2023 FDA Science Forum Agenda
On This Page:
The 2023 FDA Science Forum virtual poster sessions are exhibited here at the bottom of the web page. The posters are available for download to all FDA Science Forum registrants. The audience can e-mail their questions directly to the designated authors of the posters for their response from June 13th through July 13th, 2023.
View 2023 FDA Science Forum Posters
- Discuss FDA contributions to the evolving science of clinical, non-clinical, and post-market evaluation.
- Discuss how innovative approaches in evolving areas such as biomarkers, alternative methods for toxicity assessment, precision toxicology prediction, analytical chemistry, and advanced manufacturing may contribute to advances in regulatory decision-making and improve product quality and timeliness.
- Discuss how FDA leverages social and behavioral sciences to empower patients and consumers.
- Explain how AI and big data together can improve public health.
- Discuss scientific advances using the One Health approach to innovative and continuous surveillance of food and cosmetic safety.
- Discuss FDA’s intramural and extramural regulatory science research to support Medical Countermeasure’s (MCMs) and emerging technologies to reduce or eliminate pathogens from medical products. The presentations will discuss the application of innovative tools and approaches to support pandemic response, development, and evaluation of MCMs and the detection of emerging agents.
- Discuss how regenerative medicine and microbiome affect both individual and public health.
- Describe methods that scientists at FDA are using to study and combat problems associated with substances of abuse.
Day 1: June 13, 2023
Keynote Session
- Time:
- 9:00 am - 10:00 am ET
- Keynote Speaker:
- Deputy Director of Integrated Development, Bill & Melinda Gates Foundation, Dr. Murray Lumpkin, MD
| Time | Topics |
|---|---|
|
9:00 am - 9:05 am |
Introduction Sharron Watson - OSPD |
| 9:05 am - 9:15 am | Welcome FDA Chief Scientist, Namandjé N. Bumpus, PhD |
| 9:15 am - 9:30 am | Opening Remarks and Introduction of Keynote Speaker FDA Commissioner, Robert M. Califf, MD |
| 9:30 am - 10:00 am | Keynote Speaker Murray Lumpkin, MD, Deputy Director Integrated Development, Bill & Melinda Gates Foundation |
- 10:00 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:
- Ruth Barratt, PhD, DVM FDA Center for Drug Evaluation and Research (CDER)
| Time | Presentation | Speaker |
|---|---|---|
| 10:30 am - 10:50 am | Clinical Evidence and Medical Devices: Generating Actionable Evidence from the Real World | Mary Beth Ritchey, PhD FDA Center for Devices and Radiological Health (CDRH) |
| 10:50 am - 11:10 am | CDER/CBER Real-world Evidence Program | John Concato, MD FDA Center for Drug Evaluation and Research (CDER) |
| 11:10 am - 11:30 am | Real-world Evidence for Vaccine Effectiveness at FDA Center for Biologics Evaluation and Research | Richard Forshee, PhD FDA Center for Biologics Evaluation and Research (CBER) |
| 11:30 am - 12:00 pm | Real-world Evidence to Provide Supportive Evidence for Evaluating the Safety and Effectiveness of Therapeutic Products | Sebastian Schneeweiss, MD, ScD Harvard University |
| 12:00 pm - 12:30 pm | Panel Discussion and Q&A |
Sebastian Schneeweiss, MD, ScD |
Concurrent Session 2: Product Development Tools and Manufacturing
- Time:
- 10:30 am - 12:30 pm ET
- Chair / Moderator:
- Suzanne Fitzpatrick, PhD, FDA Center for Food Safety and Applied Nutrition (CFSAN)
| Time | Presentation | Speaker |
|---|---|---|
| 10:30 am - 11:00 am | Advancing Drug Discovery with Biofabricated 3D Tissue Models | Marc Ferrer, PhD NIH National Center for Advancing Translational Sciences (NCATS) |
| 11:00 am - 11:15 am | Advancing Translational Models and Tools into the Drug Review Process: Opportunities for Microphysiological Systems (MPS) | Kevin Ford, PhD FDA Center for Drug Evaluation and Research (CDER) |
| 11:15 am -11:30 am | Opportunities and Challenges in Using Liver Microphysiological Systems to Study Drug Metabolism and Hepatotoxicity | Qiang Shi, PhD FDA National Center for Toxicological Research (NCTR) |
| 11:30 am -11:45 am | Advanced Analytical Methods for Assessing the Efficacy of Regenerative Medicine Cellular Products | Kyung Sung, PhD FDA Center for Biologics Evaluation and Research (CBER) |
| 11:45 am - 12:00 pm | Additive Manufacturing: A Case Study in Advanced Manufacturing of Medical Devices | Matthew Di Prima, PhD FDA Center for Devices and Radiological Health (CDRH) |
| 12:00 pm - 12:15 pm | Enhancing Regulatory Toxicology Decision-making for Tobacco Products: The Role of Computational Toxicology Tools | Luis Valerio Jr., PhD FDA Center for Tobacco Products (CTP) |
| 12:15 pm - 12:30 pm | Panel Discussion and Q&A | Marc Ferrer, PhD Kevin Ford, PhD Qiang Shi, PhD Kyung, Sung, PhD Matthew Di Prima, PhD Luis Valerio Jr., PhD |
- 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:
- Kathryn LaRosa, MPH, FDA Center for Tobacco Products (CTP)
| Time | Presentation | Speaker |
|---|---|---|
| 1:30 pm - 2:00 pm | Discussion on Increasing the Diversity of Patient and Caregiver Engagement with the Center for Biologics Evaluation and Research on Food Allergy Drug Development |
Joey Mattingly, PharmD, PhD |
| 2:00 pm - 2:15 pm | Providing Information Needed to Make Decisions about COVID-19 Vaccines: Qualitative Testing of Educational Materials | Alexandria Smith, MSPH FDA Center for Drug Evaluation and Research (CDER) |
| 2:15 pm - 2:30 pm | Amplifying Equity of Voices: Empowering Patients and Consumers |
Julie Hsieh, PhD |
| 2:30 pm - 2:45 pm | FDA’s Closer to Zero Initiative: What Parents Can Do to Help Protect Children from Environmental Contaminants | Kellie Casavale, PhD FDA Center for Food Safety and Applied Nutrition (CFSAN) |
| 2:45 pm - 3:00 pm | Promoting Antimicrobial Stewardship in the Next Generation: Educational Projects Funded by the FDA’s Veterinary Laboratory Investigation and Response Network | Sarah Peloquin, DVM FDA Center for Veterinary Medicine (CVM) |
| 3:00 pm - 3:15 pm | A Patient-centered Approach Toward the Development of a Patient-reported Outcome Measure | Fraser Bocell, PhD FDA Center for Devices and Radiological Health (CDRH) |
| 3:15 pm - 3:30 pm | Panel Discussion and Q&A | Joey Mattingly, PharmD, PhD Alexandria Smith, MSPH Kellie Casavale, PhD Sarah Peloquin, DVM Fraser Bocell, PhD Kathryn LaRosa, MPH Julie Hsieh, PhD(OC/OMHHE) |
Concurrent Session 4: Tools to Effectively Use Big Data
- Time:
- 1:30 pm - 3:30 pm ET
- Chair / Moderator:
- Hesha Duggirala, PhD
FDA Center for Veterinary Medicine (CVM)
| Time | Presentation | Speaker |
|---|---|---|
| 1:30 pm - 2:00 pm | Securing Machine Endpoints in a Post-Quantum Operating Environment | Jose L. Arrieta Imagineeer |
| 2:00 pm - 2:10 pm | Reimagining Regulatory Data Submissions through Fast Healthcare Interoperability Resources (FHIR) | Jose Galvez, MD FDA Center for Drug Evaluation and Research (CDER) |
| 2:10 pm - 2:20 pm | Leveraging Large Datasets for the Development and Evaluation of New Artificial Intelligence (AI)-Enabled Medical Imaging Devices | Frank Samuelson, PhD FDA Center for Devices and Radiological Health (CDRH) |
| 2:20 pm - 2:30 pm | Using Genomic Data and Machine Learning to Study Antimicrobial Resistance in Foodborne Pathogens | Amy Merrill, MS Chih-Hao Hsu, PhD FDA Center for Veterinary Medicine (CVM) |
| 2:30 pm - 2:40 pm | Machine Learning and Case Identification in Claims Data | Ravi Goud, MD FDA Center for Biologics Evaluation and Research (CBER) |
| 2:40 pm - 2:50 pm | Using Machine Learning to Predict Non-compliance in the Global Food Supply: Improving Risk-informed Resource Allocation and Public Health Protection | Jeffrey Chou, MSPH FDA Center for Food Safety and Applied Nutrition (CFSAN) |
| 2:50 pm - 3:30 pm | Panel Discussion |
Steve Condrey, MPS Joshua Xu, PhD Yu Mei, PhD Hesha Duggirala, PhD (CVM) |
Day 2: June 14, 2023
Opening Remarks
- Time:
- 9:00 am - 11:00 am ET
| 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: Food and Cosmetic Safety
- Time:
- 9:00 am - 11:00 am ET
- Chairs / Moderators:
- Rajesh Nayak, PhD (NCTR)
| Time | Presentation | Speaker |
|---|---|---|
| 8:55 am - 9:00 am | Opening Remarks | Rokhsareh Shahidzadeh Office of Scientific Professional Development (OSPD), FDA |
| 9:00 am - 9:30 am | International Liaison Group for Methods on Risk Assessment of Chemicals (ILMERAC): Sharing Scientific Expertise in the Area of Methodologies for Chemicals in Food with National and International Risk Assessment Agencies across the Globe | Djien Liem, PhD European Food Safety Authority (EFSA), Parma, Italy |
| 9:30 am - 9:45 am | Progress and Needs for New Alternative Methods in CFSAN’s Regulatory Mission | Steven M. Musser, PhD FDA Center for Food Safety and Applied Nutrition (CFSAN) |
| 9:45 am - 10:00 am | Studies to Assess the Virulence of Enteric Foodborne Pathogens | Steven Foley, PhD FDA National Center for Toxicological Research (NCTR) |
| 10:00 am - 10:15 am | An Update on NCTR and Office of Cosmetics and Colors’ (OCAC) Collaborative Efforts to Support Cosmetics Safety Evaluation | Luísa Camacho, PhD FDA National Center for Toxicological Research (NCTR) |
| 10:15 am - 10:30 am | The US National Antimicrobial Resistance Monitoring System: Helping Ensure the Efficacy of Antibiotics | Patrick McDermott, PhD FDA Center for Veterinary Medicine (CVM) |
| 10:30 am - 11:00 am | Panel Discussion and Q&A | Djien Liem, PhD Steven M. Musser, PhD Steven Foley, PhD Luísa Camacho, PhD Patrick McDermott, PhD Rajesh Nayak, PhD (NCTR) |
Concurrent Session 6: Medical Countermeasures, Infectious Disease, and Pathogen Reduction Technologies
- Time:
- 9:00 am - 11:00 am ET
- Chairs / Moderators:
- Jenna Osborn, PhD (CDRH);
Monica (Burts) Young, PhD (CBER); and Mugimane Manjanatha, PhD (NCTR)
| Time | Presentation | Speaker |
|---|---|---|
| 9:00 am - 9:05 am | Introduction | Mugimane Manjanatha, PhD FDA National Center for Toxicological Research (NCTR) |
| 9:05 am - 9:25 am | Investing in the Future of Health Security | Sandeep Patel, PhD Biomedical Advanced Research and Development Authority (BARDA) |
| 9:25 am - 9:45 am | FDA ARGOS: Where Trusted Sequence Data Meets Quality by Design Approach | Vahan Simonyan, PhD, DSc Embleema and George Washington University |
| 9:45 am - 10:00 am | Assessing the Role of T-cell Responses in SARS-CoV-2 Protection | Marian Major, PhD FDA Center for Biologics Evaluation and Research (CBER) |
| 10:00 am - 10:15 am | Development of Regulatory Science Tools to Accelerate Development of Medical Devices in Public Health Emergencies | Jenna Osborn, PhD FDA Center for Devices and Radiological Health (CDRH) |
| 10:15 am - 10:30 am | Development of a Platform Approach to Model Neurotropic Viral Infections and Characterize the Therapeutics that Target Them | Daniela Verthelyi, MD, PhD FDA Center for Drug Evaluation and Research (CDER) |
| 10:30 am - 10:45 am | Evaluation of Testicular Organoids as a Model for Zika Virus Infection | Dayton Petibone, PhD FDA National Center for Toxicological Research (NCTR) |
| 10:45 am - 11:00 am | Panel Discussion / Q&A | Mugimane Manjanatha, PhD Sandeep Patel, PhD Vahan Simonyan, PhD, DSc Marian Major, PhD Jenna Osborn, PhD Daniela Verthelyi, MD, PhD Dayton Petibone, PhD |
- 11:00 am - 12:00 pm ET:
- Lunch
- 12:00 am - 2:00 pm ET:
- Concurrent Sessions 7 & 8
Concurrent Session 7: Advancing Products Based on Novel Technologies
- Time:
- 12:00 pm - 2:00 pm ET
- Chairs / Moderators:
- Julie Schneider, PhD
FDA Oncology Center of Excellence (OCE); and
Mugimane Manjanatha, PhD (NCTR)
| Time | Presentation | Speaker |
|---|---|---|
| 12:00 pm - 12:30 pm | Update on Personalized Cancer Vaccines | Catherine J. Wu, MD Dana-Farber Cancer Institute and Harvard Medical School |
| 12:30 pm - 12:45 pm | Use of Next Generation Sequencing (NGS) technologies in B-cell Receptor-Based Immunome Profiling and Minimal Residual Disease (MRD) Biomarker Discovery | Wenming Xiao, PhD FDA Center for Drug Evaluation and Research (CDER) |
| 12:45 pm - 1:00 pm | Host-Microbiome Crosstalk: Disruption of Gastrointestinal Barrier as Toxicity Assessment Tool | Sangeeta Khare, PhD FDA National Center for Toxicological Research (NCTR) |
| 1:00 pm - 1:15 pm | Regulatory Perspectives on Advancing Regenerative Medicine Products and Emerging Technologies | Carolyn Yong, PhD FDA Center for Biologics Evaluation and Research (CBER) |
| 1:15 pm - 1:30 pm | Dermal Drug Delivery via Dissolvable Microneedles: Formulation Variables Affecting Critical Quality Attributes (CQAs) | Nahid Kamal, PhD FDA Center for Drug Evaluation and Research (CDER) |
| 1:30 pm - 1:45 pm | Assessment of Trabecular Bone Stiffness Using Radiomics and Deep-learning Features | Qian Cao, PhD FDA Center for Devices and Radiological Health (CDRH) |
| 1:45 pm - 2:00 pm | Panel Discussion / Q&A | Catherine J. Wu, MD Wenming Xiao, PhD Sangeeta Khare, PhD Carolyn Yong, PhD Nahid Kamal, PhD Qian Cao, PhD Mugimane Manjanatha, PhD |
Concurrent Session 8: Substance Use, Misuse, and Addiction
- Time:
- 12:00 pm - 2:00 pm ET
- Chair / Moderator:
- Arit Harvanko, PhD
FDA Center for Tobacco Products (CTP)
| Time | Presentation | Speaker |
|---|---|---|
| 12:00 pm - 12:05 pm | Introduction | Marta Sokolowska, PhD FDA Center for Drug Evaluation and Research (CDER) |
| 12:05 pm - 12:35 pm | Abuse Liability Testing with Humans: Review of Standard Methods and Recent Innovations Using Cigarettes Varying in Nicotine Content as an Exemplar | Stephen T. Higgins, PhD University of Vermont |
| 12:35 pm - 12:45 pm | Field Deployable Analytical Toolkit for Rapid Analysis of FDA-Regulated Products at International Ports of Entry | LT Martin M. Kimani, PhD Office of Regulatory Affairs (ORA) |
| 12:45 pm - 12:55 pm | Blunt and Non-Blunt Cannabis Use Associated with Cigarette, E-Cigarette, and Cigar Initiation: Findings from the Population Assessment of Tobacco and Health Study | Heather L. Kimmel, PhD NIH National Institute on Drug Abuse (NIDA) |
| 12:55 pm - 1:05 pm | Leveraging Systems Modeling to Inform Policies on Opioids | Sara Eggers, PhD FDA Center for Drug Evaluation and Research (CDER) |
| 1:05 pm - 1:15 pm | Public Health Harms from Prescription Stimulant Diversion and Nonmedical Use | Rose Radin, PhD FDA Center for Drug Evaluation and Research (CDER) |
| 1:15 pm - 1:25 pm | Barriers to Prescribing Buprenorphine as a Medication for Opioid Use Disorder: Healthcare Providers’ Practices, Perspective, and Experiences | Matthew Walker, DrPH FDA Center for Drug Evaluation and Research (CDER) |
| 1:25 pm - 1:35 pm | Neonatal Opioid Withdrawal Syndrome: A Scientific and Regulatory Update | An Massaro, MD FDA Office of the Commissioner (OC) |
| 1:35 pm - 2:00 pm | Panel Discussion / Q&A | Marta Sokolowska, PhD Stephen T. Higgins, PhD LT Martin M. Kimani, PhD Heather L. Kimmel, PhD Sara Eggers, PhD Rose Radin, PhD Matthew Walker, DrPH An Massaro, MD Arit Harvanko, PhD |