Speakers

Keynote Speaker


	Margaret A. Hamburg, MD \| Commissioner, Food and Drug Administration Dr. Margaret A. Hamburg is Commissioner of the Food and Drug Administration (FDA), where she has served since May 2009. As FDA Commissioner, she is advancing regulatory science, medical product innovation and globalization of the agency, while overseeing the implementation of groundbreaking laws to curb the use of tobacco and enhance food safety. She has undertaken major efforts to streamline and modernize FDA’s regulatory pathways. Before joining FDA, Dr. Hamburg was vice president and senior scientist at the Nuclear Threat Initiative. In the 1990s, as New York City's Health Commissioner, she launched several major initiatives, including the nation's first public health bioterrorism preparedness program and an internationally recognized program to curtail the resurgence and spread of TB. President Clinton later named her Assistant Secretary for Planning and Evaluation in the U.S. Department of Health and Human Services. Dr. Hamburg earned her M.D. from Harvard Medical School.

Margaret A. Hamburg, MD | Commissioner, Food and Drug Administration

Dr. Margaret A. Hamburg is Commissioner of the Food and Drug Administration (FDA), where she has served since May 2009. As FDA Commissioner, she is advancing regulatory science, medical product innovation and globalization of the agency, while overseeing the implementation of groundbreaking laws to curb the use of tobacco and enhance food safety. She has undertaken major efforts to streamline and modernize FDA’s regulatory pathways. Before joining FDA, Dr. Hamburg was vice president and senior scientist at the Nuclear Threat Initiative. In the 1990s, as New York City's Health Commissioner, she launched several major initiatives, including the nation's first public health bioterrorism preparedness program and an internationally recognized program to curtail the resurgence and spread of TB. President Clinton later named her Assistant Secretary for Planning and Evaluation in the U.S. Department of Health and Human Services. Dr. Hamburg earned her M.D. from Harvard Medical School.

Speakers


	Mark Batshaw, MD \| Chief Academic Office & Physician-in-Chief, Children's National Health System Mark Batshaw, MD, is Chief Academic Officer and Physician-in-Chief of Children's National Health System, where he also serves as director of the Children's Research Institute. He is Associate Dean for Academic Affairs at the George Washington University School of Medicine and Health Sciences. Dr. Batshaw received his M.D. from the University of Chicago, completed a residency in Pediatrics at the Hospital for Sick Children and a fellowship in Neurodevelopmental Pediatrics at the Kennedy Krieger Institute, Johns Hopkins. He previously served on the faculty of John Hopkins and the University of Pennsylvania. Since 1998 Dr. Batshaw has been Chief Academic Officer at Children’s National Medical Center and Associate Dean for Academic Affairs at George Washington University. In 2013 he was named Physician-in-Chief at Children’s National. Dr. Batshaw has spent his entire career in the care of children with developmental disabilities. He has published over 200 articles and reviews and is senior editor of the classic textbook, Children with Disabilities now in its 7th edition. Dr. Batshaw's research has focused on inborn errors of urea synthesis, in which he is considered an international authority in drug development and is currently P.I. of an NIH funded Rare Diseases Clinical Research Center on Urea Cycle Disorders and of a program project grant on adenoassociated virus gene therapy in ornithine transcarbamylase deficiency.
	William Bentley, PhD \| Department Chair, Fischell Department of Bioengineering, University of Maryland William E. Bentley is the Robert E. Fischell Distinguished Professor of Engineering and founding Chair of the Fischell Department of Bioengineering. 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 250 related archival publications. Recent interests are on deciphering and manipulating signal transduction pathways, including those of bacterial communication networks, for altering cell phenotype. To enable discovery, his lab develops new strategies for opening ‘communication’ between devices and biological systems by the creation and facile assembly of biologically functional interfaces. These concepts are emerging as a field of ‘biofabrication’ that exploits biological components and processes for assembly. He has served on advisory committees for the NIH, NSF, DOD, DOE, FDA, USDA, and several state agencies. He 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. Dr. Bentley was recipient of the SIM’s Schering-Plough Young Investigator Award, the Charles Thom Award of the SIMB, and the AIChE’s FPB Division Award. He is also a Fellow of the ACS, AAAS, and AIMBE and is an elected member of the American Academy of Microbiology.
	Charles Berul, MD \| Chief of Cardiology, Children's National Health System Charles Berul, MD, is division chief of Cardiology and co-director of the Children's National Heart Institute at Children's National Health System. He was born in Washington, DC and raised in the area. Dr. Berul was the director of the Pacemaker Program at Children’s Hospital Boston, Harvard Medical School until coming to Children’s National Medical Center in 2009. Dr. Berul is a professor of Pediatrics at George Washington University School of Medicine. Dr. Berul is a fellow of the Heart Rhythm Society, the American Academy of Pediatrics, the American College of Cardiology, the Society for Pediatric Research, and the American Heart Association’s Council on Cardiovascular Disease in the Young. Dr. Berul has more than 150 publications in pediatric cardiology and is an invited speaker nationally and internationally and is an acknowledged expert in the area of pediatric cardiac electrophysiology.
	Robert M. Campbell, MD \| Director, The Center for Thoracic Insufficiency Syndrome Children’s Hospital of Philadelphia Dr. Campbell is Director of the Center for Thoracic Insufficiency Syndrome (CTIS) at The Children’s Hospital of Philadelphia and an attending physician in the Division of Orthopaedic Surgery. He is best known as the inventor of the VEPTR (Vertical Expandable Prosthetic Titanium Rib) device, which is used to treat rare diseases of the spine and chest wall, through surgical expansion of the chest and correction of spinal deformity, without inhibiting children’s growth. He has published extensively on the thoracic and pulmonary disability of these patients and was the first to identify the disease Thoracic Insufficiency Syndrome (TIS). In creating the Center for Thoracic Insufficiency Syndrome, Dr. Campbell has assembled an interdisciplinary team, including surgeons, pulmonologists, nutritionists and others to bring a comprehensive approach to treatment of the disorder. His primary focus at CHOP is to expand the VEPTR program and explore new devices, deepen research into the natural history of TIS and develop further advances in treatment. Dr. Campbell obtained his bachelor’s degree from Johns Hopkins University, Baltimore, MD, and his medical degree from Georgetown University Medical School, Washington, DC. He completed a orthopaedic residency at Fitzsimons Army Medical Center, Aurora, CO, and did his pediatric orthopaedic fellowship at the Alfred I. DuPont Hospital for Children, Wilmington, DE. Prior to coming to CHOP in 2009, he held the President’s Council Chair in Pediatric Orthopaedic Surgery at the University of Texas Health Science Center, San Antonio.
	Mark Chandler, MBA \| Managing Director, Upstream Partners Mark Chandler is Managing Director of Upstream Partners, where he provides a variety of advisory and transaction services in the areas of intellectual property and finance. Active for over 20 years in technology and intellectual property (IP) commercialization, Mark has helped early stage ventures, universities, research institutes, companies of all sizes, and independent inventors value, develop and commercialize their technology. Mark is also Chief Executive Officer of TAO Life Sciences Inc., an early stage medical device investment and development company that invests its capital and expertise to develop prototypes, demonstrate clinical proof of concept, and secure financial exits for its innovations. TAO has built a diversified pipeline of medical device technologies that will impact global healthcare markets and make a significant difference in people's lives. 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 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.
	Tara Federici \| Vice President, Technology & Regulatory Affairs, Advanced Medical Technology Association 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.
	Mark Fitzgerald, JD \| Partner, Wilson Sonsini Goodrich & Rosati Mark Fitzgerald is a partner in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati and has been an integral part of the office since its opening in 2000. His corporate and securities practice focuses on the representation of public and private technology, life sciences, and national defense clients at every stage of their development. Mark has counseled clients on a wide variety of matters, including private placements and public offerings of securities, mergers and acquisitions, seed and angel financings, venture capital, joint ventures, corporate governance, regulatory compliance, complex cross-border transactions, and other general corporate and securities law issues. From 1987 to 1992, Mark served as an officer in the U.S. Air Force, stationed at the Electronic Systems Center at Hanscom Air Force Base in Massachusetts, where he conducted antenna and semiconductor research as an electrical engineer and later managed information technology defense contracts. Mark currently serves as a colonel in the U.S. Air Force Reserve.
	William Fried, MD \| Senior Medical Director, Aetna Dr. William Fried is a Senior Medical Director for Aetna Inc. in the Southeast Region, serving the Maryland, District of Columbia, and Virginia markets. At Aetna, Dr. Fried has 14 years of experience with utilization management activities servicing over one million members in Aetna’s health insurance products, supporting network management, identifying and developing strategies to manage medical costs, implementing quality improvement activities, creating innovative models of care delivery, and offering consultative solutions to customers. Dr. Fried graduated from the University of Pennsylvania School of Medicine in Philadelphia, PA and completed his residency training in Pediatrics at the Children’s Hospital of Pittsburgh. He is a Fellow of the American Academy of Pediatrics and was in clinical primary care practice for 18 years. He remains an Assistant Clinical Professor at the George Washington University School of Medicine. He has previously served on hospital Boards and committees in Northern Virginia and has been active in local and state medical societies. Dr. Fried has been frequently interviewed in local newspapers and has appeared on local and national television.
	James Geiger, MD \| Executive Director, Michigan Pediatric Device Consortium Dr. Geiger is a Professor of Surgery at the University of Michigan where he serves as a Pediatric Surgeon at CS Mott Children’s Hospital. He is the Principal Investigator and Executive Director of the UM Pediatric Device Consortium or MPED funded in part with an FDA grant. In addition, Dr. Geiger directs the CS Mott Children’s Minimally Invasive Surgery Program and is Surgical Director of the Pediatric Comprehensive Weight Management Center. He is recognized as a world’s expert in the area of advanced laparoscopic surgery and robotic surgery techniques. He has developed and is commercializing a number of medical devices. He has completed multiple clinical trials in pediatric cancer immunotherapy. Dr. Geiger earned his undergraduate degree from University of Michigan and his medical degree from Case Western Reserve University School of Medicine. He completed his General Surgery residency, a Surgical Critical Care fellowship, and a Pediatric Surgery Fellowship at University of Michigan Health System in Ann Arbor. He is board certified in pediatric surgery, general surgery, and surgical critical care.
	James O. Gilkerson, DVM \| Distinguished Corporate Fellow & Clinical Advisor, Boston Scientific Dr. Gilkerson is the Distinguished Corporate Fellow of Boston Scientific Corporation and Medical Advisor for R&D of the Cardiac Rhythm Management(CRM) division of Boston Scientific. Dr. Gilkerson has been employed in the Research and Development department of BSC CRM since June, 1990. He has been the system architect for the VENTAK AV defibrillator family, PRIZM defibrillator family and most recently COGNIS and TELIGEN cardiac rhythm management devices. Prior to those assignments he was Manager of Preclinical Studies and Attending Veterinarian from 1987 through 1990. Dr. Gilkerson joined Cardiac Pacemakers Incorporated in December of 1986 as Clinical Research Administrator in the Clinical Studies department. Currently, Dr. Gilkerson serves as Medical Advisor to Dan Goldman VP of R&D and Product Development for Boston Scientific’s CRM division. He is Chair of the Institutional Animal Care and Use Committee, a member of the Product Evaluation Committee and its Clinical Subteam, and a member of the Product Performance Committee. Dr. Gilkerson functions on a dotted- line basis with the Senior Vice President for Corporate Research, BSC. He is an Advisor to the Vice Chancellor for Research of the University of Missouri. He is a member of the Coulter Foundation Oversight Committee at the University of Missouri. Dr. Gilkerson received B.S. and D.V.M. degrees from the University of Missouri. He is a Regular Member of Heart Rhythm Society, Heart Failure Society of America, and the American Veterinary Medical Association.
	Bruce Gingles \| Vice-President, Global Technology Assessment & Health Policy, Cook Medical After earning a BA (biology) from Indiana University, Bruce was hired in 1979 and relocated to Los Angeles to be Cook's first sales representative for the newly formed Critical Care division. He moved to Northern California (Mountain View) in 1984 as Regional Manager, to Bloomington in 1991 as Director of Sales and Marketing and was promoted to Global Business Leader and Vice-President, in 1999. Bruce now represents Cook in the areas of translational research, commercial regulation and technology assessment. The ethical foundation of commercial relationships and translational algorithms are personal interests. Bruce serves on the external advisory committee for the Indiana University and UCSF (devices) CTSIs. He has been invited to discuss translational research and medical device innovation at more than 30 CME/CLE-accredited programs in the US, Europe and Asia.
	Simon Goodall \| Author of BCG study on Regulation and Access to Innovative Medical Technologies Simon Goodall is a management consultant with extensive experience assisting executive teams and boards of for profit and non-profit organizations. Simon spent sixteen years working at the Boston Consulting Group, a leading global strategic management consultancy, and is currently an independent consultant working with fast growing healthcare companies. At BCG Simon was a Partner and Managing Director in the healthcare practice and worked with top biotechnology, pharmaceutical and medical technology companies in the US, Europe and Asia. He was a member of BCG’s Boston and Los Angeles offices and took on a variety of roles within the firm including leading the West Coast Healthcare practice, heading BCG’s BioPharma R&D business and leading marketing for the worldwide healthcare practice. Simon has published extensively on R&D productivity, FDA effectiveness and the economics of innovation. He has also taken a keen interest in public policy as it relates to the FDA’s role in the regulation of innovation and has published and spoken extensively on this topic. He was the lead author for the 2012 study “Regulation and Access to Innovative Medical Technologies: A comparison of the FDA and EU Approval Processes and their Impact on Patients and Industry.”
	Kara Haas, MD, MPH \| Director, Worldwide Strategic Regulatory Affairs for Medical Devices and Diagnostics, Johnson & Johnson Kara Haas, MD, MPH, FACS is a Director of Worldwide Strategic Regulatory Affairs for Medical Devices and Diagnostics at Johnson & Johnson. During her tenure at J&J she has had responsibility for Medical Affairs, Clinical Affairs, Regulatory Affairs, Evidence Based Medicine, Quality, Safety and Health Care Compliance functions. A former Lieutenant Colonel in the United States Air Force, Dr. Haas practiced general and trauma surgery and critical care medicine in both military and civilian settings prior to joining Johnson & Johnson in 1999. Dr. Haas is a graduate of Duke University where she earned her BA in Chemistry and graduate of Tulane University School of Medicine and School of Public Health where she earned her MD and MPH degrees. She completed her General Surgery residency at the University of Washington in Seattle and Postdoctoral Fellowships at University of Texas Southwestern Medical Center and Howard Hughes Medical Institute, with a focus on the molecular biology of Tumor Necrosis Factor and G-protein mediated transmembrane signal transduction amplification systems. Dr. Haas is a board certified general surgeon, Fellow of the American College of Surgeons, and a member of multiple professional medical societies.
	Steven Hirschfeld, MD, PhD \| Associate Director for Clinical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development 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.
	Michael Harrison, MD \|Principal Investigator, University of California-San Francisco Dr. Michael Harrison is Professor of Surgery, Pediatrics, and Obstetrics, Gynecology and Reproductive Sciences, Emeritus. He is a cum laude graduate of Yale University, who received his M.D. magna cum laude from Harvard Medical School, before going on to general surgical residency training at the Mass General, and finally pediatric surgery fellowship at the Rikshospitalet in Oslo, Norway and Children’s Hospital of Los Angeles. Acknowledged around the world as the “Father of Fetal Surgery,” Dr. Harrison is internationally renown for his expertise and innovation in pediatric and fetal surgery. He was one of the original founders of the International Fetal Medicine Surgery Society, the founder/director of the UCSF Fetal Treatment Center, and now the Director of the UCSF Pediatric Device Consortium. Dr. Harrison is author of more than 400 hundred peer-reviewed articles and several textbooks including three editions of “The Unborn Patient: The Art and Science of Fetal Therapy”. As a member of various medical and surgical professional societies, he has been recognized by his colleagues for his contributions to the field and honored with a number of prestigious awards, including the American College of Surgeons Jacobson Innovation Award, as well as membership into the Institute of Medicine. Recently Dr. Harrison served as the 2009 President for the American Pediatric Surgical Association. He maintains an active research lab, which is currently focused on medical device innovation, development and commercialization, and he is the recipient of one of only three FDA Pediatric Device Consortia grants awarded this past year under the Federal Recovery Act. Dr. Harrison and his wife Gretchen maintain both a residence in the San Francisco Bay Area, and an olive grove in California’s Mendocino County.
	Evan Jones, MBA \| Managing Member, jVen Capital, LLC Mr. Jones is Managing Member of jVen Capital, LLC, a life sciences investment company. He also serves as Chairman and Chief Executive Officer of Opgen, Inc., a privately held genetic analysis company. He was a co-founder of Digene Corporation, a publicly-traded biotechnology company focused on women's health and molecular diagnostic testing, serving as Chairman of the Board from 1995 until its acquisition in 2007 and serving as Chief Executive Officer from 1990 to 2006. Mr. Jones also serves as a Director of Fluidigm Corporation, Foundation Medicine, Inc., and Veracyte, Inc. Mr. Jones is a member of the Board of Directors of the Children’s National Medical Center and the Board of Directors of the Children’s Research Institute in Washington, D.C. He is Chairman of the Campaign for Public Health Foundation, an independent, not-for-profit organization dedicated to increasing funding for public health and is a member of the Board of Directors of Research!America. Mr. Jones received a B.A. degree from the University of Colorado and an MBA degree from The Wharton School at the University of Pennsylvania.
	Margaret Kavalaris, JD heads Dentons' legacy Corporate practice and is a member of the Venture Technology practice. Her practice focuses on corporate finance, securities and intellectual property licensing, with an emphasis on the representation of venture-backed, emerging growth companies, in particular, technology companies. Her transactional experience includes venture financings, mergers and acquisitions, and public offerings, including underwriter side representation of investment banks in technology company equity offerings. She also advises companies in all stages of development with respect to corporate governance and operations, technology development, transfer, licensing and distribution.
	Peyvand Khaleghian , MD, PhD \| Managing Partner, Avicenna Partners. Formerly Director of Health Policy and Strategy for the Government of Dubai, Peyvand 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 in the bank’s Europe and Central Asia healthcare practice based in Almaty, Kazakhstan. A New Zealand national with healthcare advisory and investment experience spanning Asia, Europe and the Middle East, Peyvand focuses on regulatory issues, risk management and growth strategies for healthcare companies in high-potential emerging markets with a particular focus on Asia and the Middle East. Peyvand holds a doctorate in Health Policy and Management from the Johns Hopkins University and a medical degree from the University of Auckland, New Zealand.
	Peter Kim, MD, CM, PhD \| Vice President, Belgium Institute for Pediatric Surgical Innovation at Children's National Health System Peter C. W. Kim, MD CM, PhD, a pediatric surgeon and scientist, is vice president of the Belgium Institute for Pediatric Surgical Innovation at Children’s National Medical Center. As vice president, he implements the Institute’s vision of innovative, multidisciplinary research and development in pediatric surgery. Dr. Kim’s research focuses on the development of smarter surgical tools, including image guidance and robotics; smarter simulation technologies that prepare tomorrow’s pediatric surgeons through a hands-on approach rather than the traditional lecture-based medical training model; and the potential of technologies such as high intensity focused ultrasound (HiFU) as non-invasive alternatives to conventional surgery. He has authored more than 100 papers and 50 abstracts on a range of topics, with special emphasis on developmental molecular biology as well as innovation and technology, including minimally invasive surgical techniques. Previously, Dr. Kim served as a general neonatal and thoracic surgeon at the Hospital for Sick Children in Toronto, founding Lead for the Centre for Image-Guided Innovation and Therapeutic Intervention (CIGITI) and senior associate scientist in the hospital’s research institute. Dr. Kim also held the appointment of professor of surgery at the University of Toronto. During his time at the Hospital for Sick Children, Dr. Kim co-led the clinical Airway Reconstruction Team which provided international expertise in the management of complex airway diseases. In addition, he investigated application-specific surgical robotic systems for pediatric surgery, including an image-guided minimally invasive capable robotic arm called KidsArm. Dr. Kim also led the creation of the Fetal Alert Network (FAN), a provincial network to monitor and provide care for mothers with high-risk pregnancies and babies with anomalies. Dr. Kim received his medical training, including the distinction of Master of Surgery, at McGill University in Montreal, Canada. He completed his surgical residency training at the University of Toronto as well as his fellowship in pediatric surgery at the University’s Hospital for Sick Children.
	Michael Klein, MD \| President, American Pediatric Surgical Association Michael Klein graduated from the University of Chicago and studied medieval history at Princeton before attending Case Western Reserve University where he received the M.D. in 1971. He completed training in general surgery at the New England Deaconess Hospital in Boston where he first began doing medical research with engineers in the laboratory of Judah Folkman. He completed training in pediatric surgery at the Children's Hospital of Michigan and served on the faculty at the University of New Mexico and the University of Michigan before returning to the Children's Hospital of Michigan and Wayne State University in 1983. His research work has focused on extracorporeal life support, blood-materials interactions, tissue engineering, robotic surgery, Raman spectroscopy for medical diagnosis, and quantitative decision making. Dr. Klein has served as Chair of the Executive Committees of the Extracorporeal Life Support Organization, the Surgical Section of the American Academy of Pediatrics (AAP), and the Organization of Children’s Hospital Surgeons-in-Chief. He was the first surgeon nominated as candidate for President of the AAP, and is currently Chair of the Surgical Advisory Panel of the AAP and President of the American Pediatric Surgical Association.
	Matthew M. Laughon, MD, MPH \| Faculty, Duke Clinical Research Institute Matthew M. Laughon, MD, MPH is an Associate Professor, with Tenure, in the Division of Neonatal-Perinatal Medicine in the Department of Pediatrics at The University of North Carolina at Chapel Hill (UNC). Dr. Laughon has served as the primary mentor or co-mentor at UNC or Duke for 10 neonatal-perinatal medicine fellows, 2 pediatric critical care fellows, 5 pediatric residents, 1 PhD candidate, and 5 medical students, most recently as the primary mentor of an awardee of a Doris Duke Fellowship to pursue research in clinical pharmacology. He has published more than 40 peer reviewed articles in neonatal epidemiology, pharmacoepidemiology, and clinical pharmacology, including >10 with a trainee as a first author. He is the satellite site PI of the NICHD Neonatal Research Network, a member of the NICHD Pediatric Trials Network (PTN) Steering Committee, and has a K23 to learn advanced clinical pharmacology methods. He is the Protocol Chair of 2 current PTN pharmacokinetic trials of 4 off-label therapeutics in infants.
	James Love, JD \| Partner, Oblon Spivak James R. Love is a partner in Oblon Spivak’ s Electrical Patent Prosecution practice group where he handles a wide variety of cases for his clients, including obtaining patents for leading electrical and mechanical companies to protect core technologies for information and communications systems, as well as medical devices and processes. He also works with clients to manage their patent portfolios, which include applications involving such issues as encryption, software interfaces, and medical technologies. Prior to joining Oblon Spivak, Mr. Love held several positions in the computer and technology industries. In addition, he worked in the office of the U.S. Attorney General of the District of Columbia. Mr. Love holds a J.D. from the College of William and Mary, Marshall Wythe Law School and a B.S. in Electrical Engineering with a minor in Mathematics from Cedarville University.
	Sam Maldonado, MD, MPH, FAAP \| Vice President of CHILD, Janssen Pharmaceuticals Company of Johnson & Johnson Dr. Maldonado is Vice President of Child Health Innovation and Leadership Department (CHILD), at Janssen Pharmaceutical Companies of Johnson & Johnson. He joined J&J in February 2000 as Director of Pediatric Drug Development. He is a pediatric infectious diseases physician by training. Dr. Maldonado was a Medical Officer in the Division of Anti-Infective Drug Products and subsequently in the Division of Antiviral Drug Products of the FDA from 1990 to 1998. He was a founding member of the Pediatric Committee (PediComm) in the Center of Drug Evaluation and Research (CDER) at the FDA. He participated in the policy, scientific, and regulatory processes leading to the Pediatric Exclusivity Initiative approved by the US Congress and subsequently signed into law by the President of the United States as the Best Pharmaceutical for Children Act (BPCA) under the FDA Modernization Act (FDAMA) in 1997. Dr. Maldonado has remained involved in the policy work that culminated with the signing into law of BPCA and the Pediatric Research Equity Act (PREA) in a permanent form in July 2012. Since leaving the FDA, he was worked in three pharmaceutical companies and has focused efforts in furthering pediatric drug development. Dr. Maldonado has participated in the clinical and regulatory planning and execution of multiple global pediatric programs across therapeutic areas. He also represents Regulated Industry at the FDA Pediatric Advisory Committee. Dr. Maldonado’s experience in pediatric drug development expands over 24 years, of which 8 he served as Medical Officer at the FDA and the last 16 in Industry.
	Greg Mathison \| Regulatory Strategies, Inc Starting in the medical device industry at Medtronic in 1979 as a chemical engineer, Greg moved to regulatory affairs in 1984. He has held management positions in regulatory/clinical/quality at Medtronic, American Medical Systems, Cardiac Pacemakers, Clarus Medical and Bacchus Vascular. He was an active member of the Pacemaker and Product Approval Task Teams at HIMA and a member of IAPM (International Association of Medical Prosthesis Manufacturers) during the drafting of the Active Implant Directive for the European Union. Greg founded Regulatory Strategies in February of 1993 as a full service consulting firm focusing on U.S. and international regulatory, clinical and quality. As a consultant, he has held senior management positions at Apollo Endosurgery, TVA Medical and Capture Vascular. Greg is also an advisor at the Fogarty Institute for Innovation. He continues to specialize in strategic regulatory planning and finding creative solutions to challenging regulatory issues.
	Richard Migliori, MD \| Executive Vice President, UnitedHealth Group In 2013, Dr. Migliori was appointed executive vice president of medical affairs and chief medical officer of UnitedHealth Group, working with businesses across the enterprise to help improve health care quality, access and affordability. Dr Migliori is also part of the UnitedHealth Group enterprise wide Innovation Council and is committed to deepening the value UnitedHealth Group brings to market through innovation, establishes critical strategic priorities, driving cultural change and practical support for experimentation. Previously, as executive vice president for Health Services, Dr. Migliori was responsible for the ongoing development, design and adaptation of market-leading clinical innovations aimed at ensuring clinical excellence, improving clinical and economic outcomes, and delivery robust business performance on behalf of UnitedHealth Group’s largest public and private sector clients. During his leadership at UnitedHealth Group, Dr. Migliori has spearheaded the design, organization and management of national health care delivery networks, has been appointed as a member of Governor Dayton’s, Governor’s Committee on the University of Minnesota Medical Medical School and has previously served on the Harvard University / Kennedy School of Government Health Care Delivery Policy Committee. He is a member of the American Society of Transplant Surgeons and the Advisory Committee on Transplantation advising the Secretary of Health and Human Services on public policy for human organ transplantation. He has published more than 49 articles on topics ranging from continuous quality improvement methods in a clinical setting to surgical oncology and solid organ transplant. Dr. Migliori holds a Doctor of Medicine degree from Brown University and completed a National Health Research Fellowship in immunology, transplantation and oncology funded by the National Institutes of Health. He is certified by the American Board of Surgery.
	Scott J. Mindrebo \| Director of Regulatory Affairs, Cyberonics, Inc. Scott J. Mindrebo joined Cyberonics, Inc. in June of 2001 as the Director of Regulatory Affairs. During his tenure at Cyberonics, he has held several interim management positions including Vice President (VP) of Clinical Medical Affairs (Acting) and currently holds the title of Senior Director, Clinical and Regulatory Strategic Planning where he overseeing the world-wide product registration activities, responsible for development of premarket protocols, bio-statistical support and data management activities. He joined Cyberonics from EDAP TMS, SA, a medical technology company in Lyon France and was based in their Atlanta Georgia subsidiary, where he served as the VP of Clinical and Regulatory Affairs from June 1999 to June 2001. Prior to EDAP TMS, Mr. Mindrebo was employed by Intermedics, Inc. from 1991 to 1999 as the Director of International Regulatory Affairs and was responsible for the management and oversight of all International registration activities for their Cardiac Rhythm Management (CRM) product lines. From 1986 to 1990, Mr. Mindrebo was employed by Cardiac Control Systems, Inc., a medical technology company in the CRM business and served as VP of Clinical and Regulatory Affairs. He started his biomedical career with Meadox Medicals in 1981. Mr. Mindrebo graduated from Lycoming College with a BA degree in Biology.
	Tim Moran, MBA \| Founder & CEO, PediaVascular 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 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 neurodegenerative 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 IBM Global Services 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.
	Kurt Newman, MD \| President & CEO, Children's National Health System Kurt Newman, MD, has been an integral part of the Children’s National family for more than 30 years as a surgeon and administrator. In his role as president and CEO, Dr. Newman is focused on applying innovation in all aspects of care and research, forming creative connections, and always doing the right thing for children and families. Dr. Newman began as a surgeon at Children’s National in 1984, and became the surgeon-in-chief and senior vice president for the Joseph E. Robert, Jr. Center for Surgical Care in 2003. He was instrumental in creating the Belgium Institute for Pediatric Surgical Innovation and served as its acting vice president when it was founded in 2009. He is an expert in clinical resource management and has served as a consultant to several children’s hospitals in conjunction with the Child Health Corporation of America. Dr. Newman is the author or co-author of more than 70 publications. He is a member of the Board of Commissioners of the Joint Commission and the Board of Governors of the American Pediatric Surgery Association. He also is chairman of the Surgery Section of the American Academy of Pediatrics.
	Loudon Owen, MBA \| Managing Partner, McLean Watson Captial Loudon Owen is co-founder of McLean Watson Capital. Prior to establishing McLean Watson Capital, Loudon and John Eckert financed and advised Softimage, a world leader in high-end 3D animation, in its growth from 4 to 250 employees, its IPO on Nasdaq in 1992 and the sale to Microsoft in 1994. Loudon and John served as the Joint COO for Softimage from 1993 to its sale. Prior to that, Loudon practiced corporate/commercial and securities law with a major Canadian law firm, concentrating on M&A and technology financing. He subsequently founded a corporate law firm that specialized in representing growth companies. Loudon currently serves on the Boards of Directors of i4i, Vismand Exploration, Amplus Communication, Ntegrator International (listed on SGX) and Quantec. He has served on the Boards of a range of public companies, including BPI Mutual Funds, Brookfield/BF Realty and Softimage. His pro bono activities include serving on several non-profit boards and associations. He holds a BA from the University of Toronto, an LLB from Osgoode Hall, Toronto and an MBA from INSEAD in Fontainebleau, France.
	Luke Pedersen, JD \| Partner, Baker Botts L.L.P Luke Pedersen is the head of the intellectual property section in the firm’s Washington D.C. office and Chair of the firmwide Post-Grant Practice Committee. His practice includes all aspects of intellectual property law, with a particular emphasis on technology transfers, licensing, patent prosecution and litigation involving complex and emerging technologies. Mr. Pedersen is a frequent lecturer on software related topics including the legal implications of cloud computing, software-as-a-service and open source software. Mr. Pedersen regularly drafts and negotiates technology transfer agreements pertaining to ownership rights in and to intellectual property in the context of M&A transactions and licensing programs. He has also drafted and/or prosecuted hundreds of patent applications related to a diverse range of technologies, including software, telecommunications, Internet infrastructure, aviation, oil and gas production, medical equipment and the mechanical arts. Mr. Pedersen was identified in the 2012 Intellectual Asset Management’s IAM Patent 1000 – The World’s Leading Patent Practitioners and singled out for “his ability to take a complex area of the law and explain it in a clear and simple way.” Mr. Pedersen’s litigation experience includes controversies related to misappropriation of trade secrets, patent infringement and breach of agreements governing intellectual property assets. On behalf of several clients, Mr. Pedersen has helped develop and monitor comprehensive intellectual property protection programs. These programs have allowed organizations large and small to identify, protect, exploit and enforce their intellectual property rights. While enrolled at the Rutgers College of Engineering, Mr. Pedersen’s studies focused on structural analysis, chemical and biological treatment of water and wastewater, and the design and construction of environmental treatment facilities and related components.
	Lakshman Ramamurth, \| Director at Avalere Health Lakshman Ramamurthy, Director at Avalere Health, advises clients on medical device regulation and how to incorporate FDA regulatory strategy in business planning. He currently serves as Industry Representative on the CMS Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) for a two year term starting June 2014. He aids clients on product life cycle management and evidence planning , including how best to efficiently leverage evidence generation for regulatory and reimbursement approval. Lakshman partners with pharmaceutical, device and diagnostics companies to anticipate evidentiary demands for product approval and real-world demands of purchasers and clinicians. He provides regulatory risk analysis and due diligence to private equity and venture capital companies investing in device/diagnostics companies Prior to joining Avalere, Lakshman worked at the FDA’s Center for Devices and Radiological Health (CDRH) variously as a Senior Reviewer, leading the FDA-CMS Parallel Review pilot project, Policy Advisor and Acting Associate Director. He also served in the Office of Legislation in the Office of Commissioner, FDA. Prior to FDA, Lakshman has a decade of experience in Industry including Bioinformatics Specialist at GlaxoSmithKline; and Genomics Manager at Almac Diagnostics, Inc. Lakshman has a PhD in Molecular Biology from the University of North Carolina at Chapel Hill. He is a member of FDA's strategic team guiding the Entrepreneurs in Residence program at FDA CDRH, and a member of the Clinical Laboratory Standards Institute. Lakshman serves as faculty or invited speaker at a number of conferences including the NCCN (National Comprehensive Cancer Network) Academy of Excellence and Leadership in Oncology, at the AdvaMed Medical Technology Learning Institute, and Duke Law Center for Innovation and Policy.
	Jeanmarie Sales \| Senior Regulatory Manager, Medtronic, Inc Jeanmarie Sales is a Senior Regulatory Manager and Distinguished Regulatory Advisor with Medtronic Neuromodulation. Jeanmarie has worked with a wide array of Class III active implantable medical devices, drug delivery systems, combination products, pharmaceuticals, and biologics, for adult and pediatric patients. Prior to joining Medtronic, Jeanmarie practiced law in Minneapolis. Jeanmarie began her career at Ciba-Geigy Pharmaceuticals, working in research and regulatory roles. Jeanmarie has a B.A. in Biochemistry and a J.D. from Rutgers University.
	Anthony Sandler, MD \| Senior Vice President, Joseph E. Robert, Jr., Center for Surgical Care at Children's National Health System Anthony D. Sandler, MD, is the Senior Vice President of the Joseph E. Robert, Jr., Center for Surgical Care at Children's National Health System. He is the Diane and Norman Bernstein Professor in Pediatric Surgery and also is a principal investigator in the Immunology Initiative of the Belgium Institute for Pediatric Surgical Innovation. Dr. Sandler's research interests include tumor immunology and tumor vaccine therapy, as well as the application of robotic-assisted surgery in pediatric patients. Dr. Sandler is internationally known for his work on childhood solid tumors and operative repair of certain congenital anomalies of the gastrointestinal tract. He is currently the Chair of the Publications Committee for the American Association of Pediatric Surgery and also serves on several committees of the Children’s Oncology Group. Dr. Sandler’s research interests focus on solid tumors of childhood, in which he has developed markers for determining the risk of tumor recurrence. His current research in tumor immunology investigates immunotherapeutic strategies for tumors. Dr. Sandler has published more than 60 peer reviewed manuscripts in clinical and scientific medical journals.
	Dr. Hari Cheryl Sachs \| Team Leader in the Division of Pediatric and Maternal Health, Food and Drug Administration Dr. Hari Cheryl Sachs joined the pediatric group at FDA in Sept 2002 as a medical officer and is now the pediatric team leader in the Division of Pediatric and Maternal Health. She is also a member of the Pediatric Review Committee (PeRC) and serves as one of the FDA liaisons to the American Academy of Pediatrics Committee on Drugs. Dr. Sachs graduated from the university of Maryland at College Park with a BS in Zoology, received her MD from the University of Maryland at Baltimore, and completed her residency training at Children’s’ National Medical Center. Dr. Sachs has been treating patients for over 25 years and continues to see patients on a weekly basis.
	Amy Schwartz, PhD \| Healthcare Lead, IDEO A cognitive psychologist, founder of IDEO Chicago’s Design Research Group, and senior thought-leader in the company’s Health & Wellness domain, Amy Schwartz has over 25 years of professional experience in research, design, and innovation – 16 of them at IDEO. Working for a diverse set of clients—from small, not-for-profit start-ups to industry leaders like Baxter, Medtronic, Abbott, and Geisinger—Amy has contributed her innovative research methodologies and human insights to award-winning projects ranging from the design of surgical instruments and consumer health products to adherence strategies for the treatment of chronic illnesses, new services for retail-based health clinics, and the design of a medical simulation center for a major medical school. She excels in helping clients frame problems in new ways to inspire innovative design solutions. Because Amy has worked closely with everyone from consumers, patients and their families, providers and their care teams, pharmacists, pharmaceutical companies, and payers, she has an empathic, holistic understanding of the entire modern healthcare ecosystem and the needs, desires, fears, and real- life contexts of a multitude of stakeholders. Amy’s current challenge: how to bring human-centered design-thinking to big, systemic health and wellness problems in the era of healthcare reform. An engaging speaker, Amy has presented strategies for transforming healthcare and empowering both patients and care teams to the IHI Forum, ESOMAR Global Healthcare Conference, and AcademyHealth Annual Research Meeting. She has also lectured on design research, health trends, and behavior change and adherence at Northwestern University, the University of Michigan, and the Association for the Advancement of Medical Instrumentation. Amy holds a PhD degree in cognitive psychology from Yale University and a BA in psychology from Columbia University.
	Semih Sen \| Senior Advisor, Mubadala Healthcare Semih Sen is a Senior Advisor at Mubadala Healthcare, a unit of the Abu Dhabi-based investment firm Mubadala Development Company. In this role, Mr. Sen is responsible for strategy formation and implementation, acquisitions, and technical and commercial development of projects. Prior to joining Mubadala Healthcare, Mr. Sen was the Director of Business Development from 2006 to 2008 at Dubai Healthcare City, a multi-billion dollar healthcare cluster development of Dubai Holding. Previously, he founded Casta Consultancy, a boutique advisory services and project development firm in Istanbul, Turkey. From 1998 to 2003, Mr. Sen was the Director of Business Development for DVI, Inc., a financial services company. Earlier in his career, Mr. Sen worked as Assistant Marketing Director for Siemens Leasing. He has been a member of the Executive Committee of the Cleveland Clinic in Abu Dhabi and a board member of Turkey’s first JCI accredited hospital Istanbul Memorial. Semih Sen holds a B.A. in Business Administration from Bosphorus University in Istanbul and attended the International Business Strategy Program at the London School of Economics. He also participated in the Entrepreneurial Healthcare Management Program at Harvard University’s School of Public Health, and attended the Executive Education, Leading High Performance Healthcare Organizations classes at Harvard Business School.
	Murray Sheldon, MD \| Associate Director for Technology and Innovation, Food and Drug Administration Dr. Murray Sheldon, MD received his medical degree from the University of Michigan Medical School in 1975. He completed his general surgical residency with Kaiser Permanente Medical Center in Oakland, California and his cardiovascular fellowships at the University of California, Davis and the Montefiore Hospital and Medical Center in New York. In 1983, he entered private practice as a staff surgeon in several medical centers in Northern California performing cardiac, thoracic and vascular surgery. In 2003, he chose to become engaged in a highly productive career in the medical device industry, leading device development projects and providing expert consultative services to numerous device development firms. From 2003-2009, Murray was the Medical Director for Arbor Surgical Technologies, which developed a unique two-piece, sutureless aortic valve for clinical aortic valve replacement that was sold to Medtronic. Most recently, prior to joining FDA, he was the Medical Director for the minimally invasive surgical program at BioVentrix, Inc. and developed a catheter-based procedure for surgical ventricular reconstruction for heart failure patients. This device has recently obtained a CE mark in Europe. He also was the Medical Director for Solinas Medical, Inc. and was instrumental in developing a unique device for dialysis access. That device has recently received two 510(k) clearances. Dr. Sheldon has recently joined the FDA as the Associate Director for Technology and Innovation. He oversees the Center's initiative to proactively facilitate medical device innovation to address unmet public health needs and to align what is traditionally done at FDA with what is required to support the US medical device ecosystem. His primary focus is working with staff, the medical device industry, the clinical community and others on ways to facilitate bringing innovative medical devices to the patients in the US first in the world. Dr. Sheldon currently leads the Medical Device Reimbursement Task Force, identifying methods to streamline the path from FDA approval to reimbursement.
	Linda Ulrich, MD \| Director, Pediatric Device Consortia Grant Program, FDA Linda Ulrich, M.D., is a pediatrician who works in the FDA’s Office of Orphan Products Development (OOPD). She is the Director of the FDA’s Pediatric Device Consortia Grant Program and has been involved with this program since its inception in March of 2009. Prior to starting in OOPD, Linda served as a medical officer in FDA’s Office of Generic Drugs. Before that, she served seven years as a full-time general pediatrician in the US Navy. She completed her internship and residency at Portsmouth Naval Medical Center, and received her medical degree from the Uniformed Services University in Bethesda, Maryland.
	Jeffrey Smith, PhD \| Partner, McKinsey & Company Dr. Jeffrey Smith is a Partner in the Boston office of McKinsey & Company and a leader in McKinsey’s healthcare practice. Jeff leads McKinsey’s service to drug and medical device regulatory agencies and has served several leading regulators around the globe. He has authored articles on research and development and regulation of the pharmaceutical industry. In 2013, he published a compendium of research articles entitled Regulatory Excellence: Achieving Public Health Impact Through Distinctive Regulatory Management Systems. Jeff has also served a range of biopharmaceutical companies, contract research organizations and investors on strategy, organization and operational issues related to the discovery and development of new drugs and medical devices. In addition to his core work on strategy, Jeff has worked with clients on post-merger integrations, productivity transformations and restructurings. Jeff obtained his Ph.D. in Biological Physics from University of Cambridge and was a Post-Doctoral scientist at the National Institutes of Health where he conducted research on protein structure. He also holds an M.B.A. from the Wharton School.


	Mark Batshaw, MD \| Chief Academic Office & Physician-in-Chief, Children's National Health System Mark Batshaw, MD, is Chief Academic Officer and Physician-in-Chief of Children's National Health System, where he also serves as director of the Children's Research Institute. He is Associate Dean for Academic Affairs at the George Washington University School of Medicine and Health Sciences. Dr. Batshaw received his M.D. from the University of Chicago, completed a residency in Pediatrics at the Hospital for Sick Children and a fellowship in Neurodevelopmental Pediatrics at the Kennedy Krieger Institute, Johns Hopkins. He previously served on the faculty of John Hopkins and the University of Pennsylvania. Since 1998 Dr. Batshaw has been Chief Academic Officer at Children’s National Medical Center and Associate Dean for Academic Affairs at George Washington University. In 2013 he was named Physician-in-Chief at Children’s National. Dr. Batshaw has spent his entire career in the care of children with developmental disabilities. He has published over 200 articles and reviews and is senior editor of the classic textbook, Children with Disabilities now in its 7th edition. Dr. Batshaw's research has focused on inborn errors of urea synthesis, in which he is considered an international authority in drug development and is currently P.I. of an NIH funded Rare Diseases Clinical Research Center on Urea Cycle Disorders and of a program project grant on adenoassociated virus gene therapy in ornithine transcarbamylase deficiency.
	William Bentley, PhD \| Department Chair, Fischell Department of Bioengineering, University of Maryland William E. Bentley is the Robert E. Fischell Distinguished Professor of Engineering and founding Chair of the Fischell Department of Bioengineering. 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 250 related archival publications. Recent interests are on deciphering and manipulating signal transduction pathways, including those of bacterial communication networks, for altering cell phenotype. To enable discovery, his lab develops new strategies for opening ‘communication’ between devices and biological systems by the creation and facile assembly of biologically functional interfaces. These concepts are emerging as a field of ‘biofabrication’ that exploits biological components and processes for assembly. He has served on advisory committees for the NIH, NSF, DOD, DOE, FDA, USDA, and several state agencies. He 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. Dr. Bentley was recipient of the SIM’s Schering-Plough Young Investigator Award, the Charles Thom Award of the SIMB, and the AIChE’s FPB Division Award. He is also a Fellow of the ACS, AAAS, and AIMBE and is an elected member of the American Academy of Microbiology.
	Charles Berul, MD \| Chief of Cardiology, Children's National Health System Charles Berul, MD, is division chief of Cardiology and co-director of the Children's National Heart Institute at Children's National Health System. He was born in Washington, DC and raised in the area. Dr. Berul was the director of the Pacemaker Program at Children’s Hospital Boston, Harvard Medical School until coming to Children’s National Medical Center in 2009. Dr. Berul is a professor of Pediatrics at George Washington University School of Medicine. Dr. Berul is a fellow of the Heart Rhythm Society, the American Academy of Pediatrics, the American College of Cardiology, the Society for Pediatric Research, and the American Heart Association’s Council on Cardiovascular Disease in the Young. Dr. Berul has more than 150 publications in pediatric cardiology and is an invited speaker nationally and internationally and is an acknowledged expert in the area of pediatric cardiac electrophysiology.
	Robert M. Campbell, MD \| Director, The Center for Thoracic Insufficiency Syndrome Children’s Hospital of Philadelphia Dr. Campbell is Director of the Center for Thoracic Insufficiency Syndrome (CTIS) at The Children’s Hospital of Philadelphia and an attending physician in the Division of Orthopaedic Surgery. He is best known as the inventor of the VEPTR (Vertical Expandable Prosthetic Titanium Rib) device, which is used to treat rare diseases of the spine and chest wall, through surgical expansion of the chest and correction of spinal deformity, without inhibiting children’s growth. He has published extensively on the thoracic and pulmonary disability of these patients and was the first to identify the disease Thoracic Insufficiency Syndrome (TIS). In creating the Center for Thoracic Insufficiency Syndrome, Dr. Campbell has assembled an interdisciplinary team, including surgeons, pulmonologists, nutritionists and others to bring a comprehensive approach to treatment of the disorder. His primary focus at CHOP is to expand the VEPTR program and explore new devices, deepen research into the natural history of TIS and develop further advances in treatment. Dr. Campbell obtained his bachelor’s degree from Johns Hopkins University, Baltimore, MD, and his medical degree from Georgetown University Medical School, Washington, DC. He completed a orthopaedic residency at Fitzsimons Army Medical Center, Aurora, CO, and did his pediatric orthopaedic fellowship at the Alfred I. DuPont Hospital for Children, Wilmington, DE. Prior to coming to CHOP in 2009, he held the President’s Council Chair in Pediatric Orthopaedic Surgery at the University of Texas Health Science Center, San Antonio.
	Mark Chandler, MBA \| Managing Director, Upstream Partners Mark Chandler is Managing Director of Upstream Partners, where he provides a variety of advisory and transaction services in the areas of intellectual property and finance. Active for over 20 years in technology and intellectual property (IP) commercialization, Mark has helped early stage ventures, universities, research institutes, companies of all sizes, and independent inventors value, develop and commercialize their technology. Mark is also Chief Executive Officer of TAO Life Sciences Inc., an early stage medical device investment and development company that invests its capital and expertise to develop prototypes, demonstrate clinical proof of concept, and secure financial exits for its innovations. TAO has built a diversified pipeline of medical device technologies that will impact global healthcare markets and make a significant difference in people's lives. 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 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.
	Tara Federici \| Vice President, Technology & Regulatory Affairs, Advanced Medical Technology Association 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.
	Mark Fitzgerald, JD \| Partner, Wilson Sonsini Goodrich & Rosati Mark Fitzgerald is a partner in the Washington, D.C., office of Wilson Sonsini Goodrich & Rosati and has been an integral part of the office since its opening in 2000. His corporate and securities practice focuses on the representation of public and private technology, life sciences, and national defense clients at every stage of their development. Mark has counseled clients on a wide variety of matters, including private placements and public offerings of securities, mergers and acquisitions, seed and angel financings, venture capital, joint ventures, corporate governance, regulatory compliance, complex cross-border transactions, and other general corporate and securities law issues. From 1987 to 1992, Mark served as an officer in the U.S. Air Force, stationed at the Electronic Systems Center at Hanscom Air Force Base in Massachusetts, where he conducted antenna and semiconductor research as an electrical engineer and later managed information technology defense contracts. Mark currently serves as a colonel in the U.S. Air Force Reserve.
	William Fried, MD \| Senior Medical Director, Aetna Dr. William Fried is a Senior Medical Director for Aetna Inc. in the Southeast Region, serving the Maryland, District of Columbia, and Virginia markets. At Aetna, Dr. Fried has 14 years of experience with utilization management activities servicing over one million members in Aetna’s health insurance products, supporting network management, identifying and developing strategies to manage medical costs, implementing quality improvement activities, creating innovative models of care delivery, and offering consultative solutions to customers. Dr. Fried graduated from the University of Pennsylvania School of Medicine in Philadelphia, PA and completed his residency training in Pediatrics at the Children’s Hospital of Pittsburgh. He is a Fellow of the American Academy of Pediatrics and was in clinical primary care practice for 18 years. He remains an Assistant Clinical Professor at the George Washington University School of Medicine. He has previously served on hospital Boards and committees in Northern Virginia and has been active in local and state medical societies. Dr. Fried has been frequently interviewed in local newspapers and has appeared on local and national television.
	James Geiger, MD \| Executive Director, Michigan Pediatric Device Consortium Dr. Geiger is a Professor of Surgery at the University of Michigan where he serves as a Pediatric Surgeon at CS Mott Children’s Hospital. He is the Principal Investigator and Executive Director of the UM Pediatric Device Consortium or MPED funded in part with an FDA grant. In addition, Dr. Geiger directs the CS Mott Children’s Minimally Invasive Surgery Program and is Surgical Director of the Pediatric Comprehensive Weight Management Center. He is recognized as a world’s expert in the area of advanced laparoscopic surgery and robotic surgery techniques. He has developed and is commercializing a number of medical devices. He has completed multiple clinical trials in pediatric cancer immunotherapy. Dr. Geiger earned his undergraduate degree from University of Michigan and his medical degree from Case Western Reserve University School of Medicine. He completed his General Surgery residency, a Surgical Critical Care fellowship, and a Pediatric Surgery Fellowship at University of Michigan Health System in Ann Arbor. He is board certified in pediatric surgery, general surgery, and surgical critical care.
	James O. Gilkerson, DVM \| Distinguished Corporate Fellow & Clinical Advisor, Boston Scientific Dr. Gilkerson is the Distinguished Corporate Fellow of Boston Scientific Corporation and Medical Advisor for R&D of the Cardiac Rhythm Management(CRM) division of Boston Scientific. Dr. Gilkerson has been employed in the Research and Development department of BSC CRM since June, 1990. He has been the system architect for the VENTAK AV defibrillator family, PRIZM defibrillator family and most recently COGNIS and TELIGEN cardiac rhythm management devices. Prior to those assignments he was Manager of Preclinical Studies and Attending Veterinarian from 1987 through 1990. Dr. Gilkerson joined Cardiac Pacemakers Incorporated in December of 1986 as Clinical Research Administrator in the Clinical Studies department. Currently, Dr. Gilkerson serves as Medical Advisor to Dan Goldman VP of R&D and Product Development for Boston Scientific’s CRM division. He is Chair of the Institutional Animal Care and Use Committee, a member of the Product Evaluation Committee and its Clinical Subteam, and a member of the Product Performance Committee. Dr. Gilkerson functions on a dotted- line basis with the Senior Vice President for Corporate Research, BSC. He is an Advisor to the Vice Chancellor for Research of the University of Missouri. He is a member of the Coulter Foundation Oversight Committee at the University of Missouri. Dr. Gilkerson received B.S. and D.V.M. degrees from the University of Missouri. He is a Regular Member of Heart Rhythm Society, Heart Failure Society of America, and the American Veterinary Medical Association.
	Bruce Gingles \| Vice-President, Global Technology Assessment & Health Policy, Cook Medical After earning a BA (biology) from Indiana University, Bruce was hired in 1979 and relocated to Los Angeles to be Cook's first sales representative for the newly formed Critical Care division. He moved to Northern California (Mountain View) in 1984 as Regional Manager, to Bloomington in 1991 as Director of Sales and Marketing and was promoted to Global Business Leader and Vice-President, in 1999. Bruce now represents Cook in the areas of translational research, commercial regulation and technology assessment. The ethical foundation of commercial relationships and translational algorithms are personal interests. Bruce serves on the external advisory committee for the Indiana University and UCSF (devices) CTSIs. He has been invited to discuss translational research and medical device innovation at more than 30 CME/CLE-accredited programs in the US, Europe and Asia.
	Simon Goodall \| Author of BCG study on Regulation and Access to Innovative Medical Technologies Simon Goodall is a management consultant with extensive experience assisting executive teams and boards of for profit and non-profit organizations. Simon spent sixteen years working at the Boston Consulting Group, a leading global strategic management consultancy, and is currently an independent consultant working with fast growing healthcare companies. At BCG Simon was a Partner and Managing Director in the healthcare practice and worked with top biotechnology, pharmaceutical and medical technology companies in the US, Europe and Asia. He was a member of BCG’s Boston and Los Angeles offices and took on a variety of roles within the firm including leading the West Coast Healthcare practice, heading BCG’s BioPharma R&D business and leading marketing for the worldwide healthcare practice. Simon has published extensively on R&D productivity, FDA effectiveness and the economics of innovation. He has also taken a keen interest in public policy as it relates to the FDA’s role in the regulation of innovation and has published and spoken extensively on this topic. He was the lead author for the 2012 study “Regulation and Access to Innovative Medical Technologies: A comparison of the FDA and EU Approval Processes and their Impact on Patients and Industry.”
	Kara Haas, MD, MPH \| Director, Worldwide Strategic Regulatory Affairs for Medical Devices and Diagnostics, Johnson & Johnson Kara Haas, MD, MPH, FACS is a Director of Worldwide Strategic Regulatory Affairs for Medical Devices and Diagnostics at Johnson & Johnson. During her tenure at J&J she has had responsibility for Medical Affairs, Clinical Affairs, Regulatory Affairs, Evidence Based Medicine, Quality, Safety and Health Care Compliance functions. A former Lieutenant Colonel in the United States Air Force, Dr. Haas practiced general and trauma surgery and critical care medicine in both military and civilian settings prior to joining Johnson & Johnson in 1999. Dr. Haas is a graduate of Duke University where she earned her BA in Chemistry and graduate of Tulane University School of Medicine and School of Public Health where she earned her MD and MPH degrees. She completed her General Surgery residency at the University of Washington in Seattle and Postdoctoral Fellowships at University of Texas Southwestern Medical Center and Howard Hughes Medical Institute, with a focus on the molecular biology of Tumor Necrosis Factor and G-protein mediated transmembrane signal transduction amplification systems. Dr. Haas is a board certified general surgeon, Fellow of the American College of Surgeons, and a member of multiple professional medical societies.
	Steven Hirschfeld, MD, PhD \| Associate Director for Clinical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development 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.
	Michael Harrison, MD \|Principal Investigator, University of California-San Francisco Dr. Michael Harrison is Professor of Surgery, Pediatrics, and Obstetrics, Gynecology and Reproductive Sciences, Emeritus. He is a cum laude graduate of Yale University, who received his M.D. magna cum laude from Harvard Medical School, before going on to general surgical residency training at the Mass General, and finally pediatric surgery fellowship at the Rikshospitalet in Oslo, Norway and Children’s Hospital of Los Angeles. Acknowledged around the world as the “Father of Fetal Surgery,” Dr. Harrison is internationally renown for his expertise and innovation in pediatric and fetal surgery. He was one of the original founders of the International Fetal Medicine Surgery Society, the founder/director of the UCSF Fetal Treatment Center, and now the Director of the UCSF Pediatric Device Consortium. Dr. Harrison is author of more than 400 hundred peer-reviewed articles and several textbooks including three editions of “The Unborn Patient: The Art and Science of Fetal Therapy”. As a member of various medical and surgical professional societies, he has been recognized by his colleagues for his contributions to the field and honored with a number of prestigious awards, including the American College of Surgeons Jacobson Innovation Award, as well as membership into the Institute of Medicine. Recently Dr. Harrison served as the 2009 President for the American Pediatric Surgical Association. He maintains an active research lab, which is currently focused on medical device innovation, development and commercialization, and he is the recipient of one of only three FDA Pediatric Device Consortia grants awarded this past year under the Federal Recovery Act. Dr. Harrison and his wife Gretchen maintain both a residence in the San Francisco Bay Area, and an olive grove in California’s Mendocino County.
	Evan Jones, MBA \| Managing Member, jVen Capital, LLC Mr. Jones is Managing Member of jVen Capital, LLC, a life sciences investment company. He also serves as Chairman and Chief Executive Officer of Opgen, Inc., a privately held genetic analysis company. He was a co-founder of Digene Corporation, a publicly-traded biotechnology company focused on women's health and molecular diagnostic testing, serving as Chairman of the Board from 1995 until its acquisition in 2007 and serving as Chief Executive Officer from 1990 to 2006. Mr. Jones also serves as a Director of Fluidigm Corporation, Foundation Medicine, Inc., and Veracyte, Inc. Mr. Jones is a member of the Board of Directors of the Children’s National Medical Center and the Board of Directors of the Children’s Research Institute in Washington, D.C. He is Chairman of the Campaign for Public Health Foundation, an independent, not-for-profit organization dedicated to increasing funding for public health and is a member of the Board of Directors of Research!America. Mr. Jones received a B.A. degree from the University of Colorado and an MBA degree from The Wharton School at the University of Pennsylvania.
	Margaret Kavalaris, JD heads Dentons' legacy Corporate practice and is a member of the Venture Technology practice. Her practice focuses on corporate finance, securities and intellectual property licensing, with an emphasis on the representation of venture-backed, emerging growth companies, in particular, technology companies. Her transactional experience includes venture financings, mergers and acquisitions, and public offerings, including underwriter side representation of investment banks in technology company equity offerings. She also advises companies in all stages of development with respect to corporate governance and operations, technology development, transfer, licensing and distribution.
	Peyvand Khaleghian , MD, PhD \| Managing Partner, Avicenna Partners. Formerly Director of Health Policy and Strategy for the Government of Dubai, Peyvand 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 in the bank’s Europe and Central Asia healthcare practice based in Almaty, Kazakhstan. A New Zealand national with healthcare advisory and investment experience spanning Asia, Europe and the Middle East, Peyvand focuses on regulatory issues, risk management and growth strategies for healthcare companies in high-potential emerging markets with a particular focus on Asia and the Middle East. Peyvand holds a doctorate in Health Policy and Management from the Johns Hopkins University and a medical degree from the University of Auckland, New Zealand.
	Peter Kim, MD, CM, PhD \| Vice President, Belgium Institute for Pediatric Surgical Innovation at Children's National Health System Peter C. W. Kim, MD CM, PhD, a pediatric surgeon and scientist, is vice president of the Belgium Institute for Pediatric Surgical Innovation at Children’s National Medical Center. As vice president, he implements the Institute’s vision of innovative, multidisciplinary research and development in pediatric surgery. Dr. Kim’s research focuses on the development of smarter surgical tools, including image guidance and robotics; smarter simulation technologies that prepare tomorrow’s pediatric surgeons through a hands-on approach rather than the traditional lecture-based medical training model; and the potential of technologies such as high intensity focused ultrasound (HiFU) as non-invasive alternatives to conventional surgery. He has authored more than 100 papers and 50 abstracts on a range of topics, with special emphasis on developmental molecular biology as well as innovation and technology, including minimally invasive surgical techniques. Previously, Dr. Kim served as a general neonatal and thoracic surgeon at the Hospital for Sick Children in Toronto, founding Lead for the Centre for Image-Guided Innovation and Therapeutic Intervention (CIGITI) and senior associate scientist in the hospital’s research institute. Dr. Kim also held the appointment of professor of surgery at the University of Toronto. During his time at the Hospital for Sick Children, Dr. Kim co-led the clinical Airway Reconstruction Team which provided international expertise in the management of complex airway diseases. In addition, he investigated application-specific surgical robotic systems for pediatric surgery, including an image-guided minimally invasive capable robotic arm called KidsArm. Dr. Kim also led the creation of the Fetal Alert Network (FAN), a provincial network to monitor and provide care for mothers with high-risk pregnancies and babies with anomalies. Dr. Kim received his medical training, including the distinction of Master of Surgery, at McGill University in Montreal, Canada. He completed his surgical residency training at the University of Toronto as well as his fellowship in pediatric surgery at the University’s Hospital for Sick Children.
	Michael Klein, MD \| President, American Pediatric Surgical Association Michael Klein graduated from the University of Chicago and studied medieval history at Princeton before attending Case Western Reserve University where he received the M.D. in 1971. He completed training in general surgery at the New England Deaconess Hospital in Boston where he first began doing medical research with engineers in the laboratory of Judah Folkman. He completed training in pediatric surgery at the Children's Hospital of Michigan and served on the faculty at the University of New Mexico and the University of Michigan before returning to the Children's Hospital of Michigan and Wayne State University in 1983. His research work has focused on extracorporeal life support, blood-materials interactions, tissue engineering, robotic surgery, Raman spectroscopy for medical diagnosis, and quantitative decision making. Dr. Klein has served as Chair of the Executive Committees of the Extracorporeal Life Support Organization, the Surgical Section of the American Academy of Pediatrics (AAP), and the Organization of Children’s Hospital Surgeons-in-Chief. He was the first surgeon nominated as candidate for President of the AAP, and is currently Chair of the Surgical Advisory Panel of the AAP and President of the American Pediatric Surgical Association.
	Matthew M. Laughon, MD, MPH \| Faculty, Duke Clinical Research Institute Matthew M. Laughon, MD, MPH is an Associate Professor, with Tenure, in the Division of Neonatal-Perinatal Medicine in the Department of Pediatrics at The University of North Carolina at Chapel Hill (UNC). Dr. Laughon has served as the primary mentor or co-mentor at UNC or Duke for 10 neonatal-perinatal medicine fellows, 2 pediatric critical care fellows, 5 pediatric residents, 1 PhD candidate, and 5 medical students, most recently as the primary mentor of an awardee of a Doris Duke Fellowship to pursue research in clinical pharmacology. He has published more than 40 peer reviewed articles in neonatal epidemiology, pharmacoepidemiology, and clinical pharmacology, including >10 with a trainee as a first author. He is the satellite site PI of the NICHD Neonatal Research Network, a member of the NICHD Pediatric Trials Network (PTN) Steering Committee, and has a K23 to learn advanced clinical pharmacology methods. He is the Protocol Chair of 2 current PTN pharmacokinetic trials of 4 off-label therapeutics in infants.
	James Love, JD \| Partner, Oblon Spivak James R. Love is a partner in Oblon Spivak’ s Electrical Patent Prosecution practice group where he handles a wide variety of cases for his clients, including obtaining patents for leading electrical and mechanical companies to protect core technologies for information and communications systems, as well as medical devices and processes. He also works with clients to manage their patent portfolios, which include applications involving such issues as encryption, software interfaces, and medical technologies. Prior to joining Oblon Spivak, Mr. Love held several positions in the computer and technology industries. In addition, he worked in the office of the U.S. Attorney General of the District of Columbia. Mr. Love holds a J.D. from the College of William and Mary, Marshall Wythe Law School and a B.S. in Electrical Engineering with a minor in Mathematics from Cedarville University.
	Sam Maldonado, MD, MPH, FAAP \| Vice President of CHILD, Janssen Pharmaceuticals Company of Johnson & Johnson Dr. Maldonado is Vice President of Child Health Innovation and Leadership Department (CHILD), at Janssen Pharmaceutical Companies of Johnson & Johnson. He joined J&J in February 2000 as Director of Pediatric Drug Development. He is a pediatric infectious diseases physician by training. Dr. Maldonado was a Medical Officer in the Division of Anti-Infective Drug Products and subsequently in the Division of Antiviral Drug Products of the FDA from 1990 to 1998. He was a founding member of the Pediatric Committee (PediComm) in the Center of Drug Evaluation and Research (CDER) at the FDA. He participated in the policy, scientific, and regulatory processes leading to the Pediatric Exclusivity Initiative approved by the US Congress and subsequently signed into law by the President of the United States as the Best Pharmaceutical for Children Act (BPCA) under the FDA Modernization Act (FDAMA) in 1997. Dr. Maldonado has remained involved in the policy work that culminated with the signing into law of BPCA and the Pediatric Research Equity Act (PREA) in a permanent form in July 2012. Since leaving the FDA, he was worked in three pharmaceutical companies and has focused efforts in furthering pediatric drug development. Dr. Maldonado has participated in the clinical and regulatory planning and execution of multiple global pediatric programs across therapeutic areas. He also represents Regulated Industry at the FDA Pediatric Advisory Committee. Dr. Maldonado’s experience in pediatric drug development expands over 24 years, of which 8 he served as Medical Officer at the FDA and the last 16 in Industry.
	Greg Mathison \| Regulatory Strategies, Inc Starting in the medical device industry at Medtronic in 1979 as a chemical engineer, Greg moved to regulatory affairs in 1984. He has held management positions in regulatory/clinical/quality at Medtronic, American Medical Systems, Cardiac Pacemakers, Clarus Medical and Bacchus Vascular. He was an active member of the Pacemaker and Product Approval Task Teams at HIMA and a member of IAPM (International Association of Medical Prosthesis Manufacturers) during the drafting of the Active Implant Directive for the European Union. Greg founded Regulatory Strategies in February of 1993 as a full service consulting firm focusing on U.S. and international regulatory, clinical and quality. As a consultant, he has held senior management positions at Apollo Endosurgery, TVA Medical and Capture Vascular. Greg is also an advisor at the Fogarty Institute for Innovation. He continues to specialize in strategic regulatory planning and finding creative solutions to challenging regulatory issues.
	Richard Migliori, MD \| Executive Vice President, UnitedHealth Group In 2013, Dr. Migliori was appointed executive vice president of medical affairs and chief medical officer of UnitedHealth Group, working with businesses across the enterprise to help improve health care quality, access and affordability. Dr Migliori is also part of the UnitedHealth Group enterprise wide Innovation Council and is committed to deepening the value UnitedHealth Group brings to market through innovation, establishes critical strategic priorities, driving cultural change and practical support for experimentation. Previously, as executive vice president for Health Services, Dr. Migliori was responsible for the ongoing development, design and adaptation of market-leading clinical innovations aimed at ensuring clinical excellence, improving clinical and economic outcomes, and delivery robust business performance on behalf of UnitedHealth Group’s largest public and private sector clients. During his leadership at UnitedHealth Group, Dr. Migliori has spearheaded the design, organization and management of national health care delivery networks, has been appointed as a member of Governor Dayton’s, Governor’s Committee on the University of Minnesota Medical Medical School and has previously served on the Harvard University / Kennedy School of Government Health Care Delivery Policy Committee. He is a member of the American Society of Transplant Surgeons and the Advisory Committee on Transplantation advising the Secretary of Health and Human Services on public policy for human organ transplantation. He has published more than 49 articles on topics ranging from continuous quality improvement methods in a clinical setting to surgical oncology and solid organ transplant. Dr. Migliori holds a Doctor of Medicine degree from Brown University and completed a National Health Research Fellowship in immunology, transplantation and oncology funded by the National Institutes of Health. He is certified by the American Board of Surgery.
	Scott J. Mindrebo \| Director of Regulatory Affairs, Cyberonics, Inc. Scott J. Mindrebo joined Cyberonics, Inc. in June of 2001 as the Director of Regulatory Affairs. During his tenure at Cyberonics, he has held several interim management positions including Vice President (VP) of Clinical Medical Affairs (Acting) and currently holds the title of Senior Director, Clinical and Regulatory Strategic Planning where he overseeing the world-wide product registration activities, responsible for development of premarket protocols, bio-statistical support and data management activities. He joined Cyberonics from EDAP TMS, SA, a medical technology company in Lyon France and was based in their Atlanta Georgia subsidiary, where he served as the VP of Clinical and Regulatory Affairs from June 1999 to June 2001. Prior to EDAP TMS, Mr. Mindrebo was employed by Intermedics, Inc. from 1991 to 1999 as the Director of International Regulatory Affairs and was responsible for the management and oversight of all International registration activities for their Cardiac Rhythm Management (CRM) product lines. From 1986 to 1990, Mr. Mindrebo was employed by Cardiac Control Systems, Inc., a medical technology company in the CRM business and served as VP of Clinical and Regulatory Affairs. He started his biomedical career with Meadox Medicals in 1981. Mr. Mindrebo graduated from Lycoming College with a BA degree in Biology.
	Tim Moran, MBA \| Founder & CEO, PediaVascular 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 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 neurodegenerative 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 IBM Global Services 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.
	Kurt Newman, MD \| President & CEO, Children's National Health System Kurt Newman, MD, has been an integral part of the Children’s National family for more than 30 years as a surgeon and administrator. In his role as president and CEO, Dr. Newman is focused on applying innovation in all aspects of care and research, forming creative connections, and always doing the right thing for children and families. Dr. Newman began as a surgeon at Children’s National in 1984, and became the surgeon-in-chief and senior vice president for the Joseph E. Robert, Jr. Center for Surgical Care in 2003. He was instrumental in creating the Belgium Institute for Pediatric Surgical Innovation and served as its acting vice president when it was founded in 2009. He is an expert in clinical resource management and has served as a consultant to several children’s hospitals in conjunction with the Child Health Corporation of America. Dr. Newman is the author or co-author of more than 70 publications. He is a member of the Board of Commissioners of the Joint Commission and the Board of Governors of the American Pediatric Surgery Association. He also is chairman of the Surgery Section of the American Academy of Pediatrics.
	Loudon Owen, MBA \| Managing Partner, McLean Watson Captial Loudon Owen is co-founder of McLean Watson Capital. Prior to establishing McLean Watson Capital, Loudon and John Eckert financed and advised Softimage, a world leader in high-end 3D animation, in its growth from 4 to 250 employees, its IPO on Nasdaq in 1992 and the sale to Microsoft in 1994. Loudon and John served as the Joint COO for Softimage from 1993 to its sale. Prior to that, Loudon practiced corporate/commercial and securities law with a major Canadian law firm, concentrating on M&A and technology financing. He subsequently founded a corporate law firm that specialized in representing growth companies. Loudon currently serves on the Boards of Directors of i4i, Vismand Exploration, Amplus Communication, Ntegrator International (listed on SGX) and Quantec. He has served on the Boards of a range of public companies, including BPI Mutual Funds, Brookfield/BF Realty and Softimage. His pro bono activities include serving on several non-profit boards and associations. He holds a BA from the University of Toronto, an LLB from Osgoode Hall, Toronto and an MBA from INSEAD in Fontainebleau, France.
	Luke Pedersen, JD \| Partner, Baker Botts L.L.P Luke Pedersen is the head of the intellectual property section in the firm’s Washington D.C. office and Chair of the firmwide Post-Grant Practice Committee. His practice includes all aspects of intellectual property law, with a particular emphasis on technology transfers, licensing, patent prosecution and litigation involving complex and emerging technologies. Mr. Pedersen is a frequent lecturer on software related topics including the legal implications of cloud computing, software-as-a-service and open source software. Mr. Pedersen regularly drafts and negotiates technology transfer agreements pertaining to ownership rights in and to intellectual property in the context of M&A transactions and licensing programs. He has also drafted and/or prosecuted hundreds of patent applications related to a diverse range of technologies, including software, telecommunications, Internet infrastructure, aviation, oil and gas production, medical equipment and the mechanical arts. Mr. Pedersen was identified in the 2012 Intellectual Asset Management’s IAM Patent 1000 – The World’s Leading Patent Practitioners and singled out for “his ability to take a complex area of the law and explain it in a clear and simple way.” Mr. Pedersen’s litigation experience includes controversies related to misappropriation of trade secrets, patent infringement and breach of agreements governing intellectual property assets. On behalf of several clients, Mr. Pedersen has helped develop and monitor comprehensive intellectual property protection programs. These programs have allowed organizations large and small to identify, protect, exploit and enforce their intellectual property rights. While enrolled at the Rutgers College of Engineering, Mr. Pedersen’s studies focused on structural analysis, chemical and biological treatment of water and wastewater, and the design and construction of environmental treatment facilities and related components.
	Lakshman Ramamurth, \| Director at Avalere Health Lakshman Ramamurthy, Director at Avalere Health, advises clients on medical device regulation and how to incorporate FDA regulatory strategy in business planning. He currently serves as Industry Representative on the CMS Medicare Evidence Development and Coverage Advisory Committee (MEDCAC) for a two year term starting June 2014. He aids clients on product life cycle management and evidence planning , including how best to efficiently leverage evidence generation for regulatory and reimbursement approval. Lakshman partners with pharmaceutical, device and diagnostics companies to anticipate evidentiary demands for product approval and real-world demands of purchasers and clinicians. He provides regulatory risk analysis and due diligence to private equity and venture capital companies investing in device/diagnostics companies Prior to joining Avalere, Lakshman worked at the FDA’s Center for Devices and Radiological Health (CDRH) variously as a Senior Reviewer, leading the FDA-CMS Parallel Review pilot project, Policy Advisor and Acting Associate Director. He also served in the Office of Legislation in the Office of Commissioner, FDA. Prior to FDA, Lakshman has a decade of experience in Industry including Bioinformatics Specialist at GlaxoSmithKline; and Genomics Manager at Almac Diagnostics, Inc. Lakshman has a PhD in Molecular Biology from the University of North Carolina at Chapel Hill. He is a member of FDA's strategic team guiding the Entrepreneurs in Residence program at FDA CDRH, and a member of the Clinical Laboratory Standards Institute. Lakshman serves as faculty or invited speaker at a number of conferences including the NCCN (National Comprehensive Cancer Network) Academy of Excellence and Leadership in Oncology, at the AdvaMed Medical Technology Learning Institute, and Duke Law Center for Innovation and Policy.
	Jeanmarie Sales \| Senior Regulatory Manager, Medtronic, Inc Jeanmarie Sales is a Senior Regulatory Manager and Distinguished Regulatory Advisor with Medtronic Neuromodulation. Jeanmarie has worked with a wide array of Class III active implantable medical devices, drug delivery systems, combination products, pharmaceuticals, and biologics, for adult and pediatric patients. Prior to joining Medtronic, Jeanmarie practiced law in Minneapolis. Jeanmarie began her career at Ciba-Geigy Pharmaceuticals, working in research and regulatory roles. Jeanmarie has a B.A. in Biochemistry and a J.D. from Rutgers University.
	Anthony Sandler, MD \| Senior Vice President, Joseph E. Robert, Jr., Center for Surgical Care at Children's National Health System Anthony D. Sandler, MD, is the Senior Vice President of the Joseph E. Robert, Jr., Center for Surgical Care at Children's National Health System. He is the Diane and Norman Bernstein Professor in Pediatric Surgery and also is a principal investigator in the Immunology Initiative of the Belgium Institute for Pediatric Surgical Innovation. Dr. Sandler's research interests include tumor immunology and tumor vaccine therapy, as well as the application of robotic-assisted surgery in pediatric patients. Dr. Sandler is internationally known for his work on childhood solid tumors and operative repair of certain congenital anomalies of the gastrointestinal tract. He is currently the Chair of the Publications Committee for the American Association of Pediatric Surgery and also serves on several committees of the Children’s Oncology Group. Dr. Sandler’s research interests focus on solid tumors of childhood, in which he has developed markers for determining the risk of tumor recurrence. His current research in tumor immunology investigates immunotherapeutic strategies for tumors. Dr. Sandler has published more than 60 peer reviewed manuscripts in clinical and scientific medical journals.
	Dr. Hari Cheryl Sachs \| Team Leader in the Division of Pediatric and Maternal Health, Food and Drug Administration Dr. Hari Cheryl Sachs joined the pediatric group at FDA in Sept 2002 as a medical officer and is now the pediatric team leader in the Division of Pediatric and Maternal Health. She is also a member of the Pediatric Review Committee (PeRC) and serves as one of the FDA liaisons to the American Academy of Pediatrics Committee on Drugs. Dr. Sachs graduated from the university of Maryland at College Park with a BS in Zoology, received her MD from the University of Maryland at Baltimore, and completed her residency training at Children’s’ National Medical Center. Dr. Sachs has been treating patients for over 25 years and continues to see patients on a weekly basis.
	Amy Schwartz, PhD \| Healthcare Lead, IDEO A cognitive psychologist, founder of IDEO Chicago’s Design Research Group, and senior thought-leader in the company’s Health & Wellness domain, Amy Schwartz has over 25 years of professional experience in research, design, and innovation – 16 of them at IDEO. Working for a diverse set of clients—from small, not-for-profit start-ups to industry leaders like Baxter, Medtronic, Abbott, and Geisinger—Amy has contributed her innovative research methodologies and human insights to award-winning projects ranging from the design of surgical instruments and consumer health products to adherence strategies for the treatment of chronic illnesses, new services for retail-based health clinics, and the design of a medical simulation center for a major medical school. She excels in helping clients frame problems in new ways to inspire innovative design solutions. Because Amy has worked closely with everyone from consumers, patients and their families, providers and their care teams, pharmacists, pharmaceutical companies, and payers, she has an empathic, holistic understanding of the entire modern healthcare ecosystem and the needs, desires, fears, and real- life contexts of a multitude of stakeholders. Amy’s current challenge: how to bring human-centered design-thinking to big, systemic health and wellness problems in the era of healthcare reform. An engaging speaker, Amy has presented strategies for transforming healthcare and empowering both patients and care teams to the IHI Forum, ESOMAR Global Healthcare Conference, and AcademyHealth Annual Research Meeting. She has also lectured on design research, health trends, and behavior change and adherence at Northwestern University, the University of Michigan, and the Association for the Advancement of Medical Instrumentation. Amy holds a PhD degree in cognitive psychology from Yale University and a BA in psychology from Columbia University.
	Semih Sen \| Senior Advisor, Mubadala Healthcare Semih Sen is a Senior Advisor at Mubadala Healthcare, a unit of the Abu Dhabi-based investment firm Mubadala Development Company. In this role, Mr. Sen is responsible for strategy formation and implementation, acquisitions, and technical and commercial development of projects. Prior to joining Mubadala Healthcare, Mr. Sen was the Director of Business Development from 2006 to 2008 at Dubai Healthcare City, a multi-billion dollar healthcare cluster development of Dubai Holding. Previously, he founded Casta Consultancy, a boutique advisory services and project development firm in Istanbul, Turkey. From 1998 to 2003, Mr. Sen was the Director of Business Development for DVI, Inc., a financial services company. Earlier in his career, Mr. Sen worked as Assistant Marketing Director for Siemens Leasing. He has been a member of the Executive Committee of the Cleveland Clinic in Abu Dhabi and a board member of Turkey’s first JCI accredited hospital Istanbul Memorial. Semih Sen holds a B.A. in Business Administration from Bosphorus University in Istanbul and attended the International Business Strategy Program at the London School of Economics. He also participated in the Entrepreneurial Healthcare Management Program at Harvard University’s School of Public Health, and attended the Executive Education, Leading High Performance Healthcare Organizations classes at Harvard Business School.
	Murray Sheldon, MD \| Associate Director for Technology and Innovation, Food and Drug Administration Dr. Murray Sheldon, MD received his medical degree from the University of Michigan Medical School in 1975. He completed his general surgical residency with Kaiser Permanente Medical Center in Oakland, California and his cardiovascular fellowships at the University of California, Davis and the Montefiore Hospital and Medical Center in New York. In 1983, he entered private practice as a staff surgeon in several medical centers in Northern California performing cardiac, thoracic and vascular surgery. In 2003, he chose to become engaged in a highly productive career in the medical device industry, leading device development projects and providing expert consultative services to numerous device development firms. From 2003-2009, Murray was the Medical Director for Arbor Surgical Technologies, which developed a unique two-piece, sutureless aortic valve for clinical aortic valve replacement that was sold to Medtronic. Most recently, prior to joining FDA, he was the Medical Director for the minimally invasive surgical program at BioVentrix, Inc. and developed a catheter-based procedure for surgical ventricular reconstruction for heart failure patients. This device has recently obtained a CE mark in Europe. He also was the Medical Director for Solinas Medical, Inc. and was instrumental in developing a unique device for dialysis access. That device has recently received two 510(k) clearances. Dr. Sheldon has recently joined the FDA as the Associate Director for Technology and Innovation. He oversees the Center's initiative to proactively facilitate medical device innovation to address unmet public health needs and to align what is traditionally done at FDA with what is required to support the US medical device ecosystem. His primary focus is working with staff, the medical device industry, the clinical community and others on ways to facilitate bringing innovative medical devices to the patients in the US first in the world. Dr. Sheldon currently leads the Medical Device Reimbursement Task Force, identifying methods to streamline the path from FDA approval to reimbursement.
	Linda Ulrich, MD \| Director, Pediatric Device Consortia Grant Program, FDA Linda Ulrich, M.D., is a pediatrician who works in the FDA’s Office of Orphan Products Development (OOPD). She is the Director of the FDA’s Pediatric Device Consortia Grant Program and has been involved with this program since its inception in March of 2009. Prior to starting in OOPD, Linda served as a medical officer in FDA’s Office of Generic Drugs. Before that, she served seven years as a full-time general pediatrician in the US Navy. She completed her internship and residency at Portsmouth Naval Medical Center, and received her medical degree from the Uniformed Services University in Bethesda, Maryland.
	Jeffrey Smith, PhD \| Partner, McKinsey & Company Dr. Jeffrey Smith is a Partner in the Boston office of McKinsey & Company and a leader in McKinsey’s healthcare practice. Jeff leads McKinsey’s service to drug and medical device regulatory agencies and has served several leading regulators around the globe. He has authored articles on research and development and regulation of the pharmaceutical industry. In 2013, he published a compendium of research articles entitled Regulatory Excellence: Achieving Public Health Impact Through Distinctive Regulatory Management Systems. Jeff has also served a range of biopharmaceutical companies, contract research organizations and investors on strategy, organization and operational issues related to the discovery and development of new drugs and medical devices. In addition to his core work on strategy, Jeff has worked with clients on post-merger integrations, productivity transformations and restructurings. Jeff obtained his Ph.D. in Biological Physics from University of Cambridge and was a Post-Doctoral scientist at the National Institutes of Health where he conducted research on protein structure. He also holds an M.B.A. from the Wharton School.