Program

Final Agenda

Wednesday, May 16

7:30 am Registration and Morning Coffee

8:25 Chairperson’s Opening Remarks

Kalle Levon, PhD, Research Professor, Chemical and Biomolecular Engineering Department, New York University


8:30 KEYNOTE PRESENTATION: Fluorescence Nanosensors for Continuous Glucose Monitoring

Kaiming Ye, Professor and Department Chair, SUNY,
Binghamton University

Diabetes is still an incurable, chronic disease. It is, however, fully preventable and very often reversible by normalizing the blood glucose level. In order to control blood glucose concentration, patients rely heavily on the monitoring of glucose concentration. Various sensors have been developed for invasive, minimum-invasive, or noninvasive glucose monitoring. We have developed a class of fluorescence nanosensors capable of noninvasive and continuous glucose monitoring. The translation of this technology into clinical products will allow for developing close-loop insulin delivery systems and implantable sensors for continuous glucose monitoring that will help improve diabetes management and life quality of diabetic patients.

SENSORS ROADMAP FOR THE FUTURE OF HEALTHCARE

9:00 FEATURED PRESENTATION: Wearables and Implantables: Supporting Future Physiological and Pathogen Sensors

Šeila Selimović, PhD, Program Director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health

The biosensors program at NIBIB supports research on implantable physiological sensors as well as wearable and point-of-care pathogen detectors, among others. A particular focus of the program is on Pediatric Research Using Integrated Monitoring Systems (PRISMS), which combines physiological and environmental sensors to correlate environmental factors with incidences of asthma in pediatric patients.

BIOSENSORS APPLICATIONS AND MARKET

9:30 Isolation of Circulating Tumor Cells for Next Generation Cancer Diagnostics

Viktor Shkolnikov, Senior Research Scientist, HP Labs

One major cause of cancer-associated mortality is tumor metastasis, which is caused by circulating tumor cells – cells that detach from the primary tumor, travel through the blood stream, and give rise to tumors in new locations. This talk will present challenges and current methods for isolating and analyzing circulating tumor cells, review methods currently under development, provide an overview of commercialized systems, and briefly touch on our work related to this topic.

10:00 Networking Coffee Break

10:30 Dynamic Analysis of Human Natural Killer Cell Response at Single-Cell Resolution in B-Cell Non-Hodgkin Lymphoma

Tania Konry, Assistant Professor, Pharmaceutical Sciences, Northeastern University

Natural Killer (NK) cells are phenotypically and functionally diverse lymphocytes that recognize and kill cancer cells. To correlate genetic signatures with functional anti-lymphoma activity, we developed a dynamic and quantitative cytotoxicity assay in an integrated microfluidic droplet generation and docking array. We extended this technique to characterize functional heterogeneity in cytolysis of primary cells from b-NHL patients. Taken together, our combined genetic and microfluidic analysis demonstrates b-NHL cell sensitivity to primary and therapeutic NK cell-based cytotoxicity, associated with significant heterogeneity in the dynamic interaction at single cell level.

11:00 Brain Stimulators and Sense Devices: Present and Future

Parshant Kumar, PhD, Member, Technical Staff, CS Draper Laboratory

11:30 Sponsored Presentation (Opportunity Available)

12:00 pm Luncheon Presentation (Opportunity Available) or Enjoy Lunch on Your Own

12:30 Session Break

BIOSENSORS APPLICATIONS AND MARKET (CONT.)

1:55 Chairperson’s Remarks

Kaiming Ye, Professor and Department Chair, SUNY, Binghamton University

2:00 Smartphone-Based Mobile Detection Platform for Rapid Molecular Diagnostics and Spatiotemporal Disease Mapping

Jinzhao Song, Research Associate, Department of Mechanical Engineering and Applied Mechanics, University of Pennsylvania

Thus far, Internet of Medical Things (IoMT) devices have focused on detecting physiological parameters such as heart-rate, blood-pressure, and body temperature. Here, we report a new type of IoMT device – a smartphone-based mobile detection platform for molecular diagnostics. Our system detects pathogens’ nucleic acids in body fluids with a bioluminescent reporter that does not require excitation light source and optical filters and operates electricity-free with exothermic reaction-based thermal control.

2:30 Point-of-Care Diagnosis of Hemoglobin Disorders in Low-Resource Settings

Umut Gurkan, PhD, Assistant Professor, Case Biomanufacturing and Microfabrication Laboratory, Case Western Reserve University (CWRU)

We have developed a new point-of-care (POC) HemeChip technology to screen newborns for SCD and other hemoglobin disorders. HemeChip is POC translation of the electrophoresis method, which is a current standard in SCD screening. HemeChip technology promises to break the diagnostic barrier in low-resource settings, by providing an affordable, robust, easy-to-use, POC platform for newborn screening of SCD and other hemoglobin disorders. In this talk, I will present the results of our clinical validation studies in the US, and will provide an overview of our ongoing field-testing in sub-Saharan Africa.

3:00 Refreshment Break with Exhibit and Poster Viewing

BIOSENSOR DATA INTEGRATION & UTILIZATION IN REAL TIME

3:45 FEATURED PRESENTATION: Technology Enabled Clinical Decision Support at the Point-of-Care

Uli Chettipally, MD, MPH, Founder and CTO, CREST Network, MPH, Emergency Physician, Kaiser Permanente

The cost of care keeps increasing. The outcomes are not getting better proportionately. Using risk stratification to align the resources to outcomes provides a way to decrease cost and increase quality outcomes. Implementation of electronic health records has created large amounts of data. Risk stratification of patients is now possible using this data. Giving healthcare providers access to this information at the point-of-care helps them make better decisions.

4:15 Operationalizing Data Lakes for IoT in Healthcare

Ben Sharma, CEO, Zaloni

The healthcare and medical equipment fields are going through a massive digital transformation that is centered around incorporating internet of things (IoT) devices. With the amount and variety of data being collected, companies are looking for ways to ingest it, and then get to actionable insights quickly. A data lake can provide the perfect platform from which to store and process IoT data for real-time insight, but only if it’s properly architected and operationalized.

REGULATORY CHALLENGES TO COMMERCIALIZATION

4:45 Regulatory Considerations for Commercialization of Medical Devices

Orlando Lopez, PhD, Program Director, National Institute of Dental and Craniofacial Research (NIDCR); Formerly Biomedical Engineer, Lead Regulatory Reviewer, Office of Device Evaluation, FDA

Discussion of the FDA regulatory process and associated considerations for taking a new medical device to market. Specific emphasis will be given to performance testing considerations needed to demonstrate safety and effectiveness of sensor-based devices.

5:15 Welcome Reception with Exhibit and Poster Viewing

6:15 End of Day

Thursday, May 17

8:00 am Coffee Roundtable Discussion Groups

8:55 Chairperson’s Opening Remarks

Mark Buccini, Director, Business Unit Strategy, Texas Instruments

NEXT-GENERATION WEARABLES FOR CLINICAL USE

9:00 Creating New Opportunities in Wearables from the Shift to Patient-Centric Care

Thomas Dawidczyk, PhD, Analyst, Lux Research’s Consumer IoT and Wearable Electronics Intelligence Services

Medical devices are migrating out of the hospital and integrating into patients’ daily lives. These sensing devices utilize smaller, cheaper, and more accessible sensors allowing more patient-centric solutions. Sensor technology is a major enabler of early diagnostics and preventative approaches, which is one of the current challenges facing the healthcare system. This presentation will address current and future market trends, focusing on strategies that can succeed in both the consumer and clinical markets.

9:30 Wearable Real-Time Physiological Monitors for Austere Environments

Brian A. Telfer, PhD, Senior Staff Member, Bioengineering Systems and Technologies Group, MIT Lincoln Laboratory

There are many commercial wearable devices oriented to consumers, but these devices do not provide actionable information to first responders who must operate in austere, dangerous environments. Progress will be reported on wearable sensors and analytics that can keep first responders safe from a variety of injuries, including overheating and musculoskeletal overuse, and also enhance human performance. An open system architecture to integrate multiple sensors will also be described.

10:00 Sponsored Presentation (Opportunity Available)

10:30 Coffee Break with Exhibit and Poster Viewing

11:15 Single-Chip Sensors for Wearable Sensing Devices

Ioannis (John) Kymissis, PhD, Associate Professor, Electrical Engineering, Columbia University

Wearable devices present significant system limitations on the size and power of their integrated sensors. These limitations present challenges for the deployment of wearable and pervasive electronics. The co-integration of sensing functions using thin film technologies and 3D integration on silicon integrated circuits allows for the implementation of ultra-compact, low-power sensors capable of sensing a variety of environmental parameters. In this presentation, two systems developed using this hybrid approach for single-chip sensors will be presented: a 3D-integrated single chip optical spectrometer and a high quality factor GHz-scale piezoelectric resonator. The application of these systems to a range of applications including vapor sensing, pulse oximetry, and ambient light and color analysis will be discussed.

11:45 Privacy and Security Regulatory Considerations in the Use of Wearable Devices

Roger Shindell, President and CEO, C Suite, Carosh Compliance Solutions

In the rapidly changing world of wearable medical devices, maintaining the security and privacy of information being collected and transmitted is on everyone’s mind. With more and more regulatory agencies getting involved in these privacy and security issues, a clear understanding of your obligations under HIPAA/HITECH, the Federal Trade Commission, the FDA, and even the Securities and Exchange Commission is critical.

12:15 pm Luncheon Presentation (Opportunity Available) or Enjoy Lunch on Your Own

12:45 Session Break

ADVANCED DESIGN, MODELING & SYSTEM INTEGRATION

1:40 Chairperson’s Remarks

Šeila Selimović, PhD, Program Director, National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health

1:45 Organic Semiconductor Coatings on Floating and Extended Gate FETs for Disease Detection

Kalle Levon, PhD, Research Professor, Chemical and Biomolecular Engineering Department, New York University

Organic semiconductors provide excellent surfaces for biomolecular binding analyses because the conjugation of ligands is easy with the organic molecules, the surface area can be maximized with nano structures and the band gap control offers additional electronic amplification. We shall present effective gas analysis based on acid/base reactions and counter ion interactions and also results from monitoring enzymatic reaction utilizing the redox reaction on the surface.

2:15 Multiferroic Nanoparticles to Enable Technobiology Paradigm Shift in Nanomedical Applications

Sakhrat Khizroev, PhD, Fellow of National Academy of Inventors, Professor, Department of Electrical and Computer Engineering, College of Engineering and Computing; Professor, Department of Cellular Biology and Pharmacology, College of Medicine, Florida International University

Technobiology is a rapidly emerging field at the intersection of engineering and medicine. Unlike the traditional approach of biotechnology, which focuses on biology, technobiology focuses on the principles of physics and engineering to control fundamental intracellular mechanisms. Being complementary to biotechnology, technobiology unlocks new capabilities to treat cancer, HIV/AIDS, neurodegenerative and other devastating modern diseases at a more fundamental level. A class of multiferroic nanostructures known as magnetoelectric nanoparticles (MENPs) serves as an enabling tool of technobiology. Like traditional purely magnetic nanoparticles, MENPs can be used for externally controlled drug delivery via application of a magnetic field gradient and image-guided delivery. However, unlike the traditional nanoparticles, due to the presence of a non-zero magnetoelectric effect, MENPs provide a unique mix of important properties to address key challenges in modern cancer therapy: (i) a targeting mechanism driven by a physical force rather than antibody matching, (ii) a high-specificity intracellular delivery, (iii) an externally controlled mechanism to release drugs on demand, and (iv) a capability for image guided precision medicine. This presentation gives an overview of the MENPs-based underlying physics of medical applications.

2:45 Adding Voice Commands to Battery-Powered Personal Medical Devices

Mark Buccini, Director, Business Unit Strategy, Texas Instruments

This paper describes in detail new innovation that quickly enables adding voice commands to battery-powered personal medical devices, fitness trackers and other wearable products. While voice interface with smart phones and home automation appliances has become convenient, reliable and now commonplace, this feature is relatively high-power in the 10’s of milliamp range requiring daily recharging of system batteries. By utilizing a minimal resource, light-weight recognizer, voice commands can now be added to personal medical devices requiring just micro-amps, thus enabling continuous operation for months from common batteries. Performance expectations, technical trade-offs and cost will be detailed.

3:15 Sponsored Presentation (Opportunity Available)

3:45 Refreshment Break with Exhibit and Poster Viewing

4:25 Engineered Nanopores for Fundamental and Applied Biotechnology

Liviu Movileanu, PhD, Professor, Physics Department, Syracuse University

There is a pressing need for the development of devices employed in highly selective screening of a broad range of analytes, such as small organic molecules, pollutants, proteins, and nucleic acids. Target areas for such devices include drug and biomarker discovery, genomic and proteomic profiling, as well as prognosis and early detection of diseases. In this talk, I will provide some examples regarding the use of nanopores in stochastic sensing of protein biomarkers.

4:45 Electrochemiluminescence POCT Immunosensor for High-Sensitivity and Wide Dynamic Range Analysis of Antigens

Min-Gon Kim, PhD, Professor, Chemistry, GIST (Gwangju Institute of Science and Technology), South Korea

A lateral flow immunosensor combined with an electrochemiluminescence device was developed. Mesoporous silica nanoparticles and automatic signal generation techniques were applied for high-performance rapid immuno-sensing. Troponin I was detected with 1 pg/mL of LOD and 5-log wide dynamic range in 20-minute.

5:05 Silicon Nanowire Sensors for Quantitative Measurements of Proteins and DNA in the Blood

Marcie Black, PhD, CEO, Advanced Silicon Group

Our technology has the potential to be able to quantitatively measure multiple cancer biomarkers from a blood sample using an inexpensive silicon chip-based detector. ASG’s device uses an array of millions of silicon nanowires. ASG has the technology to create nanowire arrays in a reliable, repeatable, low-cost process. The nanowires are functionalized to interact with selected biomarkers, specifically proteins and nucleic acids indicative of cancer. When the biomarkers interact with the silicon surface, the electronic properties of the silicon are altered, allowing detection via a change in electrical properties.

5:25 End of Conference