The Digital Biomarkers & Digital Measurements West Summit

Jennifer C. Goldsack co-founded and serves as the CEO of the Digital Medicine Society (DiMe), a 501(c)(3) non-profit organization dedicated to advancing digital medicine to optimize human health. Jennifer’s research focuses on applied approaches to the safe, effective, and equitable use of digital technologies to improve health, healthcare, and health research. She is a member of the Roundtable on Genomics and Precision Health at the National Academies of Science, Engineering and Medicine and serves on the World Economic Forum Global Leadership Council on mental health.

Previously, Jennifer spent several years at the Clinical Trials Transformation Initiative (CTTI), a public-private partnership co-founded by Duke University and the FDA. There, she led development and implementation of several projects within CTTI’s Digital Program and was the operational co-lead on the first randomized clinical trial using FDA’s Sentinel System.

Jennifer spent five years working in research at the Hospital of the University of Pennsylvania, first in Outcomes Research in the Department of Surgery and later in the Department of Medicine. More recently, she helped launch the Value Institute, a pragmatic research and innovation center embedded in a large academic medical center in Delaware.

Jennifer earned her master’s degree in chemistry from the University of Oxford, England, her masters in the history and sociology of medicine from the University of Pennsylvania, and her MBA from the George Washington University. Additionally, she is a certified Lean Six Sigma Green Belt and a Certified Professional in Healthcare Quality. Jennifer is a retired athlete, formerly a Pan American Games Champion, Olympian, and World Championship silver medalist.

Andreas Caduff has been a driving force in the development of non-invasive, wearable sensor technologies. He held various positions in the pharmaceutical and medical device industry. He is a frequent invited speaker on digital health and has invented numerous patents and co-authored several dozen scientific publications. He is the founder of Biovotion and served for 7 years as CEO, an organisation offering a state-of-the-art user-centric, analytics driven ecosystem, powered by medical wearable technology. Today, he is advising organisations on digital health, working at the interface of medical technology, physiological monitoring, voice analytics, data science, AI and cloud ecosystems towards a more holistic view of health.

Xuemei Cai oversees a clinical group within R&D at Pfizer focused on developing and qualifying digital endpoints in clinical trials. She also provides medical, scientific, and compliance oversight for the Pfizer Innovation Research Laboratory, an industry-leading, state-of-the-art research facility located in Cambridge, MA providing groundwork that enables the analytical and clinical validation of technology prior or in parallel to deployment in interventional clinical trials.

Xuemei is a founding member of the Digital Medicine Society. She received her MD from Harvard Medical School.  She remains a practicing ICU physician and has taken her passion for multimodal monitoring and improving functional prognostication and measurement tools for patients, families, and providers into the digital medicine space to improve the clinical trial experience for participants and enable new therapies.

Benjamin Vandendriessche is Chief Medical Officer at Byteflies, the Belgian-American company behind Sensor Dot, a powerful platform for 24/7 capture of medical insights to deliver care at home and augment clinical trials with real-world data. He is specialized in molecular biology, systems physiology, and data analytics for physiologic waveform and vital sign processing. He completed a PhD in Molecular Biology at Ghent University as an IWT Fellow, followed by a postdoc in Computer Science at Case Western Reserve University (CWRU) as a BAEF Fellow. He currently is an adjunct assistant professor at CWRU.

Andy Coravos is the CEO/co-founder of HumanFirst, a health-tech company that helps leading pharma and biotech companies run effective hybrid and at-home clinical trials. Through its robust workflow and infrastructure solutions, pulling from the most up-to-date research across more than 13,000 measures and over 2,400 wearables and sensors, HumanFirst helps organizations plan for and deploy the safest and most appropriate ways to conduct decentralized trials that are as reliable and trustworthy as those done within hospitals or research sites. 

In addition to her work with HumanFirst, Coravos is also a research collaborator at the Harvard-MIT Center for Regulatory Sciences. Formerly, she served as an Entrepreneur in Residence at the FDA working in the Digital Health Unit (DHU), focusing on the Pre-Cert program and policies around software-as-a-medical-device and AI/ML. 

Coravos has also worked as a software engineer at a leading digital therapeutic company and as a healthcare consultant at both KKR, a private equity firm, and McKinsey & Company, a management consulting firm. Coravos currently serves on the Board of the Digital Medicine Society (DiMe), and is an advisor to the Biohacking Village at DEF CON.

Tom is a Principal Scientist and leads the Digital Health efforts in Genentech’s Early Clinical Development organization. His current focus is on delivering a digital health technology strategy focusing on supporting digital health technology enabled endpoint development across the Genentech early development portfolio. Tom has over 22 years of clinical development experience, including 8 years of experience in developing and deploying digital technologies in clinical trials. He has been at Genentech since 2010 serving in a variety of roles within clinical operations, clinical trial innovation, and now digital health. An exercise physiologist by training and an avid bicycle racer since he was 16, he has been continuously tinkering with the various digital gadgets on himself before testing them on other people. He lives in San Mateo, CA with his wife Elizabeth and 4 young children. 

Larsson Omberg is a VP at Sage Bionetworks and head of Sage’s Digital Health Research Group.  He  oversees a research agenda that focuses both on genomics and participant centered research where data is being collected using remote sensors and mobile phones. The group focuses heavily on using open and team based science to get a large number of external partners to collaborate on data intensive problems. Dr. Omberg has a background in computational biology and has been developing computational methods for disease modeling, populatione genetics and digital biomarkers. Dr Omberg obtained a MSc in Engineering Physics from the Royal Institute of Technology in Stockholm Sweden and a PhD. from the University of Texas at Austin in Physics before performing a postdoctoral fellowship in Computational Biology and Biostatistics at Cornell University.

Beth Kunkoski currently works in the FDA’s Center for Drug Evaluation and Research (CDER), Office of Medical Policy (OMP). She oversees several projects involving digital health technologies and electronic records and storage in clinical investigations. She worked for 15 years in the Center for Devices and Radiological Health (CDRH) in guidance document development and as a branch chief overseeing the review of orthopedic devices. She earned a Master’s Degree in Biomedical Engineering and a Bachelor’s Degree in Chemical Engineering from the University of Michigan.

Dr. Khan is the director of the Khan Lab @ Harvard, MGH and MIT (http://khan.mit.edu). Khan Lab develops digital biomarkers for accurately & objectively assessing neurodevelopmental and neurodegenerative disorders.

From digital health tools to mobile applications for drug development, Khan Lab provides best in class, interactive and innovative digital assessment technologies that capture meaningful and patient relevant data.

I am applied mathematician with broad interests in health and medicine. Some of my work has focused on disease dynamics at both the individual and population level. Central themes are how to combine multiple data sources (eg., RWE, clinical trial data) for both inference and prediction and identification of data gaps.

Emily (Kunka) Lewis is a Global Digital Transformation Project Lead at UCB, based in Denver, CO. In her role, Emily leads projects that help solve some of the most interesting, innovative, and pressing issues which must be addressed to deliver the promising future of digitally transformed healthcare through high-quality digital products and solutions.

Joining the organization in 2020, and utilizing her deep knowledge of digital design, strategy, and product and project management, Emily is a leader, influencer, and change agent within UCB. Emily translates patient and caregiver needs into an achievable digital vision and roadmap that will improve patient experiences and outcomes by bringing transformational projects to life.

Prior to UCB she worked at Science 37, at the forefront of virtualizing trial design and democratizing trial access by putting patients first. As a thought leader in the Decentralized Clinical Trial (DCT) and hybrid trial models, she designed and implemented trials which could be conducted within the patient’s home using telemedicine and in-home nursing. Emily wholeheartedly believes that the future of healthcare delivery will no longer be confined to the four walls of a doctor’s office and is convinced that emerging technologies, real world data, and connected health can (and will) provide insights that will allow us to better predict, diagnose, and manage diseases, ultimately improving patient outcomes.

Emily received a Master of Science in Clinical Research from Northwestern University but considers herself a lifelong learner. Her specific interests include remote patient monitoring, the use of real world evidence, human-centered design, Software as a Medical Device (SaMD), immersive learning experiences like augmented reality and virtual reality, domotics, and the internet of things.

I am an internal medicine physician, faculty in hospital medicine/biomedical informatics, and Medical Informatics Director for Digital Health at Stanford Medicine, where my work is centered around the design, implementation, and evaluation of digitally enabled systems of care delivery.

I am the co-founder and Director for the Stanford Emerging Applications Lab (SEAL), where we partner with clinicians, innovators, and early stage startups to co-develop novel digital tools to improve patient care. https://med.stanford.edu/seal

Experienced Physician Executive with a demonstrated history of working in the hospital & healthcare industry focused on Innovation and Technology. Skilled in Enterprise Software, standards development, Healthcare Information Technology (HIT), and Electronic Medical Records (EMR).

Steve Berman is a Director, Translational Regulatory Affairs, at AstraZeneca.  There he provides strategic and operational regulatory leadership to the development, commercialization, and life cycle management of drugs and devices that leverage digital health technologies, novel methodologies, and novel biomarkers. Steve joined AZ after eight years at FDA, where his responsibilities spanned two main focus areas.  He began his federal service focusing on regulatory operations, efficiency, and effectiveness and led numerous improvement efforts including the stand-up of the Oncology Center of Excellence and the creation and adoption of the 21st Century Cures Workplan.  He concluded his time at FDA focused on speeding new therapies to market through drug development tool qualification.  As a member of the Biomarker Qualification Program and the leader for the ISTAND Pilot Program, Steve worked with numerous commercial and noncommercial stakeholders to advance the adoption and qualification of both traditional biomarkers and novel tools, such as digital health technologies and microphysiological systems.  Prior to joining FDA, Steve held a leadership role in Medical Affairs at Sucampo Pharmaceuticals and also has previous experience in supporting clinical and non-clinical efforts in drug discovery and development.  Steve completed his postgraduate studies in public health at Columbia University and his undergraduate studies in molecular and cell biology at Cornell University.

Jay Ahlman is Vice President of CPT Coding and Reimbursement Policy and Strategy for the American Medical Association (AMA). Jay joined the AMA in 1999 and has held various roles in healthcare strategy, policy and coding during his tenure.  Since 2008, Jay has led the AMA group responsible for the maintenance of the Current Procedural Terminology (CPT) code set and is the lead staff to the CPT Editorial Panel for the AMA.  During this time Jay has worked with the CPT Editorial Panel to lead many significant changes, including the evolution of CPT Literature Standards and the launch of new CPT coding sections including the Proprietary Laboratory Analyses (PLA) code section.  Jay is also the lead staff to the AMA’s Digital Medicine Payment Advisory Group, which is an advisory body made up of 15 industry experts charged with creating solutions to enable the integration of digital healthcare and telehealth solutions into clinical practice.  Most recently, Jay has been involved in the revision of the CPT Evaluation and Management coding structure and the addition of Remote Physiologic and Remote Therapeutic Monitoring codes to the CPT code set.

Aman Thukral is the head of Patient Data Acquisition, Digital Operations, and Clinical Systems at AbbVie. Mr Thukral has over fifteen years of experience in clinical development, technology planning & business-technology alignment. Mr Thukral is responsible for eCOA operations, wearables, and sensors and piloting new technology initiatives. Before this position, Mr. Thukral worked in Deloitte, Cognizant & GlaxoSmithKline at various levels.

Kyle Zebley is Senior Vice President of Public Policy at the American Telemedicine Association (ATA) and Executive Director of ATA Action. He is working with and on behalf of ATA and ATA Action members and like-minded organizations to eliminate barriers to the expansion of telehealth and ensure patients, providers, and payers can realize the benefits of virtual care.

Previously, Kyle was the Chief of Staff in the Office of Global Affairs (OGA) at the U.S. Department of Health and Human Services (HHS). He collaborated with senior leadership from HHS, the White House, and other cabinet departments to develop, advise, and promote U.S. global health policy, including in such policy areas as drug pricing, global health security, medical devices, and non-communicable diseases. Prior to HHS, he worked in Congress as a Legislative Director, leading a legislative team in developing policy and drafting legislation, particularly on matters concerning the House Committee on the Budget, the House Committee on Education and the Workforce, and the House Committee on Ways and Means. Kyle started his career in Washington, D.C. as a Research Assistant at Public Opinion Strategies, where he worked on campaign strategies for clients running for U.S. President, U.S. Senate, the U.S. House of Representatives, state governor, and state legislatures.

Kyle is a sought-after policy expert. He has contributed his time to organizations developing model health policies, such as the Federation of State Medical Boards Workgroup on Telemedicine, the Uniform Law Commission Uniform Telehealth Act, and the World Health Organization Independent High-level Commission on Noncommunicable Diseases. Kyle is frequently quoted in major media coverage on the topic of telehealth, including the Associated Press, Bloomberg, Harvard Business Review, Inside Health Policy, Kaiser Health News, Modern Healthcare, NBC news affiliates, NPR, Roll Call, Time, USA Today, the Wall Street Journal, and Yahoo! Finance. In early 2022, Kyle was named by Politico as one of the “Four Washington players poised to shape digital health in 2022”.

Eli Snell leads the Provider Insights Software Applications engineering organization at Roche where he oversees development of a portfolio of novel digital health solutions for providers and patients across a range of disease areas including cardiovascular diseases and neurological diseases.

Prior to joining Roche, Eli held the role of VP, Software Solutions at Proteus Digital Health, where he was responsible for software platform strategy and integration with corporate partners. At Proteus, Eli led the software engineering organization for the alliance with Otsuka Pharmaceuticals that received FDA approval for the world’s first digital medicine product.

Kate Lyden is the Chief Science Officer for VivoSense, a science and analytics company that develops and validates digital clinical measures and provides end-to-end services for their delivery in regulated clinical trials. In this role, Kate leads a team of scientists dedicated to the development of real-world digital measures that are trusted and valued by all stakeholders.

Kate has an extensive and diverse background in the development and implementation of wearable sensor methodologies across clinical, academic, and industry settings. Her research has focused on synchronizing continuous measures of real-world physical behavior with physiological signals and patient reported outcomes to build contextually rich datasets that inform patient focused drug development and clinical care.

In addition to her work at VivoSense, Kate maintains adjunct faculty positions at The University of Massachusetts, Amherst and Colorado State University, has authored many scientific publications on the objective measurement of human behaviors, and is a frequent contributor on this topic in academic, industry, and clinical working groups.

Jeremy Wyatt is the CEO of ActiGraph, a leading global provider of wearable digital health technology (DHT) solutions for clinical research. With two decades of embedded hardware systems development and related cloud technology expertise, Jeremy has a uniquely well-rounded perspective on the challenges and opportunities of deploying wearable technologies to capture accurate and meaningful patient-centric digital measures. He is considered an industry thought leader and expert in the clinical biosensor space and is a frequent representative and contributor at clinical drug development commercial events, scientific consortiums, and FDA/EMA regulatory meetings. He has an undergraduate degree in electrical engineering from the University of Florida and an MBA from the University of West Florida.  Jeremy is a member and contributor to the Digital Medicine (DiMe) Society and participates in various digital biomarker efforts with the Clinical Trial Transformation Initiative (CTTI).

Dr. Zhang is the global regulatory affairs leader for digital health technologies used in Janssen’s drug
development programs across multiple disease areas, with the focus on digital biomarker and digital
clinical outcome assessment. He also oversees the regulatory affairs function for Janssen’s legal
manufacturing entity for Software as Medical Device (SaMD).

Dr. Zhang started his regulatory careers as a software reviewer in FDA/CDRH. After leaving CDRH as a
branch chief in Office of In Vitro Diagnostics and Radiological Health (OIR) and before joining Janssen, he
worked in several companies including Inovio Pharmaceuticals, Biologics Consulting, and Abbott
Laboratories on medical devices, in vitro diagnostics, combination products, and companion diagnostics.

Amir is a Digital Health Advisor and a Global Thought Leader at the forefront of clinical research and data intelligence. Amir is inspired by the power of AI-driven technology to enable the detection and treatment of various diseases and improve patient care. Starting his career as a brain scientist at Harvard, Amir has over two decades of clinical experience in the biotech and healthcare industries. He currently sits on the Advisory Board of leading MedTech companies and holds several strategic consulting roles with both Pharma and HealthTech startups. Formerly, Amir was the Head of Digital Innovation at Pfizer, leading the development of digital solutions for neurodegenerative and rare diseases. Prior to pharma, Amir was a PI on numerous clinical trials as a Neurology Faculty and Professor of Pediatrics at Harvard Medical School. Amir has 300+ abstracts, manuscripts, peer-reviewed publications, and conference presentations worldwide.