Outsourcing in Clinical Trials: Medical Devices USA 2020

Biography: Dan is an experienced Import Director with a demonstrated history of working in the government administration industry. Skilled in U.S. Food and Drug Administration (FDA), Good Laboratory Practice (GLP), Import, Government, and Life Sciences. Strong operations professional with a MHA focused in Health/Health Care Administration/Management from University of La Verne.

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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 10-12-2020, 1:45 pm View In Agenda

Biography:

Jennifer Bolton is a Regulatory Fellow 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.

With over 24 years of Regulatory experience, Jennifer has lead key clinical and market approvals for many cardiovascular and peripheral products including the ACURATE neo2 Aortic Valve System and WATCHMAN™, the only US-approved Left Atrial Appendage Closure Device. She’s currently working with transcatheter aortic and mitral repair/replacement technologies and volunteers with a local gBETA Medtech Accelerator for early-stage startups.

Jennifer previously supported global strategies for some of Boston Scientific’s 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).

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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, Welcome to Day Two 11-12-2020, 8:50 am Chair’s summation and close of conference 11-12-2020, 2:30 pm View In Agenda

Biography: Hal has 25 years of clinical research experience ranging in perspective from the study site, small and large CROs, large pharma, and, currently, large diagnostics. During his 15 years with GlaxoSmithKline in RTP, NC, Hal spent six years designing and conducting clinical trials before joining the Global Resourcing group focusing on supplier management and strategic outsourcing. In 2013, Hal joined Roche Molecular in Northern CA as the Director of Clinical Trial Support and Strategic Outsourcing in Medical and Scientific Affairs, where he heads clinical laboratory, medical writing, TMF and material logistics, and outsourcing.

Session Details: PANEL SESSION – Exploring How We Can Encourage the CRO Industry to Meet Our Needs 11-12-2020, 11:00 am 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 10-12-2020, 12:15 pm 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: Digital Therapeutics and Telemedicine: Implications in a Post COVID 19 world and Lessons for the Future 11-12-2020, 10:00 am View In Agenda

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: KEYNOTE: Entering Emerging Markets: Key Considerations and Best Practices 11-12-2020, 1:30 pm View In Agenda

Biography: Christina’s breadth of experience and understanding of clinical research comes from working in positions throughout healthcare and clinical research in academics, medical institutions, local government (public health), and the medical device industry. She is passionate about my work, help drive change, think strategically, and am meticulous. She thrives on being challenged, creative and innovative. She enjoys mentoring and leading others positively through my actions and energy. Specialties: Clinical Research, Trial Management, Monitoring, Health Education, Project Management, Lecturer, Epidemiology, Public Health, Certified Clinical Research Associate, Leading remote and in-house teams

Session Details: Handling Company Expansion: Best Practices in Change Management and Process Improvement 11-12-2020, 11:30 am 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 10-12-2020, 4:45 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: DEBATE SESSION: “This House Believes that Aiming for Regulatory Compliance is a Low Place to Set the Bar when Designing your Clinical Trial” 10-12-2020, 9:00 am Artificial Intelligence – What’s Next? Examining the Pitfalls and Potentials of AI 10-12-2020, 2:45 pm View In Agenda

Biography: Robert J. Greenberg, M.D., Ph.D., is the Executive Chairman of the Alfred Mann Foundation. He was a co-founder and former CEO and Chairman of the Board of Second Sight Medical Products, Inc. (NASDAQ: EYES) in Los Angeles, California.  Dr. Greenberg is a leader in the field of neural prosthetics – having developed and brought to market the world’s most advanced implantable neural stimulator, the Argus II visual prostheses, to treat retinitis pigmentosa, a form of blindness.  Dr. Greenberg was also a medical reviewer at the FDA’s Office of Device Evaluation.  Dr. Greenberg is the recipient of numerous honors and awards, has over 260 issued US patents and over 100 international patents, and has published over 60 articles.  He received MD and PhD degrees from The Johns Hopkins School of Medicine in Baltimore, Maryland.  Dr. Greenberg joined AMF in 2004 as Chairman of the Board of Directors.

Session Details: Lessons Learned from Novel Device Companies 11-12-2020, 1:00 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 BioIntelliSense BioSticker 10-12-2020, 3:45 pm View In Agenda

Biography: Dave brings 20 years of experience in product execution and innovation. As the founding CEO of Striiv Corp, he spearheaded all aspects of building and executing seven generations of biometric wearables, shipping millions of devices to customers including United Healthcare, Pfizer, Walgreens, Acer, Best Buy and Qualcomm Life. Dave’s expertise is in building teams while simultaneously building products that combine multiple technology disciplines. Dave graduated from Stanford University with a dual M.S. degree in Electrical Engineering and Management Science and Engineering, and he received a B.S. in Electrical Engineering and Computer Science from UC Berkeley. He also holds over 15 patents in the fields of sensors, algorithms, edge processing and validation.

Session Details: CASE STUDY – The Benefits of Remote Healthcare and Continuous Data Monitoring: Looking at the case study of the BioIntelliSense BioSticker 10-12-2020, 3:45 pm View In Agenda

Biography: Tenley is a self-motivated, team-oriented clinical research professional that thrives in creative environments where out-of-the-box thinking is invited and encouraged. Through exceptional interpersonal skills and by establishing high standards and expectations as goals and drivers, she is able to motivate and manage individuals and large teams to exceed performance metrics. Tenley embraces opportunities to speak/present publicly and am able to engage my audience utilizing my natural leadership skills. Specific competencies include project management, departmental management, business development, regulations, and customer-service.

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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: Speaker Hosted Roundtables 11-12-2020, 9:00 am View In Agenda

Biography: Dr. Greg Maguire is founder and CEO of BioRegenerative Sciences, Inc. (bioregenerativesciences.com), a privately held stem cell therapeutics company in San Diego, and The SRM Living Foundry at UCSD (http://srmfoundry.org), a public-private venture at UCSD serving as a stem cell-based "living foundry" for the development of therapeutics, antimicrobials, nano-delivery systems, and bio-inspired building blocks for materials science and engineering. Dr. Maguire has been professor at UCSD, The University of Washington, and The University of Texas, a Fulbright-Fogarty Fellow, and his research, with over 100 publications, has been sponsored by the NIH and NSF. He is the founder of several biotech and pharmaceutical companies, and non-profits, including The San Diego Neuroscience Group, and currently serves on the Board of Nurture Earth (NE), a spin-out of MIT in Aurangabad, India. NE is a private company for the development of alternative/renewable energy, food, and healthcare technologies and products. Dr. Maguire's research and development efforts are focused on the use of stem cell released molecules (SRM) for therapeutic and technical innovation in the life sciences and materials sciences. Because SRM provides up to 80% of the therapeutic benefit of stem cell therapy, and because SRM provides the building blocks for life and the "instruction set" for the architecture of life, Maguire has begun to reverse engineer stem cell SRM processes in the human body, and other life forms. The results thus far include "systems therapeutics," the most efficacious technology and products for wound healing, anti-scarring, skin care, dry eye, and cataract. The S2RM platform technology developed at BRS also has demonstrated value in cancer, immune disease, and cognitive therapeutics.

Session Details: DEBATE SESSION: “This House Believes that Aiming for Regulatory Compliance is a Low Place to Set the Bar when Designing your Clinical Trial” 10-12-2020, 9:00 am PANEL SESSION – Exploring How We Can Encourage the CRO Industry to Meet Our Needs 11-12-2020, 11:00 am View In Agenda

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Biography: Valerie is an organized and self-motivated engineer who thrives in a collaborative team environment. Through her 5+ years as a Lead Reviewer and previously as an acting Senior Lead Reviewer at the U.S. Food and Drug Administration, she has demonstrated strong leadership and the ability to effectively and efficiently manage multiple complex regulatory submissions, including preparation for and presentation at a meeting of the Circulatory System Devices Panel. Through Valerie's graduate research experience at The University of Arizona and FDA, she has experience in the very early stages of product development. At UA, her dissertation work focused on the fabrication of a novel material for potential cardiovascular applications with specific laboratory experience in nanofibrous scaffold fabrication, cell-material interactions, and platelet activation. At The University of Arizona, Valerie also completed coursework related to teaching at the collegiate level, inclusive of coursework on how people learn and how to tailor messages to address different learning styles. This education instilled a strong value of communication, which is essential between team members, management, industry, and other stakeholders.

Session Details: Case Study: Moving your Clinical Evidence from Investigation to Market Adoption 10-12-2020, 9:45 am View In Agenda