Harnessing the potential of wearables in clinical trials
We’re excited to invite you to our upcoming 4-part webinar series on wearable devices in clinical development.
Join us and a panel of academic, regulatory, biotech and medtech industry experts, discussing how wearables are positioned to be one of the most exciting new trends in clinical development.
Wearables and medical devices must be able to provide clinically relevant measures to be relevant for drug development to support regulatory decision making. This requires collaboration between clinicians, statisticians and data scientists, and the establishment of clear regulatory pathways for the endpoints derived from sensors and for the sensor technology itself.
This 4-part series is brought to you by Natalia Muhlemann, VP, Strategic Consulting, Clinical Development, Regulatory, Market Access and Commercialization at Cytel. A passionate advocate for adaptive approaches to trial design, Natalia has been leading the integration of adaptive designs into comprehensive evidence development strategies that combine clinical, regulatory, market access and commercial plans.
With the potential to collect clinically relevant and patient-focused endpoints, wearables are positioned to be one of the most exciting new trends in clinical development. Topics discussed in the series will include:
- Use of wearables in confirmatory clinical trials
- Wearable technology for clinical and epidemiological studies: a biostatistical perspective
- Regulatory pathways for wearables-based endpoint in clinical trials
- U.S. Regulatory Aspects of Digital and Wearable Medical Devices
Webinar Schedule
Webinar 1: Use of wearables in confirmatory clinical trials
Speakers:
Natalia Mühlemann, M.D., MBA (will also moderate)
Wassim Fares, M.D., M.Sc. VP, Medical Affairs Strategy at Acceleron Pharma
Peter Fernandes, Chief Regulatory and Safety Officer, Bellerophon
Webinar 2: Wearable technology for clinical and epidemiological studies: A biostatistical perspective
Speakers:
Natalia Mühlemann, M.D., MBA
Ciprian Crainiceanu, PhD
Webinar 3: Regulatory pathways for wearables-based endpoint in clinical trials
Speakers:
Natalia Mühlemann, M.D., MBA (will also moderate)
Philippe Etter U.S.
Webinar 4: Regulatory Aspects of Digital and Wearable Medical Devices
Speakers:
Natalia Mühlemann, M.D., MBA
Greg Campbell, PhD
Introducing our speakers
Natalia Mühlemann, MD, MBA is VP, Strategic Consulting, Clinical Development, Regulatory, Market Access and Commercialization at Cytel. Natalia has over 18 years of experience in General Management, Business Development and Clinical Development in Life Sciences across several therapeutic areas. Natalia combines medical and strategic expertise enhancing business value through clinical and real world evidence generation, medical & scientific interactions and stakeholders' engagement. A passionate advocate for adaptive approaches to trial design, Natalia has been leading the integration of adaptive designs into comprehensive evidence development strategies that combine clinical, regulatory, market access and commercial plans.
Wassim Fares is the VP, Medical Affairs Strategy at Acceleron Pharma. Dr. Fares is a US board-certified pulmonologist and intensive care specialist with experience as a practicing physician, principal investigator, researcher with an extensive publication record, and pharmaceutical industry executive. Prior to joining the Pharma industry, Dr. Fares was an Associate Professor of Medicine at Yale University and director of the accredited Pulmonary Hypertension Center. He consulted on clinical trial strategy for Actelion (Janssen/J&J), Bayer, Gilead, and United Therapeutics. He then joined Johnson & Johnson as a Senior Medical Director at Janssen Pharmaceutical Company and a member of Janssen’s Pulmonary Hypertension therapeutic area development leadership team where he led developments across a broad range of potential indications, including fostering the design and execution of multiple Phase 1 through Phase 4 trials, including pivotal registration trials. He also briefly served as the Chief Medical Officer at Bellerophon Therapeutics.
Peter Fernandes - Vice President / Chief Regulatory, Quality & Safety Officer Bellerophon Therapeutics LLC
Dr. Crainiceanu is a Professor of Biostatistics at Johns Hopkins University who works on wearable and implantable technology (WIT) with application to clinical and epidemiological studies. He is the co-founder of the Statistical Methods and Applications for Research in Technology (www.smart-stats.org SMART) research group. Dr. Crainiceanu has worked on biostatistical methods development and implementation for a variety of wearable devices including accelerometers, heart monitors (rate, ECG), and GPS sensors as well as on the integration between these passive sensors and Environmental Momentary Assessment (EMA, self-report via smart phone apps). Dr. Crainiceanu is interested in all components of research from the design of the experiment to data collection and analysis.
Philippe Etter is one of the three founders of Medidee, a leading MedTech Regulatory, Clinical and Quality consulting firm. His specialties include strategic and tactical consulting on regulatory, clinical and quality on critical products such as active medical devices, AIMD, extra corporal circulation, implants and IVD. In addition to managing US and a division of European operations, Philippe’s activities include but are not limited to: Product Development Coaching, Regulatory and Clinical strategies, Interaction with Notified Bodies and Competent Authorities, EN/ISO 13485 QMS deployment, Product and process design controls, Supplier audit, Verification and validation planning and Change management in design and manufacturing operations. Philippe is the founder of the pan-European CARAQA training network, training professionals for the MedTech industry.
Dr. Gregory Campbell is the President, GCStat Consulting LLC, providing expertise in clinical trial design and statistical analysis as well as regulatory advice for a number of clients in the pharmaceutical and medical products industry in addition to serving on a number of Data Monitoring Committees (DSMBs). For 20 years he was Director of the Division of Biostatistics in U.S. Food and Drug Administration’s Center for Devices and Radiological Health (CDRH) where he was responsible for important contributions to public health, the FDA and the medical device industry by leading the Division in supplying statistical support to the entire CDRH, conducting regulatory research and providing statistical reviews of the FDA’s pre-market device submissions, bringing important and innovative medical devices to the marketplace. He led successful efforts at FDA to write guidance documents for medical devices on Pivotal Clinical Study Design, Bayesian Statistics, and Adaptive Designs. He is a Fellow of the American Statistical Association and the Society for Clinical Trials.