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)
| Time | Presentation | Speaker |
|---|---|---|
| 10:50 a.m.−10:55 a.m. | Introduction |
Rhonda Moore, PhD |
| 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
| 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
| 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
| 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
| 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
| 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
| 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
| 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 |