---

The FDA Grand Rounds is an educational presentation that is webcast monthly to highlight cutting-edge research underway across the Agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities. The 45-minute educational presentation is followed by questions from the audience. You can also view the presentation under Past Grand Rounds following the live webcast. #FDAGrandRounds.

The Development of Cellular-Level Structural and Functional Biomarkers of Eye Disease Enabled by Adaptive Optics

Thursday, November 18, 2021
12:00 p.m. - 1:00 p.m. EST
Webcast

About the Speakers

Daniel X. Hammer, PhD
Deputy Director
Division of Biomedical Physics (DBP)
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)

Daniel X. Hammer received a B.S. from Rensselaer Polytechnic Institute in 1991 and M.S. and Ph.D. from University of Texas in 1998 and 2001. He has over 25 years’ experience in the invention, development, and application of biomedical optics to a broad range of interdisciplinary research programs. Dr. Hammer has 15 patents and disclosures, >85 peer-reviewed publications, and several book chapters. He is an editor of the book Advances in Optical Imaging for Medicine. His current research interests include optical coherence tomography, adaptive optics, retinal imaging, vision science, and neuro-imaging. He is currently the Deputy Director of the Division of Biomedical Physics (FDA/CDRH/OSEL/DBP), a regulatory science research division at the Food and Drug Administration in Silver Spring, MD. He is a fellow of SPIE and AIMBE and a member of OSA and ARVO.

Zhuolin Liu, PhD
Visiting Scientist
Division of Biomedical Physics (DBP)
Office of Science and Engineering Laboratories (OSEL)
Center for Devices and Radiological Health (CDRH)

Zhuolin Liu received her B.S. and M.S. in optical engineering from China in 2007 and 2010, and a Ph.D. in vision science from Indiana University in 2016. She has over 10 years’ experience in the invention, development, and application of high-resolution biomedical optics in ophthalmology and vision science. Dr. Liu has more than 25 peer-reviewed publications, and several conference proceedings. Her current research area focuses on the development of innovative optical imaging methods, and technologies for use in disease diagnosis, monitoring, and treatment as well as other applications, particularly in ophthalmology, vision science and neuroscience. She is currently a visiting scientist at the Division of Biomedical Physics (FDA/CDRH/OSEL/DBP), a regulatory science research division at the Food and Drug Administration in Silver Spring, MD. She is a member of SPIE, ARVO, and OSA.

About the Presentation

Adaptive optics technologies allow assessment of retinal structure and function at the cellular and sub-cellular level. We will discuss how our adaptive optics regulatory science research program is designed to aid clinical translation via biomarker and clinical endpoint development.

---

Past Grand Rounds

2021

• Laboratory and Clinical Studies to Investigate Whether Ranitidine Converts to a Probable Carcinogen in Humans
• Immune System Responses to Therapeutic Proteins: Getting up close and personal
• SARS-CoV-2: Host-pathogen interaction, vaccines & variants of concern
• FDA's work with African Swine Fever from a policy and regulatory perspective 
• Project Orbis: Global Collaborative Oncology Review Program
• Electrical Safety in CTP Regulated Products
• Studies of SARS-CoV-2 NSP1 and Envelope Protein
• Research and Development of Radioanalytical Capabilities for Detection of Radionuclides in Food
• FDA Grand Rounds: The CORE Network (or How I Learned to Love Lettuce…)

2020

• Assessment of Safety and Efficacy of Fecal Microbiota for Transplantation Products
• Facial Coverings During the COVID-19 Pandemic: How well do they flatten the curve?
• Bioequivalence of Complex Topical Generics: In Vitro and In Vivo
• Advancing the Science of Real-World Data to Address the COVID-19 Pandemic
• Nanotechnology: Over a Decade of Progress and Innovation at FDA
• A Pandemic and a Call to Action for One Health: The FDA One Health Initiative
• Artificial Intelligence for Regulatory Science Research
• Analysis of Per and Polyfluoroalkyl Substances (PFAS) in foods- Analytical method development, challenges and successes
• Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology
• Detection of Transmissible Spongiform Encephalopathy Agents in Biological Products Using Protein Aggregation Assays
• Quality Control: Stopping infections before they happen through safer endoscope reprocessing

2019

• Vet-LIRN – How FDA’s Network of Veterinary Diagnostic Laboratories advance animal food safety and public health by conducting outbreak investigations and monitoring resistance in animal pathogens
• Technical and Logistical Considerations for Examining FDA-Regulated Products at International Mail Facilities using Handheld and Field-Portable Analytical Devices

• Why FDA authorized the marketing of the IQOS heated tobacco product as “appropriate for the protection of the public health”

• Overview of FDA's Perinatal Health Center of Excellence: Development and Validation of Predictive Systems

• Cyclospora Cayetanensis: The Crossroads Between Scientific Advances and Knowledge Gaps 

• Gaining Insight into the Patient’s Experience by Harnessing the Power of Social Listening and FDA Archival Data 

• Uncertainty is the only certainty there is: Potential approaches for making public health decisions

• The VICTRE trial: an in-silico replica of a clinical trial for evaluating digital breast tomosynthesis as a replacement for full-field digital mammography

2018

• Jerky Pet Treats and illness in dogs:  a collaborative approach to investigating a mysterious outbreak
• Decomposition of Seafood Products by Mass Spectrometry with Sensory-Driven Predictive Modeling
• The Science to Inform a Tobacco Product Standard for the Level of Nicotine in Combusted Cigarettes
• Bisphenol A: Toxicology and Pharmacokenetic Data to Inform Ongoing Safety Assessments
• How Simulation Can Transform Regulatory Pathways
• FDA's Predictive Toxicology Roadmap: Implications and Opportunities for Stakeholders
• Are Stem Cells Ready for Prime Time? A Look at FDA Research Advances in Regenerative Medicine
• Ethnicity- and Gender-Related Differences in Alzheimer's Disease

2017

• Assessing the Safety and Effectiveness of New and Emerging Therapeutic Ultrasound Technologies
• Developing a Mechanistic Model-Based Approach to Assess Cardiac Safety of New Drugs
• Genome Trakr: How a Large Network of Sequencing Laboratories is Transforming Food Safety and Public Health
• Serious and Actionable Risks, Plus Disclosure: investigating an Alternative Approach for Presenting Risk Information in Prescription Drug TV Ads
• Vaccine adjuvants: New ways to evaluate their safety and effectiveness
• Developing Regulatory Methods for Characterizing Nanomaterials in FDA-Regulated Products

2016

• The Host Response to Whooping Cough Infection and VaccinationExternal Link Disclaimer [Archived]
• Antibiotic resistance surveillance in the age of genomics: New answers to old questionsExternal Link Disclaimer [Archived]
• FDA Research into 3D Printing of its Regulated ProductsExternal Link Disclaimer [Archived]
• Rapid Screening of Dietary Supplements for Undeclared IngredientsExternal Link Disclaimer [Archived]
• Metabolomics and Proteomics Biomarkers: Discovery and Validation in Toxicity StudiesExternal Link Disclaimer [Archived]

Resources For You

• FDA's Predictive Toxicology Roadmap
• Don't Miss the CDC Public Health Grand Rounds