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Exponential increases in demand for the next generation of clinical diagnostic, monitoring and measuring sensors for applications in implantable and wearable devices have created new commercial market opportunities with explosive growth potential. Low-cost materials and advances in nano and micro fabrication techniques within the manufacturing process have led to significant increases in the commercialization of biological and chemical sensors for healthcare applications. This conference track will examine the latest advancements in research, engineering and manufacturing and will provide attendees with the state of the art in biosensors commercialization for healthcare.

Final Agenda

Monday, December 10, 2018

7:30 am Registration and Morning Coffee

8:25 Chairperson’s Opening Remarks

Joshua Windmiller, PhD, CTO & Founder, Biolinq Technologies, Inc.

Applications and Market for Ingested, Transcutaneous & In Vitro Sensor Systems

8:30 Continuous Glucose Monitoring Sensors: Past, Present and Future

Rohan Sonawane, MD, Clinical Manager, Diabetes, Medtronic

Continuous Glucose Monitoring (CGM) has helped people with type 1 and type 2 diabetes to manage their diabetes more effectively. We have seen tremendous improvements in sensor performance, duration and integration capabilities with insulin pump over the last few years. This presentation will talk about current solutions in the market and future trends.

9:00 Advanced Diagnostics in Endoscopy

George Duval, Principal R&D Engineer, Boston Scientific

In this talk I will present challenges associated with diagnostics and monitoring for Crohn’s Disease, an Inflammatory Bowel Disease using the current endoscopic severity indexing and highlight various industry and academic research that is indicating better ways to quantify this scoring with various sensor technologies.

9:30 Microneedle Point-of-Care Diagnostics

Ronen Polsky, PhD, Principal Member of the Technical Staff, Physical Biological & Chemical Microsensors Department, Sandia National Laboratories

The development of an on-body diagnostic platform that can continuously measure physiological markers in real-time can monitor human performance and detect illness even prior to the onset of symptoms. A microfluidic device, based on microneedles, is being fabricated which can be worn on an individual and can painlessly access biological fluid (e.g., blood and/or interstitial fluid) through the skin for real-time, long-term autonomous diagnostics of health and fitness. We also have developed non-destructive interstitial fluid extraction methods that do not rely on blister formation, vacuum, or microdialysis.

10:00 Networking Coffee Break

10:30 Objective Measures for Clinical Assessment and Precise Understanding of Disease Progression

Christopher Hartshorn, PhD, Program Director, National Cancer Institute (NIH/NCI)

Cancer patients disconnected from resource intensive cancer centers face challenges beyond simply the disease they are dealing with. Connected health solutions (i.e., autonomous or interactive devices and mobile apps that deliver health data to the user and/or clinical team) have been increasing in use, gradually over the last decade, yet very few have reached the maturity needed for cancer-specific, clinically relevant applications. This talk will look at various efforts across the National Institutes of Health attempting to enable more objective measures for out-of-clinic patient-specific assessment and longitudinal understanding of disease progression in large cohorts.

Advanced Sensor Design

11:00 Single-Molecule RNA Conductance Measurements for the Electrical Detection of Pathogens

Juan Manuel Artés Vivancos, PhD, Marie Curie Postdoctoral Fellow, Biophysics Photosynthesis & Energy en Vrije Universiteit Amsterdam/VU

I will introduce a sensor based on the single-molecule break junctions method for measuring the electrical conductance of nucleic acids, presenting our last results on RNA:DNA hybrids that enable the detection of toxins from E.coli. These electrical measurements are sensitive to single-base changes and allow discriminating between strains, achieving limits of detection in the fM range. Besides showing the performance of this proof-of-concept sensor, I will discuss the reasons behind the different electrical signals in sequences with single-base differences.

11:30 Probing Bacterial Response to Stress Using Electronic and Electrochemical Sensors

Aida Ebrahimi, PhD, Assistant Professor, Electrical Engineering, Penn State University

Time-dependent impedance analysis for probing activation of potassium transporters in response to osmotic stress. Impedance analysis reveals: Why does mild heat shock kill Salmonella quite rapidly? Two dimensional (2D) materials for in situ analysis of cellular response to environmental stress, including heat shock.

2:00 Mitigation of Capacitive Biofouling Of Electrochemical Sensors In Biomedical Measurements

Miklos Gratzl, PhD, Department of Biomedical Engineering, Case Western Reserve University

Sensor biofouling can be a major challenge when measurements in biological environments are conducted. This problem is particularly difficult to handle in monitoring in vivo, and measurements in ex vivo samples. Even in research applications when studies are often done in vitro in media that are typically much simpler than actual biological fluids, biofouling leads to drifts and gradually decreasing sensitivities. The measured data therefore lose meaning overtime. In this work we introduce the concept of capacitive biofouling, in contrast to Faradaic biofouling that, under different names, has been already extensively studied. Capacitive biofouling can be circumvented by adopting an interrogation technique of sensor response that minimizes interference from changes occurring at the surface of the sensor.

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

1:55 Chairperson’s Remarks

Christopher Hartshorn, PhD, Program Director, National Cancer Institute (NIH/NCI)

2:00 Next Generation of Diagnostic Tools: From Microneedles to Nanochannel Arrays

Beatriz Prieto Simón, Senior Research Fellow, Monash University

Our research focuses on the creation of the next generation of diagnostic tools based on highly versatile nanostructured electrochemical biosensing platforms. Tuning of the morphological features and electrochemical properties of the nanostructured material is key. We describe the design of fit-for-purpose electrochemical biosensing platforms by harnessing silicon fabrication and site-directed functionalisation methods. We have developed biosensors based on arrays of nanochannels for the label-free electrochemical detection of analytical targets ranging from DNA, toxins and even whole viruses and bacteria, that outperform platforms built on conventional flat electrodes. Arrays of nanoneedles are currently being fabricated to be used as skin patches for the minimally-invasive harvesting of bodily fluids and detection of biomarkers by means of electrochemical biosensing. These novel nanostructures feature major advantages as diagnostic tools based on electrochemical analysis, thanks to their high surface-to-volume ratio, unique charge transport properties, fine control over morphological features (nanochannel diameter and depth, single and multilayered configurations), and ease of surface modification.

Sensors Roadmap for Healthcare

2:30 Smart Healthtech Sensor Systems – Driving the Digital Health Revolution

Paul Galvin, PhD, Head of ICT for Health Strategic Programmes and Head of Life Sciences Interface Group, Tyndall National Institute, University College Cork

Breakthrough research in key enabling technologies including photonics, micro-nano- electronics, nanotechnology, biotechnology, advanced manufacturing and advanced materials is driving innovative solutions to digital healthcare. This paper will showcase exemplars of complete systems which are enabling multiparameter sensing within low cost miniaturized form factors, compatible with integration on wearable technologies, surgical tools, minimally invasive implantable devices and inline process analytical monitoring.

3:30 Refreshment Break in the Exhibit Hall with Poster Viewing

4:15 PANEL DISCUSSION: Overcoming the Challenges of Implementing Data Standardization for Biosensors, Wearables and Implantables

Moderator: George Duval, Principal R&D Engineer, Boston Scientific

Panelists: Christopher Hartshorn, PhD, Program Director, National Cancer Institute (NIH/NCI)
John Murad, Point of Care Director; Director, U.S. Marketing, Abbott

Paul Galvin, PhD, Head of ICT for Health Strategic Programmes and Head of Life Sciences Interface Group, Tyndall National Institute, University College Cork

Mark Buccini, Director, Business Unit Strategy, Texas Instruments

Standardization of data collected from digital biomarkers (biosensors, wearables, passive continuous data collection) and how to integrate with patient reported outcome is critical to the development of well managed patient solutions. This panel of experts will examine how data standardization is being approached and real-world solutions to the standardized management of sensor collected data.

5:15 Welcome Reception in the Exhibit Hall with Poster Viewing

6:15 End of Day One

*Separate registration required for Tutorial.

Tuesday, December 11, 2018

8:30 am Roundtable Discussions with Continental Breakfast

Participants choose a specific breakout discussion group to join. Each group has a moderator to ensure focused discussions around key issues within the topic. This format allows participants to meet potential collaborators, share examples from their work, vet ideas with peers and be part of a group problem-solving endeavor. The discussions provide an informal exchange of ideas and are not meant to be a corporate or specific product discussion.

TABLE 1: Clinical Workflow Integration of Wearable and Implantable Devices in the Age of IoMT

Christopher Hartshorn, Ph.D., Program Director, National Institutes of Health

  • What continue to be major barriers to the implementation of clinical decisions from sensor data, acquired remotely?
  • What will help drive integration into existing clinical workflows?  What are current approaches that can act as good examples of how to integrate without detrimentally impacting these workflows?
  • Beyond the current major use cases (e.g., diabetes, cardiovascular disease, and epilepsy), where will these devices be found next in the clinical setting?
  • What are the major healthcare providers doing to address the large scale integration and analysis of data derived from these types of devices?  What are the best examples of ‘forward’ thinking in this space relative to internal infrastructure being put in place (e.g., data scientists, predictive analytics, etc.)?

Table 2 - Alternative Energy Sources for Medical Implants

Moderator: Bill von Novak, Principal Engineer, Qualcomm

  • What harvesting technologies result in useful levels of energy for medical implants?
  • How can a typical patient environment be leveraged to harvest energy for implants?
  • What sources will result in highest patient compliance?
  • What categories of implants benefit the most from harvested energy vs externally charged or replaced batteries?
  • How can biocompatibility be maintained over the range of harvesting technologies?

Table 3 – Barriers to Commercializing Sensors in Healthcare

Moderator: Roger H. Grace, President, Roger Grace Associates

  • What are the major barriers to the commercialization of PFS/FF sensors and electronics in the healthcare sector?
  • What is unique in the design and manufacture of PFS/FF sensors and electronics vs. for other applications?
  • What role do/should the various players of the manufacturing process supply chain e.g. ink/material selection, printing/packaging/interfaces/encapsulation suppliers play in the design process of PFS/FF sensors and electronics and what needs to be done to bring the designers, manufacturers and sellers of PFS&FF sensors together to facilitate the design and manufacturing process?
  • Standards…what role do/should they play in the design and manufacture of PFS/FF sensors and electronics?  What standards currently exist and who has issued these?    
  • I have an idea but need engineering and manufacturing (i.e. someone to engineer and someone to build it) – where do I go?
  • How do I find the best source for distribution/marketing of my product?   What issues do I need to consider?  Where are the “landmines” located?

Table 4 - How Do You Make Digital Endpoint Initiatives A Success in Your Clinical Trials?

Moderator: Janet Munro, General Manager, Digital Endpoints and Evidence, Novartis

  • How do you capture what clinical trial teams want, and need, in terms of digital endpoints and sensors?
    • How do you evaluate sensors to prepare for and de-risk clinical trials?
    • How do you balance the use of “cutting-edge” versus “tried and tested” technologies?
    • Sensors allow us to measure effects and benefits of treatments 24/7 in clinical trials. What about 24/7 safety monitoring?
    • What evidence is needed to graduate a digital endpoint from exploratory to primary or secondary?

Next Generation Wearables

9:25 Chairperson’s Opening Remarks

George Duval, Principal R&D Engineer, Boston Scientific

9:30 A Front End for the Digital Health Ecosystem

Josh Windmiller, PhD, CTO, Biolinq

This talk highlights the development of a novel class of skin-applied intradermal electrochemical biosensors that facilitate the quantification of relevant metabolic information in a continuous, real-time fashion.

10:00 Soft Electronics for Noninvasive Healthcare: From the Skin to below the Skin

Sheng Xu, PhD, Assistant Professor at University of California, San Diego

Soft electronic devices that can acquire vital signs from the human body represent an important trend for healthcare. Combined strategies of materials design and advanced microfabrication allow the integration of a variety of components and devices on a stretchable platform, resulting in systems with minimal constraints on the human body. We have demonstrated a skin-mounted multichannel health monitor that can sense local field potentials, temperature, strain, acceleration, and body orientation. This technology holds profound implications for continuous and noninvasive sensing, diagnosis, and treatment of chronic diseases.

10:30 Coffee Break in the Exhibit Hall with Poster Viewing

Regulatory Compliance Challenges to Commercialization

11:15 The Future at FDA and What to Expect

Larry Stevens, Senior Regulatory and Quality Consultant, The FDA Group, LLC; Principal, One Way Consultants, LLC

It will be a discussion of recently announced and future anticipated changes in way FDA reviews new drugs and devices, all aimed at making more effective products available sooner. Actions such as Early Feasibility Studies, Use of Published Data, and Access to Investigational Products will all be discussed with examples of how FDA is using these and other programs.

11:45 FDA and the Relentless Digital Health - Challenges and Opportunities

Jafar Shenasa, Vice President, Regulatory Affairs, Proteus Digital Health

Sensor technologies are increasingly used to bring significant improvements across the health care system, from product development and clinical trials to patient care. In this talk, we will consider some recent examples of sensor technologies used in FDA regulated products and discuss how regulation can facilitate bringing such technologies to patient side.

12:15 pm End of Sensors for Healthcare Applications