Device and Diagnostics Summit

University of North Carolina at Chapel Hill

Opportunities and approaches for expanding pharmacy research in medical devices and diagnostics.

The Rizzo Center

Attendees will have the opportunity to:<ul><li>Engage with key opinion leaders and practitioners in these fields to determine issues and bottlenecks facing industry</li><li>Attend tracked sessions and various roundtable discussions with industry professionals in the pharmaceutical, biotechnology, and device industries</li><li>Join interactive networking sessions with faculty across UNC.</li></ul>Location: The Rizzo Center - Loudermilk Hall (Magnolia Room)

Agenda:8:20 a.m. WelcomeJohn Bamforth, Director, Eshelman Institute for InnovationJudith Cone, Vice Chancellor for Innovation, Entrepreneurship and Economic Development, UNC Office of Innovation, Entrepreneurship and Economic Development8:30 a.m. Opening RemarksBryant Moore, Director, Strategic Partnerships, Office of Technology Commercialization, UNC-Chapel Hill9:00 a.m. Moving to a Value-Based Health Care WorldSamir Mody, Vice President, CRHF Strategy, Economics, Reimbursement and Evidence, Medtronic9:30 a.m.Companion Diagnostics Value in Drug DevelopmentPeter Hoehn, Co Diagnostic Commercial Strategy Leader, Global Commercial Strategy, Janseen Pharmaceuticals, Johnson &amp; Johnson10:00 a.m.Regulatory Considerations in Device &amp; Combination Drug/Device DevelopmentDiana Severynse-Stevens, Global Health Technologies; Diane Earp, Corporate QA Officer and Senior Director, RTI International10:30 a.m.Breakout Session and Networking 11:00 a.m.Smart Devices and the Value they Contribute to Care DeliveryMircea Despa, Associate Director, R&amp;D. Smart Device and Data Science Group, Becton Dickinson11:30 a.m.Lessons Learned in Academic Development: Transforming Maternity Health Care and the Couplet Care BassinetTMKristin Tully, Research Associate, Carolina Global Breastfeeding Institute, Gillings School of Global Public Health, UNC-Chapel HillNoonLunch: Breakout Session &amp; Networking1:00 p.m.Growing Value and Commercial OpportunitiesRoss Meisner, Managing Director, Life Science Practice, Navigant Consulting, Inc.1:30 p.m.Panel Session: Perspectives on the Future Economic of Device/DiagnosticsAll SpeakersModerated by Stephen Eckel, Interim Chair, Division of Practice Advancement and Clinical Education, Eshelman School of Pharmacy, UNC-Chapel Hill2:15 p.m.Closing

About the Speakers:Samir Mody holds a Doctor of Pharmacy from UNC-Chapel Hill. He currently serves as Vice President Strategy, Economics, Reimbursement &amp; Evidence (ERE) for Medtronic’s Cardiac Rhythm and Heart Failure (CRHF) business. Samir is responsible for the leadership, development, and vision of the in-house and field ERE Team as well as overseeing CRHF strategy. He also serves on a number of councils and groups within Medtronic, including the Global and Cardiovascular Group Value Based Health Care Councils, the Leadership Advisory Panel, and the Asian Network. Peter Hoehn is the Diagnostics, Commercial Strategy Leader within the Global Commercial Strategy Organization of Janssen Pharmaceuticals of Johnson &amp; Johnson. He leads strategic marketing and market access for companion and complementary diagnostics (Co Dx) across all therapeutic areas. Peter and his team lead the assessment of potential diagnostic projects and commercial evaluation of prospective diagnostic partners, and lead commercial strategy development and launch readiness for Janssen Co Dx projects in development. Peter also has responsibility for Co Dx market access strategy, including development of clinical utility plans, pricing and reimbursement strategies, and Co Dx policy.Mircea Despa, Associate Director, currently leads the Smart Device and Data Sciences team, part of the Device Innovation group at BD Technologies and Innovation, in Research Triangle Park, NC. He oversees digital health R&amp;D, spanning from early- stage opportunity assessment to evidence generation through clinical studies. Under his leadership, the group has developed and performed clinical research with BD’s first prototype interconnected disease management system.Diana M. Severynse-Stevens is a Senior Director in the Global Heath Technologies group at RTI. She has 24 years of experience in the pharmaceutical industry in drug discovery, preclinical and clinical drug development. Therapeutic areas of focus include infectious, respiratory, cardiovascular, and metabolic diseases. Dr. Severynse-Stevens has been the Food and Drug Administration (FDA) regulatory contact for several drug development programs and has regulatory experience in writing, reviewing, and compiling regulatory submissions, including investigational new drug applications (INDs), briefing packages, protocols, and clinical study reports for submission to the FDA. R. Diane Earp has over 20 years of experience working effectively with regulatory agencies (e.g., FDA) and governing bodies and is RTI’s Corporate Senior Director of Regulatory Affairs, Quality Assurance, and Records Management (RQR). She reviews and oversees regulatory affairs and quality assurance activities for both regulated and unregulated studies and helps to develop regulatory strategies for medical devices, biologics, drugs, and combination products. Diane has extensive knowledge of FDA regulatory requirements for 510K, IND, NDA, PMA, BLA, and PLA submissions and annual reports, as well as validation plans, quality systems, and procedural development. Ross Meisner is the Managing Director of Life Sciences at Navigant. Ross co-leads Navigant’s medtech practice, helping early-stage ventures and established market leaders pursue better growth strategies. He co-founded Dymedex Consulting in 2007, building it into a recognized thought leader for medtech Market Development that was acquired by Navigant in 2016. Ross also helped Medtronic accelerate growth as Director of Global Market Development, co-founded or held leadership positions at four start-ups and two international joint ventures, and consulted for A.T. Kearney’s high-tech practice. John Bamforth, Director, Eshelman Institute for Innovation, UNC Eshelman School of Pharmacy. A highly successful executive for over 30 years in the pharmaceutical and life sciences industries, John recently joined the Eshelman Institute for Innovation after retiring as Vice President and Chief Marketing Officer for Eli Lilly and Company's biomedicines business unit. This $6 billion business unit included a broad portfolio of products for cardiovascular, immunological, pain and neuro-degenerative disorders. Kristin Tully, Research Associate, UNC-Chapel Hill. Kristin seeks to transform maternity care so that women and their families are treated the ways they deserve and are supported in realizing their health goals. Her research in the pregnancy, perinatal, and postpartum continuum focuses on mechanisms underlying outcomes such patient safety, breastfeeding, sleep practices, and maternal health. The objective is to enable more patient- and family-centered care, which is achieved by partnering with diverse stakeholders to identify unmet health needs and then co-develop sustainable solutions. Tully brings an interdisciplinary perspective to health and health care as evidenced by her training in economics and honors anthropology at the University of Notre Dame, in biological anthropology at Durham University, England, as well as a postdoctoral fellowship at the Duke University School of Nursing through the Carolina Consortium on Human Development. She is currently a research associate at UNC-Chapel Hill through the Carolina Global Breastfeeding Institute in the Department of Maternal and Child Health of the Gillings School of Global Public HealthStephen Eckel is Associate Dean for Global Engagement in the Eshelman School of Pharmacy at UNC-Chapel Hill. Stephen is also a clinical associate professor in the Division of Practice Advancement and Clinical Education (PACE) and currently serving as division’s interim chair. As an innovator and entrepreneur, he spearheaded the development of UNC Pharmacy Grand Rounds with ASHP and launched ChemoGLO, LLC with Bill Zamboni, PharmD, PhD. He has also founded Assure Technologies, LLC, focused upon improving the accuracy and precision of syringe measurements of medications.Roy Zwahlen is the Assistant Dean for Innovation and Strategy in the Eshelman School of Pharmacy and the Eshelman Institute for Innovation at UNC-Chapel Hill. Roy is responsible for assisting the dean in formulating, interpreting and implementing policy with a special focus on commercialization initiatives across the school. Before joining the school, he served as Associate Counsel and Director of Technology Transfer at the Biotechnology Innovation Organization. Judith Cone is the Vice Chancellor for Innovation, Entrepreneurship and Economic Development at UNC-Chapel Hill. She is veteran of national and international entrepreneurship programming. As a former Kauffman Foundation executive, she brings extensive experience to drive UNC-Chapel Hill’s innovation agenda. Judith leads Innovate Carolina, a pan-university commitment to being a place where innovators thrive. A main focus is on expeditious action to help solve the most pressing problems in North Carolina and around the world. She is a co-founder of Launch Chapel Hill, Blackstone Entrepreneurs Network and Carolina Research Ventures.Bryant Moore is Director of Strategic Partnerships in the Office of Technology Commercialization at UNC-Chapel Hill. He joined the office in 2015 after a successful career of more than 30 years in the medical device industry. His background includes product and technology development and strategy experience at the senior executive level in the clinical diagnostics, endoscopy and sports medicine, cardiology and ophthalmology business segments with Medtronic, Johnson &amp; Johnson, Smith and Nephew, and Abbott Laboratories.

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Device and Diagnostics Summit

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Device and Diagnostics Summit

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