Outsourcing in Clinical Trials: Medical Devices USA 2020

Biography: Seth A. Kaufman, MSHCA, CCRA, is the Sr. Director, Clinical Affairs at Axonics Modulation Technologies. Axonics Modulation Technologies, Inc. (NASDAQ:AXNX) is a medical technology company focused on the design, development, and commercialization of innovative and minimally invasive sacral neuromodulation (“SNM”) solutions. SNM therapy is primarily used to treat patients with overactive bladder (“OAB”), fecal incontinence (“FI”) and urinary retention (“UR”). Axonics currently has marketing approvals in Europe, Canada, and Australia for OAB, FI, and UR. He has 20+ years of life science industry experience focusing on clinical research. He has worked for numerous sponsors as well as consulting for a “Big 4”. He also has past experience with epidemiological research with the US Department of Defense. He has deep knowledge and demonstrated experience with: Good Clinical Practices; ICH; and 21 CFR Parts 50, 54, 56, 312 and 812 as well as established practice with key tools, processes and procedures for clinical operations of many therapeutic areas for complex clinical trials.

Session Details: Case Study: From vendor to partner; how you can create relationships that go above and beyond the norm 10-07-2019, 9:00 am View In Agenda

Biography: Brandy Radojcsics is currently a Clinical Research Associate at Axonics Modulation Technologies, Inc.  As part of the Axonics in house team, she has been involved in the development and execution of the Axonics pivotal FDA IDE trial.  Previously she was a Clinical Research Coordinator involved in numerous pharmaceutical and device trials for various indications.  By working on both the Sponsor and Site sides, Brandy has gained valuable insight into how clinical trials are conducted; she has gained a better understanding of the intricacies of working and collaborating with multiple vendors.

Session Details: Case Study: From vendor to partner; how you can create relationships that go above and beyond the norm 10-07-2019, 9:00 am Speaker Hosted Roundtables 11-07-2019, 2:30 pm View In Agenda

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Session Details: Debate: Pharma CRO vs Med Dev CRO – how to select the right CRO and what are the industry trends in this space for potential future selections? 11-07-2019, 9:00 am View In Agenda

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Session Details: Chair’s Opening Remarks 10-07-2019, 8:50 am Chair’s Opening Remarks 11-07-2019, 8:50 am View In Agenda

Biography: Ms. Verma brings extensive expertise in Medical Device, Pharmaceuticals and  Clinical Research and Product Development. She is recognized Healthcare and Life Science leader with more than 20 years of mentoring experience, leadership skills, strategic thinking in multi-therapeutic acumen. Ms. Verma Founder and CEO of ClinVitals as well as Head of Global Clinical Affairs at Natus Medical and served several start-up and public firms encompassing all phases and types of clinical research.

Session Details: Maximizing what technology is available in medical device trials and how this can be implemented adequately and effectively 10-07-2019, 4:00 pm View In Agenda

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Session Details: Case Study: Ensuring commercial success; will your medical device result in insurer reimbursement? 10-07-2019, 4:30 pm Panel Discussion: Determining way through which you can bring devices to market when investors are risk adverse 11-07-2019, 11:15 am View In Agenda

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Session Details: Case Study: How we prepared for FDA advisory panel review 10-07-2019, 11:15 am View In Agenda

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Session Details: Panel Discussion: Reviewing MDR and IVDR; what does it mean for US sponsors and how does it foreshadow worldwide uniformity 10-07-2019, 10:15 am View In Agenda

Biography: Stanton J. Rowe is CEO of NXT Biomedical, a medical device incubator funded by Deerfield Capital. Stanton recently retired from Edwards Lifesciences where he was Chief Scientific Officer since 2008 and also served as Corporate Vice President, Advanced Technology. He joined in 2004 when Edwards acquired Percutaneous Valve Technologies, a company he helped to found in 1999 and served as President and CEO. This company developed the first transcatheter aortic valve replacement. Previously, Rowe was Corporate Vice President for Datascope and was Vice President at Johnson & Johnson's Interventional Systems Division (JJIS) in Warren, New Jersey, responsible for the company's coronary stent development efforts. At JJIS and the related Cordis Corporation, Rowe held a variety of positions with increasing levels of responsibility, including heading the company's business development, advanced technology, worldwide clinical research and marketing groups. Rowe joined Cordis after previously holding several positions in product management for a number of medical device companies. He is on the board of directors of both InSeal Medical, Ltd., NeuralAnalytics, PQ Bypass. He is also on the Board of Directors for the Discovery Science Center in Orange County, Sage Hill School, as well as on the advisory boards for the engineering, business school, and biomedical engineering schools at UC Irvine. He also sits on the biomedical engineering advisory board of UC Davis, and Texas A&M. Rowe received a bachelor's degree from the University of Alabama.

Session Details: Panel Discussion: Determining way through which you can bring devices to market when investors are risk adverse 11-07-2019, 11:15 am View In Agenda

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Session Details: How do you enter the Chinese market and what do you need to know before trialing there? 10-07-2019, 3:00 pm View In Agenda

Biography: Hal has over 25 years of Clinical Research experience ranging in perspective from the Study Site, small and large CRO’s, large 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 in Pleasanton, CA where he oversees Clinical Contracting, Outsourcing, Process Excellence, eClinical Solutions and Logistics.

Session Details: Debate: Pharma CRO vs Med Dev CRO – how to select the right CRO and what are the industry trends in this space for potential future selections? 11-07-2019, 9:00 am View In Agenda

Biography: Thilo is a neurologist and the inventor of SONASâ, a portable, battery-powered and cost efficient ultrasound device for early stroke detection with the potential to become the ‘ECG for the brain’

Session Details: Panel Discussion: Determining way through which you can bring devices to market when investors are risk adverse 11-07-2019, 11:15 am View In Agenda

Biography: Dr. Glenn holds a doctorate in Exercise Physiology and graduate credentials in Statistical Analysis and Research Methods from the University of Arkansas. He has trained for more than 10 years in exercise physiology, aging, pathophysiology, dietetics/nutrition, and behavior change at the University of West Florida and the University of Arkansas, respectively. Dr Glenn has held a professorship appointment at Louisiana Tech University, teaching within the Kinesiology department and running a lab dedicated to nutritional interventions related to exercise performance, and placed research papers in 22 publications and presented at 38 conferences.

Session Details: Innovations in software as a medical device technology; where is the industry heading? 10-07-2019, 2:00 pm Speaker Hosted Roundtables 11-07-2019, 2:30 pm View In Agenda

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Biography: Dr. Goates joined Abbott Laboratories in February, 2014. His current role involves the design and execution of clinical and observational studies with patient reported and economic outcomes in cardiovascular and neuromodulation devices.  Dr. Goates frequently publishes articles on the cost-effectiveness of medical devices, the economic burden of disease, and the impact of quality improvement programs in clinical settings.  He chairs the communication working group for the Science of Patient Input within the Medical Device Innovation Consortium. Prior to joining Abbott, Dr. Goates worked at the Centers for Disease Control and Prevention where he conducted research and advised senior leadership on a wide variety of high priority public health issues. Dr. Goates has published in Circulation, The American Journal of Public Health, Health Affairs, Preventing Chronic Disease, American Journal of Preventive Medicine, Journal of Nursing Care Quality, Plos One and Applied Economics. Dr. Goates holds a PhD. in Economics and a Masters in Statistics from Washington State University, and a MBA from Western Governors University.

Session Details: Incorporating FDA’s Patient Preference Initiative (PPI) in your trial design to drive patient-centric innovation 10-07-2019, 12:15 pm View In Agenda

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Session Details: Panel Discussion: Reviewing MDR and IVDR; what does it mean for US sponsors and how does it foreshadow worldwide uniformity 10-07-2019, 10:15 am View In Agenda

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Session Details: A simple gap analysis can untangle complex device development issues 10-07-2019, 11:45 am View In Agenda

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Session Details: A simple gap analysis can untangle complex device development issues 10-07-2019, 11:45 am Debate: Pharma CRO vs Med Dev CRO – how to select the right CRO and what are the industry trends in this space for potential future selections? 11-07-2019, 9:00 am View In Agenda

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Session Details: A simple gap analysis can untangle complex device development issues 10-07-2019, 11:45 am View In Agenda

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Session Details: Expanding Horizons: accessing global opportunities in medical devices and diagnostics 10-07-2019, 2:30 pm View In Agenda