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  1. The FDA Science Forum

2019 FDA Science Forum Agenda

2019 FDA Science Forum: Transforming Health: Innovation in FDA Science

Wednesday, September 11, 2019 – Thursday, September 12, 2019

FDA White Oak Campus, Great Room

AGENDA and Webcast

Day One: September 11, 2019

Time Topics
8:30 a.m. – 8:35 a.m Introduction ( 00:00 - 02:08  )
Rokhsareh Shahidzadeh, MSN
8:35 a.m. – 8:45 a.m. Welcome ( 02:10 - 14:00 )
FDA Chief Scientist, RADM Denise Hinton
8:45 a.m. – 9:10 a.m. Opening Remarks and Introduction of Keynote Speaker ( 14:03 - 24:30 )
Amy Abernethy, MD, PhD, FDA Principal Deputy Commissioner, Chief Information Officer
   
9:10 a.m. – 9:40 a.m.  Keynote Speaker ( 24:38 - 1:05:48 )
Francis Collins MD, PhD, Director, National Institutes of Health
FDA and NIH: Partners in Transformation

9:40 a.m - 9:50 a.m Break

Poster Session 1
Great Room Section C and Room 1504

Time Topics
9:50 a.m. – 10:50 a.m Precision Health

Advanced Technology

Concurrent Session 1: Precision Health
Great Room Section A
Session Chairs/Moderator: Rhonda Moore, PhD (CDER), William Mattes, PhD, DABT (NCTR)

Concurrent Session 1 Webcast

Time Presentation Speaker
10:50 a.m.−10:55 a.m. Introduction

Rhonda Moore, PhD
FDA's Center for Drug Evaluation and Research (CDER), William Mattes, PhD, DABT (NCTR)

10:55 a.m.−11:10 a.m. Regulatory Perspective on Digital Health for Precision Medicine Bakul Patel, MSEE, MBA
FDA's Center for Devices and Radiological Health (CDRH)
11:10 a.m.−11:25 a.m. Sex and Gender Differences in Health and Disease Beverly Lyn-Cook, PhD
FDA's National Center for Toxicological Research (NCTR)
11:25 a.m.–11:40 a.m. Clinical Trials In 200 Microliters – Extending Approval in Rare Diseases Using In Vitro Data. Jim Weaver, PhD
FDA's CDER
11:40 a.m.−11:55 a.m. Genomic Biomarker Use in Cardiovascular Disease Clinical Trials Oluseyi Adeniyi, PhD, PharmD
FDA's CDER
11:55 a.m.−12:25 p.m. Learning Healthcare Systems and Big Data: Advancing the Goal of Precision Pain Medicine Sean Mackey, MD, PhD
Stanford University
12:25 p.m.−12:50 p.m. Panel Discussion / Q&A Bakul Patel, MSEE, MBA
Beverly Lyn-Cook, PhD
Jim Weaver, PhD
Oluseyi Adeniyi, PhD., PharmD
Sean Mackey, MD, PhD

Concurrent Session 2: Advanced Technology
Great Room Section B
Session Chairs/Moderator: Darón Freedberg, PhD

Concurrent Session 2 Webcast

Time Presentation Speaker
10:50 a.m.–11:15 a.m. Accelerating Innovation in Manufacturing Technology for Biomanufactured Products: Manufacturing U.S. and NIST Kelley Rogers, PhD
National Institute of Standards and Technology (NIST)
11:15 a.m.–11:30 a.m. MetagenomeTrakr Pilot Program for Rapid Foodborne Pathogen Detection Paul Morin, PhD
FDA's Office of Regulatory Affairs (ORA)
11:30 a.m.–11:45 a.m. The Promise of Microbial Genomics: How Microbiology is Standing Up to the Many Challenges of a 21st Century Food Supply Marc Allard, PhD
FDA's Center for Food Safety and Applied Nutrition (CFSAN)
11:45 a.m.–12:00 p.m. Editing the Genome without DNA Breaks Jakob Reiser, PhD
FDA's Center for Biologics Evaluation and Research (CBER)
12:00 p.m.–12:15 p.m. Computational Modeling for Medical Devices Pras Pathmanathan, PhD
FDA's CDRH
12:15 a.m.–12:30 p.m. Avian Influenza A Susceptibilities to Pulmonary Surfactant Protein D: Confirmation of N-glycan sub-type as a Pathogenic Factor in Influenza John Cipollo, PhD
FDA's CBER
12:30 p.m.–12:50 p.m. Panel Q & A, Advanced technology at FDA:  
Potential Utility and Regulatory Challenges 
Moderator:
Glenn Black, PhD
Kelley Rogers, PhD
Paul Morin, PhD
Marc Allard, PhD
Jakob Reiser, PhD
Pras Pathmanathan, PhD
John Cipollo, PhD
Anil Patri, PhD

12:50 p.m. – 1:40 p.m. Lunch*

Concurrent Session 3: Product Accessibility, Integrity, and Security
Great Room Section A
Session Chairs/Moderator: Stephen Perrine, M.S, .and Leslie Rivera Rosado, PhD

Concurrent Session 3 Webcast

Time Presentation Speaker
1:40 p.m.–1:45 p.m. Introduction Leslie Rivera Rosado, PhD
FDA's CDER
Stephen Perrine, MS
FDA's CFSAN
1:45 p.m.–2:00 p.m. Violent Non-State Actor Use of Food as a Delivery System: Comparing ideological and Non-Ideological Perpetrators Markus Binder, MS
University of Maryland
2:00 p.m.–2:15 p.m. Product Availability: A Drug Shortage Perspective  Hyun J. Son PharmD
FDA's CDER
2:15 p.m.–2:30 p.m. Bio-Terrorism Regulations and Food Security Desmond Brown, MS
FDA's ORA
2:30 p.m.–2:45 p.m. FDA Food Defense Efforts – A Preventive Approach to Food Terrorism Ryan Newkirk, PhD
FDA's CFSAN
2:45 p.m.–3:00 p.m. CBER-Regulated Products:  Preventing and Mitigating Shortages Anita Richardson, MAS
FDA's CDER
3:00 p.m.–3:15 p.m. On the 'Cyber-Securability' of Medical Devices Eugene Vasserman, PhD
Kansas State University
3:15 p.m.–3:40 p.m. Panel Discussion
Moderators:
Leslie Rivera Rosado, PhD
Stephen Perrine, MS
Marcus Binder, MS
Hyun J. Son PharmD
Desmond Brown, MS
Ryan Newkirk, PhD
Anita Richardson, MAS
Eugene Vasserman, PhD

Concurrent Session 4: Predictive Tools
Great Room Section B
Session Chairs/Moderator: Donna Mendrick, PhD

Concurrent Session 4 Webcast

Time Presentation Speaker
1:40 p.m.–2:10 p.m. Developing Digital Measures from Person-Generated Health Data Luca Foschini, PhD
Evidation Health
2:10 p.m.– 2:25 p.m. MRI in Nonclinical Safety Assessment Serguei Liachenko MD, PhD
FDA's NCTR
2:25 p.m.–2:40 p.m. The VICTRE Project: The First All-In-Silico Imaging Clinical Trial Aldo Badano, PhD
FDA's CDRH
2:40 p.m.– 2:55 p.m. Use of The MHC Associated Peptide Proteomic Assay to Understand the Immunogenicity Risk of Therapeutic Proteins Zuben Sauna, PhD
FDA's CBER
2:55 p.m.– 3:10 p.m. Cardiac and Hepatic Cellular Systems to Model Human Drug Effects Alexandre Ribeiro, PhD
FDA's CDER
3:10 p.m.– 3:25 p.m. C. elegans for Rapid Developmental Neurotoxicity Assessment of Mixtures Piper Hunt, PhD
FDA's CFSAN
3:25 p.m.– 3:40 p.m. Determination of Seafood Decomposition by Mass Spectrometry with Sensory-Driven Modeling Randy L. Self, PhD
FDA's ORA

Poster Session 2
Great Room Section C and Room 1504

Time Topics
3:40 p.m.– 4:40 p.m. Advanced Technology

Product Accessibility, Integrity, and Security

Predictive Tools

End of Day One

Day 2: September 12, 2019

Poster Session 3
Great Room Section C and Room 1504

Time Topics
9:00 a.m.–10:00 a.m. Predictive Tools

Advancing Digital Health and Artificial Intelligence

Concurrent Session 5: Advancing Digital Health and Artificial Intelligence
Great Room Section A
Session Chair / Moderator: Qi Liu, PhD / Richard Forshee, PhD

Concurrent Session 5 Webcast

Time Presentation Speaker
10:00 a.m. – 10:05 a.m. Welcome to Advancing Digital Health and Artificial Intelligence Qi Liu, PhD
FDA's Center for Drug Evaluation and Research (CDER)
10:05 a.m. – 10:45 a.m. Deep Learning for Polypharmacy and Drug Repurposing Marinka Zitnik, PhD
Stanford University
10:45 a.m. – 11:05 a.m. FDA’s Real-World Evidence Program – Technology and Innovation as a Cornerstone Jacqueline Corrigan-Curay, JD, MD
FDA's CDER
11:05 a.m. – 11:25 a.m. Assessment of Devices that Rely on Artificial Intelligence / Machine Learning Berkman Sahiner, PhD
FDA's Center for Devices and Radiological Health (CDRH)
11:25 a.m. – 12:00 p.m. AI at FDA: Potential Utility and Regulatory Challenges Richard Forshee, PhD
FDA's Center for Biologics and Research (CBER)
Yaning Wang, PhD
FDA's CDER
Berkman Sahiner, PhD
FDA's CDRH
Errol Strain, PhD
FDA's Center for Veterinary Medicine (CVM)
Rhonda Moore, PhD
FDA's CDER
Joshua Xu, PhD
FDA's National Center for Toxicological Research (NCTR)
Marinka Zitnik, PhD
FDA's CDER

Concurrent Session 6: Outbreak!
Great Room Section B
Session Chairs/Moderator: Surender Khurana, PhD

Concurrent Session 6 Webcast

Time Presentation Speaker
10:00 a.m.–10:30 a.m. Innovation in Science: Protecting People from Emerging Infectious Disease Threats Christopher R. Braden, MD
Centers for Disease Control and Prevention (CDC)
10:30 a.m. –10:45 a.m. Foodborne Outbreak Investigations in the Whole Genome Sequencing Era Jennifer Beal, MPH
FDA's Center for Food Safety and Applied Nutrition (CFSAN)
10:45 a.m. –11:00 a.m. Immune Responses to Zika Infections Steven Wood, PhD
FDA's CDRH
11:00 a.m.–11:15 a.m. Tracking antibiotic resistance in Salmonella: The role of the National Antimicrobial Resistance Monitoring System. Patrick McDermott, PhD
FDA's CVM
11:15 a.m.–11:30 a.m. Emerging & Pandemic Threat Preparedness Jerry Weir, PhD
FDA's CBER
11:30 a.m.–11:40 a.m. Strengthening Regulatory Science to Support the Development of Medical Countermeasures for Emerging Infectious Diseases Tracy MacGill, PhD, OC-FDA
11:40 a.m.–12:00 p.m. Panel Discussion
Moderator:
Chad Nelson, PhD
FDA's Office of Foods and Veterinary Medicine
Christopher R. Braden, MD
Steven Wood, PhD
Patrick McDermott, PhD
Jennifer Beal, MPH

12:00 – 1:00 p.m. Lunch*

Poster Session 4
Great Room Section C and Room 1504

Time Topics
1:00 p.m.– 2:00 p.m. Advancing Digital Health and Artificial Intelligence

Outbreak!

Addiction

Impacting Public Health Through Electronic Media: Empowering Consumers, Patients, and Other Stakeholders

Concurrent Session 7: Addiction
Great Room Section A
Session Chairs/Moderators: Katherine Bonson, PhD, Chad Reissig, PhD

Concurrent Session 7 Webcast

Time Presentation Speaker
2:00 p.m.–2:05 p.m. Introduction Katherine Bonson, PhD
FDA's CDER
2:05 p.m.–2:20 p.m. Drug abuse in the U.S. Chad Reissig, PhD
FDA's CDER
2:20 p.m.–2:35 p.m. FDA response to the opioid crisis Marta Sokolowska, PhD
FDA's CDER
2:35 p.m.–2:50 p.m. Assessing the structural and pharmacological similarity of newly identified drugs of abuse to controlled substances using PHASE Chris Ellis, PhD
FDA's CDER
2:50 p.m.–3:10 p.m. Preclinical pharmacology of novel synthetic opioids appearing in clandestine drug markets Michael Baumann, PhD
National Institute on Drug Abuse (NIDA)
3:10 p.m.–3:25 p.m. FDA assessment of the abuse potential of drugs, including opioids Katherine Bonson, PhD
FDA's CDER
3:25 – 4:00 p.m. Panel Discussion Chad Reissig, PhD
Marta Sokolowska, PhD
Chris Ellis, PhD
Michael Baumann, PhD
Katherine Bonson, PhD

Concurrent Session 8: Impacting Public Health Through Electronic Media: Empowering Consumers, Patients, and Other Stakeholders
Great Room Section B
Session Chair/Moderator:  Ryan Kennedy, PhD

Concurrent Session 8 Webcast

Time Presentation Speaker
2:00 p.m.– 2:20 p.m. Tobacco Regulatory Science – Understanding the Role of Flavor in E-Cigarette Marketing Ryan Kennedy, PhD
Johns Hopkins Bloomberg School of Public Health
2:20 p.m.– 2:35 p.m. Using Content Analysis to Understand Tobacco Industry Use of Technology to Engage Consumers Mario Navarro, PhD
FDA's Center for Tobacco Products (CTP)
2:35 p.m.– 2:50 p.m. Consumers’ Use of Personal Electronic Devices in the Kitchen Amy Lando, MPP
FDA's CFSAN
Michael Bazaco, PhD
FDA's CFSAN
2:50 p.m.– 3:05 p.m. Assessment of Patient Perspective on Risks and Benefits Associated with High Intensity Focused Ultrasound (Hifu) for The Ablation of Prostate Tissue in Men with Localized Prostate Cancer Charles Viviano, MD, PhD
FDA's CDRH
3:05 p.m.- 3:20 p.m. Clinical Outcome Assessments in Medical Product Development Elektra Papadopoulos, MD
FDA's CDER
3:20 p.m.– 3:35 p.m. Collect Once, Use Many Times: Challenges and Opportunities for the Use of Real-World Evidence to Improve Healthcare Gregory Pappas, MD, PhD
FDA's CBER
3:35 p.m.– 4:00 p.m. Panel Discussion
Moderator: Ryan Kennedy
Ryan Kennedy, PhD
Mario Navarro, PhD
Amy Lando, MPP
Michael Bazaco, PhD
Charles Viviano, MD, PhD
Elektra Papadopoulos, MD
Gregory Pappas, M.D., PhD

End of Day Two