2021 FDA Science Forum Agenda
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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
- Discuss FDA contributions to the evolving science of clinical, non-clinical, and post-market evaluation.
- Explain how AI and big data together can improve public health.
- Discuss how FDA leverages social and behavioral sciences to empower patients and consumers.
- Describe ways in which we are moving into the future.
- Discuss the potential utility and challenges of new technologies, such as, microphysiological systems, microbiome, or combination of both, in advancing product development and integrating this knowledge in scientific communications with regulatory and research work.
- Discuss the application of innovative tools and approaches to support pandemic response, development and evaluation of MCMs and the detection of adventitious agents.
- Distinguish the varied levels of activity within FDA and with various external stakeholders in protecting public health.
- Describe several types of regulatory science related to substance use, misuse, and addiction, and how it can be used to inform FDA regulatory activities.
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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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) |