Technical Event
FDA Policies and Procedures: What Academic Investigators and Small Business Should Know
29 January 2024 • 1:30 PM - 3:30 PM PST | Moscone Center, Room 50 (Lower Mezzanine South) 
1:30PM - 1:40PM:
Welcome and opening remarks

Session Chair:

Zane Arp
US. Food and Drug Administration (United States)

Zane Arp is the Director of the Division of Biomedical Physics (DBP) in The Office of Science and Engineering Laboratories (OSEL) Center for Devices and Radiological Health (CDRH) at the FDA. His divisions focus is developing regulatory science tools that accelerate patient access to innovative, safe, and effective medical devices through best in the world regulatory science. Research within his division has produced over 40 regulatory science tools in areas such as neurostimulation, cardiology, electrical safety, ophthalmology, in-vivo diagnostics, orthopedics, interoperability, and patient preference. Dr. Arp has a PhD in physical chemistry from Texas A&M University and 17 years of industry experience. Previously, Dr. Arp has worked at Los Alamos National Laboratories, NASA’s Johnson Space Control center at Wyle Laboratories, and GSK with a focus on developing sensor solutions for applications for space sciences, explosives, pharmaceuticals, and health care.

1:40PM - 2:00PM:
NIH perspectives

Bruce Tromberg
National Institutes of Health (United States)

Bruce Tromberg is the Director of the National Institute of Biomedical Imaging and Bioengineering (NIBIB) at the National Institutes of Health (NIH) where he oversees a portfolio of research programs focused on developing, translating, and commercializing engineering, physical science, and computational technologies in biology and medicine. In addition, he leads NIBIB’s Rapid Acceleration of Diagnostics (RADx Tech) program, a national initiative to increase SARS-COV-2 testing capacity and performance. His laboratory, the Section on Biomedical Optics (SBO) in the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), develops portable, bedside, non-contact, and wearable technologies for quantitative sensing and imaging of tissue composition and metabolism.

2:00PM - 2:20PM
Unlocking precision medicine in ophthalmology: achieving quantitative interoperability in retinal imaging to accelerate biomarker discovery and transform clinical trials

Eric Buckland
Translational Imaging Innovations (USA)

Quantitative imaging biomarkers are essential to advancing precision medicine within ophthalmology, providing objective insights into structural changes, disease progression, and treatment response. However, the path to their qualification and widespread adoption faces a significant hurdle: interoperability among imaging devices. In this presentation, we explore the role of industry standards and calibration phantoms in addressing the challenge of quantitative interoperability. We will review Maxwellian optics of the eye and implications for calibrating fundus cameras, OCT, and Adaptive Optics enabled retinal imaging systems. We explore how uniform and transparent calibrations can empower structural biomarker discovery and drive progress in ophthalmic clinical trials and personalized care.

Eric Buckland is the CEO of Translational Imaging Innovations, Inc (TII), where he is focused on intelligent data management solutions for quantitative imaging biomarker discovery in ophthalmology. Dr. Buckland pioneered handheld OCT systems for pediatric ophthalmology and microscope-integrated OCT systems for ophthalmic surgery. He earned his PhD in Optics at the University of Rochester, has been awarded more than 85 US patents, and is a Fellow of the American Institute for Medical and Biological Engineering.

2:20PM - 2:40PM
On the path towards standardized phantoms in photoacoustic imaging: prospects, challenges, and future directions

Lina Hacker
International Photoacoustic Standardisation Consortium, IPASC (United Kingdom)

International efforts to standardize emerging biomedical imaging approaches, such as photoacoustic imaging (PAI), require stable physical phantoms to enable routine quality control and robust performance evaluation across devices. Addressing this necessity, the International Photoacoustic Standardization Consortium (IPASC) has undertaken a consensus-finding exercise to establish recommendations for the properties of tissue-mimicking phantom materials and their characterization in the field of PAI. The manufacturing reproducibility of a stable copolymer-in-oil tissue-mimicking material fulfilling these recommendations was tested in an international multi-center study involving n=18 different partner sites. Here, the progress made toward these standardization efforts is outlined, highlighting prospects, challenges, and future trajectories.

Lina Hacker is a Junior Research Fellow at the Department of Oncology at the University of Oxford, UK. Her research is focused on the medical and technical validation of novel approaches for cancer imaging, specifically relating to tumour hypoxia. She received her PhD degree in Medical Sciences at the University of Cambridge, UK, developing novel test objects and materials for standardization of photoacoustic imaging systems. She holds a Master’s degree in Biomedical Engineering (RWTH Aachen, Germany) and a Bachelor’s degree in Molecular Medicine (University of Bonn, Germany).

2:40PM - 3:00PM
Leveraging industry-university partnerships to accelerate research translation

Crystal Leach
Industry University Research Centers, National Science Foundation (United States)

Crystal Leach joined the National Science Foundation as a Program Director in the Industry University Cooperative Research Center (IUCRC) program in 2021. Crystal is an Associate Professor of Practice in the School of Chemical, Materials and Biomedical Engineering at the University of Georgia. Crystal joined UGA as the founding Director of Industry Collaborations in 2016, working with faculty and administration to build industry partnerships that align with UGA’s research capabilities and strategic priorities. Previously, she spent 18 years in R&D at Kimberly-Clark, a Fortune 500 health and hygiene company, where she led engineering teams to develop and launch 25+ medical products globally. Crystal earned a bachelor’s degree in chemical engineering and a master’s in biomedical engineering at The University of Akron, then her doctorate in textiles and polymer science at Clemson University. She is a member of the Society of Women Engineers and the Society for Biomaterials and has presented at numerous conferences. She holds four U.S. and European patents; was named one of The University of Akron’s Distinguished Engineering Alumni in 2005; was elected as a Fellow to the American Institute of Medical and Biological Engineering in 2018; and was selected as a 2019 Women’s Leadership Fellow at UGA.

3:00PM - 3:30PM
Questions and final discussion