Speakers

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Brian T. Kenner was named Deputy Mayor for Planning and Economic Development (DMPED)

Brian T. Kenner was named Deputy Mayor for Planning and Economic Development (DMPED) by Mayor Muriel Bowser on January 8, 2015. Prior to his appointment, Kenner served as City Manager of Takoma Park, Maryland, managing the city’s day-to-day operations. Before taking over management of the Washington suburb, Kenner served as the Chief Operating Officer for the Deputy Mayor for Planning and Economic Development for the District of Columbia. In addition to his familiarity with DMPED’s $13 billion portfolio, Kenner’s work for the District of Columbia included managing the team that completed the reuse plan for the Walter Reed Army Medical Center site.

Kenner has also worked as a Senior Fund Manager of the Community Investments Group at Fannie Mae; served as Vice President of the Public Institutions Group at Jones Lang LaSalle specializing in public-private initiatives; as a Manager of the Government Real Estate Advisory Services Consulting Practice at Ernst & Young; and, as a Presidential Management Fellow for the federal government.

Kenner’s background over the past 15 years includes working in various leadership positions for both federal agencies as well as private sector companies. Brian has an undergraduate degree in biology from the University of Iowa and a Master’s degree in public policy from Harvard University.

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Vasum Peiris, MD MPH

FAAP, FACC, FASE
Chief Medical Officer
Pediatrics and Special Populations

Center for Devices and Radiological Health
U.S. Food and Drug Administration

Vasum Peiris, MD MPH as Chief Medical Officer for Pediatrics and Special Populations at the U.S. Food and Drug Administration Center for Devices and Radiological Health, Dr. Peiris serves as the Center’s senior clinical expert on Pediatrics and pediatric medical device issues. He provides clinical and executive leadership on Center policies and initiatives associated with medical devices intended for use in pediatric and special populations. He serves as a systems architect to facilitate internal and external synergy and innovation that enhances the ability of the Agency to optimally meet the medical device needs of historically underserved populations.

Prior to joining the FDA, Dr. Peiris was the Joon Park MD Endowed Chair in Medical Excellence and Chief of Pediatric and Adult Congenital Cardiology at Texas Tech University Health Sciences Center (TTUHSC), the Graduate School of Biomedical Sciences, and University Medical Center (UMC), with appointments in both the Departments of Pediatrics and Internal Medicine. He served as the Medical Director of the Pediatric and Adult Congenital Imaging Laboratory and Medical Director of the Pediatric and Adult Congenital Cardio-Respiratory Exercise Laboratory at TTUHSC/UMC. He provided senior leadership in the development of the TTUHSC Clinical Research Institute, promoting patient-oriented translational and outcomes research. Dr. Peiris was inaugural faculty of the Department of Public Health, and guided development of the curricula and program, offering unique training in rural health, from its inception.

Dr. Peiris is an accomplished author and researcher. He has been awarded First Prize-Young Investigator Award by the Section on Cardiology and Cardiac Surgery of the American Academy of Pediatrics. He has been supported by the Robert Wood Johnson Foundation, the American Federation for Aging Research and the Harvard Medical Scholars Program. He has been awarded an Albert Schweitzer Fellowship.

Dr. Peiris is triple board certified in Pediatrics and Pediatric Cardiology by the American Board of Pediatrics and in Adult Congenital Cardiology by the American Board of Internal Medicine. He is a Fellow of the American Academy of Pediatrics, the American College of Cardiology, and the American Society of Echocardiography.

Dr. Peiris completed residency at the Yale School of Medicine/Yale-New Haven Hospital. He completed fellowship in Pediatric Cardiology and Cardiovascular Research at Harvard Medical School/Children’s Hospital Boston with senior fellowship training in Congenital Cardiovascular Magnetic Resonance Imaging at Children’s Hospital and Brigham and Women’s Hospital at Harvard Medical School. Prior to completing his Medical Doctorate at The University of Vermont College of Medicine, he earned his Master of Public Health ‘with distinction’ at the Yale School of Medicine Department of Epidemiology and Public Health. Dr. Peiris earned his undergraduate degree in the selective program in Ethics, Politics and Economics at Yale University.

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Susan Alpert , MD

Founder & Principal, SFA Consulting

Susan Alpert, PhD, MD is currently the principle of SFA Consulting LLC, a one person firm focused on the strategies needed to place medical devices into the global market. Dr. Alpert joined Medtronic in July 2003 as Vice President of Regulatory Affairs and Compliance. She was Senior Vice President, Global Regulatory Affairs at her retirement in May, 2011 and in this role was responsible for all Medtronic global regulatory policy efforts. Prior to joining Medtronic, Susan served C.R. Bard, Inc., as Vice President of Regulatory Sciences. She also previously worked at the FDA where she held a variety of positions in the Centers dealing with drugs, devices and radiological health, and foods, including six years as the Director of the Office of Device Evaluation. She is a microbiologist and pediatrician with a specialty in infectious diseases and has practical experience in laboratory research and clinical trials.

Susan is on the board of the Society for Women’s Health Research, an organization promoting research on gender differences in health and disease, and has served on the board of the Food Drug Law Institute (FDLI), a forum for the FDA and the legal, business, academic and consumer communities to exchange perspectives on public policy, law and regulation relating to products subject to FDA jurisdiction. She served on the board of advisors for the Medical Technology Leadership Forum (MTLF), an educational organization focused on policy makers, the general public, and the media regarding critical issues affecting the development and adoption of advanced medical technology. In addition, Susan serves on the board of the Women Business Leaders (WBL), an organization of women leaders in the health care sector and on the board of the Minnesota International Center. She is also a past Chair of the Regulatory Affairs Professional Society and a Fellow in that society. Susan served on the Executive Committee of the Clinical Trials Transformation Initiative (CTTI), one of the public/private partnerships working with the FDA to streamline the development of medical products.

Susan completed her undergraduate degree at Barnard College, Columbia University in New York City and holds a master’s degree and PhD in Biomedical Sciences from New York University. She received her medical degree from the University of Miami (Florida) and completed her clinical training at Montefiore Medical Center in the Bronx, New York and at Children’s National Health System in Washington, DC.

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Steve Anderson

CEO Preceptis Medical

Steve Anderson is the CEO of Preceptis Medical, Inc. Prior to this position, he was the President of Acorn Cardiovascular, Inc., a medical device manufacturer developing life-sustaining therapies for the treatment of systolicheart failure. Steve has 30 years of experience in the medical device industry,starting with Medtronic and including senior management positions at St. Jude Medical,TÜV Product Service, St. Croix Medical, and Acorn Cardiovascular. His specific core competencies include development, regulatory, clinical, reimbursement, quality, and compliance.Steve has a BS in Materials Engineering and an MS in Biomedical Engineering from the University of Minnesota. He was an Adjunct Professor at the University of St.Thomas Graduate School, has served on multiple boards for medical device companies (both public and private), and has authored numerous publications on medical device regulation and reimbursement (both US and worldwide).

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Lisa Becker

Senior Director, Regulatory Affairs – St. Jude Medical

Lisa Becker has 18 years in the medical device industry, with 16 of those in Regulatory Affairs. Throughout her career she has worked on mainly Class III, PMA cardiovascular devices with FDA and EU Notified Bodies, but with experience on all class devices and all geographies. She has led Regulatory teams up to 70 people in obtaining and maintaining regulatory medical device approvals at all stages of product development from early feasibility studies to original PMAs and post market studies and reports, focused mainly in the cardiovascular product and therapy space.

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William E. Bentley, PhD

Inaugural Director of the Robert E. Fischell Institute for Biomedical Devices

William E. Bentley, PhD is the Robert E. Fischell Distinguished Chair of Engineering and the Inaugural Director of the Robert E. Fischell Institute for Biomedical Devices. He is also appointed to the Department of Chemical and Biomolecular Engineering at the University of Maryland, College Park and the Institute for Bioscience and Biotechnology Research. At Maryland since 1989, Dr. Bentley has focused his research on the development of molecular tools that facilitate the expression of biologically active proteins, having authored over 270 related archival publications.

He is a fellow of AAAS, ACS, AIMBE, and the American Academy of Microbiology. He has served on advisory committees for the NIH, NSF, DOD, DOE, FDA, USDA, and several state agencies and has mentored more than 30 PhDs and 15 postdocs, many now in leadership roles within industry (18), federal agencies (4) and academia (22). He co-founded a protein manufacturing company, Chesapeake PERL, based on insect larvae as mini bioreactors.

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Rene Castro Phd

McKesson Corporation SVP, Corporate Strategy & Business Development

René Castro is the Senior Vice President, McKesson Medical-Surgical. He is responsible for working closely with the rest of the leadership team to identify, prioritize and execute growth strategies for the business, including strategic investments, mergers & acquisitions and partnerships.

René has 15 years of experience in the healthcare and life sciences industries, focused on corporate development, strategy, licensing, M&A and financing transactions. Prior to joining McKesson, René served in senior corporate development positions at Harvard University, RaNA Therapeutics, Anza Therapeutics and Exelixis, and was a consultant to several other biopharmaceutical companies and life science venture capital firms. He also worked as an investment banker in the healthcare group at Goldman, Sachs & Co., advising clients across the healthcare industry on corporate finance matters.

René earned his Bachelor’s Degree in music performance and Ph.D. in organic chemistry from the University of Miami, his MBA from Dartmouth College, and was a post-doctoral fellow at the Scripps Research Institute. René lives in Richmond, VA and enjoys music, sailing, hiking and other outdoor activities.

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Eric Chen, MS

Director, Humanitarian Use Device Program

Director, Pediatric Device Consortia Grant Program Office of Orphan Products Development Food and Drug Administration

Mr.Eric Chen serves as the Director of the Humanitarian Use Device Designation Program in the Office of Orphan Products Development in the Office of Special Medical Programs at FDA, a position he has held since February 2010. In this role, he leads the program whose mission is to promote the development of devices for the diagnosis or treatment of rare diseases or conditions. He also serves as the Director of the Pediatric Device Consortia Grant Program. In this role, he leads the program whose mission is to support the development of nonprofit consortia designed to stimulate projects which will promote pediatric device development. Prior to these positions, he served as the expert Biomedical Engineer in the Circulatory Support Branch where he was responsible for the review of mechanical circulatory support devices from 2002 until 2010. Mr. Chen received a Master’s of Science Degree in Bioengineering from the University of Pittsburgh and a Bachelor of Science Degree in Biomedical Engineering from Johns Hopkins University.

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Mark Chandler, MBA

Managing Partner, Upstream Partners

Mark Chandler, MBA is Managing Director of Upstream Partners Group, a private equity group specializing in intellectual property (“IP”) based investment opportunities. Upstream also provides advisory services in the valuation, licensing and monetization of IP and technology. Mark has been active in the technology and patent investment and licensing business for 25 years, and has helped early-stage ventures, universities, research institutes, companies of all sizes and independent inventors to monetize, license, value and develop their technology.

Previously, Mark managed a $60 million early stage corporate venture capital fund for BTG plc and also helped form Primaxis Technology Ventures, Inc., a $50 million Canadian early-stage venture fund, for which he also served on the Board of Directors. He has also served on the Board of Directors for several early-stage venture-backed companies.

Mark has been selected by the International Journal of Intellectual Property Management to the Intellectual Asset Management list of the Top 300 professionals worldwide in IP management strategy in each of the eight years the list has been compiled.

Mark completed his undergraduate studies in Electrical Engineering (BSEE, Bucknell University), continued his technical education in Physics while working at the Johns Hopkins Applied Physics Lab. He practiced as a researcher building the world’s most accurate atomic clocks and implantable medical devices, and then obtained his MBA from the Wharton School of the University of Pennsylvania.

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Carla Dahl

V.P. Marketing and Education – Preceptis

Carla Dahl comes to Preceptis with twenty years strategic marketing and brand strategy leadership in consumer/retail and life-science technologies – from start-ups to large, global companies.Trusted advisor for pre-market through commercialization planning, P&L management,distinctive brand development and cross-channel communications, sales field alignment, KOL development, and global launch strategies.

Former positions held by Carla include: Director of Global Marketing Communications at St. Jude Medical; Advisory Board Co-Chair/Marketing for Life Science Alley; Director of Marketing at Cardiovascular Systems (pre-FDA clearance through commercialization for original technology launch,with $47 million in sales its first commercial year); and Communications Manager/Consultant at Medtronic in Cardiac Surgery and Neuro divisions.Prior to that, Carla used her advertising agency experience to successfully develop and launch Parentprops, a line of baby accessories marketed to parents, sold at Target Stores. Carla graduated from St. Olaf College and the University of Minnesota with a Bachelor’s degree.

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Thomas Dann, JD

Venture Partner, New Atlantic Ventures

Thomas Dann, JD is Founder and Managing Director of CastleHaven Advisors, LLC. He has been involved in venture and private equity for over 20 years both as an advisor and as a principal. Prior to founding CastleHaven, Mr. Dann co-founded and was a General Partner of ECentury Capital Partners, L.P. a Washington, DC based venture capital fund backed by investors Rothschild, Hitachi, Mitsubishi Corporation and Allied Capital. As an experienced venture manager with extensive knowledge of the SBA and SBICs, Mr. Dann has restructured funds as well as structured secondary transactions. He received his BA from Stanford University and his JD from American University Law School.

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Noelle Dubiansky

Senior Associate – Goodwin

Noelle Dubiansky is a senior associate in the firm’s Technology & Life Sciences Group. She joined Goodwin in 2014.

Ms. Dubiansky represents biotechnology, pharmaceutical, medical device, and other life science companies in a wide range of intellectual property and commercial transactions. She regularly advises private and public companies on complex commercial transactions, including strategic partnerships, licensing, technology acquisition, research and development collaborations, clinical testing, contract services, distribution and manufacturing agreements. Ms. Dubiansky also regularly counsels clients in connection with private financings, public offerings, spin-outs and M&A transactions with respect to intellectual property rights and operational risks.

Prior to joining Goodwin, Ms. Dubiansky was an associate in the Life Sciences practice group at Cooley LLP and previously, in the FDA group at Hyman, Phelps & McNamara.

While attending law school, Ms. Dubiansky was named an Edward F. Hennessey Scholar.

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Tara Federici

Vice President for Technology and Regulatory Affairs – Advanced Medical Technology Association (AdvaMed)

Tara Federici is Vice President for Technology and Regulatory Affairs for the Advanced Medical Technology Association (AdvaMed) with over 25 years of health care policy development and government relations experience.

Ms. Federici joined AdvaMed’s government relations department in 1993. Her accomplishments include successfully managing and coordinating a multi-year industry/coalition effort to enact the Biomaterials Access Assurance Act of 1998 providing liability coverage for biomaterials suppliers. In 2002, Federici moved from AdvaMed’s Government Affairs Department to the Technology and Regulatory Affairs Department to focus on policy development full-time where she is responsible for developing, managing and directing association policy for medical device clinical trials, pediatric device development and orthopedic devices among others.

Prior to joining AdvaMed, Ms. Federici worked for Rep. Bill Richardson (D-NM) from 1986 to 1993 in various capacities including as his Legislative Director and Chief of Staff. She was responsible for all health policy and legislation, and developed and implemented political and legislative strategies for an activist member of Congress. She negotiated numerous bills and amendments that eventually became law, including the Hispanic Health Parity Act, the National Health Service Corps Revitalization Amendments and the Nursing Education Reauthorization Act.

Ms. Federici earned her B.A. in Government and Philosophy at the College of William and Mary (1985), Williamsburg, Virginia where she was a member of the Pi Sigma Alpha Honor Society. She earned her A.A. in Liberal Arts at The American College in Paris (1982), Paris, France.

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Patrick FitzGerald, JD

Vice President, Entrepreneurship & Innovation – Children’s Hospital of Philadelphia

Patrick FitzGerald role as Vice President of Entrepreneurship and Innovation includes identifying potential spinouts, strategic partnerships, commercialization opportunities, early stage investment vehicles, and innovative devices, therapies and tools. His focus centers on diversification of revenue through scientific entrepreneurship and creating a culture of innovation.

Patrick specializes in strategic growth and new business initiatives, inception to implementation ventures, local and national partnerships with Fortune 500 and governmental/multinational organizations, seed stage, Series A/B capital raises, team management and investor relations.

Over the past decade, he has built or helped to build a variety of businesses, most notably Recyclebank, Nanny Caddy, Philadelphia Distilling, Deliveroo, ChargeItSpot, SeedInvest, Bungalow Insurance, Haystack Informatics, Mavuno Harvest, and Philly Car Share among many others.

Patrick currently teaches entrepreneurship at the MBA and undergrad levels and is a formal mentor in Wharton’s Venture Initiation Program (VIP). Previously, he was Managing Director at DreamIt Ventures, one of the top startup accelerators in the country with programs in Philadelphia, New York, Austin, Baltimore/DC and Tel Aviv.

Patrick received his BA from the University of Pennsylvania and his JD from Fordham University School of Law.

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Julia Finkel, MD

Pediatric anesthesiologist and Director of R&D for Pain Medicine at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Medical Center in Washington, D.C

Julia Finkel, MD is a pediatric anesthesiologist and Director of R&D for Pain Medicine at the Sheikh Zayed Institute for Pediatric Surgical Innovation at Children’s National Medical Center in Washington, D.C. and Professor of Anesthesiology and Pediatrics at George Washington University. Dr. Finkel has extensive experience both designing and conducting multi-center pediatric analgesic clinical trials and developing pharmaco dynamic assessment tools and methodologies both in the laboratory and for pediatric clinical applications. She spun out a company, AlgometRx, LLC to commercialize technology she developed to objectively measure pain and drug effect. AlgometRx is a mobile health medical device startup using a smartphonebased platform technology that implements proprietary algorithm software to provide healthcare practitioners the toolbox to optimize pain assessment and treatment.

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Richard Greenwald, PhD

Co-director, New England Pediatric Device Consortium

Dr. Greenwald is an entrepreneur and biomedical engineer with over 15 years of experience in research and development in sports and orthopedic biomechanics. He founded Simbex (Lebanon, NH), a product development company, in 2000 and has been directly involved in product development for numerous bio feedback and data acquisition products for the medical and rehabilitation industries. He and Simbex have received multiple awards from the National Institutes of Health, National Science Foundation, and Department of Defense for product development through the Small Business Innovation Program (SBIR). He co-founded iWalk, Inc. (now BionX, Cambridge, MA) with Hugh Herr, PhD, to commercialize novel robotic prosthetic technologies, and was founding CEO from 2006-2009. Dr. Greenwald previously started and managed the US Division: Orthopedics, Sports, and Rehabilitation, for TÜV Product Service, a multinational firm specializing in product testing and regulatory certification of products for sale in the European Union. He recently served as a member of the National Advisory Child Health and Human Development Council of the Eunice Kennedy Shriver National Institute of Child Health and Human Development, National Institutes of Health, as a member of the Council of Councils, Office of the Director, National Institutes of Health and as President of the International Society for Skiing Safety. He is an Associate Professor (adjunct) at Thayer School of Engineering at Dartmouth College. Dr. Greenwald is currently directing five federally funded research and development projects.

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Jeffrey Gallagher AB, JD, LLM

Virginia Bio, CEO

Jeff Gallagher is CEO of Virginia Bio, the statewide trade group of the life sciences industry in the Commonwealth. Virginia Bio connects and supports companies, research universities, entrepreneurs, investors, clinicians, patients and users and the professionals who serve them to accelerate the discovery and commercialization of bioscience products and services. Prior to leading Virginia Bio, Jeff was a co-founder and for ten years served as VP & General Counsel for Lyotropic Therapeutics, Ashland, VA, a small specialty pharma company. Previously, he practiced corporate law in Richmond, focusing on new technology company formation, international business, and intellectual property transactions. He was a co-founder and longtime Chair of the Richmond-based nonprofit World Pediatric Project,and currently serves on boards and advisory boards for technology transfer and economic development organizations across the state and region. He holds an A.B. in Government from Harvard, a J.D. from the University of Wisconsin Law School, and an LL.M in Public International Law from the University of Virginia School of Law.

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Steven Hirschfeld, MD, PhD

Assistant Vice President for Research Initiatives and Compliance Uniformed Services University of the Health Sciences

Guest Lecture at NIH

Captain Steven Hirschfeld of the Commissioned Corps of the United States Public Health Service (USPHS) earned his MD from Columbia University College of Physicians and Surgeons and his PhD in Cell Biology from New York University. He did his residency and Chief Residency at the University of California, San Francisco, research fellowship training at the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), and clinical fellowship at the National Cancer Institute (NCI), National Institutes of Health, Bethesda, MD.

Dr. Hirschfeld received board certification in general pediatrics and pediatric hematology-oncology. He worked at the National Cancer Institute as a clinical investigator and then at the Food and Drug Administration (FDA) in the Center for Drug Evaluation and Research and the Center for Biologics Evaluation and Research. He contributed to the development and implementation of the federal pediatric initiatives beginning in 1996, the International Conference for Harmonization E11 Pediatric Guidance, and the adaptation of regulations for the protection of children in FDA regulated research. In 2006 he returned to NICHD as Associate Director for Clinical Research and also serves as NIH Co-Coordinator of the Child Health Oversight Committee for the National Center for Research Resources Clinical and Translational Science Awards Consortium. In addition to regulatory, policy, and operations activities, Dr. Hirschfeld has been active in the development and implementation of data standards for acquisition, transmission, and analysis as well as exploring new methods of data analysis. He is the recipient of numerous awards, including twice the Health and Human Services Secretary’s Award for Distinguished Service and awards from the Commissioner of the Food and Drug Administration, the Director of the National Institutes of Health, and the USPHS.

Dr. Hirschfeld has deployed regularly on humanitarian and disaster relief missions with the USPHS since 1991, including two deployments to Louisiana in 2005 for the Gulf Coast Hurricanes and in 2008 to Texas for Hurricane Ike. He serves as the Chief Medical Officer and Operations Chief for the USPHS Rapid Deployment Force Team -1 based in the Washington, DC metro area.

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Peyvand Khaleghian MD, Phd

Managing Partner – Avicenna Partners Investment Company LLC

Dr.Peyvand Khaleghian is a Managing Partner at Avicenna Partners Investment Company LLC, an emerging markets-focused healthcare investment firm based in the United Arab Emirates, and co-Founder and Director of Amana Healthcare, the largest and fastest-growing provider of specialized long-term acute care, post-acute rehabilitation and home transition and respite care services in the Middle East.

Dr. Khaleghian started his career as a physician but later spent eight years as a senior healthcare specialist at the World Bank – four of them as Sector Leader inits Europe and Central Asia healthcare practice based in Almaty, Kazakhstan – with a further three years as Director of Health Policy and Strategy for the Government of Dubai. A New Zealand national, Dr. Khaleghian holds adoctorate in Health Policy and Management from the Johns Hopkins University and a medical degree from the University of Auckland.

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Matt Maltese, PhD

Research Assistant Professor – Children’s Hospital of Philadelphia

Executive Director- Philadelphia Pediatric Device Consortium

Matt Maltese research focuses on pediatric bioengineering, on such topics as translating traumatic brain injury mechanism paradigms from adults to children, development of medical devices to enhance pediatric resuscitation and critical care, and design of biofidelic (human-like) pediatric crash test dummies. As a faculty member in both a medical school and biomedical engineering school, Matt trains physicians and engineers. Matt also directs biomechanics research in the clinical and laboratory research setting, and is the Executive Director of an FDA-funded consortium to develop pediatric medical devices. His research is funded by federal and industry grants and is widely published, and is a frequent invited speaker at academic and industry venues worldwide.

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Tim Moran

Founder – PediaWorks

Tim Moran is the founder of PediaWorks, a 501.c.3 non-profit that strives to improve children’s health by developing medical devices specifically for pediatrics. He is also the founder and CEO of PediaVascular, a social venture that recently launched the first FDA-cleared angiography catheters and introducers for pediatric use. Prior to PediaWorks he was the founder and president of CSF Therapeutics, a venture-backed developer of devices to treat eurodegenerative diseases. Tim also managed the formation and initial financing of Intelect Medical (acquired by Boston Scientific) while at Innovations, Cleveland Clinic’s corporate venturing arm. Prior to Innovations he founded an IT services firm in Latin America, and served as a strategy consultant for PriceWaterhouse in the US and Europe. Tim began his career in sales and product development at 3M. He is a German Marshall Fellow, and an inventor or co-inventor on three patents. Tim received an MBA from Northwestern University (Kellogg), and a BS in finance from Miami University.

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Michael C. Morton

Vice President for Corporate Regulatory Affairs, – Medtronic, Inc

Michael C. Morton is Vice President for Corporate Regulatory Affairs, at Medtronic, Inc. Michael is responsible for public health policy advocacy in regulatory affairs, and for internal regulatory policy.

Michael has over twenty five years of experience in the medical device industry, including quality, clinical, and regulatory affairs. Before joining Medtronic, Inc., Michael worked with Carbo Medics, Inc.; W.L. Gore and Associates; Alcon Labs; and Sorin Group.

Michael has been recognized as a Fellow of the Regulatory Affairs Professional Society(RAPS). He is active in industry groups, including the Advanced Medical Technology Association (AdvaMed). He chairs the AdvaMed PMA Working Group, and the Pediatric Devices Working Group, and is a member of the Heart Valve Task Force. Michael represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force. He has also served as the industry representative to the FDA Circulatory System Devices Advisory Panel.

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Maureen Mulvihill, PhD

President & CEO – Actuated Medical Inc

Maureen L. Mulvihill, Ph.D., President and CEO, co-founded Actuated Medical, Inc. (AMI) with a vision to integrate electronically controlled actuation technologies into medical devices to improve patient outcomes. In 2006, after speakingwith a doctor about his clinical needs, she realized that there was a market need for an agile small business with electronically controlled motion ‘actuation’ expertise. AMI’s innovations focus on smaller market applications such as pediatrics and have ushered in an entirely new generation of instruments and devices. Maureen is responsible for the company’s corporate vision and maintaining its vibrant culture. In addition, she directs commercialization efforts working closely with clinicians and acquisition partners to ensure products are viable in real world settings. She has been a Finalist for the Ernst & Young Entrepreneur of the Year® Award for the Western Pennsylvania and West Virginia region twice. She has also been recognized by PA Business Central as “One of the Top 100 Business People in Central Pennsylvania”. She is an alumni from the Goldman Sachs 10,000 Small Business Program. Most recently, she was recognized as the 2015 Entrepreneur of the Year by the Chamber of Business and Industry Centre County Pennsylvania. She earned her Ph.D. from Penn State.

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Stephen Rapundalo, PhD

MichBio – President and CEO

Dr. Rapundalo has broad experience in the life sciences with an extensive background in pharmaceutical R&D. He received his Hon. BSc at Laurentian University in Canada, PhD from the Medical College of Virginia, and a post-doctoral fellowship from the University of Cincinnati College of Medicine. Prior to joining MichBio in April 2006, he spent 20 years in scientific,management and strategic planning positions with Parke-Davis Pharmaceutical Research and then Pfizer Inc. in Ann Arbor, MI. He has a strong record of innovation and is internationally recognized and published in several technology areas. At MichBio, Dr. Rapundalo has focused on raising the visibility of Michigan’s bio-industry and its many assets, capabilities and talent. At MichBio he’s launched new program initiatives and services, developed the organization as a key resource for business support, and built a robust advocacy infrastructure at the state and federal levels to shape economic development policy that can aid in growing the state’s bio-industry. Dr.Rapundalo has been a community advocate and civic leader for almost 25 years and formerly served as an elected member of the City Council in Ann Arbor, Michigan.

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Joni Rittler, MHA

VP Of Supply Chain – CHOP

Joni Rittler is the VP of Supply Chain Management biography. and(SC) for The Children’s Hospital of Philadelphia. She has worked in healthcare SC for over 20 years. She holds a bachelor’s degree in Management of Information Technology from Eastern University and a Masters Degree in Healthcare Administration from St. Joseph’s University. Joni’s current role at CHOP is to provide vision and leadership for the enterrpise supply chain. She works to ensure the purchase of the highest quality materials/services at the best cost, to establish standards of excellence, to design systems and metrics to measure both financial and operational performance, and to develop strategic internal and external alliances. She serves as the executive sponsor for the All Abilities Resource Group, an employee team working to raise awareness and provide education related to employment of people with disabilities. She serves on the Supply Executive Council for Vizient and the Supply Chain Leadership team for Children’s Hospital Association (CHA). Additionally, she serves on the Executive Oversight Group which oversees the relationship between Vizient and CHA. She is an active member of Strategic Marketplace Initiatives, an industry group that sponsors the development of tools and practices to support the healthcare supply chain industry.

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Eric M Stone

Chief Executive Officer & Co-founder – Velano Vascular, Inc

Eric is Chief Executive Officer and Co-founder of Velano Vascular, a pioneering medical device company developing more humane approaches to vascular access and blood draws in the hospital setting. A patient advocate and serial healthcare entrepreneur, Eric currently serves as National Trustee of The Crohn’s and Colitis Foundation of America (CCFA). Prior, he served as Vice President of Sales and Marketing for Molecular Health, and with Abbott Laboratories Stone launched the market-leading drug eluting stent and the worldʼs first bioresorbable coronary stent while based in Brussels, Belgium and California. A founding member of Model Nʼs(NYSE: MODN) Life Sciences division, he over saw the groupʼs marketing and partnership and alliance functions. Mr. Stone began his career in Marketing with Austin,Texas-based Trilogy Software. He co-founded Harvardʼs Student-Alumni Mentoring Initiative (SAMI) and Whartonʼs Health Care Board Fellows Program and is a former Director of Harvard Universityʼs Alumni Association Board of Directors. Eric serves on the Board of Directors of Vigilant Bio sciences and is an Advisor to 3NT Medical. He holds an MBA in Health Care Management from The Wharton School, a Masterʼs degree from Harvard University, and a BA from the University of Pennsylvania. He lives with his wife and daughter in San Francisco.

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Eric Sugalski, MBA

Founder & President – Smithwise

Eric Sugalski as Founder and President of Smithwise, Eric Sugalski is responsible for technical leadership, program management, and new business development. Some of his recent work includes a novel laparoscopic hysterectomy device, a handheld audiology 3D imaging device, and a high-throughput automated pill dispensing robot. Prior to Boston Device Development, Eric held engineering and management roles at IDEO and Insight Product Development, where he worked on a range of projects for the medical, industrial, and consumer product fields. Some of his most notable projects include the Conmed Altrus electrosurgical vessel sealing device, and the Bissell Spotbot automated stain cleaning robot. In addition to Eric’s professional experience, he has served as a lecturer at the MIT Department of Mechanical Engineering where he taught two courses in product development, Product Design & Engineering Process and Toy Product Design. Eric holds a B.S. in Mechanical Engineering from the University of Colorado Boulder and an MBA from the MIT Sloan School of Management. During Eric’s time at MIT, he focused on competitive strategy and operations management.

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Catherine Williams RN, BSN, MS, NE-BC

Director of Neuroscience and Surgical Care Nursing – Children’s National Health System

Catherine Williams currently works at Children’s National Health System where she serves as the Director of Neuroscience and Surgical Care Nursing. She received her BSN from the George Mason University and her MS from the Georgetown University. She has been a pediatric nurse since 1991 and has worked in acute care nursing and nursing administration throughout her career. Catherine is a board certified nurse executive and currently directs daily operations for a 49-bed inpatient Neuroscience (18 beds) and Surgical Care (31 beds) unit. She has published and co-published on numerous topics including prolonged fasting times for pediatric patients undergoing procedures and surgery; handoff; creating an endowed chair for a service line; and aligning staffing models with patient churn. Inaddition, she co-leads the systems efforts to improve outcomes and reduce expenses through the Clinical and Operational Effectiveness Committee.

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Tiffany Wilson MBA

Global Center for Medical Innovation / T3 Labs Chief Executive Officer

Tiffany Wilson has spent over 15 years bringing innovative medical devices from bench to bedside. She launched the Global Center for Medical Innovation (GCMI) in 2012 to accelerate medtech development & commercialization by bring together core members of the medical device ecosystem. Tiffany works with universities, clinicians, industry, investors and startups focused on innovation, patient care and economic growth. A former management consultant and investment banker, she spent 10 years with two medical device startups where she led a broad range of initiatives including corporate finance, investor relations, strategic and operational planning, business development, product development, regulatory, and reimbursement. Tiffany serves on the Board of the Southeastern Medical Device Association (SEMDA) as Past President and is the Founding Advisor of Medtech Women@SEMDA. She earned a BBA in International Business from Loyola University and an MBA from Georgetown University McDonough School of Business.