2014 HSR CommUnity Conference : Conference Faculty

Presenter Bios

Thomas J. LeBlanc, Ph.D.
Thomas J. LeBlanc, Ph.D.
Executive Vice President and Provost
University of Miami

Thomas J. LeBlanc joined the University of Miami in July 2005 as the Executive Vice President and Provost. He is the chief academic and budget officer overseeing 12 schools and colleges. Prior to this, he was Vice Provost and Robert L. and Mary L. Sproull Dean of the Faculty of Arts, Sciences, and Engineering at the University of Rochester in Rochester, NY.

Dr. LeBlanc received his Ph.D. degree in computer science from the University of Wisconsin at Madison in 1982. His research interests include the development of software systems for parallel programming, including operating systems, compilers, programming languages, and tools for debugging and performance tuning. His research has received funding from the National Science Foundation, the Advance Research Projects Agency, the Department of Defense and the Office of Naval Research.

Pascal J. Goldschmidt, M.D.
Pascal J. Goldschmidt, M.D.
Senior Vice President for Medical Affairs and Dean
Chief Executive Officer, University of Miami Health System

Dr. Goldschmidt is an internationally renowned cardiologist and cardiovascular researcher, is Senior Vice President for Medical Affairs and Dean of the University of Miami Leonard M. Miller School of Medicine. He also serves as Chief Executive Officer of the University of Miami Health System (UHealth), which includes three hospitals and more than 30 outpatient facilities in Miami-Dade, Broward, Palm Beach, Monroe and Collier counties, with more than 1,500 physicians and 8,200 staff. Since his arrival in April 2006, Dean Goldschmidt has overseen tremendous growth on the medical campus in Miami, with the November 2007 purchase of Cedars Medical Center, which is now University of Miami Hospital, the flagship hospital of UHealth. He also established the first allopathic internal medicine residency training program in Palm Beach County.

New global health clinical and research initiatives include the Global Institute for Community Health and Development and the International Medicine Institute. It was through the Global Institute for Community Health and Development that Dean Goldschmidt was able to launch and oversee the medical relief effort in Haiti after the January 2010 earthquake. A team of Miller School physicians, nurses and staff was the first to arrive in Port-au-Prince, and within nine days of the earthquake the University of Miami Hospital in Haiti was open and treating patients.

The research enterprise has also grown significantly since 2006 with the creation of the John P. Hussman Institute for Human Genomics, the Dr. John T. Macdonald Foundation Biomedical Nanotechnology Institute at UM (BioNIUM), and the Interdisciplinary Stem Cell Institute. All three institutes are headed by world-renowned researchers.

In October 2008, Dr. Goldschmidt received the inaugural Jay and Jeanie Schottenstein Prize in Cardiovascular Sciences from the Ohio State University Heart and Vascular Center. The prize is awarded biennially to an international leader in the clinical sciences of cardiovascular medicine, cardiothoracic surgery, or the basic sciences of molecular or cellular cardiology.

Dr. Goldschmidt, whose research applies genomics and cell therapy to the prevention, diagnosis and treatment of coronary artery disease, was previously chairman of the Department of Medicine at Duke University Medical Center. Before taking the chairman’s role, he served as chief of Duke’s Division of Cardiology.

Before joining the Duke faculty in 2000, he was director of cardiology at The Ohio State University College of Medicine and Public Health, where he built the Heart and Lung Research Institute and launched a heart hospital.

A native of Belgium, Dr. Goldschmidt received his medical degree from the Universite Libre de Bruxelles and completed residency and fellowship training in Brussels at Erasme Academic Hospital and in the United States at Union Memorial Hospital and The Johns Hopkins University. Following his training at Hopkins, he served as an assistant, then associate professor in the university’s Division of Cardiology in the Department of Medicine, Department of Cell Biology and Anatomy and Department of Pathology until 1997.

John L. Bixby, Ph.D.
John L. Bixby, Ph.D.
Professor of Pharmacology and Neurological Surgery
Vice Provost for Research
University of Miami

With over 140 co-authored publications and numerous NSF- and NIH-funded research studies, John Bixby, Ph.D., Vice Provost for Research and Professor of Molecular and Cellular Pharmacology and Neurological Surgery, has earned his place as a distinguished scientist and leader at the University of Miami. Dr. Bixby first joined the University in 1988 as an Assistant Professor of Pharmacology and has served as Senior Associate Dean for Graduate and Postdoctoral Studies, Director of the UM Neuroscience Center, and Founding Director of the Ph.D. Programs in Biomedical Sciences (PIBS). Prior to his arrival at the University, Dr. Bixby completed his Bachelor’s degree with distinction at Cornell University in 1975 and went on to earn a Ph.D. in Neurobiology at the California Institute of Technology in 1980. He served as a postdoctoral fellow at the University of California, San Diego, and at the University of California, San Francisco (UCSF) before becoming Assistant Research Physiologist at UCSF. Since 2003, Dr. Bixby has successfully collaborated with Vance Lemmon, Ph.D., the Walter G. Ross Distinguished Chair in Developmental Neuroscience and Professor of Neurological Surgery, to identify genes and signaling networks that promote or hinder axon regeneration following spinal cord injury.

Omaida Velazquez, M.D.
Omaida Velazquez, M.D.
Executive Dean for Research, Research Education & Innovative Medicine
University of Miami

Dr. Velazquez, Professor of surgery and David Kimmelman Endowed Chair in Vascular and Endovascular Surgery is Chief of the Division of Vascular and Endovascular Surgery at the University of Miami Miller School of Medicine. She is a member of the American Surgical Association (ASA), an elite group composed of the nation’s most prominent surgeons from the country’s leading academic medical institutions.

Dr. Velazquez’s current research focuses on further understanding and advancing new treatments for lower extremity arterial occlusive disease and diabetes-related wound healing defects. Dr. Velazquez is the Principal Investigator of a NIH-funded basic science laboratory that investigates endothelial cell biology, angiogenesis, and vasculogenesis. Her clinical expertise focuses on endovascular and other minimally invasive approaches in the surgical treatment of vascular diseases. She has extensive expertise in both open and endovascular repair of abdominal aortic aneurysms, open and endovascular treatments for carotid, mesenteric, and renal stenosis and novel treatments for critical limb ischemia.

In addition to her roles as a surgeon and a scientist, Dr. Velazquez serves as the Executive Dean of Research, Research Education and Innovative Medicine for the Miller School of Medicine. Under her leadership, investigators across campus have seen the clinical research infrastructure enhanced, administrative processes de-mystified and interdepartmental communications increased.

Dr. Velazquez obtained her B.S. from Stevens Institute of Technology in 1987 and obtained M.D. degree from the University of Medicine and Dentistry of New Jersey, New Jersey Medical School graduating Valedictorian in her class of 1991. She completed her post-graduate training in General and Vascular Surgery at the University of Pennsylvania. In addition to her clinical training, she pursued additional years in research and was the recipient of the 1997 Jonathan E. Rhoads Research Award. She received the von Liebig Foundation Award for Excellence in Vascular Surgical Research (2001), the University of Pennsylvania Center of Excellence Faculty Scholar Award (2002), and the Joel J. Roslyn Faculty Research Award (2003). Before joining the Miller School of Medicine, Dr. Velazquez served on the faculty at the University of Pennsylvania for eight years and became an Associate Professor with tenure.

Dushyantha Jayaweera, M.D., MRCOG (UK), FACP, CIP
Dushyantha Jayaweera, M.D., MRCOG (UK), FACP, CIP
Associate Vice Provost for Human Subject Research
Professor of Medicine
University of Miami

Dr. Jayaweera has over 20 years of experience in HIV and serves as the Director for the HIV/HCV co-infection clinic. Jayaweera has led and continues to lead numerous industry-funded trials of medications for patients with viral diseases and has published more than 70 peer-reviewed research articles, while maintaining a busy clinical practice and serving the UM research community. He has received grant funding from both the National Institutes of Health and the National Science Foundation. Additionally, he serves the larger South Florida community as an AIDS educator, and is a senior faculty member of the AIDS Education and Training Center. In 2012, he was appointed Associate Vice Provost for Human Subject Research overseeing the activities of the IRB committees and of the HSRO staff, and acting as a liaison between the IRBs and senior institutional leadership.

He received his M.D. degree in Sri Lanka, and trained in medicine in Sri Lanka, Great Britain, and Loyola University of Chicago. In 1992, he came to UM after serving as senior registrar (equivalent to chief resident) at Birmingham, and at Walsgrave Hospital in Coventry in the United Kingdom. In conjunction with other esteemed faculty members at UM, he has been instrumental in initiating minority HIV care clinics and HIV–HCV co-infection clinics in Miami. He has also contributed to inner-city education in Miami-Dade County as well as disaster relief in Honduras, Sri Lanka, Pakistan and Haiti.

Elizabeth Alonso, Ph.D.
Elizabeth Alonso, Ph.D., CCRA
Director of Quality
Department Public Health Sciences
University of Miami

Dr. Alonso is the Director of Quality at the Department of Public Health Sciences at the University of Miami, Miller School of Medicine. She oversees all quality control and monitoring activities in the Florida Node Alliance of the National Drug Abuse Treatment Clinical Trials Network (NIDA CTN). She has over 10 years of experience in clinical trial implementation and quality monitoring, with a primary focus on public health level interventions for substance abuse and HIV, and provides consultation and training in the areas of Good Clinical Practices, Quality Control/ Assurance, and research ethics. Currently, Dr. Alonso also provides quality-related training and consultation as part of international technology transference collaborations aimed at helping to develop clinical research infrastructure in academic institutions in Mexico and Ecuador.

Maria J. Arnold, CIP
Maria J. Arnold, CIP
Clinical Research Manager

Maria Arnold is the Clinical Research Manager for the Baptist Health South Florida Institutional Review Board. Maria is a Certified IRB Professional (CIP). Her office is responsible for monitoring the conduct of human subjects research for the Baptist Health system.

For the past 30 years her responsibilities have included directing a human subjects program in both academia and a hospital health system, consulting, educating investigators regarding human subjects research regulations, and establishing policies in accordance with OHRP and FDA regulations.

She is a long time member of the national organization Public Responsibility in Medicine & Research (PRIM&R). Where she serves as a mentor to new members in the human subjects research field, participates in conference planning committees, and serves as faculty for meeting sessions.

Laura Ruse Brosch, RN, PhD
Laura Ruse Brosch, RN, PhD
Colonel, US Army, Retired

Dr. Brosch is the Director, Office of Research Protections (ORP) at the US Army Medical Research and Materiel Command (USAMRMC) at Fort Detrick, Maryland. Her office is responsible for the oversight of human subjects protection and animal welfare for research managed by the U.S. Army Medical Command Research Institutes and the Army Medical Command Army Medical Treatment Facilities. Her office provides regulatory oversight for research conducted by numerous Army and DoD organizations as well as for DoD-supported extramural research conducted in 58 countries and over 1500 institutions.. Dr. Brosch is an expert in DoD research protections who chaired the USAMRMC, Human Subjects Research Review Board for six years and served as a member of a DOD IRB continuously for over 11 years. She served as the Army representative on the Executive Secretariat to the DoD Coordinating Committee for Human Research Protection from 2001-2005.

Dr. Brosch is a health services researcher who retired as a Colonel in the Army Nurse Corps with 26 years of service. She served for four years as the Nursing Research Consultant to the US Army Surgeon General. Her faculty appointments include the Uniformed Services University of the Health Sciences, and the University of Maryland, Baltimore.

Dr. Brosch received her BSN from DePaul University, her MSN from the University of Illinois at the Medical Center, Chicago and her PhD from the University of Maryland, Baltimore. She is a graduate of the U.S. Army Command and General Staff College. She is a recipient of the Anita Newcomb McGee Award for Distinguished Service to the Nation as an Army Nurse Corps Officer and of the USAMRMC Combat Casualty Care Research Program Award for Excellence for her leadership in establishing the first Human Research Protection Program and IRB approval process for human research conducted in a Combatant Command.

Anthony Carna, M.B.A.
Anthony Carna, M.B.A.
Director, Sponsored Programs Administration
New York University School of Medicine

Tony joined the New York University School of Medicine in May 2010 and has served as the Director of Sponsored Programs through Superstorm Sandy and the ongoing recovery efforts. He also serves on the Office of Science and Research, Sandy Advisors and Recovery Assistance (SARA) advisory team that supports faculty and department administrators regarding the Sandy recovery effort. Prior to Sandy, NYU SoM SPA had implemented a new electronic grants management system and service delivery model.

Amanda Coltes-Rojas, MPH, CIP, CHRC
Amanda Coltes-Rojas, MPH, CIP, CHRC
Director for Regulatory Affairs & Educational Initiatives
University of Miami-Human Subject Research Office

Amanda joined the Human Subject Research Office (HSRO) in 2005 and has been the Director of Regulatory Affairs and Educational Initiatives since 2007. [Amanda holds undergraduate degrees in Molecular Biology and French Literature from U.C. San Diego, a Master of Public Health degree from Florida International University, and recently completed a Graduate Business Certificate program at UM.] Her regulatory expertise is a resource for the HSRO and researchers alike.

Frank Conte, MS
Frank Conte, MS
Manager, Huron Education
Huron Consulting Group, Inc.

Frank Conte is a manager with Huron Consulting Group’s Higher Education practice. Frank has more than twelve years of project management experience in higher education. He focuses on assisting higher education and healthcare organizations with research administration initiatives including human research protection program evaluation and process improvement, research administration system software selection, design and implementation and clinical research program evaluations.

Stephen DeGennaro, MS
Stephen DeGennaro, MS
Director, IT
Research Information Technology and Data informatics
University of Miami

Stephen DeGennaro holds a B.S. in Computer Science from Florida International University and a M.S. in Computer Information Systems from the University of Miami. He has worked at the University of Miami for the past 11 years, and currently leads the Research Information Technology and Data Informatics teams as Director of IT. He has extensive experience deploying and integrating research systems, including the institution’s clinical trials management system, IRB system, grants system, and reporting systems.

Jenny Esteves, MBA/HSA, LBBP
Jenny Esteves, MBA/HSA, LBBP
Lean Facilitator

Jenny Esteves is a doctoral candidate in Health Services Administration at the University of Phoenix. Her professional experience consists of a myriad of fields such as banking, engineering, pharmaceutical, and healthcare. Ms. Esteves holds several degrees from different universities; BA in Business Administration, BS in Computer Information Systems, an MBA with Health Services Administration and a Graduate Certificate in Finance. Ms. Esteves also holds a Lean Black Belt Professional Certificate from the Management and Strategy Institute. Implementation of procedures and processes has always been part of Ms. Esteves’ working environment specifically in banking and research, using TQM and other quality operational methodologies.

Ms. Esteves joined Miami Children’s Hospital (MCH) in 2006, became an MCH Facilitator in 2008 and transferred to the Research Institute during the same year. Ms. Esteves was responsible for the acquisition of the AAHRPP accreditation for the Research Institute in 2009. As an MCH Lean Facilitator, Ms. Esteves has participated in several lean initiatives such as the Brain Institute’s multidisciplinary clinics, Food and Nutrition’s set-up project, cardio perioperative project, MCH standard work project, and the restructuring of processes for the Research Institute. Some of the lean initiatives facilitated at the Research Institute were: AAHRPP element identification by process, the clinical trials start-up, ongoing and closure processes.

Michelle Feige, MSW
Michelle Feige, MSW
Chief Education Specialist
Division of Education and Development
Office for Human Research Protections (OHRP)

Michelle Feige is the Chief Education Specialist in the Division of Education and Development at the Office for Human Research Protections. Since joining OHRP in 2007, Michelle has worked to provide the research community with guidance and education regarding the HHS regulations for the protection of human subjects through presentations and quality improvement activities.

Prior to joining OHRP, Michelle spent eight years working in the Office of the Clinical Director at the National Institute of Mental Health (NIMH) at the NIH. She was a founding member of a group of senior clinicians who started a novel program at NIMH designed to provide an extra layer of protection to research subjects with severe psychiatric illnesses. Before NIH, Michelle spent several years as a study coordinator conducting psychiatric clinical trials at Georgetown University Hospital. Michelle received her M.S.W. from the University of Michigan, and her B.A. from the University of Wisconsin.

David Forster, J.D., MA
David Forster, J.D., MA
Chief Compliance Officer
WIRB-Copernicus Group

David Forster has a law degree and a Masters in medical ethics from the University of Washington.

David Forster joined Western Institutional Review Board (WIRB) in 1996 and is currently the Chief Compliance Officer, Office of Compliance for both Western Institutional Review Board and Copernicus Group Independent Review Board.

David co-chairs the SACHRP Sub-Committee on Harmonization (SOH), and serves on the Certified IRB Professional (CIP) Council and the Harvard Multiregional Clinical Trials Work Group (MRCT).

David completed a four-year term as a member of the Secretary’s Advisory Committee on Human Research Protections (SACHRP) in 2012, and separate terms as a member of the SACHRP Sub-Committee on Inclusion of Individuals with Impaired Decision-Making in Research (SIIIDR) and the World Health Organization Quality Management and Evaluation Advisory Committee (QMAC).

Ann Glass, RN, BSN, MBA
Ann Glasse, RN, BSN, MBA
Director, Regulatory Support
Clinical Research Operations and Regulatory Support
University of Miami

Ms. Glasse is a registered nurse who holds a master’s degree in Business and bachelor’s degrees in Health Science Education and Nursing. She has over 20 years of combined critical care nursing and clinical research experience in the medical device/biotech/pharmaceutical industries. Her experience and expertise includes clinical trial strategy and management, regulatory and clinical monitoring oversight. In addition Ms. Glasse has provided clinical and regulatory support for start-up medical device/biotech companies. Ann Glasse currently directs the Clinical Research Operations & Regulatory Support office at the Miller School of Medicine, University of Miami. This includes oversight of clinical research monitoring group for Sponsor-Investigators, regulatory support and clinical research related training and education.

Colleen Gorman
Senior Director, Investigator Site Business Process Owner
Pfizer Development Operations
Clinical Trial Practice & Quality

Colleen is currently Senior Director, Business Process Owner, Investigator Site for Pfizer Inc. In that role, she has responsibility for defining the processes, standards and controls for the selection, management and monitoring of investigator sites used in the conduct of sponsored clinical research. In addition, her role includes continuously improving those processes to achieve quality, time and cost objectives.

Colleen has deep expertise in study operations having worked as a study coordinator at Memorial Sloan Kettering Cancer Center and holding roles of increasing responsibility at Pfizer within Development Operations. In addition, she worked as a management consultant in the Pharma R&D practice of PricewaterhouseCoopers. Colleen holds a BS in Biology from The College of William and Mary and a MPH in Health Policy and Management from Columbia University Mailman School of Public Health.

Cynthia Hahn
Cynthia Hahn
Vice President, Clinical Research & Regulatory Affairs, The Feinstein Institute for Medical Research

Cynthia Hahn is the VP, Clinical Research at NSLIJ and has served as a Research Compliance Officer, Chair of the Conflicts of Interest in Research Committee, Research Privacy Officer, the sequestering official for Research Misconduct, and staff to the Audit and Compliance Committee of the Board for one of the largest secular health system in the United States with a budget of over $7 billion dollars. She is responsible for ensuring provision of comprehensive regulatory guidance to the research community and development of a research compliance program that includes analysis of trends in the marketplace and changes in regulation, as well as distribution of written policies, procedures and standards of conduct that promote adherence to applicable federal and state laws and institutional policies. She has over eighteen years of experience in the design, conduct and implementation of research protocols and has served as a co-investigator on multiple projects aimed at improving the environment for research compliance, is an active member of Public Responsibility in Medicine and Research (PRIMR), is on the steering committee for the Clinical Trials Transformation Initiative (CTTI), served as Nominating Chair for the NY Metro Chapter of the Association for Clinical Research Professionals (ACRP) and on the National Council of University Research Administrators (NCURA) Network Neighborhood for Compliance. She is currently a team lead on the CTTI project “Advancing the Use of Central IRBs for Multicenter Clinical Trials” and a recent article “Using Central IRBs for Multicenter Clinical Trials in the United States” was published in January 2013 by PLOS ONE.

She has extensive experience in grants and contract management, including thorough familiarity with current federal regulatory research compliance regarding use of animals in research, protection of human subjects, biosafety, issues of research misconduct and financial conflicts of interest.

Lory Hayes, Ph.D.
Lory Hayes, Ph.D., CHRC
Associate Director, Disclosures and COI Management
University of Miami

Dr. Lory Hayes received her PhD from the University of Massachusetts in 2001, and throughout her career has held scientific and managerial positions in both industrial and academic settings. She joined the University of Miami in 2008, and in 2010 took on her current post of Associate Director for Disclosures and COI Management, now part of the UM Office of the Vice Provost for Research.

Sergio Litewka, M.D., M.P.H.
Sergio Litewka, M.D., M.P.H.
Director of International Operations, Ethics Program
University of Miami

Dr. Sergio Litewka, M.D is a native of Argentina who received his medical degree (MD) from the University of Buenos Aires, Argentina in 1979 and his Masters of Public Health (MPH) from the University of El Salvador, Buenos Aires, Argentina, in 2000. He is the current Director of International Operations for the University of Miami Ethics Programs, a World Health Organization on Ethics and Health Policies and the International Director of the Collaborative Institutional Training Imitative Program (CITI Program). In 2011, he was appointed by President Obama to the United States Presidential Commission for the Study of Bioethical Issues.

Dr. Litewka is a former consultant for healthcare reform projects in Latin America, and he is now involved in research and education activities on human subject’s protection and the responsible conduct of research for global biomedical research.

He is a faculty member in the University Of Miami Department Of Surgery and the project director for the Pan American Bioethics Initiative (PABI), Dr. Litewka develops collaborative projects for research ethics and the responsible conduct of research education with governmental organizations, universities and the private sector in Argentina, Brazil, Colombia, Costa Rica, Honduras, Mexico and Peru.

Ross E. McKinney, Jr., M.D. FAAP, FIDSA
Ross E. McKinney, Jr., MD, FAAP, FIDSA
Director, Trent Center for Bioethics, Humanities and History of Medicine
Duke University Medical Center

Ross McKinney, Jr, MD is a professor of pediatric infectious diseases and director of the Trent Center for Bioethics, Humanities, and History of Medicine, at the Duke University School of Medicine in Durham, NC. He has been at Duke since 1979, when he began his residency in general pediatrics. He completed a fellowship in infectious diseases under the tutelage of Dr. Catherine Wilfert in 1985 and joined the faculty in the division of infectious diseases. He became division chief in 1994 and held that position until 2003. From 2002-2007, Dr. McKinney was the Vice Dean for Research for the Duke School of Medicine, and in 2007 he was appointed director of the Trent Center.

Dr. McKinney served two terms as the chair of the Infectious Diseases Sub-Board of the American Board of Pediatrics. He also served two terms on the editorial board of Pediatrics. He was a member of the Steering Committees of the Pediatric Infectious Diseases Society and the North Carolina Pediatric Society.

In the realm of research ethics, Dr. McKinney’s expertise is focused on conflict of interest, but he has also published articles related to the ethics of sports medicine and issues related to informed consent. He is a member of the Executive Committee of the AAMC’s Forum on Conflict of Interest in Academe, which he chaired for two years, and has served as co-chair of an Institute of Medicine Committee evaluating a reconciled approach to conflict of interest reporting.

Khurram Nasir, MD, MPH
Khurram Nasir, MD, MPH
Director Prevention and Wellness & Director High Risk CVD Clinic

Dr. Khurram Nasir area of interest lies in population health management, role of cardiovascular imaging for identification of high risk individuals, risk assessment and outcome evaluation, with a particular emphasis on innovative paradigms for health care delivery based on evidence and emerging technologies with goals of appropriate resource allocation.

He is currently the director of Prevention and Wellness Research as well Director of High Risk CVD clinic at Baptist Health South Florida, Miami FL. Dr Nasir received his MD training from Pakistan followed by a Masters in Public Health at John Hopkins University with an emphasis on population health care delivery. Additionally he received postdoctoral training at the division of cardiology at Johns Hopkins Hospital followed by a year of internal medicine training at the University of Pittsburgh. He is also a recipient of NIH training award for cardiac imaging training program at the Massachusetts General Hospital, Boston, USA. Dr. Nasir Completed his internal medicine residency at the Boston Medical Center in Boston, MA followed by clinical cardiology fellowship at Yale University, New Haven CT.

Dr Nasir has published more than 280 publications in his area of interest. He is an Associate Editor for the journal, “Atherosclerosis”, “Circulation: Cardiovascular Quality and Outcomes” and “Journal of American Cardiology: Cardiac Imaging” as well serves on the editorial board for the Journal of Cardiac CT. He is currently the chair of prevention council for the Society of Atherosclerosis Imaging and Prevention as well member of board of directors for Society for Cardiac CT (SCCT) and BHSF Prevention & Wellness Steering Council.

He was awarded in 2013 for his contributions the “Johns Hopkins Distinguished Alumni Award”, which honors alumni who have typified the Johns Hopkins tradition of excellence and brought credit to the University by their personal accomplishment, professional achievement, or humanitarian service

Suzanne Liv Page, JD
Executive Director
Office of Research Administration
University of Miami

Suzanne is the Executive Director of the Office of Research at the University of Miami. She is responsible for pre-award research activities including contracts, budgets, grant applications, and billing grids at the University. She joined the University of Miami in 2007 to lead the clinical research initiation services office created to facilitate research initiation and research billing compliance. Prior to joining the University of Miami, she served as a Director at the University of Washington’s Office of Sponsored Programs.

Suzanne possesses over 22 years of experience and has served in various corporate capacities including Senior Vice President and General Counsel for Getty Images, Inc., and Platforms Business Manager for Microsoft Corporation. She also worked in private legal practice where she focused on corporate and intellectual property matters. Suzanne holds her Juris Doctor and Finance degrees from Indiana University.

Jose E. Pedomo, RN, MHSA, JD
Jose E. Perdomo, RN, MHSA, JD
Vice President
Chief Ethics and Compliance Officer
Miami Children’s Hospital

Mr. Perdomo has over twenty-five years experience in the health care field. He is currently Vice President and Chief Ethics and Compliance Officer for Miami Children’s Hospital. He oversees the Compliance, Regulatory, Internal Audit and Bioethics services. He leads the Research team that oversees and is responsible for numerous government funded, commercially sponsored, and institutionally developed research. Prior to that he served as Associate General Counsel and was Vice President for Ambulatory Services at Miami Children’s where he was responsible for the development and execution of the institutions strategic plan for ambulatory services, including the establishment of multiple ambulatory/outpatient centers throughout South Florida. During his tenure at Miami Children’s Hospital he has served as Director for Diagnostic Services, which encompassed the major diagnostic areas of the hospital and the International Program. Jose started his career at Miami Children’s as a nurse where he worked in the intensive care units, emergency departments, PACU and various pediatric units.

Mr. Perdomo obtained his juris doctor from Florida International University and his Masters in Healthcare Administration from Barry University. He is a graduate from University of Miami where he obtained his Bachelors in Nursing.

Patricia L. Price, Ph.D.
Patricia L. Price, Ph.D.
Professor of Geography, Department of Global and Sociocultural Studies

Patricia Price is a Professor of Geography in the Department of Global and Sociocultural Studies at Florida International University in Miami, Florida, USA. I am an American Council on Education Fellow, class of 2013-2014. From 2011 – 2013 I served as Faculty Fellow in the Office of the Provost at Florida International University. In this role I served as a liaison between faculty and administration, as the Chair’s Ombudsman, and on special projects at the university or state system level. Finally, I have an appointment in FIU’s Division of Research, co-chairing our Institutional Review Boards and working to improve compliance. My research interests encompass critical geographies of race and ethnicity, diversity in higher education, and Latinos/as in the US. I am currently researching a National Endowment for the Humanities-funded project on Cuban exile landscapes in Miami and how nostalgia shapes and connects places. I have authored many journal articles and four books: Dry Place (Minnesota, 2004), The Cultural Geography Reader (Routledge, 2008), The Human Mosaic, 12th edition (WH Freeman, 2012), and Contemporary Human Geography, 1st edition (WH Freeman, 2015).

Maribeth Rouseff, MBA
Maribeth Rouseff, MBA
Assistant Vice President, Employee Health Services and Wellness Advantage
Baptist Health South Florida

Maribeth Rouseff is the Assistant Vice President of Employee Health Services and Wellness Advantage for Baptist Health South Florida. Ms. Rouseff joined Baptist Health in 1986 as the Nurse Recruiter for Baptist Hospital. Over the years, she has held several different positions including corporate director of recruitment and assistant vice president. Her responsibilities included recruitment, community education, quality, ambulatory surgery, pharmacy, employee health, medical staff office and service excellence.

Ms. Rouseff also served as director of SkunkWorks –– an internal think tank that encourages employees within large organizations to use “outside-the-box” thinking to develop innovative programs. Consequently, her focal point since 2000 has been the conceptualization, implementation and management of Wellness Advantage, Baptist Health’s employee wellness program.

Wellness Advantage has been recognized repeatedly at the national level as one of the most effective programs in America. It serves more than 15,000 employees and their dependents and has brought about significant positive shifts in behavior and health metrics.

Current initiatives include research validating the effectiveness of our programs, the implementation of electronic medical records and the application of big data in our journey to improve the lives of employees, their families and the community.

Ms. Rouseff is a Miami native with a bachelor’s degree from Tulane University and an MBA from Nova University. She lives in the Redland of South Dade County and spends her spare time with her husband, Joe, and their horses.

Eve Sakran, MS
Eve Sakran, MS
Corporate Director
Jackson Health System Research Office

Eve Sakran has worked at Jackson Health System for the past 20 years. During that time she has collaborated with several governmental agencies as well as private to obtain funding and develop programs for children and adolescents in mental health. Eve has had the privilege of working with nationally recognized researchers and the Center of Treatment Research for Adolescent Drug Abuse (CTRADA) in collaborative projects and studies to implement assessment and treatment programs through NIDA grants for this population. This was an excellent learning experience as well as lesson in collaboration and effort.

Eve is the Corporate Director of the Jackson Health System (JHS) Office of Resaerch. She established the JHS Clinical Trials Office (CTO) in January 2007. The JHS was completing a Corporate Integrity Agreement (CIA) at the time. The Hospital has two operating agreements: one with the University of Miami and second with Florida International l University. In that time Eve has developed a centralized office for the health system where all research must be reviewed and approved before it may commence on any JHS site. This entails the submission of the research review by the Clinical Research Review Committee (CRRC), negotiation of the contract, Medicare Coverage Analysis, the bill hold and ultimately the bill scrub.

Eve Sakran has a Bachelors of Science from the University of Florida and Masters of Science from Nova Southeastern University.

Megan Kasimatis Singleton, J.D., MBE, CIP
Megan Kasimatis Singleton, J.D, MBE, CIP
Associate Director, IRB, Office of Regulatory Affairs
University of Pennsylvania

Megan Kasimatis Singleton is the Associate Director of the IRB at the University of Pennsylvania. In this role she is responsible for oversight and direction of the staff that support Penn’s nine IRBs, serves as a regulatory representative during the convened meetings and assists in the development and presentation of educational initiatives for IRB staff, IRB members and the research community. She also serves as the IRB liaison to the University’s Conflicts of Interest Standing Committee and the HIPAA Research Privacy Officer. Ms. Singleton is a licensed attorney in Pennsylvania and a certified IRB professional. She earned her law degree from Temple University and her Masters in Bioethics from the University of Pennsylvania.

Johanna L. Stamates, RN, MA, CCRC, CHRC
Johanna L. Stamates, RN, MA, CCRC, CHRC
Executive Director, RCQA (Research Compliance and Quality Assurance)
University of Miami

Ms. Stamates holds a master’s degree and a bachelor’s degree (hospital economics, registered nursing), and completed several certifications for the conduct of research and research compliance. She has over 30 years of combined experience in healthcare, healthcare compliance, as well as research compliance and management. Her expertise ranges from nursing, study coordination, the development and delivery of research training and seminars, research site management and research compliance, to the creation, implementation and oversight of total quality management systems, in accordance with International Organization for Standardization (ISO) 9000. Johanna Stamates currently directs the Office of Research Compliance and Quality Assurance (RCQA) at the University of Miami. This includes the oversight of human subject research compliance programs such as Quality Assurance, Clinical Trials Disclosure, Corrective and Preventive Action System and research compliance related education.
She maintains memberships with ACRP, SQA, University of Miami Bio Ethics Committee and HCCA.

Elyse, I. Summers, J.D.
Elyse I. Summers, J.D.
President & CEO
Association for the Accreditation of Human Research Protection Programs, Inc. (AAHRPP)

Elyse I. Summers joined the Association for the Accreditation of Human Research Protection Programs (AAHRPP) as President and CEO in Fall of 2013. Ms. Summers brings almost 15 years of experience in research protections, most recently as Director, Division of Education and Development, at the Office for Human Research Protections (OHRP). She has held positions with the Food and Drug Administration and Association of American Universities (AAU). As an attorney, Ms. Summers has practiced the law of tax-exempt organizations and advised clients on federal regulations and ethical issues related to conducting biomedical research and to the drug approval process.

Leonardo Tamariz, MD, PhD
Leonardo Tamariz, M.D., Ph.D.
Associate Professor of Medicine, University of Miami
IRB Chair, Chief of Staff, Miami VA Hospital

Dr.Tamariz completed his residency at the University of Miami Internal Medicine program and a clinical research fellowship at Johns Hopkins University. He is currently the IRB chairperson and a practicing hospitalist at the Miami VA hospital. His research interest are informed consent comprehension, the role of health literacy in research participation and using large databases for outcomes research. He also directs the Residency Scholarly Program at the University of Miami and satellite campus and teaches research methods courses as well as biostatistics in the public health division.

Stella Uyeno, MS
Stella Uyeno, MS
Director, Application Systems Development
Research Information Technology
University of Miami

Stella earned a BA in Sociology from UCLA, a Master’s degree in Computer Information Systems from the University of Miami, and is a certified PMP. She is currently a Director of Application Systems Development at the University of Miami, working in Research Information Technology. Since 2006 she has been involved in the management and configuration of the university’s IRB system, and currently oversees the project management and help desk functions within Research IT.

Gary D. Wimsett, Jr., J.D., LHRM
Gary D. Wimsett, Jr., J.D., LHRM
Director, Conflict of Interest Program
University of Florida

Mr. Wimsett directs the Conflict of Interest Program for the College of Medicine. He is a lecturer in Bioethics, Interdisciplinary Family Health, and the Business of Medicine. He is a member of the UF Health Shands Ethics Committee. Mr. Wimsett also serves as a member of the UF Contracting Group and the President’s Council on Diversity. On the national level, he is a member of the Steering Committee for the Forum on Conflict of Interest for the Association of American Medical Colleges and a member of the Executive Leadership group for the Association of Academic Health Centers.