Outsourcing in Clinical Trials: Medical Devices USA 2023

Biography: Jennifer Bolton is a Senior Fellow, Regulatory Affairs, at Boston Scientific Corporation.  Boston Scientific is dedicated to transforming lives through innovative medical solutions that improve the health of patients around the world, specifically with less-invasive technologies engineered to diagnose and treat a wide range of medical conditions. Jennifer has over 25 years of Regulatory experience.  She’s led key market and clinical approvals for many cardiovascular and peripheral products including the ACURATE neo2 Aortic Valve System and the WATCHMAN Left Atrial Appendage Closure Device.  She also facilitates a Regulatory Strategy Board, serves on the MDIC ENRICHMENT Industry Advisory Council, volunteers with a local Medtech Accelerator for early-stage start-ups, and is an Adjunct Instructor for the St. Cloud State University Regulatory Affairs and Services master’s program. Jennifer previously supported global strategies for some of Boston Scientific’s transcatheter aortic valve repair devices, left atrial appendage closure devices, drug-eluting stents, abdominal and thoracic aortic stent grafts, peripheral balloons and guidewires, and vascular surgery grafts/fabrics.  Prior to Boston Scientific, Jennifer worked with orthopedic implants at US Medical Products (now Consensus Orthopedics).

Session Details: KEYNOTE ADDRESS: Getting FDA approval for your device – top tips 08-06-2022, 9:15 am View In Agenda

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Biography: Long aims to continue to work in a research environment that allows him to learn, adapt, and lead research teams in new therapeutic areas, with new products, in new countries. He is also focused on continuing to teach, present, and educate clinical researchers of the dynamic and changing pharmaceutical industry.

Session Details: Successful strategies for conducting global clinical trials 08-06-2022, 1:45 pm PANEL DEBATE: Building successful sponsor-CRO relationships to deliver a robust performance and optimized trial execution 09-06-2022, 11:15 am View In Agenda

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Session Details: Mitigating the impacts of COVID-19 on clinical trials – lessons learned and long term implications 09-06-2022, 10:15 am PANEL DEBATE: Building successful sponsor-CRO relationships to deliver a robust performance and optimized trial execution 09-06-2022, 11:15 am View In Agenda

Biography: Dr. Gal has over 30 years of medical device experience as a practicing veterinarian, academician at Tufts University School of Medicine and subsequently in industry. Dov held R&D, clinical marketing and clinical affairs positions with increasing responsibilities in private start-up, and medium to large public medical device companies. Most recently, Dov led the clinical organization for the Heart Valve Therapy business at Edwards Lifesciences, overseeing clinical trials of Class III implantable devices. Prior to Edwards Lifesciences, he led the clinical organization at Broncus Technologies, a start-up with an investigational, minimally invasive device-drug combination product for the treatment of patients with severe COPD. The system was evaluated in an international clinical trial under an IDE. Prior to Broncus, Dov was a director of clinical research at Medtronic Vascular responsible for the AAA stent graft product line

Session Details: PANEL DEBATE: Building successful sponsor-CRO relationships to deliver a robust performance and optimized trial execution 09-06-2022, 11:15 am View In Agenda

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Session Details: CASE STUDY Leveraging the RFP process to identify a great CRO partner 09-06-2022, 1:45 pm View In Agenda

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Session Details: How to build a lean start up clinical operation - lessons learned from an early stage medtech company 09-06-2022, 12:15 pm View In Agenda

Biography: Few people with a cause walk the talk as boldly and graciously as Christine Von Raesfeld, founder and CEO of People with Empathy. Christine is a pillar of patient advocacy and allyship in the rare and chronic disease community. Through the lens of her lived experiences in healthcare, she has become a champion for patient voices, diversity and inclusion in clinical research, and equitable patient-sponsor partnerships. Christine has brought her unique perspective and honed expertise to countless roles as a featured speaker for numerous conferences dedicated to the rare disease community and disease awareness initiatives. Wherever possible, Christine generates momentum toward progress along her patient advocacy interests and stimulates dialog on a range of topics relevant to patients, clinicians, and industry. As a patient advisor, Christine has assisted several initiatives including the Stanford "Humanwide" Precision Medicine Program, All of Us Research, and the 23andMe Lupus initiative. For her many contributions to her field, she has been named one of the top 100 Women of Influence by Silicon Valley Business Journal, a member of the 2021 HIMSS Future 50, and one of Medika Life's medikal life 50 most influential voices in healthcare 2022  among other distinctions. With her guidance and support, we will continue to optimize the patient journey for people worldwide.

Session Details: WORKSHOP: Successful patient recruitment and retention strategies 09-06-2022, 2:45 pm View In Agenda

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Session Details: KEYNOTE ADDRESS: Clinical trials: what can go wrong and what you can do about it 09-06-2022, 9:15 am View In Agenda

Biography: Dr. John Hsu worked 29 years as an anesthesiologist and pain management physician.  In his practice he often found it difficult to monitor medication adherence and was always concerned about misuse and diversion.  To solve this problem in his practice, he founded iPill Dispenser for medication adherence monitoring, secure storage, active control dispensing, and destruction of unused pills. In his past, Dr. Hsu founded QuivivePharma, a drug development company that combined an opioid with a respiratory stimulant.  After receiving a NIDA NIH grant,  he is working with the Cleveland Clinic on a clinical study.   QuivivePharma has gone from an FDA 505(b)2 PreIND meeting to an FDA drug filing.  He also founded Fentavive, an abuse deterrent Fentanyl patch that has will have a commerical product in about a years time.  He co-founded   NAOMI systems, a digital software platform integrating digital X-rays devices, practice management, EMR and RCM billing systems. He currently holds 8 granted patents in digital medicine, medical devices and drug development.

Session Details: CASE STUDY: Best practice in remote patient monitoring to improve real-time data collection, minimize study participant loss and reduce costs 08-06-2022, 11:15 am 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 09-06-2022, 2:15 pm View In Agenda