SPEAKERS

Amy Basken

Patient Representative

Amy is founder and Director of Programs at the Pediatric Congenital Heart Association. As the mother of a child with a heart defect, Amy has had the privilege of spending the last nine years leading congenital heart disease (CHD) policy efforts for many of the largest national congenital heart organizations, coalitions and consortiums. Her accomplishments include the introduction, passage and funding of the Congenital Heart Futures Act, the development and growth of the Congressional Congenital Heart Caucus, as well as championing national policy program initiatives including Critical Congenital Heart Disease Screening and Patient Empowerment through Transparency. Amy has a Masters of Sciences degree from the University of Wisconsin – Madison, graduating in 1996. She worked for 10 years as a clinical speech pathologist with an expertise in voice and swallowing pathology. When she’s not working to empower others, Amy is busy managing an active household that includes her husband and three school age children. In any spare time, you will find Amy singing, knitting, or escaping into a good book.

3:15p | Plenary Case 4: Pediatric Device Benefit-Risk Assessment: Voice of the Patient

Robin Meier

Patient Representative

Robin Meier is the mother of Elena who is one of Dr. Oetgen’s pediatric patients. Elena was born with NF-1 and congenital pseudarthrosis of her right tibia and fibula. When Elena was 2 years old, her walking became more difficult and the decision was made to go ahead with surgery to correct the pseudarthrosis. Elena’s surgery involved use of a Rush rod, graft from her iliac crest, application of bone morphogenetic protein, and a Taylor Spatial frame. Elena was also given two infusions of Zoledronic acid post surgery. Elena’s leg achieved union after approximately three months.

2:15p | Plenary Case 3: Off-Label & Investigational Use of Marketed Medical Devices in Pediatric Population

Kalee Polk

Patient Representative

Kalee Polk is 10 years old born February 05, 2015 diagnosed with Biliary Artesia. Kalee’s diagnosis came two weeks after birth with symptoms of white colored stools and jaundice of skin and eyes. After visiting an GI specialist other test were performed to ultimately conclude a consultation for transplantation of the liver was required. Test such as elevated liver enzymes and MRI, which revealed sclerosis developed in the liver, and ultrasounds confirmed the need of transplant. Kalee underwent surgical procedures prior to transplant such as the Kasai, Liver biopsies, several treatments for esophageal varices and began diuretics due to paracentesis. Kalee was placed on a waiting list for transplant at one year’s of age, during a routine check a tumor was discovered, 72 hours later Kalee received the first of two transplants in August 2007 at the age of two year’s old. Seven days later the transplant failed due to arterial blood flow clotaged, another transplant was performed to include an aortic jump graft. Post transplant Kalee was taking 15 medications, one if which is Prograf (tacrolimus), which she currently takes today and is a lifelong prescription. Kalee’s had PICC line and Triple Lumen PICC line catheters placed to have homehealth care administer her medications at home due to gastritis. Kalee began to participate in a clinical trial study Immunosuppresion Withdrawal for Stable Pediatric Liver Transplant Recipients (iWITH) in May 2013. Kalee went into rejection and was released from the study but still participates in the clinical trial portion. In addition Kalee participates in split data base clinical study trial. Since Kalee’s two transplants she’s had three rejection episodes, four liver biopsies, two EGD procedures and numerous hospital admissions. Kalee struggles academically due to absences and appointments having her held back in a grade, she is currently enrolled in an IEP and private tutoring lessons. Today Kalee is a beautiful, loving child that is active in life such as cheerleading, training for ambitions of joining a swim team and a great soccer player. Kalee along with her family give all credit to our Lord Jesus Christ for her life and recovery, Kalee is a fighter and no matter what will never give up.

Jackson Radandt

Patient Representative

Jackson (Jack) Radandt was born on April 15, 2001, with hypoplastic left heart syndrome (HLHS). He successfully completed the three stage palliative reconstruction by age three and had an active childhood that included excellent school performance and participation in sports. At age eleven, he developed rapidly progressive heart failure that failed conventional pharmacologic therapies leaving replacement therapy his only option. While on the transplant list, Jack’s heart failure continued to progress necessitating support with a ventricular assist device. Eventually, Jack received his heart transplant on May 20, 2013, and has had an uneventful post transplant course and is a freshmen at Manitowoc Lutheran High School in Wisconsin.

Jack’s journey through staged palliation for HLHS has spanned participation in several innovations in the care of children afflicted with congenital heart disease (CHD). Specifically, he was one of the initial children to participate in the Home Monitoring Program for high-risk infants with shunt dependent congenital heart disease. Findings from this program developed by Children’s Hospital of Wisconsin have been widely adopted nationally and internationally and is considered instrumental in improving interstage survival. Options for Jack when it was determined he needed mechanical circulatory support as a bridge to transplant were limited. At that time, the recently FDA approved Heartware ventricular assist device (HVAD) had not been studied in children with single ventricle disease. Jack was the first child with single ventricle CHD in the United States to have the HVAD implanted and the first child in the world to go home on the HVAD. His experience with the HVAD led to a case report in the Annals of Thoracic Surgery. Jack has been an important voice of CHD by sharing his journey at local and national conferences. Notably, he is the youngest presenter in the history of the American College of Cardiology.

9:15a | Plenary Case 1: Ventricular Assist Devices for Children – The Case of the Berlin Heart EXCOR

Miyah Williams

Patient Representative

Miyah Williams is a 3 year old girl and an Above The Knee Amuptee. Miyah’s condition was caused by Amniotic band syndrome. She had her first surgery in May of 2013, to cut off extra skin, so she could be fitted for her first prosthesis. She received it within few months but it was very difficult to use. The prosthesis wrapped around her stomach and was very heavy. In order, to bend the knee a cord had to be pulled first, which made it impossible to move around correctly. In 2014, Miyah received her second prostheses and a new socket. The prostheses itself was great. The socket was where the problems came in to play. It was very tight, gave her no upper thigh movement, caused sores, induced sweating, and she complained about her “bone” hurting and how uncomfortable it was. After a year of searching for something better, she was offered the chance to try a new socket in August of 2015 from LIM. Once she received it, she noticed the difference right away. She was able to keep her prostheses on all day. It no longer made sores, it stayed dry longer, allowed her to play without complaining. Most importantly she was able to have more freedom with walking and movement. LIM has been a blessing to Miyah. “You will never be able to change the fact that she is an amputee but what can be changed is the quality of life she has. LIM has definitely changed Miyah’s life for the better…”

Timothy Baldwin, PhD, MS

Deputy Chief/ Program Director, Advanced Technologies & Surgery Branch, Basic and Early Translational Research Program, Division of Cardiovascular Sciences | National Heart, Lung, and Blood Institute, NIH

Dr. Baldwin has a B.S. degree in Mechanical Engineering from Virginia Tech (1985) and M.S. and Ph.D. degrees in Biomedical Engineering from Penn State University (1987 and 1990). His expertise is in the fields of biomedical engineering, circulatory assist devices, modeling of biological systems, diagnostic instrumentation, and biomedical sensing devices.

From 1991 to 2002, Dr. Baldwin developed and directed a state-of-the-art laboratory to test and evaluate an array of prosthetic heart valves developed by Carbomedics, Inc., at that time a leading prosthetic heart valve company. He joined NHLBI in December 2002, where he manages and fosters a portfolio of grants and contracts to develop and advance the use of various types of cardiovascular devices, diagnostic and surgical tools and technologies, and related computational techniques. While at NHLBI, he has served as the project officer for the NHLBI Pediatric Circulatory Support Contract Program since its inception in 2004 and has been involved in development and ongoing activity of the NHLBI-funded Interagency Registry for Mechanically Assisted Circulatory Support (INTERMACS). He currently serves as the project officer for the NHLBI-sponsored PumpKIN (Pumps for Kids, Infants, and Neonates) Program.

9:15a | Plenary Case 1: Ventricular Assist Device for Children – The Case of the Berlin Heart EXCOR

Maria Berkman, MD, MBA

Director | Broadview Ventures

Maria Berkman, MD, shares responsibility for the day-to-day operations of Broadview Ventures, including identification and screening of new opportunities, due diligence, negotiation of deal structure, as well as portfolio company board involvement. Prior to joining Broadview Ventures Maria was a management consultant for Monitor Group, where she specialized in life sciences with a focus on biopharmaceutical corporate strategy, franchise and asset-level commercialization strategy, and competitive strategic planning. Before joining Monitor Group, Maria completed Transitional Year training within the Partners HealthCare System at Newton Wellesley Hospital, splitting her time between Internal Medicine and General Surgery. Maria earned her MD from the UCLA School of Medicine, graduating Alpha Omega Alpha with a research focus in cardiothoracic and trauma surgery. Maria earned her MBA from the Anderson School of Management at UCLA. Maria currently serves as the Board Observer for 480 Biomedical, Apama, BioKier, Cardero, Cardialen, Vascular Graft Solutions and Zumbro Discovery.

1:15p | Plenary Case 2: Lessons from Drugs to Devices: Gap Funding in Pediatric Surgical & Medical Devices

Charles Berul, MD

Division Chief of Cardiology & Co-Director of the Children’s National Heart Institute | 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.

10:30a | Make Your Medical Device Pitch for Kids! Competition

Anthony C. Chang, MD, MBA, MPH

Chief Intelligence & Innovation Officer | Children’s Hospital of Orange County

Dr. Chang attended Johns Hopkins University for his B.A. in molecular biology prior to entering Georgetown University School of Medicine for his M.D. He then completed his pediatric residency at Children’s Hospital National Medical Center and his pediatric cardiology fellowship at Children’s Hospital of Philadelphia.

He accepted a position as attending cardiologist in the cardiovascular intensive care unit of Boston Children’s Hospital and as assistant professor at Harvard Medical School. He has been the medical director of several pediatric cardiac intensive care programs (including Children’s Hospital of Los Angeles, Miami Children’s Hospital, and Texas Children’s Hospital) and is currently the Chief Intelligence and Innovation Officer as well as the medical director of the heart failure program at Children’s Hospital of Orange County.

He is also known for several innovations in pediatric cardiac care, including introducing the cardiac drug milrinone and co-designing (with Dr. Michael DeBakey) an axial-type ventricular assist device in children as well as implementing novel practice elements. He has helped to build a successful cardiology practice as a company and was able to complete a deal on Wall Street. He is a committee member of the National Institute of Health pediatric grant review committee. He is the editor of several textbooks in pediatric cardiology, including Pediatric Cardiac Intensive Care and Heart Failure in Children and Young Adults.

He is the founder of the Pediatric Cardiac Intensive Care Society (PCICS) that launched the multi-disciplinary focus on cardiac intensive care for children. He is also the founder of the Asia-Pacific Pediatric Cardiac Society (APPCS), which united pediatric cardiologists and cardiac surgeons from 24 Asian countries and launched a biennial meeting in Asia that draws over 1,000 attendees. This society will also be organizing medical missions to needy parts of Asia for advanced cardiac care in children and will be forming the Asia-Pacific Pediatric Cardiac Foundation, the charitable arm of the APPCS.

12:00p | Lunch Keynote

James Clessuras, JD

Partner | The Law Firm of Wilson Sonsini Goodrich & Rosati

James Clessuras is a partner at Wilson Sonsini Goodrich & Rosati, where he leads the Washington, D.C., office’s technology transactions practice. James focuses on business transactions driven by the use or acquisition of technology and intellectual property rights. He has helped clients structure and negotiate a variety of complex transactions, including joint ventures, strategic alliances, technology licenses, and patent-purchase agreements, as well as product research, development, manufacturing, supply, and distribution relationships. He also works on all intellectual property aspects of mergers, acquisitions, and venture capital investments.

10:30a | Make Your Medical Device Pitch for Kids! Competition

Martha Connolly, PhD

Director, Mtech Baltimore | University of Maryland

Dr. Connolly is a biomedical engineer and director of Mtech Baltimore, a program of the Maryland Technology Enterprise Institute (Mtech) at the A. James Clark School of Engineering at University of Maryland. Dr. Connolly is an adjunct faculty member in the Bioengineering graduate program at the A. James Clark School of Engineering, and teaches courses in entrepreneurship in the life sciences. She is the former Director of the Maryland Industrial Partnerships (MIPS) program which accelerates the commercialization of technology in Maryland by providing matching funds for collaborative R&D projects between companies and University System of Maryland faculty. Dr. Connolly holds BS and MS degrees in Chemistry from Stevens Institute of Technology, and a Ph.D. in Biomedical Engineering from The Johns Hopkins University. She is a former faculty member at Johns Hopkins, and the University of Maryland, Baltimore. She is the author of 36 publications in cardiovascular systems physiology. She is the former Senior Biotechnology Specialist for the State of Maryland’s Department of Business and Economic Development. She also was a founder of an entrepreneurial technology development company, and directed business development at a publicly traded biopharmaceutical company. She is a fellow of the American Institute of Medical and Biological Engineering.

10:30a | Make Your Medical Device Pitch for Kids! Competition

Charles D. Fraser, Jr, MD

Surgeon-in-Chief | Texas Children’s Hospital

Charles D. Fraser, Jr., M.D., is Surgeon-in-Chief, Chief of Congenital Heart Surgery, and Cardiac Surgeon-in-Charge at Texas Children’s Hospital, the largest pediatric hospital in the United States. His academic appointments include Professor of Surgery and Pediatrics (tenured), Baylor College of Medicine, and Adjunct Professor of Bioengineering at Rice University. Dr. Fraser holds the Donovan Chair in Congenital Heart Surgery at Texas Children’s Hospital and the Susan V. Clayton Chair in Surgery at Baylor College of Medicine. Dr. Fraser has joint clinical appointment at the Texas Heart Institute, where he also serves as Director of the Adult Congenital Heart Surgery Program.

As Chief of the Division of Congenital Heart Surgery at Baylor and Co-Director of the Texas Children’s Heart Center, Dr. Fraser works to refine the surgical treatment of small babies, children and adults with congenital cardiac disease. Dr. Fraser’s focus is on the surgical care of these patients with particular emphasis on complex neonatal repairs of serious cardiac malformations. Dr. Fraser has developed dedicated pediatric heart and lung transplant and mechanical circulatory support teams to offer every available therapy in the care of critically ill children.

Dr. Fraser received a bachelor’s degree with honors in mathematics from The University of Texas at Austin in 1980. He received his medical degree in 1984 from The University of Texas Medical Branch in Galveston.

9:15a | Plenary Case 1: Ventricular Assist Devices for Children – The Case of Berlin Heart EXCOR

Kara Haas, MD, MPH, FACS

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.

3:15p | Plenary Case 4: Benefit-Risk Assessment & Voice of the Patient

Michael Harrison, MD

Professor of Surgery, Pediatrics, OB-GYN, & Reproductive Sciences, Emeritus; UCSF Pediatric Device Consortium | 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.

2:15p | Plenary Case 3: Off-Label & Investigational Use of Marketed Medical Devices in Pediatric Population

Steven Hirschfeld, MD, PhD

Associate Director for Clinical Research, Eunice Kennedy Shriver National Institute of Child Health and Human Development | Food & Drug Administration

Pediatric hematologist-oncologist. Captain, U.S. Public Health Service. Education: Columbia University, Pediatric Training: UCSF. Fellowship: NIH. Worked at FDA and co-developed federal pediatric initiatives. Currently at NIH with research oversight, policy development and implementation responsibilities. Coordinate international pediatric research consortium, NIH Point of Contact, pediatric device development. Activities include trial design and methods, ethics, informatics. Consulted for World Health Organization, European Medicines Agency, Organization for Economic Cooperation and Development, national authorities. Deployed for multiple disaster relief efforts with Public Health Service.

1:15p | Plenary Case 2: Lessons from Drugs to Devices: Gap Funding in Pediatric Surgical & Medical Devices

Maureen Japha, JD

Associate Director, Regulatory Policy and Legal Counsel | Faster Cures

Maureen Japha is the Associate Director for Regulatory Policy at FasterCures and Legal Counsel for the Milken Institute. Maureen works closely with the policy team at FasterCures, analyzing legislative and regulatory initiatives that impact the broader patient community. Specifically, she is actively involved in FasterCures´ efforts to advance the science of patient engagement by identifying ways to more effectively and systematically integrate the voice of the patient into the development, approval, and delivery of medical products. Maureen’s programmatic work also focuses on intellectual property issues in drug development, specifically those that arise in grant agreements between foundations and academic institutions.

Prior to joining FasterCures, Maureen worked as an associate in the law firm of Covington & Burling, LLP in Washington D.C. She has broad experience representing and advising clients on a range of intellectual property and regulatory issues, with a primary focus in the area of Hatch-Waxman litigation. During her time at Covington, Maureen also maintained an active pro bono practice, including a six-month rotation at DC’s Children’s Law Center. Maureen graduated magna cum laude from Tufts University with a B.S. in biology and earned her J.D. from Washington University School of Law in St. Louis.

3:15p | Plenary Case 4: Pediatric Device Benefit-Risk Assessment: Voice of the Patient

Peyvand Khaleghian, MD, PhD

Managing Partner | Avicenna Partners Investment Company LLC

Dr. Peyvand Khaleghian is a Managing Partner at Avicenna Partners Investment Company LLC, an emerging markets-focused healthcare investment firm based in the United Arab Emirates. He is a Director of Amana Healthcare, the largest and fastest-growing provider of specialized long-term acute care, post-acute rehabilitation and home transition and respite care services in the Middle East, and e-Kare Inc., a 3D wound assessment technology firm founded as a spin-off enterprise of Belgium Institute for Pediatric Surgical Innovation at Children’s National Health System in Washington DC. Dr. Khaleghian started his career as a physician but later spent eight years as a senior healthcare specialist at the World Bank – four of them as Sector Leader in its Europe and Central Asia healthcare practice based in Almaty, Kazakhstan – and a further three years as Director of Health Policy and Strategy for the Government of Dubai. He is also a member of the Board of Directors of the Hamdan Bin Mohammad College of Dental Medicine. A New Zealand national, Dr. Khaleghian holds a doctorate in Health Policy and Management from the Johns Hopkins University and a medical degree from the University of Auckland.

10:30a | Make Your Medical Device Pitch for Kids! Competition

Chester Koh, MD

Associate Professor of Urology, Pediatrics; Director, Pediatric Robotic Surgery Program; Pediatric Urology Fellowship Program Director | Texas Children’s Hospital / Baylor College of Medicine

Dr. Chester Koh is a pediatric urologist at Texas Children’s Hospital and an Associate Professor of Urology (Pediatric) at Baylor College of Medicine. He also serves as the director of the Pediatric Robotic Surgery Program at Texas Children’s Hospital, and the Pediatric Urology Fellowship Program Director. Dr. Koh received his B.S. degree in Mechanical Engineering from U.C. Berkeley and his medical degree from Tufts University School of Medicine. He completed his urology residency at USC and his pediatric urology fellowship at Children’s Hospital Boston / Harvard Medical School.

His clinical area of expertise is in minimally invasive surgery in children, especially with robotic surgery and single incision laparoscopic surgery. He currently serves on the Executive Council of the Society for Pediatric Urology, as well as the newsletter editor for the AAP Section on Advances in Therapeutics and Technology (SOATT). He has been an NIH-funded principal investigator, where his lab investigated novel therapeutic pathways for bladder regeneration / inflammation and other non-cancer urologic conditions. In addition, he is a co-founder of the Southern California Consortium for Technology and Innovation in Pediatrics (CTIP), a FDA-funded pediatric medical device consortium that is dedicated to improving children’s health through innovative pediatric medical devices.

9:15a | Plenary Case 1: Ventricular Assist Devices for Children – The Case of Berlin Heart EXCOR

Robert Kroslowitz

President & CEO | Berlin Heart, Inc.

Robert Kroslowitz is responsible for Berlin Heart’s North American Operations. He joined Berlin Heart Inc. in 2005 as Vice President Clinical Affairs, and was appointed President and CEO in 2011. Prior to joining Berlin Heart, Robert held leadership roles in other internationally renowned cardiovascular medical device companies having most recently served as Director of Marketing and then Director of Clinical Operations. Previously, he held both clinical and research positions in the cardiovascular space having served as director of several clinical departments in well-known US medical centers.

9:15a | Plenary Case 1: Ventricular Assist Devices for Children – The Case of Berlin Heart EXCOR

Russell Lindemann

Founder & CEO | JustRight Surgical, LLC

For over 25 years Russ has demonstrated the ability to lead the development of strategy, communicate direction, and implement plans that lead to results in the medical device industry. Russ finished his 19 year career at Valleylab as President from 2002-2003 where he completed integration of manufacturing facilities resulting in $4 million first year efficiencies and increased operating profit by 15%, all while boosting employee moral through promoting a vision focused on customer and employee satisfaction. His vision and leadership as Valleylab’s VP Sales, Marketing, and Business Development from 1998-2002 resulted in the successful launch of the Ligasure product lines (world’s first vessel sealing technology) and double digit sales growth. Russ’ career spanned all aspects of the Sales, Marketing, and Business Development functions at Valleylab including VP Sales 1996-1997, and Director of Marketing from 1994-1996. Russ holds a B.A. in Marketing from Cal State Chico, and a M.B.A. from Saint Marys College. From 2004 to 2010 he formed and operated several very successful small businesses during which time he significantly increased revenue and profits. Russ is one of six founders of JustRight Surgical, LLC, a company dedicated to the development of right-sized technology for the pediatric surgery market. Over the past 5 years, JustRight Surgical has raised funds, developed breakthrough devices, and commercially launched products in the US and Europe specific to this market.

1:15p | Plenary Case 2: Lessons from Drugs to Devices: Gap Funding in Pediatric Surgical & Medical Devices

Michelle McMurry-Heath, MD, PhD

Worldwide Vice President, Medical Devices | Johnson & Johnson

Michelle McMurry-Heath is a physician and scientist with more than two decades of experience bridging the gap between science and policy, between medical solutions and patients. After studying biochemistry at Harvard University, Dr. McMurry-Heath became the first African-American to receive both M.D. and Ph.D. degrees from Duke University. Dr. McMurry-Heath has committed her life’s work to providing patients with better health information and greater clinical options. Her bench training in molecular immunology only enhanced her resolve to facilitate the diffusion of innovative science into the practice of medicine. She oversaw health for Senator Joseph Lieberman and was the senior health policy advisor for the Lieberman for President Campaign. She was the founding director of the Aspen Institute’s Health, Biomedical Science and Society Initiative which brought pharmaceutical leaders together with leaders in the patient advocacy and health care to focused projects on issues ranging from regulation to tackling chronic diseases in the context of health insurance reform. Her health diplomacy work included projects in 11 countries, including Cambodia and Rwanda. From 2010-14, Dr. McMurry-Heath was the Associate Center Director for Science in CDRH science at the FDA’s Center for Devices and Radiological Health (CDRH). Dr. McMurry-Heath led the FDA team tasked with defining a new role for patients in the regulation of medical devices and diagnostics. She drew on this experience as the primary architect of the Medical Device Innovation Consortium (MDIC), a novel public-private partnership between the FDA and almost 50 members of the medical technology industry and patient advocacy community. MDIC members have pooled resources and talent to take on some of the most intractable topics in medical device innovation: optimizing clinical trials, applying computer modeling to device design and regulation, compliance science, pathways for insuring the clinical validity of new diagnostics, and the science behind measuring patient preferences. She joined Johnson & Johnson as Worldwide Vice President of Regulatory Affairs for medical devices.

3:15p | Plenary Case 4: Benefit-Risk Assessment & Voice of the Patient

Michael C. Morton

Vice President, Corporate Regulatory Affairs | Medtronic

Michael C. Morton is Vice President for Corporate Regulatory Affairs, at Medtronic, Inc. Michael is responsible for public health policy advocacy in regulatory affairs, and for internal regulatory policy. Michael has over twenty five years of experience in the medical device industry, including quality, clinical, and regulatory affairs. Before joining Medtronic, Inc., Michael worked with CarboMedics, Inc.; W.L. Gore and Associates; Alcon Labs; and Sorin Group. Michael has been recognized as a Fellow of the Regulatory Affairs Professional Society (RAPS). He is active in industry groups, including the Advanced Medical Technology Association (AdvaMed). He chairs the AdvaMed PMA Working Group, and the Pediatric Devices Working Group, and is a member of the Heart Valve Task Force. Michael represented industry within Study Group 1 (Premarket) of the Global Harmonization Task Force. He has also served as the industry representative to the FDA Circulatory System Devices Advisory Panel.

3:15p | Plenary Case 4: Pediatric Device Benefit-Risk Assessment: Voice of the Patient

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 Chief Executive Officer, 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.

8:00a | Welcome & Introduction

Matthew Oetgen, MD

Division Chief, Orthopaedic Surgery and Sports Medicine | Children’s National Health System

Dr. Oetgen joined the faculty at Children’s National in 2009 after finishing the Dorothy and Bryant Edwards Fellowship in Pediatric Orthopaedic Surgery and Scoliosis at Texas Scottish Rite Hospital for Children in Dallas, Texas. Dr. Oetgen completed his medical training at Georgetown University and residency at Yale University. Since joining our faculty, he has been an integral part of the Joseph E. Robert, Jr., Center for Surgical Care and within the Division of Orthopaedic Surgery and Sports Medicine. He maintains a very busy clinical practice, in addition to his active research endeavors. His research interests include optimizing the treatment of early onset scoliosis, the orthopaedic management of children with Neurofibromatosis-1, and the use of robotic and imaged guided therapy in pediatric orthopaedics. He currently serves as the Director of Orthopaedic Research, a research scientist in the Belgium Institute, and as principle investigator on several grant-funded clinical studies. Most recently, in January 2015, he was named the Chief of the Division of Orthopaedic Surgery and Sports Medicine at Children’s National Health System.

2:15p | Plenary Case 3: Off-Label & Investigational Use of Marketed Medical Devices in Pediatric Population

Loudon Owen, JD, MBA

Managing Partner | McLean Watson Capital Inc.

Loudon Owen is a career venture capitalist/investor and lawyer. He is passionate about entrepreneurship, including protecting and monetizing property rights through product development, litigation, licensing or sale. He also provides investment funds and manages patent litigation on behalf of clients. As chairman of i4i, Loudon was personally responsible for launching, championing and raising the capital for i4i to enforce its patent against Microsoft. He co-managed the case, which resulted in a $290 million judgment in favor of i4i that was upheld before the US Supreme Court in 2011. He also co-founded McLean Watson Capital Inc – one of Canada’s pre-eminent venture capital firms. He has invested in a wide range of industries including information technology and life sciences/biotech. Before establishing McLean Watson Capital, Loudon and his partner financed and advised Softimage (three-dimensional animation software) in its growth from four to 250 employees, its initial public offering on NASDAQ and its sale to Microsoft. During his tenure as joint chief operating officer, it was selected as one of the Forbes Top 100 Small Companies in the World. Loudon holds a BA in international relations and economics (University of Toronto), a JD (Osgoode Hall Law School) and an MBA (Insead, France).

1:15p | Plenary Case 2: Lessons from Drugs to Devices: Gap Funding in Pediatric Surgical & Medical Devices

Andrew Pedtke, MD

CEO | LIM Innovations

Andrew Pedtke, MD is the CEO and Co-founder of LIM Innovations and a practicing orthopaedic surgeon. Blending a background in medical device development, health care decision-making, cost-effectiveness research and global health care policy, Dr. Pedtke brings a comprehensive look at the medical device industry, patients it serves and health care demands of today.

Dr. Pedtke has published and presented both nationally and internationally on limb salvage surgery and acts as a visiting Assistant Professor at the University of California, Davis. His interests and expertise combine knowledge of clinical orthopaedics and an entrepreneurial spirit to lay the groundwork for collaboration between researchers, clinicians and innovators. “A multidisciplinary effort founded in sound understanding of indications,” according to Dr. Pedtke, “is necessary to increase expectations and options for amputees and medical devices as a whole.”

Andrew was an Echols scholar at University of Virginia majoring in International Health Care/Policy and he completed medical school at the University of Minnesota. He did his orthopaedic residency at the University of California, San Francisco. Dr. Pedtke’s visionary outlook and desire to advance the medical field in a meaningful way led to the creation of LIM Innovations.

3:15p | Plenary Case 4: Benefit-Risk Assessment & Voice of the Patient

Vasum Peiris, MD, MPH, FAAP, FACC, FASE

Chief Medical Officer – Pediatrics and Special Populations, Center for Devices and Radiological Health | Food & Drug Administration

Dr. Vasum Peiris is a proponent of patient/family-centered care. He is dedicated to developing and advancing systems that provide high-quality, safe and efficient healthcare via evidence- and value-based process.

As Chief Medical Officer for Pediatrics and Special Populations with the FDA Center for Devices and Radiological Health, Dr. Peiris serves as the Center’s senior clinical expert on pediatric medical device issues, providing clinical and executive leadership on Center policies associated with medical devices intended for use in pediatric and special populations.

Dr. Peiris will serve on the Steering Committee for the Patient Engagement Advisory Committee (PEAC), established by the FDA to assure that needs and experiences of patients are included in deliberations on complex issues relating to regulation and use of medical devices.

Prior to joining the FDA, Dr. Peiris was Endowed Chair in Medical Excellence and Chief of Pediatric and Adult Congenital Cardiology at Texas Tech University Health Sciences Center. He helped develop the Department of Public Health.

Dr. Peiris achieved his undergraduate and graduate degrees from Yale University, medical doctorate from The University of Vermont, completed residency at the Yale School of Medicine/Yale-New Haven Hospital and fellowship in Pediatric Cardiology and Cardiovascular Research at Harvard Medical School/Children’s Hospital.

3:15p | Plenary Case 4: Pediatric Device Benefit-Risk Assessment: Voice of the Patient

B. Stephens Richards, MD

Chief Medical Officer | Texas Scottish Rite Hospital

Dr. Steve Richards is currently the Chief Medical Officer at Texas Scottish Rite Hospital for Children, and Professor of Orthopaedic Surgery at the University of Texas Southwestern Medical Center. He has been very involved with the Scoliosis Research Society, having served as its President in 2012. He served as President of the Pediatric Orthopaedic Society of North America in 2009. He is on the editorial board of the Journal of Pediatric Orthopaedics and is a consultant reviewer for the journals Spine Deformity and Spine. Dr. Richards earned his medical degree at St. Louis University School of Medicine, completed his surgical internship at the University of California, San Diego, and his residency in orthopaedic surgery at the University of Utah. He completed the Harrington Fellowship of Pediatric Orthopaedics and Scoliosis at Texas Scottish Rite Hospital for Children in 1987. Dr. Richards is a member of the American Orthopaedic Association; the American Academy of Orthopaedic Surgeons; the American Medical Association; the Dallas County Medical Society; and the Texas Medical Association.

2:15p | Plenary Case 3: Off-Label & Investigational Use of Marketed Medical Devices in Pediatric Population

Anthony Sandler, MD

Senior Vice President and Surgeon-in-Chief Joseph E. Robert, Jr., Center for Surgical Care | 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.

9:15a | Opening Keynote

Ken Schaner, JD

General Counsel | Cystic Fibrosis Foundation

In his more than 40 years of private practice, Ken has represented many for profit and non-profit entities in the corporate and tax aspects of a wide variety of agreements, transactions, financings, licenses, mergers and acquisitions.

Ken began his career at the Internal Revenue Service’s (IRS) legislative and regulations division. During his time with the IRS, Ken worked on the 1969 Tax Reform Act and was one of the principal drafters of the new private foundation provisions.

In 1982, Ken co-founded Swidler Berlin, LLP. While a partner in that firm, he also served as managing member and chair of the corporate group. After Swidler Berlin’s merger with Bingham McCutchen, LLP in 2006, Ken remained a partner until 2008, when he formed Schaner & Lubitz to focus on representing tax-exempt organizations.

Since 1983, Ken has served as general counsel to the Cystic Fibrosis Foundation (CFF). In that capacity, Ken represented CFF in its first venture philanthropy transaction with Aurora Biosciences Corporation (now Vertex), and subsequently represented CFF’s affiliate, CFFT, in the historic monetization of the Vertex royalty interest in 2014. Ken has represented numerous clients in venture philanthropy transactions and related legal matters. Ken also serves as general and outside counsel to many non-profits. He advises on the full range of issues faced by Section 501(c)(3), (c)(4) and (c)(6) organizations, including board governance, business, and tax-exempt compliance issues.

1:15p | Plenary Case 2: Lessons from Drugs to Devices: Gap Funding in Pediatric Surgical & Medical Devices

Justin Shaka, MBA

Co-founder & CEO | REBIScan

Mr. Shaka is Co-founder and CEO or REBIScan, a Cambridge, Massachusetts startup specializing in ocular scanning devices. REBIScan’s first product is the Pediatric Vision Scanner, which is designed to detect amblyopia and strabismus, the leading causes of preventable vision loss worldwide. Through management of the regulatory, reimbursement, and manufacturing processes, Mr. Shaka has become a leader in the medical optics space.

Prior to founding REBIScan, Mr. Shaka served as financial analyst for Children’s Hospital Ophthalmology Foundation at Boston Children’s Hospital. In this role, he managed over $25 million in funds, including those of the lab for Dr. David Hunter, codeveloper of the Pediatric Vision Scanner as well as Mr. Shaka’s co-founder at REBIScan.

Mr. Shaka is a Phi Beta Kappa graduate of the University of New Hampshire with a degree in Economics, and received his MBA from the Tepper School of Business at Carnegie Mellon University. In 2011, Mr. Shaka was named Carnegie Mellon’s Canfield-Roseman Entrepreneur of the Year.

10:30a | Make Your Medical Device Pitch for Kids! Competition

Erik D. Skarsgard MD, MSc, FRCSC, FACS, FAAP

Professor, Pediatric General Surgeon, Chief of Surgery | BC Children’s Hospital

Dr. Erik Skarsgard is the chief of surgery at BC Children’s Hospital and professor of surgery at the University of British Columbia. He is a graduate of the UBC School of Medicine and received training in pediatric surgery at Toronto’s Hospital for Sick Children, and fetal surgery at the University of California San Francisco. After seven years on the surgical faculty at Stanford University, Dr. Skarsgard joined BC Children’s Hospital in 2001. In May 2012, he was appointed Chief of Surgery.

Dr. Skarsgard is co-chair of the Centre for Surgical Research at UBC, and a member of the Scientific Advisory Board for the Institute of Human Development, Child and Youth Health (IHDCYH), Canadian Institutes of Health Research (CIHR). He serves as President Elect for the Canadian Association of Pediatric Surgeons and Governor for the American Pediatric Surgical Association. He is a member of the Pediatric Surgery Advisory Council for the American College of Surgeons, and surgeon champion for his hospital’s National Surgical Quality Improvement Program (NSQIP) program. He is the founding Director of the CIHR-funded Canadian Pediatric Surgery Network (CAPSNet), which targets knowledge mobilization for improved care and outcomes for surgical birth defects.

His primary interests include surgical quality and safety, as well as policy development and implementation of patient-centered surgical innovation.

3:15p | Plenary Case 4: Pediatric Device Benefit-Risk Assessment: Voice of the Patient

Eric Stone, EdM, MBA

CEO & Co-founder | Velano Vascular

Mr. Stone is Co-founder and Chief Executive Officer of Velano Vascular, a pioneering medical device company that has developed a novel approach to more humane blood draws in the hospital setting. Stone currently serves on the National Board of Trustees of the Crohn’s and Colitis Foundation of America (CCFA). He has served as Vice President of Sales and Marketing for MolecularHealth, and with Abbott Laboratories he launched the market-leading drug eluting stent while based in Brussels, Belgium and the worldʼs first bioresorbable coronary stent. Stone is a founding member of Model Nʼs (NYSE: MODN) Life Sciences division, and he began his career in Marketing with Austin,Texas-based Trilogy Software. He is the co-founder of Harvardʼs Student-Alumni Mentoring Initiative and Whartonʼs Health Care Board Fellows Program, and is former Committee Chair and Director of Harvard Universityʼs Alumni Association Board of Directors. Stone currently serves on the Boards of Directors of Velano Vascular and Vigilant Biosciences, and is an Advisor to 3NT Medical and Empower Interactive. Mr. Stone holds an MBA in Health Care Management from The Wharton School, a Masterʼs degree from Harvard University, and a BA from the University of Pennsylvania. Stone, his wife and daughter live in San Francisco, CA.

1:15p | Plenary Case 2: Lessons from Drugs to Devices: Gap Funding in Pediatric Surgical & Medical Devices

Marshall Summar, MD

Division Chief, Genetics and Metabolism | Children’s National Health System

Marshall Summar, MD, is the Chief of the Division of Genetics and Metabolism and the Margaret O’Malley Chair of Molecular Genetics. He joined Children’s National Health System from Vanderbilt University School of Medicine, where he directed the Program in Translational Genetics, the DNA Core program, and started the inborn errors of metabolism program. Dr. Summar is board-certified in pediatrics, clinical genetics, and biochemical genetics.

Dr. Summar is an expert in translational studies, taking basic molecular genetics research and developing direct clinical applications. His work has piloted treatments from the rare disease field to common conditions, especially in the intensive care and emergency room setting. His work in the urea cycle has involved the development of treatment protocols, translational research, and basic molecular research into these rare defects in nitrogen metabolism. This involves clinical trials to improve the outcomes of patients with congenital heart defects, acute lung injury, asthma, and premature infants using compounds from metabolic pathways he studies.

Currently, the focus of Dr. Summar’s research is the study of the interactions between common genetic variations and the environment. This work involves research in heart disease, asthma, pulmonary hypertension, oxidant injury and aging, Down syndrome, and liver disease.

Dr. Summar serves on the editorial board of The Journal of Pediatrics and is the president-elect for the Society of Inherited Metabolic Disease. He serves on the National Institutes of Health study section for the CETT program, the National Human Genetic Research Institute Fellowship Training Program Board, and the NASA radiation research review panel.

4:30p | Closing Keynote

Mark Throdahl, MBA

President & CEO | OrthoPediatrics Corp

Mark Throdahl has more than 35 years of leadership experience in the medical device industry. He is President and CEO of OrthoPediatrics, the only company focused exclusively on orthopedic surgical implants for children. Founded in 2007, OrthoPediatrics has 18 FDA-approved surgical systems.

Formerly, Mark was Group President of Zimmer Holdings. From 2001 to 2007 he served as Chief Executive of Consort Medical plc in London, a public British company which is a leader in medical devices for inhaled drug delivery and anesthesia.

During a 13-year career at Becton Dickinson & Co, he served as Senior Vice President of BD’s international organizations, President of the Drug Delivery Sector, and President of Nippon Becton Dickinson in Tokyo. He began his career at Mallinckrodt Group.

Mark has degrees from Princeton University and the Harvard Business School.

2:15p | Plenary Case 3: Off-Label & Investigational Use of Marketed Medical Devices in Pediatric Population

Warren VanHout, RN, BSEE

Manager, Field Clinical Research | Medtronic

Warren VanHout (BA (Psych), RN, BSEE) is a manager of Field Clinical Research at Medtronic PLC. Over the last 25 years Warren has worked as a Field Clinical Engineer, Research Team Manager and Heart Failure Training and Education Manager. He is currently, also, Manager of the Office of Medical Affairs for the Cardiac Rhythm and Heart Failure business at Medtronic. Warren has been a guest lecturer at University of Michigan in Professional Engineering Ethics and at Eastern Michigan University’s MS in Clinical Research Administration on Device Development and on Clinical Evaluation of Medical Devices/Therapies.

2:15p | Plenary Case 3: Off-Label & Investigational Use of Marketed Medical Devices in Pediatric Population

Bryan Vartabedian, MD, FAAP

Pediatric Gastroenterologist | Baylor College of Medicine and Texas Children’s Hospital

Founder | 33 charts

Bryan Vartabedian an Assistant Professor of Pediatrics at Baylor College of Medicine. Present in the health blogosphere since 2006 Dr. Vartabedian has been an active witness to the social health revolution and its influence on doctors and patients. As an active keynote/panel speaker in the area of technology and the future of medicine, he has addressed numerous national organizations in the U.S. and abroad. He writes about the intersection of medicine, social media and technology on his blog, 33 charts.

10:30a | Make Your Medical Device Pitch for Kids! Competition

Tracy Warren

Managing Partner | Astarte Ventures

Tracy serves as general partner of Astarte Ventures, the first of its kind venture firm focused on women’s and children’s health and wellbeing. Currently, Tracy also serves as a general partner of Battelle Ventures and its affiliate fund, Innovation Valley Partners, for which she focuses on investments in health & life sciences, with an emphasis on institutional-based transactions. Tracy has worked closely with the technology transfer and economic development organizations in medical centers, universities and laboratories, including six of the U.S. Department of Energy National Laboratories, and the Health and Life Sciences division of Battelle Memorial Institute, the world’s largest nonprofit research and development organization.

Alongside Dr. Cymbeline Culiat, Tracy co-founded NellOne Therapeutics, a soft-tissue regenerative medicine company based on the NELL1 gene and Dr. Culiat’s work at Oak Ridge National Laboratory. As CEO, she leads the company’s efforts with respect to strategy, fundraising, business development and licensing. In addition to her investment activities, she also provides early-stage leadership to other businesses, currently serving as an adviser and mentor to female entrepreneurs through Springboard Enterprises.

1:15p | Plenary Case 2: Lessons from Drugs to Devices: Gap Funding in Pediatric Surgical & Medical Devices

Tiffany Wilson, MBA

Executive Director | Global Center for Medical Innovation

Tiffany has spent over a decade bringing innovative medical technology from benchtop to bedside. She leads the Global Center for Medical Innovation, the Southeast’s first medical device innovation center and works with university innovators, clinicians, entrepreneurs, industry, investors, and startups focused on innovation, patient care, and economic growth.

Tiffany joined GCMI after ten years in two different medical device startups. At Scientific Intake, she was VP of Business Development & Strategy focused on product development and global commercialization efforts. In 2002, she launched ACell as VP of Corporate Strategy & Finance, leading a broad range of initiatives, including regulatory, reimbursement, and the scientific advisory board. A former consultant & investment banker, she brings considerable experience in strategic planning, business development, operations, and financial analysis.

Tiffany is the past President of the Southeastern Medical Device Association (SEMDA), Chair of the T3 Labs Advisory Board, a Member of the National Advisory Council on Innovation and Entrepreneurship (NACIE) and on the Advisory Board of the Digital Health Accelerator in Philadelphia. She earned a BBA in International Business from Loyola University and an MBA from the Georgetown University.

10:30a | Make Your Medical Device Pitch for Kids! Competition