WAMIII - Virtual Talk Series

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WAMIII Virtual Talk Series

The WAMIII virtual talks series will continue to convene and educate the global community of technologists, clinicians, healthcare professionals, regulatory, patient advocates, bio/pharma professionals and any other stakeholder who have a common interest in developing solutions around the safe, responsible and validated use of connected wireless medical devices in, on, and around us.

Upcoming Sessions

WAMIII VIrutal Series -- Session 13
12 August 2020 11AM - 12PM ET



Technology and Institutional Review Board (IRB) Considerations for Decentralized Clinical Trials (DCT)

Mathew Rose, MD MS - Founder & CEO SAAVHA Inc.

Lindsay McNair, MD, MPH, MSB - Chief Medical Officer at WIRB-Copernicus Group  

Alex Gerwer - Former Technical Product Director at Anthem/IBM Watson

Less than 10% of the US patient population engages in clinical trials today. And among those, 18% of randomized trial patients will drop out due to compliance challenges or other reasons.  As a result of Covid-19, further obstacles have been placed across the entire world dramatically impacting how the clinical trial industry functions and emphasizing a significant need for remote monitoring.

How do we design study protocols to accommodate for collecting data in the real-world setting of a person’s home or community facility?

This panel aims to introduce and discuss new technologies as well as IRB considerations for protocol design in adopting remote clinical trials.


+ Read Mathew Rose, MD MS's Bio

Dr. Mathew Rose is founder and CEO of SAAVHA Inc, a company that offers a patient centric pseudo-anonymizing identity management, consent, and data access platform to improve patient and family engagement across all services in healthcare and clinical research. As a physician with over 9 years of experience in Translational Medicine, he realized blockchain technology would have a large impact in healthcare and has been heavily involved in the tech sector since 2015. He has a specific interest in ethical health, cybersecurity, and data interoperability innovations. Dr. Rose was the author of one of the first 75 white papers on interoperability among U.S. hospitals through blockchain technology for the ONC/NIST 2016 white paper competition. He serves as a vice-chair for the IEEE SA IC19-004-01 committee on Data Harmonization for Enabling Remote Clinical Trials; is an Advisor to several start-ups; and holds a BS in Neuroscience and Business, a Masters in Biotechnology and Physiology, and a Medical Degree.


+ Read Lindsay McNair, MD, MPH, MSB's Bio

Lindsay McNair, MD, MPH, MSBioethics is the Chief Medical Officer for the WIRB-Copernicus Group (WCG). Prior to joining WCG, she was a consultant to multiple biopharma companies, providing medical guidance on clinical development strategies and study designs for new drug studies, and medical oversight of all phases of clinical trials. Before becoming a consultant, Dr. McNair was the medical lead for the telaprevir development program at Vertex Pharmaceuticals, with oversight of the phase 1-3 studies. Dr. McNair is adjunct faculty at Boston University and teaches graduate courses on the scientific design of clinical research studies. She oversees the physician team within the WCG IRBs, and provides consultation to institutions and pharma/biotech companies on a wide range of issues related to protocol design, regulatory compliance, human subject protection, and ethical policy development (pre-approval access, subject compensation).

Dr. McNair graduated from the University of Connecticut School of Medicine and trained in general surgery at Boston University Medical Center. She completed her Master’s in Public Health at Boston University concentrating in Biostatistics/Epidemiology, and her Master’s of Science in Bioethics at Union Graduate College concentrating in research ethics. Dr. McNair is an associate editor for the Journal of Empirical Research on Human Research Ethics, and serves on multiple committees including the NYU Compassionate Use Pre-Approval Access (CUPA) Working Group, the Human Subjects Review Board of the US Environmental Protection Agency (EPA HSRB), and the Advancing Effective Research Ethics Oversight (AEREO) consortium.


+ Read Alex Gerwer's Bio

Alex has held a variety of positions in the medical products industry over the past 30 years. While at a small start-up company, Diatek, Alex was responsible for the development of the first automated anesthesia record keeping system, the Arkive. Alex was also in charge of strategic planning and business development in the U. S. for a leading Japanese patient monitoring company, Nihon Kohden. Alex has been a principal partner in a management consulting firm specializing in serving medical product company clients. Alex moved from working with traditional medical product companies to taking an active role in bringing the confluence of IT and telecommunications to healthcare. In pursuing this ambition, Alex joined Acer America, where he was responsible for Healthcare Strategic Business Development. During his tenure at Acer, Alex led the team responsible for making the Acer TM110 the most widely used Tablet PC in healthcare. Alex then joined Nortel, where he was responsible for creating and managing the healthcare market vertical. Alex was also involved with Healthcare Solutions Business Development and Strategy for Siemens where he succeeded in creating a program where Siemens brought to market unique and relevant healthcare solutions, combining product components from different Siemens operating companies. Alex lead work with machine learning and analytics to support provider collaboration programs at Anthem. Alex has been a volunteer with the Obama Healthcare Policy Team. Alex has also been a member of a variety of other organizations, including the Anesthesia Patient Safety Foundation and the IEEE Medical Information Bus Committee. Alex did his undergraduate work in chemistry and physics at the University of Michigan, his graduate work in Chemical Physics at the California Institute of Technology, and attended medical school at the University of California at San Diego. He has also completed studies in healthcare leadership and management as well as business administration at UCLA.

Sessions on Demand

 

 

WAMIII Virtual Series – Session 1 on Demand
26 March 2020 11AM - 12PM ET

Blockchain and smart contract security in practice
Dr. Sebastian Banescu, Senior Research Engineer, Quantstamp

Blockchain and DLT-based applications are often assumed to be secure by design, and by using such technologies one can effortlessly secure the application they are building. However, this is far from the truth. Numerous vulnerability types may be present in such applications, e.g. reentrancy, front running, time manipulation, access control, arithmetic issues, etc. In this webinar we will take an example based approach to learning about vulnerabilities in blockchain applications. More importantly, we will discuss best practices about how to detect such vulnerabilities and minimize the impact of a hack.


+ Read Speaker Bio

Dr. Sebastian Banescu is a senior research engineer at Quantstamp, a crypto native start-up based in San Francisco, that provides world class blockchain security and enterprise solutions. He holds a Ph.D. in Computer Science with an emphasis on software security from the Technical University of Munich in Germany. Previously he graduated with honors from the Information Security Technologies track of the Eindhoven University of Technology in the Netherlands. His research spans across several areas of computer security such as reverse engineering, malware detection, software protection and privacy. Before joining Quantstamp, Sebastian worked as a security engineer at Philips and BMW.

 

 

WAMIII Virtual Series – Session 2 on Demand
27 March 2020 11AM - 12PM ET

The Knowledge Model
Ron Schilling, Director CEO Coach, EchoPixel and Histolix

The Knowledge Model is a framework for thinking. It is focused on increasing the interoperability driven enterprise to achieve increased patient outcomes. Knowledge, comprised of cognitive and intuitive factors requires balance as noted in the quote by Albert Einstein, "The intuitive mind is a sacred gift and the cognitive mind is a faithful servant. We have created a society that honors the servant and has forgotten the gift.” With appropriate balance, significant gains in patient outcomes have been demonstrated.


+ Read Speaker Bio

Ron Schilling - started at RCA Labs as part of the team developing CMOS. Then went to Motorola where, as marketing director for the 6800 microprocessor, took on Intel’s 8080, resulting in being #2 in the industry. Made a big jump to the medical industry at GE when the CT scanner was born. As the 1st marketing director, launched in US, formed a Joint Venture with Yokogawa in Japan, placed 1st scanner in China, with GE ultimately became #1 worldwide. As head of GE Strategic Planning and Business Development, got GE into MRI. Then became President of MRI at Diasonics, becoming #2 worldwide behind GE. Diasonics MRI was later acquired by Toshiba, and I became Senior Vice President for Toshiba America Medical Systems. I then became co-founder of EchoPixel to create Interactive Mixed Reality technology for achieving major gains in Patient Outcomes. Presently serving as Director CEO Coach at both EchoPixel and Histolix, providing leadership technology in Digital Pathology.

 

 

WAMIII Virtual Series – Session 3
01 April 2020 11AM - 12PM ET

Cracking the Code on Medication Adherence with an Ingestible Sensor
Erick Buffkin, etectRX 

etectRx will discuss the recently FDA-cleared ID-Cap system for tracking medication adherence as an application of ingestible sensors. The session will also describe the technology platform upon which the system is built - eBurst.


+ Read Speaker Bio

Eric has a passion for new ventures, new technologies, product design and development. He is a serial entrepreneur, having launched technology, product, and services companies in the technology and healthtech sector. Over the course of his thirty years in technology ventures, Eric has been instrumental in establishing industry standards for networking the digital home. These standards have ultimately influenced how we all enjoy digital media, access information, and manage our homes with connected devices.

Eric is currently Senior VP, R&D/Operations for etectRx Inc., a healthcare technology company creating a platform for digital pills and other ingestible sensors.

Eric is committed to enabling and empowering new entrepreneurs. He is an angel investor and mentor to new technology companies in his community of Gainesville, Florida and a constant promoter of the power of the innovation economy. He holds a bachelor’s degree in electrical engineering from the University of Florida and an MBA from Rollins College.

On a personal note, Eric is married with three children. He is a lifelong resident of Florida and a dedicated fisherman, boater, and outdoorsman. When he is not offshore somewhere on his boat, you can reach him at the Innovation Hub or through LinkedIn.

 

 

WAMIII Virtual Series – Session 4
03 April 2020 11AM - 12PM ET

Overview of Medical Device Communication Test Methods and the NIST Test Framework
John J. Garguilo, Supervisory Computer Scientist, National Institute of Standards and Technology (NIST)

NIST Computer Scientist John J. Garguilo will provide an overview of activities regarding medical device communication landscape, standards development, and domain development efforts to effect safe, semantically reliable, and verifiable data communications (primarily) from the medical device point-of-care to the healthcare “enterprise”. Mr. Garguilo will discuss several prominent and current standards activities and medical device domain development efforts to produce common “device profiles” derived from high-impact use cases and via the NIST Test Framework - a set of test tools leading to standards-based test instances. Such tooling advances the level of rigor and provides a “single source of truth” based on Health Level Seven (HL7.org) messaging standards and the IEEE SA (standards.ieee.org) medical device communication nomenclature and domain information models. Mr. Garguilo will also provide an overview of the freely and publicly available NIST Test Framework components which contribute to common use and device conformance leading to interoperability.


+ Read Speaker Bio

John J. Garguilo is a supervisory computer scientist at the National Institute of Standards and Technology (NIST) of the United States Department of Commerce. John’s the Group Leader of the Systems Interoperability Group and leader of the Semantic Interoperability of Medical Devices (SIMD) project focused on medical device communication research and testing and aimed at enabling the adoption of medical device communication standards by acute, point-of- care, and personal health medical device manufacturers.

John currently serves as the Health Level Seven (HL7) Healthcare Device Working Group Co- Chair and over a decade as the test lead as well as six years as the Technical Committee Co-chair for the Integrating the Healthcare Enterprise – Patient Care Device (IHE-PCD) domain. John is also serving an elected two-year term as the Secretary of the IEEE 11073 Medical Device Communications Point of Care (PoCD) working group. John’s focus over the past fourteen years has been on developing conformance test tooling in support of standardization of medical device information exchange and working with device standard and Standards Development Organizations (including HL7 V2 and ISO/IEEE 11073). His work includes testing and promoting adoption of standards for medical device communications throughout the healthcare enterprise as well as integrating it into the electronic health record. John works and is closely engaged with medical device experts within the HL7, IHE-PCD domain, and ISO/IEEE Healthcare Devices and Personal Health Devices working groups. John also leads the HL7 message validation test tooling effort and development of an industry adopted harmonized medical device terminology database containing ISO/IEEE 11073 terminology.

John holds a Master’s degree from the Johns Hopkins University, Baltimore, Maryland and Undergraduate degree from the State University of New York, Potsdam, both in computer science. John has extensive experience over the past 30 years working on and managing software systems to support research, testing, automating work flow applications, data communications, and electronic commerce.

 

 

WAMIII Virtual Series – Session 5
03 April 2020 12PM - 1PM ET

TIPPSS for Connected Healthcare - Trust, Identity, Privacy, Protection, Safety, Security
Florence Hudson, Founder and CEO, FDHint

The increasingly connected healthcare world including clinical Internet of Things (IoT) devices is creating great opportunity for improved data sharing, better access to information, and deployment of devices to extend and improve healthcare. There is also increased risk. We will discuss the challenges in Trust, Identity, Privacy, Protection, Safety and Security of devices, data, and patients, and the standards efforts working to address these issues. 


+ Read Speaker Bio

Florence Hudson is the founder and CEO of FDHint, an advanced technology and diversity & inclusion consulting firm. She is Interim Executive Director of the Northeast Big Data Innovation Hub at Columbia University, and Special Advisor for the NSF Cybersecurity Center of Excellence at Indiana University. She is Chair of the IEEE standards working group on Clinical IoT data and device interoperability with TIPPSS, and on the IEEE Engineering in Medicine and Biology Standards Committee. She serves on advisory boards at Princeton University, Cal Poly San Luis Obispo, Stony Brook University, and Blockchain for Healthcare Today. Former IBM Vice President and Chief Technology Officer, and Internet2 Senior Vice President and Chief Innovation Officer, she began her career as an aerospace engineer at Grumman and NASA. Her education includes a Bachelors Degree in Aerospace and Mechanical Engineering from Princeton University, and Executive Education at Columbia University and Harvard University Graduate Schools of Business.

WAMIII Virtual Series – Session 6
16 April 2020 12PM - 1PM ET

Unique Device Identification (UDI) Across The Device Landscape
Terrie Reed, Principal, Reed McCullough LLC
Ken Fuchs, Sr., Standards Consultant, Draeger Medical Systems, Inc

This session will discuss the current status of the US and Global UDI System, how UDI continues to be integrated into public policy, software applications, data and device communication standards to enhance data used for supply chain, clinical and regulatory decision making.  In 2013 the FDA published the UDI regulation requiring device manufacturers to apply a unique device identifier to the label of most medical devices and to submit data to the FDA’s Global Unique Device Identification Database. AccessGUDID, the public portal for GUDID, contains over 2.5 million device model records.  Vendors are beginning to take advantage of this global identifier, scanning the UDI to reduce patient exposure to expired and recalled product and to monitor long term outcomes.  While there is no specific requirement that UDI be integrated into personal health or point of care devices, it is clear that in order to better track use of these devices,  UDI data must  flow smoothly from these devices to consuming applications this needs to be accomplished.  Fortunately, standards from ISO/IEEE 11073 and IHE PCD are already well positioned for this eventuality and will be discussed.


+ Read Terrie Reed's Bio

Terrie Reed, the former FDA Associate Director of Informatics and Senior Advisor for UDI adoption, has over 20 years of healthcare information management and systems engineering experience.  As FDA Associate Director of Informatics Ms. Reed led the cross-disciplinary UDI team that established the initial UDI regulatory policy, designed and rolled out resources now used by software developers, supply chain professionals, clinicians, researchers, manufacturers and regulators as a means to transform the tracking of device-related patient procedure information. Later, as FDA Senior Advisor for UDI adoption, Ms. Reed collaborated across stakeholder groups advocating for UDI to be included in health IT standards to support the scanning of UDI and use of data in AccessGUDID by both manufacturers and healthcare workers. Ms. Reed has also used feedback from innovative pilots and first adopters to inform regulatory strategies impacting the overall UDI system. Now, in her role as an independent consultant, Terrie is excited to advise organizations that seek to achieve the original vision of the UDI system including preventing harm and empowering patients to make more informed care choices by giving them access to timely and accurate UDI-based device information.


+ Read Ken Fuchs' Bio

Ken is currently the Sr. Standards Consultant at Draeger Medical Systems, Inc. a manufacturer of electronic medical devices including patient monitoring, ventilation, anesthesia and warming therapy systems.

Ken is currently responsible for coordination of Drager Medical Systems’ participation in US and International standards development activities. He is also personally active in medical device clinical as well as interoperability related standards.  He currently serves as the chair of the IEEE 11073 Standards Committee (SC) for medical device communication, he co-chairs the AAMI MP working group for multi-parameter patient monitors, is Secretary for the IEEE P2733 SC and is involved in a number of other standards development efforts in ISO, IHE, HL7 and AAMI.

Ken’s background has focused on networking, connectivity and system architectures at various point of care medical devices companies including Draeger Medical Systems, Siemens Medical Solutions, Mindray Medical and the non-profit Center for Medical Interoperability.

 

 

WAMIII Virtual Series – Session 7
17 April 2020 12PM - 1PM ET

Self-Powered Wearable Devices and Sensing Systems from the ASSIST ERC
Adam Curry, Innovation Ecosystem Director, Center for Advanced Self-Powered Systems of Integrated Sensors and Technologies (ASSIST)

ASSIST is an NSF engineering research center (ERC) based at NCSU that is advancing self-powered and low-powered wearable devices and sensing systems. Application spaces include health & wellness, IoT, manufacturing, automobiles, and agriculture. The Center includes faculty and student researchers from 8 universities, along with representatives from over 25 member companies. Research follows 4 thrusts: 1) energy harvesting and storage; 2) low-power physiological, biochemical, and environmental sensing; 3) low-power electronics and radios; and 4) integration and testing. Adam will give an overview of the Center and highlight a few mature technologies developed at the Center, including a self-powered shirt transmitting electrocardiogram (ECG) wirelessly in real-time; low-power wrist-worn heart rate, environmental, and biochemical sensors; and sweat sampling and sensing technologies.
 
Learning Objectives:
1.     Gain exposure to technologies enabling self-powered sensing systems
2.     Understand applications enabled by self-powered sensing systems
3.     Become familiar with opportunities to engage with ASSIST 


+ Read Speaker Bio

Adam Curry manages industry relations and promotes technology commercialization at ASSIST. Adam's background includes 11 years in scientific research at Becton, Dickinson & Co., where he developed diagnostic instrumentation and smart technologies for drug administration, health records, and supply chain. Adam holds a PhD in Biomedical Engineering from Duke University and MS and BS degrees in Mechanical Engineering from NC State University.

WAMIII Virtual Series – Session 8
30 April 2020 12PM - 1PM ET

What Medical Device Vendors Can Learn From Past Cybersecurity Vulnerability Disclosures
Vidya Murthy, MedCrypt
Kate Schneiderman, Marketing Analyst, MedCrypt

In 2016, the United States Food and Drug Administration (FDA) released a guidance document entitled Post-Market Management of Cybersecurity in Medical Devices, in which the FDA makes several recommendations to medical device vendors and healthcare delivery organizations on how to manage the cybersecurity risk that connected medical devices introduce. One of the recommendations is for device vendors to participate in “threat sharing”, in which information about security vulnerabilities is shared with the medical device community via Information Sharing Anal- ysis Organizations (ISAO). Two of the presumed benefits of threat sharing are that 1) industry stakeholders have the information necessary to minimize their cybersecurity risk and 2) other medical device vendors can use this information to prevent their products from having the same or similar vulnerabilities.  Assessing medical device vulnerabilities disclosed, we will discuss trends in vulnerability disclosures, status of the current regulatory environment and best practices identified to be proactively secure. 


+ Read Vidya Murthy's Bio

Vidya is fascinated by the impact of cybersecurity on the healthcare space.  Beginning her career in consulting, she realized a passion for healthcare and worked for global medical device manufacturer Becton Dickinson. She has since joined MedCrypt, a company focused on bringing cybersecurity leading practices to medical device manufacturers. Vidya holds an MBA from the Wharton School. 


+ Read Kate Schneiderman's Bio

Kate is a Marketing Analyst passionate about technology’s impact on society. Prior to joining MedCrypt, Kate helped establish the AI for Social Good program at Intel.

WAMIII Virtual Series – Session 9
08 June 2020 8AM - 9AM ET

The Great Migration Online: Connected Health and Wellness in a Challenged Cyberspace
Nicholas Napp, Founder, Xmark Labs & Steering Committee Member, IEEE Digital Reality Initiative
Monique Morrow, Senior Distinguished Architect, Emerging Technologies, Syniverse
Dr. Becky Inkster, Neuroscientist; The Lancet Digital Health, International Advisory Board Member
Moderator: Greg Adamson, Chair, IEEE SA Digital Inclusion Identity, Trust & Agency Industry Connections Program

Abstract: The Covid-19 crisis has forced hundreds of millions of people to consider what it means to live a significantly greater part of their lives, especially their working lives, on-line (“in cyberspace”). Whether working, attending conferences, or socializing, it isn’t only about having affordable and reliable access. It is having the human interaction of the physical world, maintaining community-enhancing behaviors, ensuring security in our engagements, privacy of our information, and myriad other challenges. 

Turning the switch from a hybrid in-person/on-line social society to a fully digital one comes with critical tolls on security and privacy including:

  • The exponential growth of non-clinical "mental health" apps and VR therapies addressing anxiety and isolation in the new spatially distant paradigm
  • The unruly approach in utilizing commercial communication platforms to meet healthcare professional demand for telehealth delivery 
  • The rise in on-line gaming participation and need to enable children and adults with tools for mental and social balance in these interactions.

For the past three years IEEE SA’s DIITA program has been working on these challenges: how we can build technology that provides safe, trusted access to cyberspace and that supports and promotes human dignity.

Our panelists are experts in designing, building, specifying and evaluating such technologies, including those from eXtended reality, digital mental health therapeutics, and on-line gaming fields which will play an important part in future interactions in cyberspace.


+ Read Nicholas Napp's Bio

Nicholas is focused on the role of Digital Reality in enterprise digital transformation. Digital Reality is IEEE's catch-all term that encompasses multiple technologies, including Blockchain, IoT, AI & Machine Learning and Virtual and Augmented Reality.

Nicholas works at the intersection of strategy, technology and corporate narrative with the primary goal of accelerating business growth. He has launched over 40 products across a wide range of consumer and enterprise markets. His clients include a variety of mid-size and Fortune 500 companies such as AT&T, HTC, Sony, and Tencent. He has also led and advised multiple startups.

Nicholas is also Chairman of the Board at FabNewport, a non-profit provider of maker-centered learning programs and services for middle school and older students.


+ Read Monique Morrow's Bio

With over 25 years’ experience as a global technology leader, Monique Morrow is Senior Distinguished Architect for Emerging Technologies at Syniverse Technologies where her main role and responsibilities is to provide thought leadership and to help the strategic direction and vision for Syniverse's identified emerging technologies across the company, partners and industry forum. Specific focus areas include extensions of Distributed Ledger Technology [DLT] and other emerging components of Blockchain technologies to Syniverse’s Lines of Business and our Enterprise. Emerging technology areas include DLT interoperability; Zero Knowledge Proofs/Data Anonymization, Trust and Identity and Mobile Payments.

She has worked across the industry including AMD, Ascom Hasler, Swisscom, Cisco and has been active in the start-up community. She is also an active member of the IEEE Ethics in Action Executive Committee as well as Co-Chair of the IEEE Ethics in Action Extended Reality Committee.


+ Read Dr. Becky Inkster's Bio

Dr. Becky Inkster is a mental health neuroscientist with a strong passion for serving the public and society. She seeks to find innovation using her skills across the fields of genomics and molecular biology (Oxford University; University of Toronto), neuroimaging (Imperial College London; GlaxoSmithKline; Kings College London), epidemiology, Big Data project management (£5.3m; NSPN) and public health (Cambridge University).

In recent years, she has expanded her interests to examine how social media data could be used in positive ways to help develop innovative strategies for mental health interventions, preventive measures and identifying risks in digital data. Dr. Inkster is particularly passionate about working with disadvantaged groups: the underserved, the underdog, the underbelly and the underground to learn lessons about resilience and overcoming environmental risks and social adversity. Dr. Inkster is also a co-founder (with Dr. Akeem Sule) of the social venture, Hip Hop Psych, which seeks to reduce stigma about mental illness through education and engagement.


+ Read Greg Adamson's Bio

Greg is a cyber security consultant specialising in health technologies, and a Fellow in the Australasian Institute of Digital Health. He is a former president of the IEEE Society on Social Implications of Technology, and 2020 chair of the IEEE Ethics and Member Conduct Committee. He has a strong interest in on-line identity and is chair of Digital Inclusion, Identity, Trust and Agency (DIITA). He is on the executive committee of the IEEE Standards Association's Ethically Aligned Design global initiative.

He
is an Associate Professor (hon) at the University of Melbourne, and is completing a Master of Commercial Law at the Melbourne Law School.


WAMIII Virtual Series – Session 10
11 June 2020 11AM - 12PM ET


The Open Wearables Initiative: Helping Realize the Potential of Wearables to Revolutionize Clinical Trials 
Geoffrey Gill, Founder, Open Wearables Initiative

This session will introduce the audience to the Open Wearables Initiative (OWEAR).  OWEAR is a collaboration to promote the effective use of high-quality, sensor-generated measures of health in clinical research through the open sharing of algorithms and data sets.  We will discuss why OWEAR was started, its mission, what we are currently doing, and how people can help.


+ Read Speaker Bio

Geoffrey Gill is the President of Shimmer Americas.  In addition to leading all U.S. operations, he is heavily involved in global product strategy and is the product champion of the Verisense platform – a wearable sensor solution designed from the ground up to meet the challenges of clinical research. Geoff is also a founder and current leader of the Open Wearables Initiative, a non-profit initiative to foster the creation and use of open source algorithms and data sets associated wearable sensors.

Prior to Shimmer, Geoff performed a wide variety of roles at Innerscope Research, Inc., a leading consumer neuroscience company, most recently as CFO/SVP of Operations.  Other experience includes VP of R&D for Bayer Diagnostics Critical Care division and Global Market Manager at Weidmann Electrical Technology.  Geoff has a AB in Applied Math and Physics from Harvard University and an MS in Management of Technology from the MIT Sloan School of Management.

WAMIII Virtual Series – Session 11
18 June 2020 11AM - 12PM ET

Wearable Computing Systems based on Body Sensor Networks: State-of-the-Art and Future Research Challenges
Prof. Giancarlo Fortino, University of Calabria, Italy

This session will discuss the state-of-the-art of currently available wearable computing systems based on Body Sensor Networks (BSNs). It will focus on the main results achieved in the SPINE project, led by Prof. Fortino’s research group, in terms of defined models, methodology, algorithms and real prototypes (e.g. activity/gesture recognition systems, fall detection systems, mobile ECG processing systems, elbow/knee rehabilitation systems, emotion recognition systems, etc.). The session will also enumerate and discuss future research challenges along with possible solutions in such an exciting research domain.


+ Read Speaker Bio

Giancarlo Fortino (SM’12) is Full Professor of Computer Engineering at the Dept. of Informatics, Modeling, Electronics and Systems (DIMES) of the University of Calabria (Unical), Rende (CS), Italy. He has a Ph. D. degree and Laurea (MSc+BSc) degree in Computer Engineering from Unical. He is High-end Foreign Expert of China (term 2015-2018), Adjunct and Guest Professor at the Wuhan University of Technology (China), High-end Expert of HUST (China), CAS PIFI Visiting Scientist at Shenzhen (2019-2021), and Associated Senior Research Fellow at the Italian National Research Council - ICAR Institute. He is the director of the SPEME (Smart, Pervasive and Mobile Systems Engineering) Lab at DIMES, Unical and co-director of two joint-labs on IoT technologies established with Wuhan University of Technology and Shanghai Maritime University, respectively.

He is co-founder and CEO of SenSysCal S.r.l., a spin-off of Unical, developing innovative IoT-based systems for e-health and domotics. He is the Chair of the IEEE SMC Italian Chapter, Member-at-large of the IEEE SMCS BoG, Member of the IEEE Press Board of Directors, and founding chair of the IEEE SMC Technical Committee on “Interactive and Wearable Computing and Devices”.

 

WAMIII Virtual Series – Session 12
29 July 2020 12PM - 1PM ET



Tech and Data Harmonization for Decentralized Clinical Trials (DCTs): Challenges and Opportunities

Craig Lipset, Advisor, Clinical Innovation Partners

Isaac R. Rodriguez-Chavez, Ph.D., M.H.S., M.S., FDA Officer, Clinical Research Methodology, Regulatory Compliance & Policy Development, FDA
 
Walter De Brouwer PhD, CEO of Doc.ai

Moderator - Tory Cenaj, Editor, Blockchain Healthcare Today

What are the current challenges that the industry is facing with the implementation of decentralized clinical trials -DCTs- during the COVID-19 pandemic? What will be the persisting challenges related to DCTs after COVID-19?  Successful implementation of DCTs requires careful coordination of medical, logistical/operational, regulatory/quality, technological and legal matters that involve multidisciplinary teams.  Currently, DCTs represent novel clinical research approaches led by industry efforts to expedite and optimize medical product development, testing and commercialization.  Two industry experts -Mr. Craig Lipset and Mr. Walter DeBrower-, and a regulator and clinical scientist expert -Dr. Isaac Rodriguez-Chavez- will share thoughts about the opportunities that exist in revolutionizing business strategies to enhance DCT efficiencies by harmonizing new technology applications with existing platforms.  This live broadcast session is an open opportunity for all attendees to participate in a question and answer interactive format.  This session will include the following learning points:

  • The advantages of using digital health technologies -DHTs (e.g., wearables and sensors) in DCTs
  • The use of AI and real-world data to optimize trial processes (e.g., patient recruitment, diagnosis, and phases of trials)
  • The appraisal of pharma’s interests to revolutionize clinical research processes with the introduction of new technologies
  • The regulator’s perspectives to validate and verify DHTs/platforms and trust trial outcomes using novel technologies

 


+ Read Craig Lipset's Bio

Craig Lipset is a recognized leader at the forefront of innovation in clinical research and medicine development. He is the founder of Clinical Innovation Partners, working with pharma, tech and venture capital to bring vision and driving action at the intersection of research, digital solutions, and patient engagement. Craig was the Head of Clinical Innovation and Venture Partner at Pfizer, on the founding Operations Committee for TransCelerate Biopharma, and on the founding management teams for two successful startup ventures.

Craig is Adjunct Assistant Professor in Health Informatics at Rutgers University. He serves on the Board of Directors for the Foundation for Sarcoidosis Research and the MedStar Health Research Institute, as well as on the Editorial Board for Therapeutic Innovation & Regulatory Science.

Craig has been listed among the PharmaVOICE most inspiring people in the life sciences (Red Jacket hall-of-fame), Pharmaceutical Executive’s Emerging Leaders, CenterWatch Top 20 Innovators in Clinical Trials, and the AlleyWatch Who's Who in eHealth. 


+ Read Isaac R. Rodriguez-Chavez PhD's Bio

Dr. Rodriguez-Chavez serves as an FDA Officer for Clinical Research Methodology, Regulatory Compliance and Medical Policy Development at CDER. He leads the FDA work on Decentralized Clinical Trials, and he is directly involved in programs for the modernization of clinical research. Dr. Rodriguez-Chavez is a biomedical leader with expertise in Virology, Microbiology, Immunology, Vaccinology, and Viral Oncology. Overall, he has over 20 years of work experience at the National Institute of Health (NIH), industry and non-profit research organizations.

Past positions he held include CEO and Founder of a biomedical consulting firm, 4Biosolutions Consulting; Vice-President for Research at the Texas Biomedical Research Institute; Director of the AIDS and Immunosuppression Program at National Institutes of Dental and Craniofacial Research (NIDCR), NIH; Senior Clinical Scientist at Schering Plough Corporation; and Director of Portfolio for HIV Vaccine Programs at National Institutes of Allergy and Infectious Diseases (NIAID), NIH.

Dr. Rodriguez-Chavez has expertise in science and technology, pre-clinical and clinical research, development and operations, regulatory affairs, approval or licensure of medical products, and quality control and quality assurance. He has led basic, translational, pre-clinical and clinical research (phase I – IV global trials). He has issued the first U.S. GCLP Guidelines and published numerous scientific and technical articles. He has a B.S. in Biology (Venezuela), M.S. in Microbiology (Venezuela), M.H.S. in Clinical Research (Duke School of Medicine), and a Ph.D. in Virology and Immunology (University of Delaware).


+ Read Walter Debrower PhD's Bio

Walter De Brouwer is the founder and CEO of the Palo-Alto based, Deep Learning company doc.ai. which is building AI-powered pipelines for the pharma and healthcare industry. He is an adjunct professor at Stanford University School of Medicine (CERC) and the executive Chairman of xy.ai, a Harvard spin-off that uses satellite data to map the impact of the exposome on human health. Additionally, Walter is Chair of the IEEE-SA IC19-004-01 - Synthetic Control Arms with RWD -; a member of RDSC, the ROCHE Data Science Coalition; a member of Anthem’s Digital Leadership; a member of TED and of the American Mathematical Society. He holds a master’s degree in Formal Linguistics from the University of Ghent, Belgium and a Ph.D. in Computational Semantics from the Catholic University of Tilburg, the Netherlands. His current interests include 5G Cognitive Radio, TinyML, Quantum Computing, Federated Edge Learning, and Information Theory.


+ Read Tory Cenaj's Bio

Tory Cenaj is the Founder of Partners in Digital Health, a forward reaching publishing and communications company. She is the publisher of the world’s first peer review journal disseminating distributed ledger technology research and innovations - Blockchain in Healthcare Today, Telehealth and Medicine Today, and curates the companion Converge2Xcelerate (ConV2X) annual conference and Pitch Competition. Ms. Cenaj has extensive experience in all facets of healthcare publishing and communications heading a premier multi-specialty portfolio including digital and international licensing in Europe, Asia, Middle East and Latin America. Her leadership experience includes clinical trials management, budgeting and outsourcing, publication planning, and medical education. She received her BA from Smith College in Northampton, Massachusetts, and is a former certified medical publication professional. Tory's passion is harnessing breakthrough innovations in the health communications and technology landscapes. She’s inspired by the hope and change these discoveries bring health consumers and communities worldwide - especially if they provide affordable quality care and cure.

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Registration

Note:  When you register for the Series you get access to the recorded sessions. You'll receive a weekly email announcing new sessions for the week, links to ALL recorded sessions and you will receive reminder emails (24 hour and 30 minutes) prior to each session.

The WAMIII virtual talks series will continue to convene and educate the global community of technologists, clinicians, healthcare professionals, regulatory, patient advocates, bio/pharma professionals and any other stakeholder who have a common interest in developing solutions around the safe, responsible and validated use of connected wireless medical devices in, on, and around us. Participation in these sessions includes the following:

  1. Hearing global expert perspectives (from every corner of the world) on the technical and regulatory challenges and viable clinical applications of wireless medical devices on, in around the patients.
  2. Learning, sharing ideas and building consensus for development of solutions to address challenges impeding trust and adoption of these technologies for diagnosing, monitoring and treating patients.
  3. Access to a platform without geographic bounds enabling a global community of progressive thinkers with common initiatives to harmonize recommendations and form collaboratives to drive solutions through the development of technical and data standards.

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