Medical Device Trials: A Virtual Experience

Biography: Faouzi has over 15 years of multi-disciplinary cross-functional experience in the fields of development and marketing of medical devices, diagnostic imaging and clinical research. Areas of expertise include medical liaison, clinical research, strategic product positioning and new therapy development. Excellent knowledge of energy based ablation therapies (cardiac arrhythmia, cancer treatment, etc.). Strong clinical, technical and market knowledge of the cardiovascular and neurovascular fields. Proven ability to comprehend scientific concepts and effectively communicate with a high-level audience.

Session Details: Chair’s Opening Remarks and Welcome 16-07-2020, 10:00 am View In Agenda

Biography: Dr. Hsu is anesthesiologist and pain management physician, but also a serial entrepreneur. His most recent activity is as CEO and Founder of QuiVivePharma, a company he took from inception to a FDA face-to-face PreIND meeting in just 1 year. He is also President of SBS Medical Management, a healthcare economic consulting firm for investment banks and Expert Medical Reviews, including the California Medical Board. Other companies he has founded or co-founded include: 1) IMTH, a real estate investment trust with properties through the state of California; 2) iPill Dispenser, a medical device that uses a mobile app to control a secure, stand-alone pill dispenser to prevent opioid sharing, diversion, and drug overdoses; and 3) NAOMI systems, a practice management software company that integrates digital X-rays devices in PACS, EMR and RCM billing modules. After years of watching the opioid crisis develop, John has developed an innovative drug and dispenser to safely treat pain and deter abuse.  His drive to improve healthcare is based on passion, compassion and hope.

Session Details: CASE STUDY: Exploring the Advantages of a Combined Digital Health/Medical Device Solution in Opioid Diversion and the Collection of Accurate Post Market Data 16-07-2020, 6:00 pm View In Agenda

Biography: Tracy MacNeal is an engineer, healthcare entrepreneur, and MedTech investor.  She is CEO of Materna Medical, a Series B startup focused on transforming the standard of care in women’s pelvic health.  As an investor in Portfolia’s FirstStep fund, she supports the commercialization of high-growth segments typically undervalued and overlooked by traditional investing approaches.  Tracy serves as the national Chair of Advamed’s Women’s Executive Network, connecting and amplifying the top women leaders in the MedTech industry. She previously served as President of Diagnostics and Digital Health for Ximedica, held by SV Life Sciences, a private equity healthcare firm, after serving in Chief Strategy Officer and Chief Financial Officer roles at two successful medical devices companies.  Tracy received a Bachelor of Chemical Engineering with full scholarship at the Cooper Union in New York City and an MBA from Duke’s Fuqua School of Business, graduating summa cum laude as a Fuqua Scholar.

Session Details: Unpacking Women’s Health & FemTech: Innovations and Lessons for the Future 16-07-2020, 5:00 pm View In Agenda

Biography: Everett Crosland is a commercial leader in digital health, focused on scaling complex therapeutic solutions across a diversity of channels. At AppliedVR, Everett leads the company’s commercial, sales, and health economic efforts overseeing the health system sales, DoD and VA sales and partnerships, and launch readiness for AppliedVR’s leading virtual reality medical device pipeline.

Session Details: Exploring the Use of New Technologies in Patient Centricity 16-07-2020, 2:45 pm View In Agenda

Biography: Prior to joining Fitbit Health Solutions, Carolyn Walsh served as senior director of global marketing for Qualcomm Life, Inc. Ms. Walsh joined the Qualcomm Life leadership team from HealthyCircles, an enterprise healthcare software-as-a-service platform company, where she led Business Development and Client Services. HealthyCircles was acquired by Qualcomm Life in April 2013. Prior to HealthyCircles, Walsh was the global director of New Ventures, Franchise Development for Johnson & Johnson Diabetes Care. Walsh was responsible for the digital health strategy, software innovations and formulating growth strategies for the emerging markets of India and China. While at Johnson & Johnson, Walsh served in global commercial leadership roles spanning acute, health care professional and consumer engagement channels. Before transitioning into the health care industry, Walsh was a versatile executive with Coca-Cola with a proven track record of success in sales management, strategic marketing, brand building and channel development in a major U.S. market along with international assignments in Poland and New Zealand.

Session Details: CASE STUDY: The Benefits of Remote Healthcare and Continuous Data Monitoring: Looking at the case study of the Bio Intelli Sense BioSticker 16-07-2020, 7:00 pm View In Agenda

Biography: Nick is a serial entrepreneur with broad experience in medical devices and digital health. He has nearly fifteen years of experience as a healthcare entrepreneur, engineer, and leader. He is currently Co-Founder & CEO of Zenflow, a clinical-stage company developing a novel office-based therapy for urinary obstruction related to benign prostatic hyperplasia (BPH). Zenflow has raised over $35 million in funding and treated over 50 patients successfully to date. Zenflow originated in the Stanford Biodesign fellowship, where Nick and co-founder Shreya Mehta spent one year as fellows. Prior to Biodesign, Nick co-founded Avail MedSystems (f.k.a. Nurep), a company aiming to transform surgical support. Nurep allows medical device representatives to support operating room cases remotely via a mobile device. In this role, Nick led the technical development effort to bring the company's product to market and also played key roles in strategy, sales, and fundraising. Nick also spent four years as a Research Engineer at EBR Systems developing a leadless cardiac pacing system. In this role, he designed and implemented several key algorithms critical to the functionality of the device. Before EBR, he worked in R&D engineering for Kensey Nash Corporation and performed clinical research in Cardiothoracic Surgery at Washington University in St. Louis. Nick grew up on the east coast and earned his M.S. and B.S. with Distinction in Management Science & Engineering from Stanford University.

Session Details: Best practices for working with CROS across different global regions 16-07-2020, 6:00 pm View In Agenda

Biography: Andrew Thompson is the Director of Therapy and Analysis at GlobalData Healthcare, responsible for data collection and forecasting within the Medical Devices portfolio. Andrew is passionate about developing innovative approaches to the world of medical devices industry research. Andrew joined the team in 2012, following 20 years working within the academic and industry sectors, developing a specialty in advanced diagnostics for infectious disease. With multiple patents in molecular detection technologies, publications’ covering a breadth of topics and leading product development teams, Andrew has established a strong reputation within molecular diagnostics. Having worked on the frontline, Andrew can share a global understanding of the medical device industry, with both a highly developed understanding of the technologies, new and emerging, and of the business dynamics fueling medical device usage in healthcare. Responsible for the content and direction of global medical device portfolios, GlobalData forward-looking approach generates stimulating analysis and reports, to explore what these changes mean for GlobalData’s clients and their customers.

Session Details: Impact of the Medical Device Regulation on Device Approvals 16-07-2020, 2:15 pm View In Agenda

Biography: John Shillingford, PhD is an experienced clinical researcher whose career in the Pharmaceutical, Medical Device and CRO industries has stretched over 40 years.  John has both lived and worked in a number of European Countries as well as the USA.   He is now lives in Germany. His wide experience of Drug and Medical Device Development in Europe and the USA has been acquired during the management of both Clinical and Data Operations for major Global Programmes. John has held senior positions in Management, Clinical Operations and Project Management for, Aptiv Solutions, Averion International (a Medical Device Research Company), PRA International and Imform GmbH. Currently John is Clinical Operations Director and a member of the Board of Afon Technology Ltd, a UK based Medical Device Company, Consultant to International Research Companies  and additionally continues to run a number of training courses in Vendor and Project Management.

Session Details: An Exploration of Wearable Devices and Advances in Technology: Focusing on Non-Invasive Glucose Measuring Technology 16-07-2020, 1:00 pm View In Agenda

Biography: Romil has 12 years of regulatory experience in Class III combination products (Transcatheter Mitral/Aortic Valve Replacement Systems and Drug Eluting Stents) and Class II medical devices (Alpha-1 antitrypsin test, Software validation, Endoscope defogging device, Holter recorder, etc) Romil has an in-depth understanding of regulatory, quality and clinical requirements, and he has a history of successfully managing regulatory submissions such as Premarket approval (PMA), Investigational Device Exemption (IDE), Early Feasibility Study (EFS-IDE), Premarket Notification [510(k)], Design Dossier (CE Mark), European Directorate for the Quality of Medicines & HealthCare (EDQM) Certification, Shonin Submission (Japan), Clinical Trial Applications (Europe & Japan), Global Regulatory Submissions, Amendments, Supplements and Annual Reports.

Session Details: CASE STUDY: Investigational device exemption 101 16-07-2020, 5:00 pm View In Agenda

Biography: Hayley Lewis serves as the Senior Vice President of Operations, where she oversees the functional areas of Nonclinical, R&D, Analytical Development and QC, Operations and Engineering, Manufacturing, and Regulatory Affairs, and continues to be responsible for overseeing all regulatory interactions with the FDA and other government agencies. Hayley joined the company as the Vice President of Regulatory Affairs and Quality in October 2015. Prior to joining Zosano, Hayley spent over 11 years in Regulatory Affairs at Depomed, Inc., a specialty pharmaceutical company, where she was involved in the approval of 3 commercial products. Over the course of her career, she has enabled 9 investigational products to be studied in humans, 6 of which have advanced to completion of Phase 3 trials. Hayley’s pharmaceutical development experience, spanning over 20 years, covers solid oral dosage forms, and combination products such as systemic and local inhalation products, a single entity combination injectable, and transdermal systems. Ms. Lewis received a B.S. in Pharmaceutical Sciences from the University of Greenwich in England, and has attained several management diplomas from Kellogg School of Management, as well as Stanford’s Graduate School of Business.

Session Details: Getting FDA approval for your trial 16-07-2020, 4:00 pm View In Agenda

Biography: Sabine Hauck is Vice President Research & Development at Munich-based biotech company LEUKOCARE. She has 20 years of experience in biotech industry, in which she held various positions in development, quality assurance and regulatory affairs. For about 10 years during this time she was responsible for clinical trial materials that consisted of a Medicinal Product and a Medical Device, and during this time she acquired a lot of experience in the use of Medical Devices in clinical trials and in development of combination products. In the current position Sabine Hauck is responsible for R&D activities at LEUKOCARE AG. In this role she oversees the customer projects and internal development projects including the algorithm-based formulation development approach at LEUKOCARE AG.

Session Details: Artificial Intelligence in Development of Stable Biologics Formulations 16-07-2020, 12:00 pm View In Agenda

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Session Details: Update on the Implementation of the Medical Device Regulation in Europe 16-07-2020, 10:30 am View In Agenda

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Session Details: CASE STUDY: From Device Design to the Market: Telling the Paragonix Story 16-07-2020, 3:15 pm View In Agenda

Biography: Jón I. Bergsteinsson, M.Sc. Biomed. Eng. is the VP of Global Business Development and the co-founder of SMART-TRIAL, he also served as the CTO until 2017 where he paved the way for the platform’s quality standards, data security, and compliance. With a strong technical background, and 10 years of experience in clinical informatics, research, and medical devices, Jón’s primary mission is to share valuable insights and know-how on clinical data management with the MedTech industry.

Session Details: How to Conduct a Successful Post Market Clinical Follow-Up Survey 16-07-2020, 11:30 am View In Agenda

Biography: Ian has worked within the pharmaceutical industry since 1978 and is a Charted Chemist. Before moving into the contracting environment Ian was employed by Bayer Schering, during his time at Bayer Schering he worked within Quality and Manufacturing of Medical Devices. Ian joined Sharp Clinical Services as General Manager in 2010 and is responsible for P&L, Customer Services, Operations and Quality; prior to joining Sharp Ian implemented a Clinical Trial Services business unit for Piramal Healthcare and MHRA approval. Previous roles include Customer Service Director at Fisher Clinical Services and Operations Director at Quintiles Transnational.

Session Details: Case Study: Operational Factors from Phase III Clinical Trials to Commercialisation of Medical Device/Drug 16-07-2020, 1:30 pm View In Agenda

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As Founder & Chief Executive Officer of Axiom, Andrew Schachter provides the visionary leadership integral to the company’s more than 17 years of eClinical technology and managed services success.

Axiom’s Fusion eClinical Suite, the leading unified eClinical platform, has been used to run hundreds of studies across a wide range of therapeutic areas, from Phase I to global Phase III studies and registries.

Session Details: The Criticality of Having a Unified eClinical Platform to Running Your Medical Device Trial 16-07-2020, 6:30 pm View In Agenda

Biography: Paul O’Donohoe is Scientific Lead, eCOA and Mobile Health at Medidata Solutions, a clinical software platform provider. He is responsible for developing the company's scientific expertise for electronic clinical outcome assessments and mobile health in clinical trials and supports internal teams and Sponsors around the implementation of industry and regulatory best practices in studies using eCOA. He is passionate about developing the field of eCOA and mobile health through research and active involvement in industry consortia, and is currently the Industry Vice-Director of the C-Path ePRO Consortium.

Session Details: Reconsidering Trial Design for Medical Device Companies to Ensure Data Capture in the Challenging COVID-19 Era 16-07-2020, 11:00 am Reconsidering Trial Design for Medical Device Companies to Ensure Data Capture in the Challenging COVID-19 Era 16-07-2020, 7:00 pm View In Agenda

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Session Details: Technical Center – Designing and Testing your Packaging 16-07-2020, 1:00 pm View In Agenda

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Session Details: Technical Center – Designing and Testing your Packaging 16-07-2020, 1:00 pm View In Agenda