Time:
9:00 am - 11:00 am ET
Chairs / Moderators:
Beverly Lyn-Cook, PhD, and Silvia Pineiro, PhD
Mediasite Webcast:
https://fda.yorkcast.com/webcast/Play/4f169c55537f4e17b17dde8c2b2986f21d
YouTube:
https://youtu.be/GT2dN870hgY
Concurrent Session 5: Advancing Products Based on Novel Technologies
Time Presentation Speaker
9:00 am - 9:05 am Introduction Silvia Pineiro, PhD
CVM/FDA
9:05 am - 9:30 am Overcoming Challenges in Co-Culture of Super Strict Anaerobes with a Healthy Human Colon Mucosal Barrier    Linda G. Griffith, PhD
Professor, Biological and Mechanical Engineering, Massachusetts Institute of Technology
9:30 am - 9:40 am Advancing Regulatory Science Through Organ on a Chip   Daniel Tadesse, PhD
CVM/FDA
9:40 am - 9:50 am Microbiome as an Additional Criterion for Safety Assessment   Sangeeta Khare, PhD
NCTR/FDA
9:50 am - 10:05 am Emergence of Nosocomial Associated Opportunistic Pathogens in the Gut Microbiome after Antibiotic Treatment Revealed by a Mouse Model Metagenome Analysis Zhihua Li, PhD
CDER/FDA
10:05 am - 10:15 am Safety and Effectiveness of Fecal Microbiota Transplantation Products   Paul Carlson, PhD
CBER/FDA
10:15 am - 10:30 am Microphysiological Systems Regulatory Research Considerations: Evaluation of a Model System   Kirsten Eckstrum, PhD
CFSAN/FDA
10:30 am - 10:40 am Evaluation of Endothelial Cell Responses to Nanomaterials Using a Dynamic Flow Model   Shelby Skoog, PhD
CDRH/FDA
10:40 am - 10:50 am Microphysiological Systems to Assess the Functional Capacity of Regenerative Medicine Cellular Products   Kyung Sung, PhD
CBER/FDA
10:50 am - 11:00 am Closing Remarks/Discussion Beverly Lyn-Cook, PhD
NCTR/FDA

Concurrent Session 6: MCM, Infectious Disease and Pathogen Reduction Technologies

Time:
9:00 am - 11:00 am ET
Chairs:
Monica Young, PhD, and CAPT Tracy MacGill, PhD
Moderator:
Carol Weiss, MD, PhD
Mediasite Webcast:
https://fda.yorkcast.com/webcast/Play/a6528d3f063d432da5badc6398125e6a1d
YouTube:
https://youtu.be/hYiX4KVKi5E
Concurrent Session 6: MCM, Infectious Disease and Pathogen Reduction Technologies
Time Presentation Speaker
9:00 am - 9:05 am Introduction Carol Weiss, MD, PhD
CBER/FDA
9:05 am - 9:30 am Outbreak Preemption and Response in the Genomic and Information Age Pardis Sabeti, MD, PhD
Institute Member,
Broad Institute of the
Massachusetts Institute of Technology (MIT)/ Harvard Medical School
9:30 am - 9:45 am Evaluation of Pathogenesis of SARS-CoV-2 Variants Tony Wang, PhD
CBER/FDA
9:45 am - 10:00 am Artificial Intelligence-Powered Drug Repurposing Against COVID-19  Zhichao Liu, PhD 
NCTR/FDA
10:00 am - 10:15 am Device Medical Countermeasure Activities During the COVID-19 Pandemic   Heather Agler, PhD
CDRH/FDA
10:15 am - 10:30 am Emerging Technologies for Adventitious Agent Detection and their Application to CDER Products Kathryn King, PhD
CDER/FDA
10:30 am - 10:45 am ORA’s Work in Support of Medical Countermeasures   Elizabeth Miller, PharmD
ORA/FDA
10:45 am - 10:55 am Panel Discussion / Q&A Heather Agler, PhD
Kathryn King, PhD
Zhichao Liu, PhD
Elizabeth Miller, PharmD
Pardis Sabeti, MD, PhD
Tony Wang, PhD
10:55 am - 11:00 am Closing Remarks Carol Weiss, MD, PhD
11:00 am - 12:00 pm ET:
Lunch
12:00 am - 2:00 pm ET:
Concurrent Sessions 7 & 8

Concurrent Session 7: Food and Cosmetic Safety: The Role of Innovation and Technology

Time:
12:00 pm - 2:00 pm ET
Chairs / Moderators:
Chad Nelson, MSPH, PhD, Jeffrey Ward, DVM, and Zhichao Lin, PhD
Mediasite Webcast:
https://fda.yorkcast.com/webcast/Play/4f169c55537f4e17b17dde8c2b2986f21d
YouTube:
https://youtu.be/GT2dN870hgY
Concurrent Session 7: Food and Cosmetic Safety: The Role of Innovation and Technology
Time Presentation Speaker
12:00 pm - 12:05 pm Introduction Chad P. Nelson, MSPH, PhD
CFSAN/FDA
12:05 pm - 12:35 pm One Health as a Collaborative Response to Food Safety Risks Kalmia Kniel, PhD,
Professor, Animal and Food Sciences
University of Delaware
12:35 pm - 12:50 pm CFSAN’s Use of Innovative Science to Address Current and Emerging Public Health Priorities Susan Mayne, PhD
CFSAN/FDA
12:50 pm - 1:05 pm FDA Support of Recent Foodborne Illness Outbreak Investigations Daniel Rice, MS, DrPH
ORA/FDA
1:05 pm - 1:20 pm What Won’t an Animal Eat? Innovation in Animal Diets  David Edwards, PhD
CVM/FDA
1:20 pm - 1:35 pm Mind the [Data] Gap: Contributions of FDA’s NCTR to Evaluate Cosmetics Safety  Luisa Camacho, PhD
NCTR/FDA
1:35 pm - 2:00 pm Panel Discussion / Q&A Moderator: Jeffrey Ward, DVM
Chad P. Nelson, MSPH, PhD
Kalmia Kniel, PhD
Susan Mayne, PhD
Daniel Rice, MS, DrPH
David Edwards, PhD
Luisa Camacho, PhD

Concurrent Session 8: Substance Use, Misuse, and Addiction

Time:
12:00 pm - 2:00 pm ET
Chair / Moderator:
Marta Sokolowska, PhD
Mediasite Webcast:
https://fda.yorkcast.com/webcast/Play/a6528d3f063d432da5badc6398125e6a1d
YouTube:
https://youtu.be/hYiX4KVKi5E
Concurrent Session 8: Substance Use, Misuse, and Addiction
Time Presentation Speaker
12:00 pm - 12:05 pm Introduction Marta Sokolowska, PhD
CDER/FDA
12:05 pm - 12:35 pm Substance Use Disorders Linked to COVID-19 Susceptibility Nora D. Volkow, MD
Director, National Institute on Drug Abuse/National Institutes of Health
12:35 pm - 12:50 pm COVID-19 and the Opioid Crisis: A Social Media Perspective Jill Settle, PhD
CDER/FDA
12:50 pm - 1:05 pm And the Kids Vaped On: Teens, Tobacco, and the National Youth Tobacco Survey   Karen Cullen, PhD, MPH
CTP/FDA
1:05 pm - 1:20 pm Investigation of Opioid Exposure and Neural Tube Defects – In Vivo and In Vitro Approaches   Amy Inselman, PhD
NCTR/FDA
1:20 pm - 1:35 pm Tobacco and Cannabis – Did EVALI Teach Us Anything? Priscilla Callahan-Lyon, MD
CTP/FDA
1:35 pm - 2:00 pm Panel Discussion / Q&A Moderator: Marta Sokolowska, PhD
Nora Volkow, MD (NIH/NIDA)
Jill Settle, PhD (FDA/CDER)
Karen Cullen, PhD (FDA/CTP)
Amy Inselman, PhD (FDA/NCTR)
Priscilla Callahan-Lyon, MD (FDA/CTP)
 
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