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 Virtual Series – Session 18
29 October 2020 12PM - 1PM ET

Quantum-Safe Security Solutions for Remote Patient Monitoring and Telehealth

Maëva Ghonda - ATARC Chair, group leader of the Cybersecurity and Privacy for Remote Patient Monitoring project for IEEE SA Industry Connections
Bruno Huttne - Director of Strategic Quantum Initiatives, ID Quantique

At first sight, healthcare and quantum do not have a lot in common. However, with the forecast advent of the quantum computer, which will be able to solve some complex mathematical problems, assumed to be unsolvable with current computers, things are changing. The issue is that these very problems are at the heart of current cryptography. And highly confidential information about the patients is routinely exchanged on public networks, with cryptography as its only protection. In order to safeguard patient data, new cryptographic solutions have to be applied. These are known as quantum-safe. 

This presentation will introduce the quantum computer, describe the threat on current cryptography and suggest possible solutions. We will also try to provide a few useful hints about what you could do to protect your patients now and in the future.


+ Read Maëva Ghonda's Bio

Maëva is also the chair of the Quantum Risk Management Roundtable for the Board of Directors and the chair of the Quantum Initiative Advisory Board for the Advanced Technology Academic Research Center. As a scientist and an engineer, Maëva’s research interests include: Quantum Computing, Cryptography, Blockchain, Digital Health Security, and Quantum Money. Cybersecurity Issues Towards the Adoption of Blockchain-Based Remote Patient Monitoring Systems The global market for remote patient monitoring systems and wearable medical devices is expected to reach $612 billion within the next 24 months. Remote patient monitoring (RPM) technologies enable rapid detection of ailments in real-time; however, many are vulnerable to cyber-attacks. This presentation will focus on implementations of blockchain technology that can help ensure security of RPM systems.


+ Read Bruno Huttner's Bio

Bruno Huttner is the Director of Strategic Quantum Initiatives, and a Quantum Key Distribution Expert at ID Quantique. He is also the co- chairman of the Quantum-Safe Security Working Group (QSS WG) organized by the Cloud Security Alliance.

Bruno joined ID Quantique in 2014, participating in business development and product management in the Quantum Security division. He then started the space programs, aiming at developing quantum key distribution globally, using satellites.

Bruno is an engineer (Ecole Centrale Paris) and a physicist (PhD from the Technion, Israel Institute of Technology). After an early career in academia, Bruno moved to business. Prior to joining ID Quantique, he participated in the creation of a startup company, Luciol Instruments, which used quantum technologies for improving test and measurement equipment.

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

Learn more about this activity and join the working group.

 


+ 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.

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.

Learn more about this activity and join the working group.


+ 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.

WAMIII Virtual Series - Session 14
27 August 2020 10AM - 11AM ET

Achieving Inclusion, Diversity and Quality in Patient Recruitment with Decentralized Clinical Trials (DCTs)

Shelly Barnes -  GCSO Innovation, UCB Pharma
Basker Gummadi - Director Technology and Innovation at Bristol-Myers Squibb
Moderator: Melissa Swoope - Sr. Manager II, Specialty Pharmacy Clinical Program Development & Outcomes, Walmart  

Patient recruitment, engagement and retention are increasingly detrimental challenges to successfully conducting a clinical trial. Identifying a diversified, qualified patient pool for a particular research study has become a laborious and inefficient process with mixed results. For targeted and efficient trials, the right patients need to be found. Decentralized clinical trials open the doors to reaching a more diverse and inclusive patient pool as geographic limitations, lack of access to patients and general unawareness of trials will be significantly reduced. This live interactive webinar will welcome questions from attendees while addressing the following key learning benefits:

  • New tools, technologies and approaches to patient recruitment, engagement, retention for more efficient enrollment process
  • Targeted matching of research study design with patients therapeutic and genetic disposition patient recruitment, awareness, retention 
  • New technologies and tools for real-time training, adoption and support for patients, clinical investigators and supporting personnel
  • Training adoption and support for investigator sites and personnel
  • Establishing one record of truth via the electronic information consent

Learn more about this activity and join the working group.


+ Read Shelly Barnes' Bio

Shelly Barnes, UCB Global Clinical Science and Operation Innovations – Accelerating innovative strategies, leading UCB into the era of Decentralized Clinical Trials and solutions to drive the improvement of the patient experience within the conduct of our clinical trials. Delivering solutions using novel technologies, transforming from traditional clinical trials to patient preferred clinical trials while maintaining quality, compliance and stakeholder commitments. Actively represents UCB on several industry consortiums including TransCelerate and IMI.


+ Read Basker Gummadi's Bio

My current focus area is digitalization of an organization with Automated Robotic Process Automation, Block Chain, AI, and Big data.

I have a strong background in project, program management, technical architecture and business process modeling. I led several merger and acquisition efforts across global R&D organizations and delivered innovative, award winning global projects to realize strategic enterprise business goals.

I am very passionate about innovation and as an innovation coach I mentor teams in Design Thinking and Systematic Inventive Thinking methodologies to foster innovation.

I have a great understanding of technology enablers like Artificial Intelligence, Machine Learning, BlockChain and Big Data. I am researching, collaborating, and exploring the right leverage of technologies to execute Digital transformations.


+ Read Melissa Swoope's Bio

Melissa Swoope is a Senior Manager II of specialty pharmacy clinical program development and outcomes for Walmart Specialty Pharmacy in Orlando, FL and Walmart Retail Stores. She obtained her doctorate from Temple University School of Pharmacy in Philadelphia, Pennsylvania. She has over 15 years of experience in both clinical services and pharmacy operations. Melissa has worked in various areas of pharmacy including hospital, community, and managed care throughout her career. Melissa has developed and scaled numerous specialty pharmacy programs to optimize patient outcomes, improve patient experience, and lower total costs of healthcare through adherence programs, disease state specific programs, and patient/caregiver education. Her collaboration with her clinician teams to help patients make sense of their condition and be a liaison to specialty prescribers has provided a framework to engage patients and prescribers, build relationships with patients and prescribers, and influence patient outcomes. She has an established track record of growing a business through clinical programs and services. Melissa focuses on providing the best possible experience for patients along their journey. She has demonstrated leadership and communication skills through organizing and delivering community health campaigns, patient education, and staff presentations. She has devoted her career to developing her teams, cross collaboration with stakeholder teams, and putting the patient at the center of every decision, program, and service. Her love for fostering growth in her associates in a diverse and inclusive environment is the core of her values. She looks forward to continuing to bring quality, patient care to all patients and all communities that truly transforms healthcare.

WAMIII Virtual Series - Session 15
9 September 2020 12PM - 1PM ET

Patient Safety and Privacy for Decentralized Clinical Trials

Jean-Remy (JR) Behaeghel - Sr Director, Clinical Informatics, Moderna
Dr. Nirav Shah
- Senior Scholar, Stanford University
Dr. Greg Licholai - Chief Medical Officer, PRA Health Sciences / Yale University Faculty

Data integrity and continuity of collection with Decentralized Clinical Trials (DCTs) is critical and when there are no standards you have to re-invent the wheel every time. What’s at stake? The sponsor-vendor collaboration, chain of integrity, documented flow, investment and time!    

How critical is data security? Ensuring patient privacy and data integrity is paramount when using mobile platforms and connections over different telecom networks and prevent hacking or other data violations. In addition, ensuring decentralized trials use high integrity personal identity verification systems to certify the verified patient is using a mobile platforms or device.

In this webinar we will discuss these critical DCT elements along with:

  • Using systems that deliver connected devices (phones, tablets and wearable devices) and medications to patients to ensure products accurately reach their destination and the right patients
  • Digital endpoints to ensure they are meaningful for tracking symptoms and disease progression
  • Connectivity where systems ensure periodic connection with patients to receive feedback and encourage compliance, eg call center model
  • Ensure that mobile platforms continuously confirm patient compliance with regard to data collection and medication adherence with systems for feedback to sites and including training where necessary

Participants will learn 

  1. How multi stakeholder perspectives from payer, provider, pharma, and regulatory impact patient safety and privacy from DCT protocol development to data validation
  2. Where DHT best facilitates clinical trials components and 
  3. What the landscape has recently unveiled and what we can expect in the near future.

Learn more about this activity and join the working group.


+ Read Jean-Remy (JR) Behaeghel's Bio

Jean-Remy Behaeghel (JR) is the Sr Director for Clinical Informatics at Moderna leading the digital strategy for clinical, regulatory, safety and medical affairs. Prior to joining Moderna JR was at Vertex pharmaceuticals where he transformed Clinical IT into a technology technology team enabling drug development processes and supporting the approval of five innovative medicines. He is a strong believer that people should be the main driver for technology to "make easy things easy and hard things possible". JR is passionate about delivering life changing therapies to patients in need.


+ Read Dr. Nirav Shah's Bio

Nirav R. Shah, MD, MPH, is Senior Scholar at Stanford University’s School of Medicine. He is a global leader in digital health and innovation, patient safety and quality, and the strategies required to transition to high value, patient-centered care. Board-certified in Internal Medicine, Dr. Shah is a graduate of Harvard College and Yale School of Medicine, and is an elected member of the National Academy of Medicine. Dr. Shah serves as a Senior Fellow of the Institute for Healthcare Improvement (IHI), as an independent director for STERIS plc, as a trustee of the John A. Hartford Foundation, and on the HHS Secretary's Advisory Committee (Healthy People 2030). Previously, he served as senior vice president and Chief Operating Officer for clinical operations for Kaiser Permanente in Southern California, and as Commissioner of the New York State Department of Health.


+ Read Dr. Greg Licholai's Bio

Greg teaches at Yale School of Management and is Co-Director of the Center for Digital Health. He is Chief Medical and Information Officer at PRA Health Sciences, a leading pharmaceutical service, healthcare data and contract research provider. Previously, he was President of rare disease at Moderna Therapeutics; President and Chief Medical Officer at Castle Creek Pharmaceuticals and was partner at McKinsey & Co. where he ran the healthcare data service line. He was also a senior executive at Proteostasis, Amicus Therapeutics and Medtronic Neurological as well as venture investor for Domain Associates. He was co-founder of Immunome Therapeutics. Greg has degrees from Harvard Business School, Yale School of Medicine, Columbia University and Boston College. He trained at the Brigham and Women's, Children's, and Massachusetts General Hospitals. He serves on multiple company and non-profit boards including advisor to the Clinical Trials Transformation Initiative (CTTI), a public private partnership co-founded by Duke University and the Food and Drug Administration (FDA). He writes about innovation in healthcare for Forbes.

WAMIII Virtual Series – Session 16
22 September 2020 9AM - 10AM ET


Mental Health & Resilience - Supporting Health, Wellness, Identity & Agency During COVID-19

Greg Adamson - 
Chair, IEEE SA Digital Inclusion Identity, Trust & Agency Industry Connections Program
Amandeep Gill
- Project Director/CEO Ambassador
John C. Havens - 
Executive Director, The IEEE Global Initiative on Ethics of Autonomous and Intelligent Systems
Maneesh Juneja
- Digital Health Futurist
Bogdana (Bobi) Rakova - Data Scientist

COVID-19 has made it deeply evident that the need for caregiving is more important than ever.  Even before the pandemic, loneliness and depression rates had risen dramatically in many parts of the world.  While addressing mental health is a complex and deeply contextual issue, there are some core areas to address that can help remove the stigma surrounding these issues and provide a positive and pragmatic direction for the technology we build, including:

  • Mental Health and Resilience - Global policy expert and former UN Ambassador Amandeep Gill will discuss core issues regarding mental health and resiliency based on his recent work with the International Digital Health and Artificial Intelligence Research Collaborative (IDAIR), and digital health futurist Maneesh Juneja will share his thoughts on resilience based on first-hand experience with Covid-19.

  • Metrics that Matter - Caregiving and mental health are critical yet largely ignored by most global Indicators.  Until the factors most directly relating to human wellbeing are prioritized, they will continue to be marginalized. Bogdana Rakova will speak about how to adjust our metrics to measure what matters.

  • Inclusive and Sovereign Engagement - There are various policy developments to help kids and other constituencies be active participants online while protecting their data and identity.  DIITA chair Greg Adamson will speak to issues around inclusive design and data sovereignty and how to protect and enhance human agency in the age where online is a critical and necessary complement to offline life.

  • Responsible Data and Digital Technologies for Global Health - Based on the subjects above, how can we bring all these factors together to get policy and technology design to honor data, mental health and improving human wellbeing long-term? 

 


+ 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.


+ Read Amandeep Gill's Bio

Amandeep Gill is Director of the Global Health Centre project on International Digital Health & AI Research Collaborative (I-DAIR) at the Global Health Centre of the Graduate Institute for International and Development Studies in Geneva. Amandeep Gill was Executive Director and co-Lead of the Secretariat of the UN Secretary General’s High-Level Panel on Digital Cooperation until August 2019. He previously served as India’s Ambassador and Permanent Representative to the Conference on Disarmament in Geneva. Ambassador Gill joined the Indian Foreign Service in 1992 and has served at the Indian Missions in Tehran, Colombo, and Geneva. From 2013-2016, he served as Head of the Disarmament and International Security Affairs Division in the Ministry of External Affairs. In 2017, he helped set up the National Task Force on AI for India’s Economic Transformation. Ambassador Gill chaired the Group of Governmental Experts of the Convention on Certain Conventional Weapons (CCW) on emerging technologies in the area of lethal autonomous weapon systems from 2017-2018. He serves on the UN Secretary General’s Advisory Board on Disarmament Matters and on UNESCO's Ad hoc Group of Experts on AI Ethics. He has served as Co-Chair of WEF’s Global Futures Council on Values, Ethics, and Innovation and as a member of the GFC on Global Public Goods. He is a Commissioner on the Lancet/FT Commission on ‘Governing health futures 2030: growing up in a digital world’. Ambassador Gill has a B Tech in electronics and electrical communications from Panjab University, Chandigarh and an Advanced Diploma in French History and Language from Geneva University. His PhD degree from King’s College London is on Nuclear Learning in Multilateral Forums. His book ‘Nuclear Security Summits: A History’ has been published by Palgrave Macmillan recently.


+ Read John C. Haven's Bio

John C. Havens is Executive Director of The IEEE Global Initiative for Ethical Considerations in Artificial Intelligence and Autonomous Systems and The Council on Extended Intelligence. He is the author of Heartificial Intelligence and Hacking Happiness (Penguin/Random House) He is also a contributing writer for Mashable, The Guardian, and The Huffington Post. A former EVP for a top-ten global PR firm, he has counseled clients like Gillette, HP, and Merck on emerging and social media issues, and has been quoted on issues relating to technology, business, and well being by USA Today, Fast Company, BBC News, Mashable, The Guardian, The Huffington Post, Forbes, INC, PR Week, and Advertising Age. Havens was also a professional actor in New York City for over 15 years, appearing in principal roles on Broadway, television, and film.


+ Read Maneesh Juneja's Bio

Maneesh Juneja is a Digital Health Futurist who explores the convergence of emerging technologies to see how they can make the world a healthier and happier place. He looks at these technologies in the context of socio-cultural, political and economic trends, helping organisations around the world to think differently about the future.

He believes the products and services that will have the biggest impact on our health, will not come from healthcare, but from outside of healthcare.

He is also living with lingering symptoms of covid-19, 5 months after contracting the virus.

How should we be using technology to combat the COVID-19 pandemic? How will this pandemic change the way healthcare is delivered in years to come? How can individuals, organisations and governments be more prepared for future pandemics?

He is passionate about ensuring that the choices we make in society result in a better future, not just for the privileged few, but for everyone.

In a career spanning nearly 20 years, Maneesh has worked with data to improve decision-making across a number of industries. From supporting the Whitehall study at University College London, managing the Tesco database at DunnHumby, and most recently, working with the world’s largest U.S. health insurance claims & European EHR databases at GSK R&D.


+ Read Bogdana (Bobi) Rakova's Bio

Bogdana (Bobi) Rakova is a Data Scientist at the Responsible AI team at Accenture and a Research Fellow at Partnership on AI. She is also part of the Happiness Alliance NGO working towards the well-being of communities and the sustainability of ecosystems. She was one of the key contributors to the IEEE P7010 IEEE Recommended Practice for Assessing the Impact of Autonomous and Intelligent Systems on Human Well-Being. She was part of the Assembly: Ethics and Governance of AI program in 2018, a collaboration between the Berkman Klein Center for Internet and Society at Harvard Law School and the MIT Media Lab. Previously, a research engineer at an innovation lab at Samsung Research, a student and later a teaching fellow at Singularity University, and a startup co-founder in the intersection of AI, Future of Work, and Manufacturing. Bobi has done research in the fields of fairness, accountability, and transparency of machine learning, and AI for social good. She is passionate about what it means to create social change through designing systems that empower everyone to participate, enabled by governance frameworks for AI, AI impact assessments, and multi-stakeholder collaboration frameworks.

WAMIII Virtual Series – Session 17
12 October 2020 11AM - 12PM ET

Practical Implications for Data Interoperability and Use of Blockchain in Decentralized Clinical Trials 

Kieran Connolly - Senior Director, Client Technology Partner, Parexel
Jim Nasr - CEO, Acoer
Mathew Rose, MD MS - Founder & CEO SAAVHA Inc.

The clinical trial industry is in the midst of major changes.  Studies will operate on a spectrum from being localized to one site (centralized) to being conducted completely electronically using data access authorized by qualifying patients.  In addition to such shifts, the 21st century cures act is forcing the healthcare industry toward interoperability that gives health consumers greater controls.  So, what impact will these regulations have on the changing clinical trial industry?  How will we ensure quality and authenticity of data?

This panel aims to discuss current shifts in ways clinical trials will be performed and the methodologies/technology required to ensure patient safety. 

Learn more about this activity and join the working group.


+ Read Kieran Connolly's Bio

Kieran Connolly has been Senior Director, Client Technology Partner at Parexel since May 2019. In this role he is a senior technology leader on Parexel’s engagements with Sponsors, responsible for meeting clinical technology needs, including decentralized trials, eCOA, CTMS, EDC and system integrations.

Prior to his current role, Kieran was responsible for account leadership for Parexel’s services at a number of large Sponsors. From 2014 to 2017, Kieran was located in Shanghai and led the Parexel Informatics business unit in APAC. His remit included leadership of operations and the development of the division’s strategic and organizational strategy. In addition, Kieran focused on further strengthening client relationships in APAC, as well as leveraging Parexel’s industry leadership role to support eClinical technology growth in APAC clinical research. In 2009, Kieran established Parexel’s IRT client services team in California, significantly increasing sales and revenue in the region. Kieran joined Parexel in 2005 and held management positions in Software Development and Product Management in both Medical Imaging and IRT before relocating from Massachusetts to California. Prior to joining Parexel, he held various technical positions in the CRO, technical consulting and financial services industries.

Kieran holds a degree in Business Information Systems from University College Cork, Ireland and an MBA with a concentration in global management from Babson College, MA, USA.


+ Read Jim Nasr's Bio

Jim Nasr is the CEO of Acoer, a technology firm focused on building usable, open, blockchain-enabled software for healthcare. Prior to his current role, Jim was the Chief Software Architect at the US Centers for Disease Control (CDC)—leading the modernization of the agency’s scientific applications, culminating in the development of OpenCDC.

Jim has more than twenty years of experience in the technology industry, has co-authored several technology books, guest lectured for a number of universities and spoken globally at numerous industry events. Jim is a Technical Fellow at pioneering digital identity leader EP3 Foundation, co-chair of IEEE Supply Chain/Clinical Trials Technology Implementation, and Architecture Lead for PhUSEBlockchain Working Group.


+ 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.

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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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