General Session Speakers:

Barbara Buch, M.D.
Your host for the Pediatric Clinical trials workshop is Dr. Barbara Buch,fellowship-trained Orthopaedic surgeon who came to FDA in 2001 on a sabbatical from private practice as a clinical consultant for CDRH’s Orthopaedic Devices Branch. During her time at FDA, she has worn several hats including clinical review and management, staff education, clinical trial interests, developing and participating in intercenter working groups related to combination products involving musculoskeletal disease and Orthopaedic devices,  developing, participating and promoting outreach programs to Orthopaedic professional societies and Orthopaedic industry.  She currently functions as a Clinical Deputy Division Director for the Division of Surgical, Orthopaedic and Restorative Devices in the Office of Device Evaluation in the FDA’s Center of Devices and Radiologic Health. Her interests range from Pediatric Musculoskeletal Disease to Women’s health and osteoporosis, Foot and Ankle disorders as well as advancements in the treatment of arthritic conditions.  Her involvement in this special project as its originator is directly related to her interest and work in the Center toward the implementation of the FDAAA legislation as it relates to the development of pediatric devices.

Linda Ulrich, M.D.
Linda Ulrich works as a medical officer in the Office of Orphan Products Development at the FDA.  A general pediatrician by training, Linda has been involved in implementing the Pediatric Device Consortia Grants Program.  Linda is also a member of the pediatric staff at the National Naval Medical Center, Bethesda.   Her professional interests include rare diseases, pediatric medical device development, and neurodevelopmental disabilities.

Judith Cope, M.D.
Dr. Judith Cope is a Pediatric Medical Officer and Epidemiologist with the Office of Pediatric Therapeutics, within the Office of Commissioner at the Food and Drug Administration (FDA). She has been with the FDA for the past five years, working first with the Center of Devices and Radiological Health on pediatric-device related issues and then with the Office of Pediatric Therapeutics within the Office of the Commissioner to focus on pediatric safety for FDA-regulated products.  Her clinical background is in adolescent medicine, general pediatrics and epidemiology and then after several years of clinical and academic practice received an MPH in epidemiology and biostatistics

Donald A. Berry, Ph.D.
Donald Berry holds the Frank T. McGraw Memorial Chair for Cancer Research at The University of Texas M. D. Anderson Cancer Center, where he is Head of the Division of Quantitative Sciences and Chairman of the Department of Biostatistics. He serves as a faculty statistician on the Breast Cancer Committee of the Cancer and Leukemia Group B (CALGB), a national oncology group. In this role he has designed and supervised the conduct of many large U.S. intergroup trials. He is well known as a developer of Bayesian adaptive designs that minimize sample size while increasing the likelihood of detecting drug activity, efficiently using information that accrues over the course of the trial. Since moving to M.D. Anderson Cancer Center in 1999 his department has designed over 300 clinical trials that take a Bayesian approach. He is co-developer (with Giovanni Parmigiani) of BRCAPRO, a widely used program that provides individuals’ probabilities of carrying mutations of breast/ovarian cancer susceptibility genes BRCA1 and BRCA2. Dr. Berry received his Ph.D. in statistics from Yale University, and previously served on the faculty at the University of Minnesota and at Duke University, where he held the Edger Thompson Professorship in the College of Arts and Sciences. Dr. Berry is the author of several books on biostatistics and over 300 published articles, including first-authored articles in the New England Journal of Medicine, the Journal of the American Medical Association, and Nature. Dr. Berry has been the principal investigator for numerous research grants from the National Institutes of Health and the National Science Foundation. He is a Fellow of the American Statistical Association and of the Institute of Mathematical Statistics.

Michelle Roth-Cline, M.D., Ph.D.,
Dr. Michelle Roth-Cline is a Health Scientist in the Ethics Program in the Office of Pediatric Therapeutics at the U.S. Food and Drug Administration. She received an M.D. and a Ph.D. in Clinical Trials from the University of Wisconsin–Madison. She was also a lecturer in biomedical ethics and clinical trials and served on the Health Sciences Institutional Review Board for 7 years. Her current research interests lie at the intersection of ethics, statistics, and medicine, particularly as they pertain to clinical trial design in children.

Captain Steven Hirschfield, M.D., PhD.
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 National Institute of Child Health and Human Development (NICHD) and clinical fellowship at the National Cancer Institute, 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.

Loice Swisher, M.D.
Over the past ten years, I have developed myself as a free lance advocate working with a wide variety of organizations for families of children with pediatric brain tumors.  My combined personal experience as a mother of a child with a medulloblastoma brain tumor and as an emergency physician has given me unique insights and opportunities.  My primary focus within the brain tumor community has been parental support through the internet and development of collaboration of parent advocates with researchers.   In 2006, I became an FDA patient representative for pediatric brain tumors and childhood cancer.

Arleen F. Pinkos, M.T. (ASCP)
Ms. Pinkos is a clinical review scientist in the Office of In Vitro Diagnostic Device Evaluation and Safety within the Center for Devices and Radiological Health (CDRH).  She is a member of the CDRH Pediatric Steering Committee, Chair of the Interagency Artificial Pancreas Working Group and is the Principle Investigator for FDA’s Artificial Pancreas Critical Path Initiative.

Breakout group Moderators

Michael Vitale, MD, MPH
Musculoskeletal Disease
Michael G. Vitale MD, MPH is the Chief of the Pediatric Spine Service at the Morgan Stanley Children’s Hospital of New York-Presbyterian and the Ana Lucia Associate Professor of Orthopaedic Surgery at Columbia University. He has served on the Board of the Pediatric Orthopaedic Society of North America and the Orthopaedic Section of the American Academy of Pediatrics, and is on the executive committee of the Chest Wall and Spinal Deformity Study Group. Dr Vitale's clinical niche focuses on treatment of early onset scoliosis with a strong interest in the assessment of outcomes in pediatric populations; he has published roughly 50 articles within pediatric orthopaedics. He participated as a consultant to the 2005 Institute of Medicine Symposium on pediatric medical devices leading to a chapter entitled “The Dynamics of Pediatric Device Innovation: Putting Evidence in Context” in Safe Medical Devices for Children, 2005.
       
Robert Vincent M.D.; C.M.; FRCP(C); FACC; FSCAI 
Cardiovascular Disease
Robert was born in Montreal Canada.  He did his undergraduate degree in science and Medical degree at McGill University.  Following a 3 year pediatric residency at Montreal Children’s Hospital he then completed a 3 year fellowship in pediatric cardiology at Children’s Hospital in Boston.  He then went to the University of Manitoba in Winnipeg for 3 years and has spent the last 22 years in Atlanta.  He is currently Professor of Pediatrics at Emory University School of Medicine, Director of the Cardiac Catheterization Laboratories and co-Director of Pediatric Heart Transplantation for Children’s Healthcare of Atlanta.  He is past Chairman of the Congenital Heart Disease Committee of the Society for Cardiovascular Angiography and Interventions, President Elect of the GA Chapter of the American College of Cardiology and Governor elect to the ACC Board of Governors.  His major interests are in pediatric interventional cardiology, transcatheter devices, healthcare policy and reform.
       
Evan P. Nadler, M.D.
Abdominal and GI diseases
Evan P. Nadler has recently joined Children’s National Medical Center as an Attending Surgeon and Co-Director of the Obesity Institute.  Before then, he served as the Director of Minimally Invasive Pediatric Surgery at  the New York University School of Medicine where he where he participated in FDA-approved studies using laparoscopic adjustable gastric banding in obese adolescents.  He also has a National Institutes of Health funded basic science laboratory that investigates the pathogenesis of hepatic fibrosis in an animal model of biliary atresia.  Dr. Nadler serves on several national committees including as one of the initial members of the Childhood Obesity Committee of the American Pediatric Surgery Association.  He is also actively involved in NIH and FDA consortia regarding the use of medical devices in pediatric patients.  He was formerly a member of the Institutional Review Board and Patient Safety Committee at NYU.

Shenandoah Robinson, MD, FAAP, FACS
Neurologic Disorders
Dr. Robinson is a pediatric neurosurgeon at Rainbow Babies & Children’s Hospital/University Hospitals Case Medical Center, and an Associate Professor of Neurological Surgery and Neurosciences at Case Western Reserve University School of Medicine in Cleveland, Ohio.  She obtained her undergraduate and medical education at Northwestern University in Chicago, trained in neurological surgery at Case Western Reserve University in Cleveland, and completed a fellowship in pediatric neurosurgery at St. Louis Children’s Hospital, Washington University in St. Louis.  She is the Surgical Director of the Rainbow Comprehensive Pediatric Epilepsy Center.  Dr. Robinson is the representative from the AANS/CNS Joint Section of Pediatric Neurosurgery to the Drugs and Devices Committee.           

Michael Hsieh, M.D.
GU/Renal Diseases
Michael Hsieh, M.D.  is an Assistant Professor in the Department of Urology at the Stanford University School of Medicine. He is a fellowship-trained pediatric urologist who specializes in minimally invasive surgery. Michael studies how host-microbial interactions result in commensalism, mutualism, or parasitism by using the genitourinary tract as a model. He is involved in both clinical and basic research examining bacterial and parasitic urinary tract infections.
                
Arthur Boothroyd, M.D.
Audiologic Disorders; Hearing, Speech and Language
Arthur Boothroyd is Distinguished Professor Emeritus in the doctoral program in Speech and Hearing Sciences at the City University of New York and Scholar in Residence at San Diego State University. Although retired, he remains active as a teacher, consultant, and researcher. Current research includes the tracking of auditory development in aided and implanted deaf children and the development of tools for its assessment. This work is being carried out under an NIH grant to the House Ear Institute, directed by Dr. Laurie Eisenberg.

Breakout Group Discussion Panelists: (Alphabetical order)

Behrooz Akbarnia, M.D.
Dr. Behrooz Akbarnia is Clinical Professor of Orthopaedic surgery at University of California, San Diego, Medical Director of San Diego Center for Spinal Disorders and Director of San Diego spine fellowship program. He is past president of Scoliosis Research Society and is on the Board of directors of Orthopaedic Research and Education Foundation (OREF). His most recent research interest has been on Early Onset Scoliosis and disorders of growing spine where he has published extensively and is the editor  of a textbook on EOS and growing spine. He chairs the Growing Spine Study Group(GSSG) and Growing Spine Foundation that supports GSSG and other research and educational activities in this area through partnership with OREF.”

Ron Alterman, MD
Ron Alterman is a proud product of the New York City Public School System. He received his undergraduate degree from the University of Pennsylvania, graduating magna cum laude with a major course of study in molecular biology. He received his medical degree from the Albert Einstein College of Medicine, graduating with distinction for neuropathology research. After completing his Neurosurgery Training at Montefiore Medical Center in the Bronx, he was the first fellow in Stereotactic and Functional Neurosurgery at New York University Medical Center. Dr. Alterman has held academic appointments at NYU, U. Penn, and Albert Einstein. For the last five years he has been director of functional and restorative neurosurgery at the Mt. Sinai School of Medicine, where he is Professor of Neurosurgery. Dr. Alterman has authored and co-authored seminal papers on the application of Deep Brain Stimulation technology in children with dystonia.
Andrea Behrman, PhD, PT, FAPTA
Andrea Behrman, PhD, PT, FAPTA is an Associate Professor in the Department of Physical Therapy in the College of Public Health and Health Professions at the University of Florida. Her research targets developing activity-based rehabilitation strategies for the recovery of walking after spinal cord injury in adults and children. She is currently the PI of the Kids STEP Study examining the effect of locomotor training on walking recovery in non-ambulatory children post-SCI and neural substrates that may be associated with recovery.

Laurel C. Blakemore, MD
Dr. Blakemore is the Chief of Orthopaedic Surgery and Sports Medicine, and associate professor of pediatrics and orthopaedic surgery at George Washington University School of Medicine, Children’s National Medical Center. Dr. Blakemore specializes in spinal deformity in addition to general pediatric orthopaedics. Current research focuses on the evaluation and treatment of scoliosis in children and adolescents.

Dr. Robert M. Campbell, Jr.
Dr. Robert M. Campbell, Jr.,  of  the Division of Orthopedics, Children’s Hospital of Philadelphia; A pediatric orthopaedist, he is best known as the inventor of the VEPTR (Vertical Expandable Prosthetic Titanium Rib), a device which is used for treatment of rare diseases of the spine and chest wall in children. The VEPTR device was approved by the FDA as a Humanitarian Use Device in 2004. In 2007 he testified to the Senate Committee on Health in support of the Pediatric Device Safety and Improvement Act. He recently relocated to CHOP from the University of Texas Health Science Center in San Antonio, where he was a tenured Professor of Orthopedics, holding a President’s Council endowed Chair of Pediatric Orthopedics .He has described the new disease thoracic  insufficiency syndrome , and has published extensively on the thoracic and pulmonary disability of these patients.  His current focus at CHOP is research into natural history of TIS and into improving its surgical and medical treatment.  

Tim Feltes, M.D.
Tim Feltes is Chief of Cardiology and Co-Director of The Heart Center at Nationwide Children’s Hospital in Columbus Ohio. Tim has been a principal investigator on several multicenter clinical trials including the RSV prevention Palivizumab Cardiac Trial (MI-CP048) and the recently completed Motavizumab Cardiac Trial (MI-CP124) between which 2500 children with congenital heart disease were enrolled. He has served on several DSMBs. He is an investigator on a recently funded T32 Training Grant in Congenital and Acquired Heart Disease between Nationwide Children’s Hospital and the Davis Heart and Lung Research Institute at Ohio State University.

Thomas Forbes, M.D.
Thomas Forbes is Associate Professor in Pediatrics at Wayne State University and Director Cardiac catheterization laboratories at Children's Hospital of Michigan in Detroit, Michigan. His medical school and pediatric residency training was at Creighton University/UNMC in Omaha, Nebraska, with his fellowship in cardiology being completed at Baylor University/Texas Children's Hospital in Houston, Texas in 1996. He completed his interventional fellowship in cardiology at Northwestern University/Children's Memorial Hospital in Lincoln Park, Ill. in 1997. He joined Children's Hospital of Michigan (CHM)/Wayne State University in 1997. CHM is the coordinating center for the Congenital Cardiovascular Interventional Study Consortium (CCISC). This consortium evaluates particular questions in interventional pediatric cardiology and works with industry for approval of drugs and devices in pediatric cardiology.

Judy Harrison, MA
Judy Harrison, MA is the Director of Programs at the Alexander Graham Bell Association for the Deaf and Hard of Hearing (AG Bell). As an educational specialist in the field of hearing health, Judy has been an early interventionist for children with hearing loss and their families and specialized in pediatric cochlear implantation as an educational consultant at the Manhattan Eye, Ear and Throat Hospital and Beth Israel Medical Center. In her position at AG Bell, Judy oversees programs that support families, as well as the certification program for Listening and Spoken Language Specialists. Judy represents AG Bell on the Joint Committee on Infant Hearing and is the current president of the Council on Education for the Deaf.

Timothy M. Hoffman, MD
Timothy M. Hoffman, MD is the Medical Director of the Heart Transplant and Heart Failure Program at Nationwide Children’s Hospital and an Associate Professor of Pediatrics, Division of Pediatric Cardiology at The Ohio State University College of Medicine.   Dr. Hoffman has been involved in several multicenter research collaborations focusing on treatment of the failing myocardium, cardiac support in the peri-operative period, and heart transplant care. He is an active participant and co-author for the Pediatric Heart Transplant Study Group. In recent years, he was the National Co-Principal Investigator, a Steering Committee member, and Primary Author for the PRIMACORP multi-center trial (Prophylactic Intravenous Use of Milrinone After Cardiac Surgery Operation in Pediatrics).  He was recently named Co-Chair of the Outcomes and Genomics Committee of the Pediatric Heart Network/NIH, Peri-operative Working Group. 

Mark Holterman , MD-PhD
Mark Holterman , MD-PhD, is board certified in general  pediatric surgery, with more than 20 years of academic, clinical and administrative achievements to his credit.   He graduated with a MD/PhD from the University of Virginia where he received his general surgical residency. He completed a fellowship in Pediatric Surgery at the Seattle Children’s Hospital. Dr Holterman is an Associate Professor at the University of Illinois College of Medicine and has been named the first Surgeon-in-Chief for the newly established Department of Pediatric Surgery at Advocate Hope Children’s Hospital.  He is recognized by Castle Connolly Medical, Ltd. as one of the nation’s top physicians in pediatric comprehensive surgical care for infants and children.

Frank F. Ing, MD
Dr. Frank F. Ing is currently an associate professor of pediatrics at Baylor College of Medicine and serves as the director of the cardiac catheterization laboratory at Texas Children’s Hospital.  He is board certified in pediatric cardiology.   In addition to training pediatric cardiology fellows and interventional fellows and conducting various clinical trials, he serves on various committees in the Society of Cardiac Angiography and Interventions related to congenital and structural heart disease and on the steering committee of the Congenital Heart Disease Registry for the National Cardiovascular Data Registry.  His primary interests are in the field of interventional pediatric cardiology including the use of implantable cardiovascular devices to treat various congenital heart defects.

Kathy J. Jenkins, MD, MPH
Dr. Kathy Jenkins serves as Senior Vice President and Chief Patient Safety and Quality Officer at Children’s Hospital Boston. Kathy Jenkins received her MD from Harvard Medical School and her MPH from the Harvard School of Public Health.  She completed an internship, residency and fellowship at Children’s Hospital Boston and holds an appointment of associate professor at the Harvard Medical School. She maintains a practice of general pediatric cardiology patients. She coordinates a clinical research group that conducts studies examining variation in outcomes for patients with congenital heart disease, and evaluation of new therapeutic modalities to treat congenital heart defects. Dr. Jenkins co-teaches a longitudinal clinical research course to fellows, junior faculty and nurses on an annual basis while lecturing nationally and internationally on the development of pediatric outcome measures.   She serves on several committees that are leading national efforts to define and measure quality of care for pediatric measures. Dr. Jenkins is the recipient of the Kobren Family Trust chair awarded in recognition of her leadership in patient safety and quality and the vision for implementing the Children’s Hospital Boston Program for Patient Safety and Quality. Dr. Jenkins is a strong advocate for ensuring that the public, regulatory agencies and payers understand the challenges in measuring pediatric outcomes. She recently provided public testimony on definitional issues in reporting serious reportable events occurring in the pediatric population to the Massachusetts Department of Public Health. 

Sudha Kilaru Kessler M.D
Sudha Kilaru Kessler M.D. is an assistant professor of pediatrics and
neurology at the Children's Hospital of Philadelphia. Her research interests
include developing the use of transcranial magnetic stimulation for diagnostic
and treatment purposes in pediatric epilepsy.

Karen Iler Kirk, PhD
Karen Iler Kirk, PhD is Professor of Communication Sciences and Disorders and Otolaryngology-Head and Neck Surgery at The University of Iowa.  For more than 20 years, Dr. Kirk has been a member of multidisciplinary teams investigating long-term speech and language outcomes in pediatric cochlear implant recipients. Spoken word recognition tests developed by Dr. Kirk have been used extensively in FDA clinical trials of new cochlear implant systems.  Her current translational research is aimed at developing new theoretically-motivated, audiovisual tests of spoken word recognition for persons with sensory aids.  Dr. Kirk’s research is funded by the National Institutes of Health. 

Kevin D. McBryde, MD:
Dr. McBryde received his Bachelor of Arts from the University of Pennsylvania, and his Medical Doctorate from Emory University School of Medicine. Dr. McBryde completed his residency in pediatrics at St. Christopher’s Hospital for Children in Philadelphia, Pennsylvania, and his fellowship in pediatric nephrology at the University of Michigan C.S. Mott Children’s Hospital in Ann Arbor, Michigan. During his fellowship, Dr. McBryde received a F32 Individual National Research Service Award from the NIDDK, NIH, as well as a K30 Institutional Training Program in Clinical Research. Upon completion of his fellowship, Dr. McBryde joined the faculty of Children’s National Medical Center and The George Washington University School of Medicine in Washington, DC. Dr. McBryde received an institutional K12 award from the NCRR, NIH, as well as a Bench-to-Bedside award for a collaborative research protocol with Jeffrey Kopp, MD at the NIDDK, NIH. In 2007, Dr. McBryde joined the Food & Drug Administration, Center for Devices and Radiological Health in the Office of Device Evaluations. Currently, Dr. McBryde serves as a Medical Officer providing clinical consultation reviews of pre-market notification for renal-related medical devices seeking FDA approval for marketing in the United States, as well as for post-market monitoring of renal devices. In addition, Dr. McBryde has been awarded two intramural grants through Title III of the FDA Amendment Acts and from the Office of Women’s Health to evaluate leachable release from hemodialysis circuits and the development of urine and serum biomarkers, respectively. Dr. McBryde serves as a Special Volunteer at the Clinical Center for the NIDDK, NIH.

Richard McCarthy, M.D.
Richard E. McCarthy, M.D., Professor, Chief of Spinal Deformities, University of Arkansas for Medical Sciences and Arkansas Children’s Hospital, Department of Orthopaedics. He is currently serving as President of the Scoliosis Research Society. His area of research is early onset spinal deformities in children, adolescent idiopathic scoliosis, and neuromuscular/syndromic scoliosis.

Carlos Peña, Ph.D., M.S.
Dr. Carlos Peña is a Senior Science Policy Advisor in the Office of Science and Public Health, within the Office of the Commissioner at the FDA. He currently serves a lead role in the development of the agency’s approach to science, policy, and research needs for nanotechnology. He also leads as Principal Investigator on a medical device clinical study sponsored by FDA and focused on the treatment of pediatric neurologic disorders. Before joining FDA, Dr. Peña was a Program Analyst at the National Institute of Neurological Disorders and Stroke, National Institutes of Health. He completed his neurosciences doctoral training at Case Western Reserve University in Cleveland, Ohio. Prior to graduate school, he attended the University of Connecticut for the Masters in Comparative Physiology, and the City College of New York, City University of New York, where he received a Bachelors in Developmental Biology.

Hans Pohl, MD
Hans Pohl, MD, was born in Los Angeles, and moved to Washington, DC, for medical school. During medical school, Dr. Pohl became interested in surgery, with a particular fascination for reconstructive procedures. He remained at GW in the Department of Surgery and Urology as a resident. During his rotation at Children’s National Medical Center as a Urology resident, he found himself particularly drawn to Pediatric Urology and, more specifically, to understanding how best to treat patients with urinary tract infections and vesicoureteral reflux.
Dr. Pohl has experience in treating patients with spina bifida and bladder exstrophy, in addition to the other more common diagnoses, and in using laparoscopy to perform surgery through minimally invasive techniques.

B. Stephens Richards MD
B. Stephens Richards MD, Professor, Orthopaedic Surgery, Univ Texas Southwestern
Immediate Past President, Pediatric Orthopaedic Society of North America
Current Vice President, Scoliosis Research Society
Member, Spinal Deformity Study Group, Prospective Pediatric Scoliosis Study
Spine Research: Scoliosis implants, repeat spine surgery and infection, scoliosis bracing .

David Robinowitz, M.D.
David Robinowitz is an assistant professor of anesthesia at UCSF. Prior to training in anesthesia (UCSF), he was a pediatrician, pediatric chief resident (UCSF), and pulmonary medicine fellow (UCSF), with research in health policy and performance evaluation. His background prior to medicine includes computer science (MS, Columbia; prior work at Sun Microsystems), public health (MHS, Johns Hopkins), aviation and music. His research and clinical interests include the use of simulation for anesthesia training, anesthesia for abdominal organ transplantation, airway and media technology in pediatric anesthesia, and medical informatics.

Carlos E. Ruiz, MD, PhD, FACC
Dr. Ruiz was the Director of the Pediatric and Adult Cath Lab at Loma Linda University Medical Center and Children’s Hospital from 1991 to 1999.  He was the Director of Pediatric Interventional Cardiology and the Pediatric Cath Lab at Rush Children’s Heart Center, Rush University from 1999 to 2001, and Chief of Pediatric Cardiology at the University of Illinois, Chicago from 2001 to 2006.  Since 2006 Dr. Ruiz has served as Director of the Adult and Pediatric Structural and Congenital Heart Disease Program at Lenox Hill Heart and Vascular Institute at Lenox Hill Hospital in New York City.

Brian D. Snyder, M.D., Ph.D
Brian D. Snyder, M.D., Ph.D. is a Board Certified Pediatric Orthopaedic surgeon on staff at Children’s Hospital, where his clinical practice focuses on spinal deformity related to congenital and neuromuscular etiologies, hip dysplasia and acquired deformities about the hip, cerebral palsy and pediatric trauma.  In addition, he is an Associate Professor of Orthopaedic Surgery, Harvard Medical School and Director of the Orthopedic Biomechanics Laboratory at the Beth Israel Deaconess Medical Center.  The Laboratory is a multi-disciplinary core research facility associated with the Departments of Bioengineering at Harvard University, Massachusetts Institute of Technology Boston University, Harvard Medical School and the Harvard Combined Orthopaedic Residency Program.  The laboratory focuses on basic and applied research in musculoskeletal biomechanics.  In particular, Dr. Snyder has merged the sophisticated analytic techniques developed in the Laboratory with the innovative diagnostic and surgical techniques developed at Children’s Hospital for treating musculoskeletal diseases. Dr. Snyder has been principal investigator of NIH/NCI RO1, NIH/NIAMS R21, NASA, DOD, private foundations (Whitaker, OREF, Susan B Komen, AO/ASIF, Coulter, POSNA, SRS) and industry sponsored grants.  In addition to his basic science research, Dr. Snyder has patented a unique modular spine instrumentation system to treat spinal deformity and degeneration in children and adults; co-founded a company that is developing a polymer to supplement synovial fluid that minimize cartilage wear in early osteoarthritis and is developing technology for contrast enhanced, quantitative CT imaging of cartilage in synovial joints.  He has been chairman of the research committees and evidence based medicine committees for both the Pediatric Orthopaedic Society of North American and Scoliosis Research Society. He has been a member of several NIH/NIAMS study sections including the SBIR panel that evaluates orthopaedic devices and biologics.

Linda J. Spencer PhD
Linda J. Spencer PhD is an assistant professor in the Department of Communicative Disorders & Sciences at the State University of New York at Geneseo. She also holds a complimentary appointment as an Investigator on the University of Iowa Hospitals and Clinics Children's Cochlear Implant Project where she was an assistant research scientist and a research assistant for  the past 15 years where she part of a research project examining language and literacy development of deaf children with cochlear implants. She earned her bachelor's and PhD degrees in speech and hearing science at the University of Iowa. She has published in journals such as Ear and Hearing, Journal of Speech Language and Hearing Research, Journal of the Acoustical Society of America and Journal of Deaf Studies and Deaf Education. Her current line of research involves examining the relationship between phonology, language skills and reading abilities in children with normal hearing and in children with hearing loss. She has experience working in the public school system as a speech-language pathologist where her caseload included deaf and hard of hearing children between the ages of 3 and 18 who were educated with a Total Communication, and she used extensive sign language in this position. She is on the editorial board for the Journal of Deaf Studies and Deaf Education as well as Contemporary Issues in Communication Science and Disorders.  She is also a peer reviewer for over 10 Journals such as American Journal of Speech-Language Pathology, Audiology and Neurotology, Clinical Linguistics and Phonetics, Ear and Hearing. Journal of Child Language, and Journal of Speech Language and Hearing Research.