Clinical Trials for Medical Devices 2021- Virtual Conference

Biography: Gordon Chu is the Director of Investigations Branch at the Food and Drug Administration (FDA) Division of West Coast Imports (DWCI) within the Office of Enforcement and Import Operations (OEIO). In this role, Mr. Chu develops, manages, and evaluates inspectional matters for DWCI covering all FDA import activities associated with air and sea port operations in the States of Hawaii, California, Nevada, Oregon, and Washington. The Investigations Branch handles: importer inspection, import sample collection, field examination, entry review, investigation, and inspection of imported FDA regulated products. He works cooperatively and collaborates with Federal, State, and local agencies to ensure appropriate consumer protection. Mr. Chu began his FDA career in 2002 as a Consumer Safety Officer (CSO). As a CSO, he conducted domestic food inspection, consumer compliant investigation, recall traceback investigation, and inspection of imported FDA regulated products. In 2010, he became a Supervisor Consumer Safety Officer (SCSO). As a supervisor, he had the opportunity to manage an Import Field Operation Team, an FDA team in the Centralized Examination Stations (CES), and the Los Angeles International Mail Facility. Mr. Chu was also the Import Program Manager (IPM) for the FDA Los Angeles District. As the IPM, he is the District liaison to FDA Headquarter handling import related issues and concerns. Mr. Chu was selected to be the Director of Investigations Branch (DIB) for DWCI in June 2018. Mr. Chu has served as a mentor for the Federal Executive Board in Los Angeles, CA. He also served on multiple FDA Headquarter working group and committee related to Food Safety Modernization Act (FSMA), import process improvement, strategic framework, rapid screening technology, and partnership agreements. He also been instrumental in enhancing FDA relationship with U.S. Customs and Border Protection (CBP) and other Partnering Government Agencies. Mr. Chu holds a Bachelor of Science in Applied Ecology from the University California of Irvine.

Session Details: KEYNOTE ADDRESS 23-06-2021, 10:00 am View In Agenda

Biography: Mr. Solis is a recognized expert in FDA import operations who has served as the acting assistant commissioner and director of ORA’s Office of Enforcement and Import Operations (OEIO) since March 29, 2020. During this time, he has provided leadership and direction to all OEIO field import divisions as well as the Division of Food Defense Targeting and Division of Import Operations at FDA HQ. He brought about the leadership and stability needed during the COVID-19 Pandemic. Mr. Solis was selected as the Assistant Commissioner for Import Operations on November 22, 2020 and prior to that he was the Division Director for the Division of West Coast Imports since February 9, 2018. He started his career with FDA in 1998. Prior to working in FDA, Mr. Solis worked in the Bioresearch field focusing on Medical Device and Drug Application Products after graduating from the University California of Irvine and the University of La Verne. Mr. Solis has held many positions within FDA that includes working at the FDA lab in Irvine, Ca. as a Microbiologist, HQ position within the Division of Import Operations in Rockville, MD, working as an Import Compliance Officer and working in the FDA Los Angeles District Office as a Director of Import Operations Branch. Mr. Solis is an experienced collaborator who has played an integral role in FDA operational activities with other federal agencies, partnering with Customs and Border Protection, Homeland Security Investigations, U.S. Department of Agriculture, U.S. Fish and Wildlife Service, Drug Enforcement Agency, and state and local law enforcement agencies. Additionally, he conducts local and national training on imports, is a member of the National Leadership Development Workgroup at FDA’s Office of Training and Education Development, and has served as a mentor for the Federal Executive Board in Los Angeles and ORA’s Potential Supervisors Program. In his new role, Mr. Solis serves as the principal advisor to Associate Commissioner for Regulatory Affairs and report to the Deputy Associate Commissioner for Regulatory Affairs (DACRA) on all import matters. This includes providing direction and oversight to FDA field import operations, reviewing prior notice and intelligence data on human and animal food, and leading the development and implementation of new import programs and procedures. Mr. Solis has had many accomplishments within FDA and these are a few notables: Implementation of PREDICT at all ports in the US, the implementation of electronic communications and paperless transactions initiatives with the Trade Associations, formation of the CBP/FDA Teams including the Opioid Task Force, formation of the West Coast Import Advisory Council, formation of Federal and State Task Forces, conducting Federal Operations, streamlining the refusal process in the Ports of LA, San Francisco and Seattle, and development of strong partnerships with the filers, brokers and importers in the Pacific Region. Mr. Solis is nationally recognized as a subject matter expert in the program area of Import Operations and gives local, as well as, national training on Imports Investigations. He is a member of the National Leadership Development Workgroup at FDA’s Office of Training and Education Development, has served as a mentor for the Federal Executive Board in Los Angeles and the Potential Supervisor Program within FDA. He also has had integral roles in FDA Operations with other Federal Agencies, working with CBP, HSI, USDA, FWS, DEA and State and local law enforcement agencies. Currently, aside from his duties at the port, Mr. Solis is also a member of the FSMA – Foreign Supplier Verification Program (FSVP) Implementation Team as well as the Associate Commissioner’s IT Advisory Workgroup, the Associate Commissioner’s Import Advisory Panel, member of AFDO, WAFDO, ASQ, OCRA and the Pacific Island Health Officers Association (PIHOA). Mr. Solis holds a Masters Degree (MS) in Healthcare Administration from the University of LaVerne and a Bachelor’s Degree (BS) from University California of Irvine.

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Biography: Hal has 30 years of Clinical Research experience ranging in perspective from the study site, small and large CRO’s, big pharma, and large diagnostics companies.  During his 15 years with GlaxoSmithKline, Hal spent six years designing and conducting Clinical Trials before focusing on outsourcing and supplier management.  In 2013, Hal joined Roche Molecular Systems in Pleasanton, CA where he oversees Clinical Contracting, Outsourcing, Clinical Quality, eSolutions and Logistics for Clinical Operations and Biometrics.

Session Details: LIVE PANEL DISCUSSION 23-06-2021, 11:00 am View In Agenda

Biography: Specialized in development of ophthalmic medical devices with strengths in clinical, regulatory and quality aspects. Has gained extensive experience in clinical research and clinical project management by leading high priority projects to successfully develop and launch best-in-class products in eye care business. Has experience in building and defending regulatory strategies, as well successfully led and defended multiple internal and external audits, including FDA inspection and recall process. Oversaw development of Human Factors Evaluations. Has led high performing global, cross functional teams to respond to short term, immediate needs and developing strategies for long term sustainability by building R&D pipeline. Proven success with Fortune 500 companies, as well as start-up firms. Specialties: Clinical product development, clinical operations, building and executing systems, strategies to streamline processes and improve efficiency. Develop new strategic alliances and evaluating new technologies. Organizational development.

Session Details: LIVE PANEL DISCUSSION 23-06-2021, 11:00 am View In Agenda

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Session Details: LIVE PANEL DISCUSSION 23-06-2021, 11:00 am View In Agenda

Biography: Edward Cox has been the Chief Executive Officer and Chairman of the Board of Dthera Sciences since September 2016. Previously, he was Chairman and Chief Executive Officer of EveryStory, which merged with Dthera Sciences. Prior to EveryStory, he was an Executive Officer at Apricus Biosciences, a NASDAQ listed pharmaceutical company. In the 5 years he was at Apricus, he led Commercial Development, Business Development, Investor Relations, and Corporate Development. Mr. Cox served as the President and Director of Bio-Quant, Inc. from January 2007 until Bio-Quant’s merger with NexMed, Inc., which was renamed Apricus Biosciences. Prior to late 2009, Mr. Cox served as an executive or board member of both public and private companies in the areas of Healthcare, Life Science, Technology and Resources. Mr. Cox holds a Master of Science in Management degree from the Warrington College of Business Administration at the University of Florida.

Session Details: LIVE PANEL DISCUSSION 23-06-2021, 11:00 am View In Agenda

Biography: Tenley Koepnick has worked in the clinical trial industry for more than 30 years.  She is the Sr Director, Global Clinical Operations for Transcather Heart Valves at Edwards Lifesciences, Inc based in Irvine, CA and manages a global team of 100+ people across many different clinical and operational disciplines. Tenley is passionate about getting needed heart valve treatments to all patients and improving access to clinical trial participation for women.  Her work focuses on delivering exceptional service to clinical trial sites and vendors and ensuring high quality trial results for the advancement of cardiovascular health.  Tenley’s creative side surfaces in her big-picture, out-of-the-box thinking.  When she’s not executing trials, she can be found enjoying the outdoors or designing interior spaces.

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Biography: Dr Frances Rubenstein has worked in clinical data management for more than 20 years in both medical device and pharmaceutical companies. She has extensive experience in leading data management activities for multiregional clinical trials in all phases and several therapeutic areas. Frances has an undergraduate degree in Physiology and a PhD in medical science from the University of Sydney. Frances has been working at Nevro Corp, a medical device company for the past 10 years as Director, Database Management. In her role at Nevro, Frances is responsible for leading the data management team, driving the adoption of new technologies and innovative data management processes to bring new treatments to patients.  

Session Details: The data management challenge – barriers and solutions 23-06-2021, 12:00 pm View In Agenda

Biography: Louis-Pierre Marcoux likes to think of himself as a regulatory minesweeper, clearing the path of obstacles for the commercialization of medical devices. He has spent the last 20 years bringing innovative medical technologies to new markets, and currently serves as Sr. Director of Regulatory Affairs for NeoTract | Teleflex Interventional Urology. Prior to joining NeoTract, Marcoux served in various leadership roles in at ZELTIQ (now AbbVie), Coapt Systems (now MicroAire) and Stryker. His expertise is in Regulatory, Quality, and Compliance, and he has lectured at various industry conferences and events on Regulatory Affairs, Quality Management and Supplier Quality.

Session Details: The latest EU Medical Device Regulation - understanding the legislation and its requirements 23-06-2021, 1:00 pm 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: The digital transformation of clinical trials – the importance of data accuracy 23-06-2021, 1:00 pm View In Agenda

Biography: Ms. Verma is Director of Global Clinical Affairs with Natus Medical, founder and President of ClinVitals and Advisory member with Wai Technologies bringing extensive expertise in Medical Device clinical research and product development. A recognized health care and life science leader with more than 20 years of mentoring experience, leadership skills, strategic thinking in multi-therapeutic acumen. Ms Verma has served several start-up and public firms encompassing all phases and types of Medical Device clinical research.

Session Details: Successful strategies for creating self-sufficient local trial operations globally 23-06-2021, 2:00 pm View In Agenda

Biography: Vice President of Clinical Operations: Reporting to the COO and 4th employee of the company, built a clinical operations team and led re-design, enrollment and completion of the pivotal (IDE) trial of the Jada System for abnormal postpartum uterine bleeding and hemorrhage. Strategic leadership for all U.S. and O.U.S. clinical operations. In this role Kathryn has; • Led 15-center US pre-market pivotal IDE study, enrolling the maximum of 107 subjects in a challenging recruitment setting. Developed site relationships, negotiated favorable study contracts and budgets with each site, led training program that certified over 700 site team members as investigators and research staff, drove enrollment programs that approached >16,000 patients and secured informed consent from >7,000 in under 15 months. • Built clinical study team from 0 to maximum of 6 team members including the roles of Director, Prof Ed Manager, In-house, Field-based and Contract CRAs and Clinical Coordinator. Recruited key talent to executive and adjacent teams. • Designed and executed “Continued Access” program to ensure extended data collection after close of pivotal study, including successful FDA approval of IDE. • Presented Clinical Operations updates to quarterly BOD Meetings and investor presentations. • Developed relationships and key interactions with OB/GYN and Maternal Fetal Medicine specialist KOLs for understanding and advancement of the Jada System.

Session Details: Successful patient recruitment and retention strategies 23-06-2021, 2:00 pm View In Agenda

Biography: Nick Damiano is a serial entrepreneur with broad experience in medical devices and digital health. He has 15 years of experience as a healthcare entrepreneur, innovator, and leader. He is currently Co-Founder & CEO of Zenflow, which is developing a novel office-based therapy to relieve symptoms of benign prostatic hyperplasia (BPH), a urologic condition that impacts quality of life over 500 million men globally. The company has raised over $60 million in funding and conducted successful clinical trials in five countries. Zenflow is backed by leading venture firms including Invus and F-Prime and was one of the first medical device companies funded by Y Combinator, the world’s leading startup accelerator. Prior to Zenflow, Nick was an Innovation Fellow at Stanford University. Before Biodesign, he co-founded Avail MedSystems (f.k.a. Nurep), a company developing telemedicine solutions for medical device procedures that has raised over $100 million in venture funding. In this role, Nick led the successful technical development effort to bring the company's product to market and also played key roles in strategy, sales, and fundraising. Prior to Avail, he worked in engineering roles for several small medical device companies, including developing critical algorithms for the world’s first leadless cardiac pacing system at EBR Systems. Outside of Zenflow, Nick plays an active role in mentoring and advising medtech and healthcare entrepreneurs and startups. He has served as an advisor in various capacities at StartX, Y Combinator Startup School, Stanford Byers Center for Biodesign, and the Rosenman Institute. He is also a Venture Partner at Pioneer Fund, a venture fund led by Y Combinator alumni. 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: Mitigating the impacts of COVID-19 on clinical trials – lessons learned and long term implications 23-06-2021, 3:00 pm View In Agenda

Biography: Jennifer has a comprehensive background in managing global clinical development programs spanning from phases I-IV across multiple therapeutic areas in Oncology, She has expertise in Transplantation, Urology, Infectious Disease, Cardiovascular, CNS, and personalized cellular immunotherapies and rare disease. Seasoned in managing external CROs and vendors. Sound regulatory experience. Excellent verbal & written communicator. Strong track record of building, leading and motivating clinical teams.

Session Details: Transitioning to a hybrid or decentralized trial strategy 23-06-2021, 3:00 pm View In Agenda

Biography: My work with gynecologists, nurse practitioners, physical therapists, other healthcare providers and their patients since 2002 in the treatment of female urinary stress and mixed incontinence made me keenly aware of how urinary incontinence reduces the quality of patients’ lives.  Despite the high efficacy of the pelvic floor exercise device we rented to them, patients with mild dementia could not remember the protocol, those with MS and paraplegia could not contract their pelvic floor muscles (PFM) and younger women busy with work and family responsibilities did not have the time to exercise.  Cheri Grantham, an experienced medical assistant, and I began developing a medical device which blocks unwanted urine leaks and does not require exercise or the cooperation of the patient.  I bring to this task over fifty one years of medical device experience, both in academia, private industry and consulting.  I have the leadership and technical skills, industry contacts and FDA experience to take this device all the way into the market so that we can greatly improve the quality of life of not just incontinent women, but of their caregivers and families, as well as saving third party payers such as Medicare a significant sum now paid to institutionalize some of these patients due to their incontinence, as well as funds paid for surgery and absorbent products. In previous positions I designed and ran local and international clinical trials of medical devices that diagnosed or treated eye diseases and skin conditions. Our team is currently navigating the difficulties COVID-19 has created for running a clinical study, both indirectly by keeping subjects home and directly by infecting one of our team members.

Session Details: How to maximize opportunities for investment and partnering deals in clinical trials – lessons learned from an early stage medtech company 23-06-2021, 4:00 pm View In Agenda

Biography: Srihari has worked mainly in Women’s Health and Dermatology/Quality Of Life improvement; Cardiology, Oncology and Orthopedics. He has performed Front End Research, Conceptual Design, IP Generation, Multi-generational prototyping, Design Improvements, Verification and Validation (V&V), Assembly Process Design, Design Transfer, New Product Introduction, Manufacturing Process Development/Improvement and Service Process Development. Srihari is a Certified SolidWorks Expert, and carry several other CAD certifications and several thousands of hours, with experience ranging from Design, to Solution Implementation, Troubleshooting, Product Data and Lifecycle Management. He also has experience in Finite Element Analysis (FEA) and Computational Fluid Dynamics (CFD), ranging all the way from simple linear analysis to non-linear analyses. He has worked with several customers, across various industries, helping them solve complex modeling, analysis, and product data management issues.

Session Details: Transforming clinical trials with the power of AI 23-06-2021, 4:00 pm View In Agenda

Biography: Judy Skroback is the former Director of Clinical Research at SynCardia Systems, LLC, where she spent 10 years overseeing medical device trials and continues as a Consultant. She is a Certified IRB Professional, a Certified Clinical Research Contract Professional and an Affiliated IRB Member at Advarra. She previously served for 16 years in the Human Subjects Protection Program of a major research university

Session Details: Successful models for collaborating with the FDA 23-06-2021, 4:30 pm View In Agenda

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Session Details: Discovering innovation in digital health and connected medical devices 23-06-2021, 4:30 pm View In Agenda

Biography: Diran Adelakun is the Manager of Clinical Monitoring Services at Clinlogix. He is responsible for supporting the company’s global strategies as it relates to study monitoring design and implementation. He has been working in the clinical stratosphere for 15+ years over a vast array of therapeutic experience.

Session Details: Global monitoring strategies in a Post-Covid environment 23-06-2021, 1:30 pm View In Agenda

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Yan Yiannakou is the Clinical Director of the NIHR Patient Recruitment Centre (Newcastle). He has been a director of R&D at a National Health Service (NHS) Trust and has also served as regional clinical lead for commercial research for the NIHR Clinical Research Network. His main interest is in improving access to clinical trials through community-based participation, consent for contact registries and a digital media platform. He has used innovative and collaborative strategies to develop and refine a multi-modality ‘recruitment engine’ and led one of the UK’s first ‘virtual’ interventional trials.

Session Details: How to deliver medical device trials virtually; the benefits and challenges 23-06-2021, 2:30 pm View In Agenda

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Theo Christie is a Business Development Manager (Commercial) for the NIHR Clinical Research Network (CRN). He facilitates discussions between the life sciences industry and the Clinical Research Network and provides advice to companies on how they are able to access government-funded support to ensure clinical trials are set up efficiently and recruit to time and target in the UK.

Session Details: How to deliver medical device trials virtually; the benefits and challenges 23-06-2021, 2:30 pm View In Agenda

Biography: Iman is a strong clinical and regulatory expert with 15+ years’ experience in managing pharmaceutical and device studies, including domestic US trials, and larger multinational global studies. She works closely with the Regulatory department in the development and submission of IDE, IND, 510(k), and PMA applications for orthopedic devices. As Sr. Clinical Director, Iman leverages her expert knowledge of FDA regulations and ICH/GCP guidelines to design pre- and post-market clinical studies in a manner that helps drive clinical and regulatory compliance and ensures superior data quality. She assists clients with the identification and qualification of orthopedic sites that help ensure their trial’s success. She has assisted with the development of clinical protocols that incorporate strategic regulatory, statistical and reimbursement objectives so that our clients can use each clinical trial to collect data required by all stakeholders. She also advises clients on the use of innovative statistical analyses that can help reduce a study’s sample size and/or allow for an early success/failure determination. Iman also provides strategic guidance to clients on how to maintain inspection readiness at research sites, and how to prepare for a BIMO inspection. Prior to joining MCRA, Iman worked under the functional service provider arm of a large CRO (Syneos, previously known as Inventiv), where she conducted risk based monitoring, and was responsible for overseeing all aspects of Phase I/II study implementation for a major pharmaceutical company.  Prior to working at Inventiv, she led several DoD funded trials at a medical device start up and served as a safety reporting consultant at NIAID (NIH). She also spent 5+ years managing Phase I-III HIV prevention trials funded by the Gates Foundation in the US, UK, Europe and Africa. Iman graduated from Stanford University with a Bachelor of Science in Human Biology before gaining her Master of Science in Biotechnology from Georgetown University.  

Session Details: Outsourcing considerations for your clinical trial 23-06-2021, 3:30 pm View In Agenda

Biography: Derk Arts MD, PhD has over fifteen years of experience in medicine, research and technology. He founded Castor to solve the biggest issues in clinical research: a lack of inclusivity, patient focus and impact of data. Castor enables sponsors worldwide to run patient-centric trials on a unified platform, that helps them maximize the impact of research data on patient lives. Dr. Derk Arts believes the key to achieving lasting change in the industry is through scalability and standardization. Technology to run better trials and maximize the impact of data should be available to all researchers. Over the past 12 months, Castor provided pro-bono support to over 300 COVID-19 trials, and provided the entire infrastructure for the World Health Organizations’ Solidarity Trials.

Session Details: Decentralized and Hybrid trials for Medical Devices and Diagnostics 23-06-2021, 10:30 am View In Agenda

Biography: Brandy is an accomplished clinical research professional with 7 years of experience in medical device trials and 15 years in the cardiovascular clinical setting. She started her clinical research career at Cardiopulmonary Science and Research Institute (CRSTI), specializing in Class III cardiovascular medical device studies. Brandy began as a Clinical Trial Assistant, quickly moving to Lead Clinical Research Coordinator with CRSTI. In 2016, Brandy began working as a Clinical Research Associate II at a Sponsor company, where she oversaw the daily operations of a Class III Pivotal prosthetic heart valve study. In this role, her duties included ensuring regulatory and protocol compliance, conducting on-site and centralized monitoring visits, as well as managing CRAs with a contracted CRO for report monitoring, protocol training, and as an escalation resource. Brandy came to Covance (then Chiltern) in 2017 as a Clinical Research Associate II. During her time at Covance, Brandy has progressed from CRA II, Senior CRA, a hybrid role of Sr. CRA / Associate Line Manger and now serves as Manager, Clinical Operations. Brandy has also managed clinical affairs for a biotech start-up company where she was responsible for developing study protocol, management plans, and subject recruitment plans for a Class II artificial intelligence diagnostic device. Trial and Therapeutic Experience Brandy has been participating in and monitoring clinical trials with FDA Class II and Class III medical devices over the past 7 years. She has experience with implantable cardiovascular devices for transthoracic aortic valve replacement, atrial fibrillation, coronary artery disease, in-stent restenosis, stroke, and peripheral artery disease. These trials have encompassed feasibility, pivotal and registry studies. Her experience also includes Neurology studies focusing on embolic protection devices. Her expertise also includes managing clinical trials for compliance with ICH GCP Guidelines and FDA regulations, and building strong, productive relationships with sponsors, investigators and coordinators.

Session Details: The Comeback: Patient Recruitment & Engagement for Medical Device Trials in our ‘current reality’: How COVID-19 has presented opportunities throughout the industry to relearn patient recruitment, site engagement and execution of studies 23-06-2021, 11:30 am View In Agenda

Biography: Chris Kim received his medical degree from the Perelman School of Medicine at the University of Pennsylvania and has been in medical device research and development for 15 years. He currently teaches at two medical schools in the Philadelphia area on best research practices while working as the VP of Clinical Research and Human Factors at Schlesinger Group. Chris has worked on over 300 different medical devices over the course of his career (ranging from scalpels to phone applications) and is a trusted source of regulatory knowledge in the area of human factors both for the U.S. and  outside of the U.S.

Session Details: Utilizing Traditionally Consumer Product Driven Tools for Conducting Human Factors/Simulated-Use Medical Device Testing 23-06-2021, 2:30 pm View In Agenda

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Biography: Shannon Childs consults with clients on strategic initiatives and partners closely with our Schlesinger Clinical Research team on regulated healthcare research to facilitate real-world insight and evidence, marketing claims, label comprehensions, parity, and superiority testing. With over 25 years of experience, Shannon has worked with large pharma, medical device, and biotech organizations generating quality information to inform strategic decision making. Before joining Schlesinger Group in August of 2020, she spent most of her career at Ipsos Healthcare (and several years prior at the insights firm PG Research). Shannon is a critical thinker, focused on problem-solving, and is seasoned in leading teams that deliver above industry satisfaction scores. Shannon has a Bachelor of Science Degree in Marketing from Clemson University and a Masters in Business Administration from Meredith College. Shannon lives in North Carolina with her husband Doug, has 3 children, 3 beagles, and volunteers in her spare time as a cheer coach.

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Biography: Hal has 30 years of Clinical Research experience ranging in perspective from the study site, small and large CRO’s, big pharma, and large diagnostics companies.  During his 15 years with GlaxoSmithKline, Hal spent six years designing and conducting Clinical Trials before focusing on outsourcing and supplier management.  In 2013, Hal joined Roche Molecular Systems in Pleasanton, CA where he oversees Clinical Contracting, Outsourcing, Clinical Quality, eSolutions and Logistics for Clinical Operations and Biometrics.

Session Details: LIVE PANEL DISCUSSION 23-06-2021, 11:00 am View In Agenda

Biography: Ms. Bulliard has over 25 years’ experience in conducting real-world evidence studies, patient registries, safety surveillance programs, and other specialized real-world programs. She has an extensive global portfolio, specializing in medical device & diagnostics studies. Ms. Bulliard works with medtech companies around the world to design & deliver solutions that translate evolving methodological real-world research standards and real-world data generation methods into feasible operational delivery strategies to meet the needs of regulators, payers, providers & patients. A subject matter expert in RWE medical device, diagnostic and digital health studies with a robust knowledge of the current and evolving clinical, regulatory, scientific and commercial medtech landscape, she seeks to generate product value by leveraging the most effective, innovative and compelling strategies within the marketplace. Ms. Bulliard is a member of IQVIA’s MedTech Center of Excellence representing the domain of real world evidence. She has previously held senior positions in the field of post market safety and real world research in medical device and biotech companies. Education She has obtained her Bachelor of Science in Nursing, BScN, RN, from Dr Steevens Hospital  / Trinity College Dublin Ireland, with a P. Grad. Dip in Critical Care ICU Dublin, Ireland and Lausanne, Switzerland.

Session Details: A new world of real world evidence generation 23-06-2021, 1:30 pm View In Agenda