Workshop on Measurement Needs 

for Biofabrication of Tissue 

Engineered Medical Products

Thursday December 1, 2022

11:00 AM – 5:00 PM ET
Goal: discuss and identify measurement needs for

characterizing biofabricated, tissue engineered medical

products for clinical applications.

Scope: Biofabricated tissue-engineered constructs have the

potential to transform personalized medicine. However,

characterizing these constructs post-fabrication and

throughout preclinical use remains challenging. We will hold a

one-day workshop on measurement needs for biofabricated

constructs that contain cells, focusing on metrology for the

structure of the constructs, cell viability in the constructs, and

functional capacity of the constructs. This workshop will

enable future research directions, standards development,

and the adoption of these constructs for clinical use.

https://www.nist.gov/news-events/events/2022/12/workshop-measurement-needs-biofabricationtissue-engineered-medical

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10:00 AM – 11:00 AM Login to BlueJeans and Test System

11:00 AM – 11:10 AM Welcome Address: Sheng Lin-Gibson, NIST

11:10 AM – 11:45 AM Plenary: Jennifer H. Elisseeff, Johns Hopkins University

Manufacturing complex biologics for regenerative medicine 

Session 1: Cell Viability

Discussion leader: Alicia Henn, BioSpherix

11:55 AM – 12:05 PM Naresh Menon, ChromoLogic

Non-invasive non-contact real-time monitoring of cells within bioreactors by direct imaging with optical coherence tomography

12:05 PM – 12:15 PM Mrignayani Kotecha, O2M Technologies 

Nondestructive Cell Viability Assessment Using Oxygen Imaging 

12:15 PM – 12:25 PM Carl G. Simon, Jr., NIST

Optical coherence tomography imaging for label-free measurement 

of cell viability in scaffolds

12:25 PM – 12:55 PM Panel discussion

12:55 PM – 1:25 PM Lunch

Session 2: Cell Phenotype

Discussion leader: Jeff Halpern, University of New Hampshire

1:25 PM – 1:35 PM Marc Ferrer, National Center for Advancing Translational Sciences

Advancing Drug Discovery with Biofabricated 3D Tissue Models

1:35 PM – 1:45 PM Marcie Black, Advanced Silicon Group

Protein sensing

1:45 PM – 1:55 PM Kersti Alm, Phase Holographic Imaging 

Non-invasive quantitative live cell imaging 

1:55 PM – 2:25 PM Panel discussion

2:25 PM – 2:35 PM Break

Session 3: Tissue Characterization

Discussion leader: Nathan Castro, Nanochon Inc.

2:35 PM – 2:45 PM Rohan Shirwaiker, North Carolina State University

Dielectric spectroscopy for in line monitoring of engineered tissue 

constructs

2:45 PM – 2:55 PM Adam Feinberg, FluidForm

In situ volumetric imaging and analysis of 3D bioprinted constructs 

using optical coherence tomography

2:55 PM – 3:05 PM Bao-Ngoc Nguyen, U.S. Food and Drug Administration

Characterization of Tissue Engineered Medical Products

3:05 PM – 3:35 PM Panel Discussion

3:35 PM – 3:45 PM Break

3:45 PM – 3:55 PM Workshop Survey Review, Carl Simon, NIST

Technical Program

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Discussion leader: Greta Babakhanova, National Institute of Standards and Technology (NIST)
Technical Program

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Breakout Session

Topics: Moderators:

1. Potency & phenotype measurements Richard McFarland, ARMI*

2. Cell viability measurements Mary Clare McCorry, ARMI*

3. Measurements of construct structure Kimberlee Potter, VA§

Leanne Friedrich, NIST#

4. pH, O2 & metabolite measurements Zeeshan Ahmed, NIST#

Billyde Brown, GTMI^

5. Mechanical property measurements Callie Higgins, NIST#

6. Sterility measurements Kirsten Parratt, NIST#

7. Measurements of cell distribution in constructs Taneka Jones, Vericel

8. Measurements of raw materials Rohan Shirwaiker, NC State University

9. Scaffold reference material Dawn Henke, Standards Coordinating Body

10. Tissue mimics Lexi Garcia, ARMI*

11. Tissue reference data Kaiming Ye, Binghamton University

3:55 PM – 4:35 Breakout session

Closing Session

4:35 PM – 4:55 Report back

4:55 PM – 5:00 PM Closing remarks

Greta Babakhanova, NIST

*ARMI – Advanced Regenerative Manufacturing Institute

§ VA – United States Department of Veterans Affairs

#NIST – National Institute of Standards and Technology

^GTMI – Georgia Tech Manufacturing Institute
Guillermo Ameer Northwestern University

Greta Babakhanova National Institute of Standards and Technology

Leanne Friedrich National Institute of Standards and Technology

Dawn Henke Standards Coordinating Body

Callie Higgins National Institute of Standards and Technology

Jay Hoying Advanced Solutions Life Sciences

John Huang TheWell Bioscience, Inc.

Taneka Jones Vericel Corporation

Mary Clare McCorry Advanced Regenerative Manufacturing Institute

Marian Piekarczyk Thermo Fisher Scientific

Laura Pierce National Institute of Standards and Technology

Kimberlee Potter U.S. Department of Veterans Affairs

Itedale Namro Redwan CELLINK

Jane Romantseva National Institute of Standards and Technology

Jonathan Seppala National Institute of Standards and Technology

Rohan Shirwaiker North Carolina State University

Carl G. Simon, Jr. National Institute of Standards and Technology

Workshop Steering Committee

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Workshop Participants

(Alphabetical Order)

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Dr, Zeeshan Ahmed is currently a project leader in the Sensor Science Division at NIST

where his research activities focus on the development of novel, disruptive technologies

that aim to replace legacy-based measurement platforms. Specifically, his current

research is focused on the development of physics constrained machine learning models

for photonic and quantum sensors. This line of inquiry seeks to enable a cost-effective,

integrated multi-functional sensor package with intelligent-calibration capabilities. He

currently serves as Chairman of Task group on Emerging Technologies under Contact

Thermometry at the Bureau International des Poids et Mesures (BIPM). In addition, he holds

an Affiliate Faculty position with George Mason University’s Chemistry department and the

Quantum Science and Engineering Center (QSEC). His background includes work in data

analytics, nanophotonics, Terahertz spectroscopy of biomaterials and pharmaceuticals,

surface enhanced deep UV resonance Raman spectroscopy, and time-resolved vibrational

spectroscopy of proteins. He received his PhD from University of Pittsburgh and BSc from

George Mason University.

Zeeshan Ahmed, Ph.D.

Chemist, Project Leader

National Institute of Standards and Technology

zeeshan.ahmed@nist.gov

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Dr. Alm has cooperated with PHI since 2005 and is a vital part of the PHI team since 2009.

All insights gained through her PhD studies at Lund University, Sweden, her postdoc time at

Roswell Park, Buffalo, NY, and the years after that working as a researcher and lecturer at

Lund University, have been applied in the development of a genuinely novel cell analysis

system. Her focus has been to develop a method that will neither cause cell stress nor harm

while also providing accurate kinetic data. This goal has been reached both through inhouse studies and collaborations as well as joint publications with researchers around the

world, e.g., at Malmö and Lund universities, Northeastern University in Boston, UCSF in

California, and many more.

Digital holographic imaging has existed as a brainchild since the '70s. Now, it is a reality

since computers became powerful enough to handle the algorithms required to

reconstruct the hologram of an imaged object – or even living cell cultures. PHI has proudly

been part of this development and today advances cutting-edge research by applying

digital holography to cell-based science.

Kersti Alm, Ph.D.

Chef Scientific Officer 

Phase Holographic Imaging (PHI) 

kersti.alm@phiab.se

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Non-invasive quantitative live cell imaging 

Abstract: Cells that will be used for clinical applications need to go through rigorous quality

controls before being administered to patients. Many analyses require sacrificing parts of

the precious sample and removing the sample from the production line. Label-free cell

phenotype measurements can contribute to a wide scope of cell health and quality

controls without losing any part of the sample and removing the sample from the product

line. Digital holography is a label-free, robust, minimally destructive imaging method for cell

analysis. The cells can stay in their preferred cell carriers in their preferred environment

while being monitored continuously. The resulting quantitative data can be used for cell

health controls, proliferation and viability measurements, differentiation monitoring, and

even release criteria. My talk will briefly describe digital holography and how relevant cell

phenotype data can be extracted.
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Dr. Ameer is the Daniel Hale Williams professor of Biomedical Engineering and Surgery in

the Biomedical Engineering Department at the McCormick School of Engineering and the

Department of Surgery at the Feinberg School of Medicine, Northwestern University. He is

the founding director of the Center for Advanced Regenerative Engineering (CARE). His

research interests include regenerative engineering, biomaterials, additive manufacturing

for biomedical devices, controlled drug delivery and bio/nanotechnology for therapeutics

and diagnostics.

Dr. Ameer’s laboratory pioneered the development and tissue regeneration applications of

citrate-based biomaterials (CBB), the core technology behind the innovative bioresorbable

orthopaedic tissue fixation devices CITREFIXTM, CITRESPLINETM, and CITRELOCKTM,

which were recently cleared by the FDA for clinical use and marketed worldwide. CBBs are

the first thermoset synthetic polymers used for implantable biodegradable medical

devices. The co-founder of several companies, Dr. Ameer has over 300 publications and

conference abstracts and 65 patents issued and pending in 9 countries.

His awards include the Key to the City of Panama, the Society for Biomaterials (SFB)

Clemson Award for Contributions to the Literature, the SFB Technology Innovation and

Development Award, the Chinese Association for Biomaterials Global Biomaterials

Leadership Award, the Tissue Engineering and Regenerative Medicine Society Innovation

and Commercialization Award, and the Bioactive Materials Lifetime Achievement Award.

Dr. Ameer is a member of the National Academy of Medicine, and a Fellow of the American

Institute of Medical and Biological Engineering (AIMBE), Fellow of the Biomedical

Engineering Society, Fellow of the AIChE, Fellow of the American Association for the

Advancement of Science (AAAS), Fellow of the Materials Research Society, and Fellow of

the National Academy of Inventors. Dr. Ameer is a Deputy Editor for the AAAS journal

Science Advances, Associate Editor for the Regenerative Engineering and Translational

Medicine journal, a member of the board of directors of the Regenerative Engineering

Society and AIMBE, and chair of the AIMBE College of Fellows.

Guillermo A. Ameer, Ph.D.

Daniel Hale Williams Professor

Northwestern University

g-ameer@northwestern.edu
Dr. Greta Babakhanova is a Physicist in the Biomaterials Group at the National Institute of

Standards and Technology (NIST). She completed her Ph.D. in Chemical Physics from the

Advanced Materials and Liquid Crystal Institute, Kent State University in 2019. She is a

recipient of the 2020 Glenn H. Brown Prize awarded by The International Liquid Crystal

Society for her outstanding contribution to the science of liquid crystals. After graduation,

she was awarded the NIST-NRC Postdoctoral Research Fellowship (2019-2021) which

enabled her to work on cell viability projects at NIST. Her current primary technical

objective is to develop robust non-destructive methods for characterization of tissue

engineered medical products. Since April 2022 Dr. Babakhanova is also working in the

Program Operations Division at the Office of Advanced Manufacturing, where she assists

with the program management of NIST-funded initiatives.

Greta Babakhanova, Ph.D.

Physicist

National Institute of Standards and Technology

greta.babakhanova@nist.gov

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Dr. Marcie Black is the co-inventor of the silicon nanowire array biosensor. Dr. Black brings

expertise in building strong teams, managing development projects, patents, IP strategy,

encouraging a healthy company culture, cost modeling, and running a startup. Prior to

founding ASG, Marcie was the co-founder of Bandgap Engineering, which focused on

lowering the cost of solar electricity through black silicon or silicon nanowire solar cells.

Bandgap raised over $10 million of investment from VCs, angels, state, and national grants.

In 2009, she was awarded an R&D 100 award for her contributions to work at LANL. Marcie

also was honored as one of the ten “Women-to-Watch in 2010” by Mass High Tech.

Marcie Black, Ph.D.

Co-founder & CEO, 

Advanced Silicon Group

marcie@advancedsilicongroup.com

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Protein Sensing

Abstract: Dr. Black will discuss basic methods for measuring cell phenotype – especially

proteins – and review some of the advantages and challenges for these. Then she will

present the photoelectric ELISA biosensor, LightSense. LightSense will be able to detect a

wide range of protein concentrations, monitor multiple proteins simultaneously, and

measure proteins at low-concentrations even when submerged in a high-concentration of

another protein and do so at a low-cost. Lastly, Dr. Black will point out a few other

technologies that she finds promising to meet the market need for sensing.
Dr. Billyde Brown is a Senior Research Faculty and Education and Workforce Development

(EWD) Director at the Georgia Tech Manufacturing Institute (GTMI), one of eleven

interdisciplinary research institutes at the Georgia Institute of Technology. Dr. Brown’s

overall role is to create strong partnerships among industry, government, and academia in

the area of manufacturing research, development, and deployment, while acquiring and

managing sponsored research programs.

Dr. Brown is currently the PI of an Advanced Regenerative Manufacturing Institute (ARMI

BioFabUSA) funded project to develop a wireless sensor system for real-time in-situ

monitoring of critical quality attributes including pH, glucose, lactate, and protein

biomarkers in human mesenchymal stem cell expansion bioreactors. Dr. Brown manages a

Manufacturing Certificate program and proctors a Manufacturing Seminar Course for the

Georgia Tech College of Engineering while hosting a 10-week GTMI Lunch and Learn

Lecture Series each semester with high profile industry, government, and academic

speakers to share advanced manufacturing knowledge within a global community. Dr.

Brown also coordinates an annual 10-week Research Experience for Undergraduates (REU)

summer program called REVAMP (Research Experiences for student Veterans in Advanced

Manufacturing and entrePreneurship) sponsored by the National Science Foundation that

maintains target demographics of 50% student veterans and 40% underrepresented

minorities with STEM majors. Dr. Brown has strong expertise in several technical areas

including electrochemical biosensors, nanomaterial synthesis and characterization, thinfilm additive manufacturing, and electrochemical energy storage. Dr. Brown has over 20

peer-reviewed publications and is a regular reviewer of high impact factor peer reviewed

journals. He earned his B.S. and Ph.D. degrees in Electrical Engineering from NC State

University and Duke University, respectively.

Billyde Brown, Ph.D.

Senior Research Faculty, EWD Director

Georgia Tech Manufacturing Institute

billyde.brown@gatech.edu

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Dr. Nathan J. Castro is an experienced biomedical researcher and entrepreneur. He has

assisted in the design, testing, regulatory approval and clinical translation of 3D printed

medical devices, as well as co-founded Nanochon, Inc. He is skilled in policy analysis, life

sciences, data analysis, and quantitative research with particular interest in clinical

translational (bench-to-bedside).

Nathan J. Castro, Ph.D.

Co-founder

Nanochon, Inc. Inc.

nathan.castro@nanochon.com

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Dr. Elisseeff is the Morton Goldberg Professor and Director of the Translational Tissue Engineering Center at

Johns Hopkins Department of Biomedical Engineering and the Wilmer Eye Institute with appointments in

Chemical and Biological Engineering, Materials Science and Orthopedic Surgery. She was elected a Fellow of

the American Institute of Medical and Biological Engineering, the National Academy of Inventors, a Young

Global Leader by World Economic Forum. In 2018, she was elected to the National Academy of Engineering

and National Academy of Medicine and in 2019 she received the NIH Directors Pioneer Award. In 2022, she

was elected a fellow of the American Association of Arts and Sciences.

Jennifer received a bachelor’s degree in chemistry from Carnegie Mellon University and a PhD in Medical

Engineering from the Harvard–MIT Division of Health Sciences and Technology. Later she was a Fellow at the

National Institute of General Medical Sciences, Pharmacology Research Associate Program, where she

worked in the National Institute of Dental and Craniofacial Research. She is committed to the translation of

regenerative biomaterials and has founded several companies and participates in several industry advisory

boards including appointment by the governor to the State of Maryland’s Technology Development

Corporation. Dr. Elisseeff’s laboratory has developed technologies licensed to startups, small and large

companies. Lab-grown products have reached clinical testing as drugs, biologics, and devices in orthopedics,

plastic and reconstructive surgery and lab is now running a Phase 2 clinical trial. She has served on an FDA

panel and presented products to the FDA.

Jennifer’s initial research efforts focused on the development of biomaterials for studying stem cells and

designing regenerative medicine technologies for application in orthopedics, plastic and reconstructive

surgery, and ophthalmology. Clinical results revealed the importance of the immune response in the

biomaterial and regenerative medicine responses. This led to a significant shift in research efforts to

biomaterials-directed regenerative immunology and leveraging the adaptive immune system to promote

tissue repair. The group is now characterizing the immune and stromal environments of healing versus nonhealing wounds and tumors. Biomaterials are now being applied to model and manipulate tissue

environments and studying the impact of systemic and environmental factors such as aging and senescent

cells, sex differences, and infection/microbiome changes on tissue homeostasis and repair. She has

extensively published and lectured nationally and internationally on these topics.

Jennifer H. Elisseeff, Ph.D.

Morton Goldberg Professor

Director of the Translational Tissue Engineering Center 

Johns Hopkins University

jhe@jhu.edu

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Manufacturing complex biologics for regenerative medicine

Abstract: Tissue repair is a coordinated process that includes multiple immune and stromal cells working in

concert to remove damage and rebuild matrix. Therapies that target multiple cell types and pathways in the

repair process, and combination therapies, will likely be most effective in rebuilding tissue. Complex products

such as biological scaffolds derived from the extracellular matrix (ECM) of tissues contain many components

that can more broadly target the network of cells that promote wound healing. New regenerative

immunotherapies derived from helminth soluble egg antigens contain a multitude of proteins and lipids that

together stimulate tissue repair. Without a single agent mechanism of action, these complex products can be

difficult to characterize with

respect to variability in batch-to-batch composition and biological activity. This presentation will discuss

regenerative immunotherapies with complex composition and methods for screening efficacy and product

development.
Dr. Adam Feinberg is Co-Founder and CTO of FluidForm Inc, a start-up company

commercializing FRESH 3D bioprinting technology, and a Professor at Carnegie Mellon

University in the departments of Biomedical Engineering and Materials Science & Engineering.

He earned his BS in Materials Science & Engineering from Cornell University in 1999 with Co-op

experience at Abiomed, Inc., working on total artificial hearts. He then earned his PhD in

Biomedical Engineering from the University of Florida, focused on engineering cell-material

interactions to prevent and enhance adhesion. This was followed by postdoctoral training at

Harvard University, developing new biomaterials and stem cell-based cardiac tissue engineering

strategies.

Dr. Feinberg has co-authored over 50 peer-reviewed publications, holds over 20 US patents and

patent applications, and has received multiple honors including the NSF CAREER Award, the NIH

Director’s New Innovator Award, and Fellow of the American Institute for Medical and Biological

Engineering. A primary research focus is engineering extracellular matrix (ECM) protein scaffolds

using advanced biomanufacturing and 3D bioprinting approaches for multiple applications

including cancer models, regenerative scaffolds, skeletal muscle, and cardiac muscle tissue

engineering. At FluidForm, he is driving the commercialization of the FRESH 3D bioprinting

platform for a wide range of applications in the pharma, medical device, and regenerative

medicine industries.

Adam Feinberg, Ph.D.

Co-Founder and Chief Technology Officer 

FluidForm Inc,

adam@fluidform3d.com

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In situ volumetric imaging and analysis of 

3D bioprinted constructs using optical coherence tomography

Abstract: As 3D bioprinting has grown as a fabrication technology, so too has the need for

improved analytical methods to characterize engineered constructs. This is especially

challenging for engineered tissues composed of hydrogels and cells, as these materials readily

deform when trying to assess print fidelity and other properties non-destructively. Establishing

that the 3D architecture of the bioprinted construct matches its intended anatomic design is

critical given the importance of structure-function relationships in most tissue types. I will

present the development of a multimaterial bioprinting platform with integrated optical

coherence tomography for in situ volumetric imaging, error detection, and 3D reconstruction.

This enables quantitative 3D volumetric imaging with micron resolution over centimeter length

scales, the ability to detect a range of print defect types within a 3D volume, and real-time

imaging of the printing process at each print layer. These advances provide a comprehensive

methodology for print quality assessment, paving the way toward the production and process

control required for achieving regulatory approval and ultimately clinical translation of

engineered tissues.
Dr. Ferrer is the Director of the National Center for Advancing Translational Sciences

(NCATS) 3D Tissue Bioprinting Laboratory, a multidisciplinary group with the goal of

creating, validating, and using 3D bioengineered tissues for disease modeling and drug

discovery and development. Previously, Marc was a Team Lead at the NIH Chemical

Genomics Center working on the discovery of small molecule probes to study protein

function. Before joining NIH, he was Director of Assay Development and High Throughput

Screening at the Department of Automated Biotechnology at the Merck Research

Laboratories. Marc received a BSc degree in Organic Chemistry from the University of

Barcelona, and a Ph.D. degree in Biological Chemistry from the University of Minnesota.

Marc Ferrer, Ph.D.

Director, 3-D Tissue Bioprinting Laboratory

National Center for Advancing Translational Sciences

marc.ferrer@nih.gov

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Advancing Drug Discovery with Biofabricated 3D Tissue Models

Abstract: The NCATS 3D Tissue Bioprinting Laboratory (3DTBL) is a multidisciplinary

laboratory with experts in bioengineering, assay development, HTS, automated biology and

cell microscopy with the goal of creating a versatile and robust platform of biofabricated 3D

tissue models for drug screening. We are assembling a portfolio of biofabricated normal

and disease 3D tissue models that recapitulate faithfully the morphology, physiology and

pathology of human tissues. These biofabricated 3D tissue models are produced in a

multiwell-plate format with disease relevant phenotypic assays to quantitatively assess

drug efficacy and toxicity. The expectation is that these physiologically relevant 3D tissue

models will be clinically predictive cellular assays for drug discovery and development.
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Dr. Leanne Friedrich (she/her) is a materials scientist at the National Institute of Standards

and Technology working on embedded 3D printing of soft materials. Leanne earned a B.S.

in materials science and engineering from Northwestern University in 2015. She earned a

Ph.D. in materials from University of California Santa Barbara in 2020, developing methods

to 3D print polymer matrix composites with controlled property gradients using direct ink

writing with acoustophoresis. She joined NIST in 2020 as an NRC postdoc. Leanne's work

focuses on developing guidelines for material selection and printing parameter selection in

embedded 3D printing. By examining how the rheology of the ink, rheology of the support,

and interfacial tension influence defects in printed structures, we can achieve more reliable

prints with better shape fidelity, mechanical integrity, and functional properties. Leanne

uses computational fluid dynamics simulations in OpenFOAM to study the underlying

physics of the printing process, and she uses in-situ imaging experiments to measure

defects in printed structures.

Leanne Friedrich, Ph.D.

Material Scientist

National Institute of Standards and Technology 

leanne.friedrich@nist.gov
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Lexi Garcia is the Director of Strategic Projects at the Advanced Regenerative

Manufacturing Institute (ARMI) | BioFabUSA. As such she is responsible for coordinating and

leading cross-functional teams to drive key project activities to help shape the long-term

vision of the company. She leads ARMI | BioFabUSA’s strategic standards initiatives, which

includes guiding both ARMI members and other tissue engineered medical product (TEMP)

subject matter experts through the standards development process, particularly those

related to bioprinting. Lexi has a wide TEMP network and works to facilitate connections

between key stakeholders throughout the tissue engineering community to enable

partnerships that will propel the field forward. With degrees in Neuroscience from

Middlebury College, and Conservation Biology and Sustainable Development from the

University of Maryland, College Park (UMD) she has a unique systems perspective and

approach to nurturing the tissue engineering ecosystem to garner consensus and improve

collaborative efforts.

Lexi Garcia, M.S.

Director of Strategic Projects 

Advanced Regenerative Manufacturing Institute (ARMI)

lgarcia@armiusa.org
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Prof. Jeffrey M. Halpern (he/him) earned his PhD in Chemical Engineering in 2010 at Case

Western Reserve University in Chemical Engineering. Halpern pursued a first postdoc

(2011-2012) funded through an NIH NRSA fellowship at Case Western Reserve University in

Biomedical Engineering and a second postdoc through Fulbright and Lady Davis

Fellowships (2013-2014) in Israel at the Technion in the Department of Chemical

Engineering. He joined the Department of Chemical Engineering at the University of New

Hampshire. Recently, Halpern leads an NSF EPSCoR Track II (#2119237) team the

development of “universal” biotechnology sensing platforms to enable the use of

advanced manufacturing principles in biomanufacturing. As a collaboration across four

states, NH, AL, ME, and WY, we aim to develop engineering principles to guide on-demand

biosensor design covering the full assortment of sensor components: the recognition

elements that bind analytes; the stimuli-responsive linkers that amplify the binding signal;

the form factor of the sensor; and the final transduction of the signal. You can read more

about our team here.

Jeffrey Halpern, Ph.D.

Associate Professor

University of New Hampshire

Jeffrey.Halpern@unh.edu
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Dr. Dawn Henke has extensive experience in the advanced biological sciences and has

played an active role in the regenerative medicine community throughout her career. Prior

to joining SCB, she worked as a post-doctoral fellow at the National Institutes of Health,

National Eye Institute performing stem cell research focused on developing retinal

organoids from stem cells for testing and therapeutic purposes. She holds a PhD in

Genetics and Genomic Sciences from the University of Alabama at Birmingham. As Senior

Technical Program Manager, Dawn is the supervisor of the program manager team and

acts as a liaison between the program managers and the executive director.

Dawn Henke, Ph.D. 

Senior Technical Program Manager

Standards Coordinating Body (SCB)

dhenke@regenmedscb.org
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Alicia D. Henn PhD MBA is Chief Scientific Officer for BioSpherix, Ltd. Previously, Dr. Henn

was an academic researcher in the cancer and immunology fields. Dr. Henn owns the In

Vitro Reproducibility and Physiologic Cell Manufacturing groups on LinkedIn, promoting

clonable, physiologically relevant cell environments for better scientific reproducibility and

translatability.

Alicia Henn, Ph.D., MBA

Chief Scientific Officer

BioSpherix, Ltd.

ahenn@biospherix.com
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Dr. Callie Higgins is the Co-Project Leader of the Photopolymer Additive Manufacturing

(PAM) Project at the National Institute of Standards and Technology (NIST) in Boulder, CO

and is an adjunct faculty at the Colorado School of Mines. Her work with Co-Project Leader,

Jason Killgore, studying the fundamental properties of PAM systems was recently the sole

awardee of one of the Federal Government's highest honors, the Samuel J. Heyman

Service to America Medal (SAMMIES) for Emerging Leaders. She graduated with her PhD

from CU Boulder's Department of Electrical Engineering with specialties in optics and

material science where she characterized the fundamental properties of photopatterned

hydrogels for use in regenerative medicine. Outside of the lab, she loves to adventure

around the mountains; skiing, hiking, and picnicking the whole way up with her husband,

friends, and family.

Callie Higgins, Ph.D.

Materials Engineer, Co-Project Leader

National Institute of Standards and Technology 

callie.higgins@nist.gov
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Dr. James (Jay) Hoying is a Partner and Chief Scientist at Advanced Solutions Life Sciences

with more than 30 years of experience in basic and applied biological sciences with a focus

in tissue biology, tissue vascularization, and tissue fabrication. Prior to joining ASLS, he was

Professor and Chief of the Division of Cardiovascular Therapeutics at the Cardiovascular

Innovation Institute (CII) where he developed a broad background in tissue fabrication, cell

therapeutics, and translation of discoveries to industry and the clinic. Dr. Hoying is an

inventor of the AngiomicsTM microvessel technology and holds numerous patents related

to vascularizing tissues and related cell-based therapies. Dr. Hoying received his BA and

MS degrees in Biology and Molecular Biology from Case Western Reserve University and

his PhD in Cardiovascular Physiology, with an emphasis on the microcirculation, from the

University of Arizona. Following degree work, Dr. Hoying served as a New Investigator in

the National Institutes of Health Program of Excellence in Molecular Biology of the Heart

and Lung (POEMB). He currently serves on the Editorial staff of national scientific journals

and reviews for individual and program grant proposals for the National Institutes of Health,

the Veterans Affairs, the American Heart Association, and international funding agencies.

Dr. Hoying is also a Fellow of the American Heart Association.

James (Jay) Hoying, Ph.D. 

Partner and Chief Scientist

Advanced Solutions Life Sciences

jhoying@advancedsolutions.com
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Dr. John Huang is an inventor and entrepreneur in advanced biomedicine and bioengineering with a number of patented technologies. He is actively involved in product

development and commercialization with great enthusiasm for novel biotechnologies and

their influences on the life science industry. John is the founder and CEO of TheWell

Bioscience, Inc., a pioneer in the 3D biomimicking platform for precision medicine, cell

therapy, and biomanufacturing. The company uses its state-of-art biomatrix system to

closely mimic the natural extracellular matrix of the human microenvironment and

establish a robust 3D cell culture platform and smart delivery system to advance drug

discovery, tissue engineering, cell therapy, and personalized medicine. The company

received multiple awards, including Most Innovative 3D Hydrogel System in 2020

Healthcare & Pharmaceutical Awards, Listed as #1 of 8 Top 3D Bioprinting Startups

Impacting The Biotechnology Industry, and Leading Innovators in Cell Therapy Research

2021 Healthcare & Pharmaceutical Awards. John served as an editorial board member and

ad-hoc reviewer of 11 academic journals. He is the recipient of the Anheuser-Bush

fellowship, the research foundation award, and 22 new ingenuity awards.

John Huang, Ph.D.

Founder & Chief Executive Officer

TheWell Bioscience, Inc

johnh@thewellbio.com
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Dr. Taneka Jones is a visionary and inventor. Inspired by her ancestors, education is highly

valued. She received a Ph.D. and a Master of Science Degree in Bioengineering from the

University of Illinois-Chicago. Additionally, she holds a M.A in Teaching and earned a B.S. in

Biological Sciences with a minor in Chemistry.

Dr. Jones served as a licensed professional educator with Chicago Public Schools while

completing her graduate studies, and credits her continued success to her faith, which is

her guidepost. In her current role as a Medical Science Liaison, she interfaces between

academia and industry for an FDA-approved cell therapy product. A rising entrepreneur,

her research consulting company Biopraise seeks to educate, motivate, and empower

students, educators, administrators, and biotechnology stakeholders. She has designed

and implemented three entry-level programs in the science, technology, engineering, and

mathematics (STEM) fields to enhance and empower youth in disadvantaged areas to

reach this goal. Her five favorite hobbies include international travel, outdoor adventures,

middle- and long-distance running, watching documentaries and enjoying a great cup of

coffee.

Taneka Jones, Ph.D.

Medical Science Liaison

Vericel Corporation

tjones@nsbe.org
Dr. Mrignayani Kotecha is a founding member and the president of Chicago-based biotech

company O2M Technologies, LLC. In this role, Dr. Kotecha provides guidance and leadership for

developing the world’s first EPR oxygen imaging preclinical and clinical instruments, accessories,

synthesis of oxygen-sensitive spin-probes, scientific research, fundraising, and outreach. She leads

the “Oxygen Measurement Core” research facility at O2M that performs cutting-edge research

involving oxygen imaging in cancer and regenerative medicine. Dr. Kotecha holds a Ph.D. in Physics

from Jabalpur University, India and has over 25 years of experience in magnetic resonance

technologies. She has published over fifty peer-reviewed articles and is the lead editor of the 2017

Wiley book “Magnetic Resonance Imaging in Tissue Engineering”.

Mrignayani Kotecha, Ph.D. 

President

O2M Technologies, LLC

mk@oxygenimaging.com

26

Nondestructive Cell Viability Assessment Using Oxygen Imaging 

Abstract: Cell viability is an essential parameter for cell therapy, tissue engineering, drug screening,

and many other biological processes and products. These products rely on viable, healthy, and

functional cells to work as intended for solving various medical conditions, such as cancer, type I

diabetes, arthritis, liver, kidney, bone damage, neurodegenerative, cardiovascular damage, etc.

However, current methods that rely on assays to measure cell viability are destructive and

inadequate for three-dimensional tissues. Besides, these methods do not assess cell functionality, a

key parameter for cell therapy and tissue engineering medical products. In addition, these methods

have not been tested for their interference with biomaterials commonly used in the field, therefore,

may provide an inaccurate assessment when used with artificial tissue grafts involving scaffolds.

Electron paramagnetic resonance oxygen imaging (EPROI) is a noninvasive oxygen mapping

method with high precision and absolute accuracy. Similar to nuclear magnetic resonance imaging

(MRI), EPRI uses magnetic field gradients to generate the spatial distribution of electron spins. In

contrast to conventional MRI, EPRI relies on a much smaller magnetic field (in the milli Tesla range),

generated by cryogen-free magnets and gradients that do not change during signal detection.

EPROI uses the linear relationship between electron spin-lattice relaxation rate and partial oxygen

pressure (pO2) of an injectable non-toxic soluble contrast agent, trityl OX071, for obtaining oxygen

maps in tissues. We have developed the world’s first dedicated 25 mT preclinical EPROI instrument

JIVA-25TM, which operates at 720 MHz radiofrequency.

I will present the concept and data showing how EPROI can be used for noninvasive cell viability

assessment and why it is superior to current methods of cell viability measurements. This is the first

demonstration of noninvasive cell viability assessment in a three-dimensional system without

destroying the cells or scaffold. The method can be extended to perform cell viability and

functionality assessment for all tissue engineering medical products of any size and dimensions.
Dr. Sheng Lin-Gibson is the Chief of the NIST Biosystems and Biomaterials Division. She

oversees a multidisciplinary research portfolio that includes regenerative medicine and

advanced therapies, precision medicine, synthetic biology, and complex microbial systems.

She leads and coordinates the development of global standards for emerging

biotechnology, many of which support regenerative medicine and advanced therapy. She

has coauthored over 80 peer-reviewed publications, serves on many Interagency Working

Groups as well as numerous expert review panels and advisory boards. She has received

two Department of Commerce Gold Medals.

Sheng Lin-Gibson, Ph.D.

Chief of the Biosystems and Biomaterials Division

National Institute of Standards and Technology (NIST)

sheng.lin-gibson@nist.gov

27
28

Dr. Mary Clare McCorry is the Director for Technology and Process Development at the

Advanced Regenerative Manufacturing Institute (ARMI). At ARMI, Dr. McCorry is advising

the development of several scalable, modular, automated and closed tissue

manufacturing production lines as well as leading the development of novel

manufacturing technologies. As part of her role, Dr. McCorry is responsible for directing

Institute funded technical projects and strategic partnerships to advance manufacturing

technologies in cell, tissue, and organ engineering. Prior to joining ARMI, she was an

American Institute for Medical and Biological Engineering (AIMBE) Scholar at the U.S. Food

and Drug Administration in the Center for Devices and Radiological Health (CDRH). As an

AIMBE Scholar, she led science policy initiatives and coordinated collaborations between

experts in academia, industry, government and non-profit organizations. Mary Clare joined

FDA from Cornell University where she designed cell-based assays to study

biomechanical/chemical mechanisms of action of cells in tissue engineered constructs.

She also consulted for industry on the design of specialized single use tissue bioreactors.

Mary Clare received her Ph.D. from Cornell University and her BS in Biomedical

Engineering from Worcester Polytechnic Institute.

Mary Clare McCorry, Ph.D.

Director for Technology and Process Development 

Advanced Regenerative Manufacturing Institute 

mmccorry@armiusa.org
29

Richard McFarland is an immunopathologist and the Chief Regulatory Officer at the

Advanced Regenerative Manufacturing Institute (ARMI) where he over the regulatory affairs

for ARMI and its BioFabUSA program. Dr. McFarland is also a Principal Consultant at

BioFabConsulting where he consults with members on product classification, regulatory

strategy, and CMC, preclinical and clinical studies. Prior to joining ARMI as its first postaward hire in 2017, Dr. McFarland was Associate Director for Policy (ADP) of the Office of

Tissues and Advanced Therapies (and its predecessor office) at the Food and Drug

Administration’s Center for Biologics Evaluation and Research (FDA/CBER) for eleven years

after six years a reviewer in FDA/CBER. In addition he, served on the federal government’s

interagency for tissue engineering and regenerative medicine, the Multi-agency Tissue

Engineering Sciences group (MATES) for fifteen years, including five years as its Chair. Dr.

McFarland received his undergraduate, graduate, and medical school training at the

University of North Carolina-Chapel and his post-graduate medical specialty training in

anatomic/clinical pathology and subspeciality training in immunopathology at University of

Texas Southwestern Medical Center in Dallas.

Richard McFarland, Ph.D., MD

Chief Regulatory Officer, Advanced Regenerative 

Manufacturing Institute

Principal Consultant, BioFabConsulting

rmcfarland@armiusa.org
As the founder of ChromoLogic, Dr. Menon is passionate about developing novel

biomedical solutions that not only lead to superior patient outcomes but also ensure that

the solutions are cost effective and affordable. He received his PhD in Physics from Purdue

University with an emphasis in sensor fabrication, instrumentation and novel data analytic

methods that were applied at multiple national and international laboratories towards

fundamental physics discoveries. His early career was spent at Corning Incorporated and

Northrop Grumman Mission Systems where he was groomed for leadership positions in

multiple businesses.

Founded in 2007, ChromoLogic is a boutique product focused innovation center

developing solutions that save lives and make the world secure. The Biomedical Solutions

division develops point of care solutions with the goal of delivering best health outcomes

at the lowest cost. Their capabilities span four key verticals: Wound Care and Infectious

Disease, Diagnostics/Screening, Drug Delivery, and Telehealth. Their customers and

collaborators include medical manufacturers, academic institutions, government agencies,

and care providers. To meet the needs of this broad customer and market base, they bring

together the brightest minds from every engineering and science discipline and form

collaborations across academia and industry. Since 2019, ChromoLogic has made

significant investments in cell therapy, in terms of therapeutics as well as instrumentation.

Their current programs include a novel genetically modified bacteria that delivers

cytokines to manage side effects from cancer treatment and an optical system that can

non-invasively monitor cell growth, concentration & viability within bioreactors in real-time.

Naresh Menon, Ph.D.

Chief Executive Officer

ChromoLogic

nmenon@chromologic.com

30

Non-invasive non-contact real-time monitoring of cells within bio-reactors by direct 

imaging with optical coherence tomography

Abstract: We have developed OCTiCell for monitoring cell growth in suspended agitated

bioreactors based on optical coherence tomography. OCTiCell is an in-line, completely

non-invasive instrument that can operate on any suspended-cell bioreactor with a window

or transparent wall. In traditional optical coherence tomography, the imaging beam is

rastered over the sample to form a three-dimensional image. OCTiCell, instead uses a fixed

imaging beam and takes advantage of the motion of the media to move the cells across the

interrogating optical beam.
Dr. Bao-Ngoc Nguyen is a Biomedical Engineer in the Tissue Engineering Branch (TEB) of

the Division of Cellular and Gene Therapies (DCGT) in the Office of Tissues and Advanced

Therapies (OTAT)/Center for Biologics Evaluation and Research (CBER). She conducts

regulatory review of cellular therapies, tissue engineered products, and devices regulated

in OTAT, focusing on the chemistry, manufacturing, and controls of these products. Dr.

Nguyen earned her B.S. and Ph.D. in Bioengineering at the University of Maryland, College

Park.

Bao-Ngoc Nguyen, Ph.D.

Biomedical Engineer 

The Food and Drug Administration

Bao-Ngoc.Nguyen@fda.hhs.gov

31

Characterization of Tissue Engineered Medical Products

Abstract: Tissue engineered medical products (TEMPs) are complex and require

assessment of the cells, scaffold, and final cell-scaffold product. Depending on the TEMP,

final product release testing may require use of parts or entire final products. When only

parts of the final product or surrogate products are used, sufficient supporting data may be

necessary to demonstrate that they adequately represent the clinical product. Early

consideration of final product release testing methods is critical in supporting the safety

and effectiveness of TEMPs.
Dr. Kirsten Parratt is a Biomedical Engineer in the Biosystems and Biomaterials Division at

the National Institute of Standards and Technology (NIST). Currently, she develops flow

cytometry experimental and computational methods to characterize live, whole cell,

microbial materials. This work supports biomanufacturing stakeholders, for example, those

interested in Live Biotherapeutic Products and Rapid Microbial Testing Methods for

advanced therapy products. Kirsten obtained her BSE in Chemical Engineering from

Princeton University. She obtained her MS in Materials Science and Engineering, and PhD in

Bioengineering from the Georgia Institute of Technology, where her graduate dissertation

was related to stem cell biomanufacturing and tissue engineering.

Kirsten Parratt , Ph.D.

Biomedical Engineer 

National Institute of Standards and Technology

kirsten.parratt@nist.gov

32
33

Marian S. Piekarczyk is a Senior Regenerative Medicine Technical Specialist with Thermo

Fisher Scientific within their Life Sciences Division. Her background is in stem cell science

and biology and immunology. Marian currently leads business development for cell

therapy and translational medicine applications in the central Midwest region of the United

States. Her career spans over 30 years in academic research, small biotech, and industry

related research, technical, and commercial operations.

Marian S. Piekarczyk, M.S., MBA 

Senior Regenerative Medicine Technical Specialist 

Thermo Fisher Scientific 

marian.piekarczyk@thermofisher.com
34

Laura Pierce is a Biomedical Engineer in the Biomaterials Group at the National Institute of

Standards and Technology. She is responsible for technical planning and conducting

studies to support measurement capabilities and assurance for cell therapy products. In

that capacity, she routinely performs cell counting measurements on a variety of lab

instrumentation typically used in the Regenerative Medicine field, and she supports

analysis and dissection of data with collaborators to define the points in their experimental

workflow which introduce measurement error and uncertainty and offers

recommendations to improve precision and robustness of measurements. Laura has

supported the development of the Cell Counting Part II ISO standard and COMET

application for comparison of cell counting methods, and is currently involved in the

development of a draft Cell Viability consensus standard through the International

Standards Organization.

Laura Pierce, M.S. 

Biomedical Engineer 

National Institute of Standards and Technology

laura.pierce@nist.gov
35

Dr. Potter joined the Office of Research and Development at the Department of Veterans

Affairs in 2011, where she is the Scientific Portfolio Manager of Surgery, Trauma, and

Restorative Medicine. She currently serves as the VA representative on the Forum for

Regenerative Medicine at the National Academies of Sciences, Engineering, and Medicine,

the Armed Forces Institute of Regenerative Medicine Oversight Committee, and CDMRP’s

Programmatic panel for the Reconstructive Transplantation Research Program. She

received her undergraduate degree in Engineering Chemistry from Queen’s University in

Canada and her Ph.D. from Cambridge University in England. She joined the National

Institutes of Health as a visiting scientist and she spent 10 years at the Armed Forces

Institute of Pathology as the Technical Director of the Magnetic Resonance Microscopy

Facility where she applied non-invasive imaging techniques to the study of forensic,

pathologic, and engineered tissues. Dr. Potter credits her training in Chemical Engineering,

Chemistry, Medical Imaging, and Tissue Engineering as the ideal framework to support the

translation of biofabrication solutions to the operating room.

Kimberlee Potter, Ph.D.

Scientific Program Manager

Department of Veterans Affairs

Kimberlee.Potter@va.gov
36

Dr. Namro Redwan holds a PhD degree in Chemistry with emphasis on Medicinal/Organic

Chemistry from the University of Gothenburg. She obtained her Postdoctoral training in

Chemical Biology at the Gladstone Institutes in San Francisco. She was an Assistant

Professor at the Clinical Chemistry and Transfusion Medicine at the University of

Gotehnburg prior to joining CELLINK as a Senior Principal Scientist/Scientific Officer.

Today, Itedale is the Chief Scientific Officer, currently leading the Science and Applications

team in the R&D department at CELLINK.

CELLINK is the world leading Bioprinting company and Itedale ́s team has commercialized

45+ bioinks and published 15+ application notes in the field of Biofabrication.

Itedale Namro Redwan, Ph.D.

Chief Scientific Officer

CELLINK

inr@cellink.com
37

Eugenia (Jane) Romantseva is a staff engineer supporting the Cellular Engineering Group at

the National Institute of Standards and Technology (NIST). Jane leads NIST’s efforts to

develop measurement assurance and tools towards improving reproducibility in cell-free

expression. Jane is also part of the collaborative effort to leverage automation, specifically

the NIST Living Measurement Systems Foundry, for high throughput measurements to

advance genetic sensor engineering and address challenges in scalability for engineering

with living measurement systems. Jane received a B.S. in Mechanical Engineering from

Boston University and a M.S. in Material Science and Engineering from Johns Hopkins

University.

Jane Romantseva, M.S.

Engineer

National Institute of Standards and Technology

eugenia.romantseva@nist.gov
Dr. Jonathan Seppala leads the Polymer Additive Manufacturing and Rheology Project, developing

multi-modal and in situ measurements that enable control over the complex non-equilibrium

material dynamics that characterize soft matter processing. His current research uses infrared

thermography, rheology, polarized light, fracture mechanics, and neutron and x-ray reflectivity and

scattering to study the polymer physics of thermoplastic additive manufacturing processes.

Jonathan earned a B.S. in Chemical Engineering from Michigan Technological University and a Ph.D.

in Chemical Engineering from Michigan State University studying the rheology and thermodynamics of polymer nanocomposites. Following his Ph.D., Jonathan worked as a Postdoctoral

Researcher studying thin film self-assembly of block copolymers and equilibrium dynamics of

amphiphilic micelles at the University of Delaware. Before joining the Additive Manufacturing and

Rheology Project, Jonathan studied ballistic witness materials and shear thickening fluids as part of

NIST's Personal Body Armor Project.

Jonathan Seppala, Ph.D.

Chemical Engineer

National Institute of Standards and Technology

jonathan.seppala@nist.gov

38
Dr. Shirwaiker is a Professor and Pleasant Faculty Scholar of Industrial & Systems

Engineering and Associate Director of the Comparative Medicine Institute at NC State

University. His research program focuses on the development and optimization of

manufacturing processes and quality monitoring techniques to create and assess

engineered tissues for a variety of biomedical and cellular agriculture applications. His

research has been supported by the NSF, NIH, DOD, and the industry. Shirwaiker is a

recipient of the NSF CAREER Award, SME Outstanding Young Manufacturing Engineer

Award, and IISE Manufacturing & Design Outstanding Young Investigator Award. He

currently serves on different boards and committees of IISE, SME, ASME, and ASTM.

Rohan Shirwaiker, Ph.D.

Professor

North Carolina State University 

rashirwa@ncsu.edu

39

Dielectric spectroscopy for in line monitoring of engineered tissue constructs

Abstract: This talk will highlight the application of dielectric spectroscopy, which leverages

the responses of living cells to alternating electric fields, for the monitoring of engineered

tissue constructs. Examples of mapping of dielectric parameters to critical quality attributes

of constructs under scenarios ranging from static culture of cell-seeded scaffolds to

perfusion bioreactor-based maturation of bioprinted constructs will be presented.

Application of machine learning for more effective dielectric data analysis and decisionmaking will also be discussed.
Dr. Simon is a biologist in the Biomaterials Group at the National Institute of Standards &

Technology. He leads projects on characterization of tissue engineered medical products, cellmaterial interactions and tissue engineering scaffolds. Dr. Simon is active in the Society for

Biomaterials and is Chair of ASTM Committee F04.43 “Cells and Tissue-Engineered Constructs”

where documentary standards are being advanced to support the development of medical

products.

Carl G. Simon, Jr., Ph.D.

Biologist

National Institute of Standards and Technology

carl.simon@nist.gov

40

Optical Coherence Tomography Imaging for 

Label-Free Measurement of Cell Viability in Scaffolds

Abstract: In the field of tissue engineering, 3D scaffolds and cells are often combined to yield

constructs that are used as therapeutics to restore tissue function in patients. Viable cells may be

required to achieve the intended mechanism of action for the therapy, where the live cells may

build new tissue or may release factors that induce tissue regeneration. Thus, there is a need to

reliably measure cell viability in 3D scaffolds as a quality attribute of a tissue-engineered medical

product. Here, we developed a label-free, 3D optical coherence tomography (OCT) method to

image large sample volumes (1 mm3) to quantitatively assess cell viability and distribution within

scaffolds. OCT imaging was used to assess a model scaffold-cell system consisting of a

polysaccharide-based hydrogel seeded with human Jurkat cells. Four test systems were used: i)

hydrogel seeded with live cells, ii-iii)hydrogel seeded with heat-shocked or fixed dead cells and iv)

hydrogel without any cells. OCT images revealed time-dependent changes in the refractive index

(RI) within live cells that were due to intracellular movement of organelles (referred to as speckling

patterns). The time-dependent changes in RI (speckle patterns) were not observed for hydrogels

without cells or with hydrogels loaded with dead cells. The changes in speckle patterns were used

to generate live-cell contrast by image subtraction where objects with large changes in RI were

binned as live cells. When using 3D OCT imaging to count live cells within a gel volume, the results

were within 13% of the expected value derived from the number of live cells that were seeded into

the gels. Additionally, the 3D distribution of live cells was mapped within a hydrogel scaffold to

assess the uniformity of their distribution across the volume. These results demonstrate a label-free

method to assess the spatial distribution of live cells within a 3D scaffold that may be useful for

assessing tissue-engineered medical products.
41

Kaiming Ye is a SUNY Distinguished Professor, Chair of the BME Department, and Director,

Center of Biomanufacturing for Regenerative Medicine at Binghamton University, SUNY.

He is Fellow of BMES and AIMBE. He is past Chair of the Council of Chairs of Biomedical

Engineering and a funding Chair of BMES Advanced Biomanufacturing SIG (ABioM-SIG). He

has contributed significantly to national policy-making in science and engineering. During

his tenure at NSF, he directed a biomedical engineering program. He was a member of the

Interagency Workgroup for Neuroscience, Interagency Modeling and Analysis Workgroup,

and Multiagency Tissue Engineering and Regenerative Medicine Workgroup. He served on

NIH/NIDDK Rebuilding Kidney Consortium’s Advisory Committee. Ye pioneered human

islet organoid development from pluripotent stem cells (PSCs). His group is the first one

demonstrated the feasibility of generating the whole human islets from PSCs. His work in

3D tissue bioprinting was featured in Prism in 2015. He is one of the pioneers in developing

fluorescence resonance energy transfer nanosensors for continuous glucose monitoring.

As a researcher, he has secured more than $43 million grants as PI or co-PI. He has

published more than 100 research articles, book chapters, and reports. He has chaired and

co-chaired more than 18 international and national conferences and delivered more than

150 keynote/plenary/invited speeches in international and national conferences and

graduate seminars in more than 100 universities.

Kaiming Ye, Ph.D.

Distinguished Professor, Chair of the BME Department 

Director, Center of Biomanufacturing for Regenerative 

Medicine, Binghamton University

kye@binghamton.edu