Emily Baldwin
Certified Investigator, Specialist
Office of Bioresearch Monitoring Inspectorate (OBMI)
Office of Inspections and Investigations (OII)
Food and Drug Administration (FDA)
Emily Baldwin is a Bioresearch Monitoring Specialist as a Certified Investigator for the Office of Bioresearch Monitoring Inspectorate (OBMI) within the Office of Inspections and Investigations (OII) in the Food and Drug Administration (FDA). Throughout her FDA career, she has conducted domestic and international inspections to ensure human subject protection, and that data are reliable.
Shiowjen Lee, PhD
Deputy Director, Division of Biostatistics Office of Biostatistics & Pharmacovigilance Center for Biologics Evaluation and Research
US Food & Drug Administration
Shiowjen Lee, PhD, is currently Deputy Director of the Division of Biostatistics, Office of Biostatistics and Pharmacovigilance, Center for Biologics Evaluation and Research (CBER), FDA. She joined CBER as a statistical reviewer in 2008 and became Team Lead of the Cell, Tissue and Gene Therapy team in 2012. Within these various roles, Dr. Lee led and closely involved in the approval of several innovative and high-profile gene/cellular therapy products. She has been active in working groups of several topics and guidance/policy development such as surrogate endpoint, biomarker, and real-world data/real-world evidence and, importantly, advising and helping with the professional development of Division staff. Prior to joining CBER, Dr. Lee worked as a statistical reviewer in Center for Drugs Evaluation and Research’s Office of Biostatistics and in Center for Devices and Radiological Health’s Division of Biostatistics. Dr. Lee has received numerous awards at the Center and FDA levels including the Outstanding Service award, the Team Excellence award, the Managerial Excellence award, and others. She holds a PhD in Statistics from the University of South Carolina.
Sujatha Sridhar, MBBS, MCE
Associate Vice President, Research Compliance
UT Health, Houston
Sujatha Sridhar, Associate Vice President for Research Compliance at the University of Texas Health Science Center at Houston, brings over 30 years of expertise in clinical research administration and human subjects protection. She oversees key compliance areas, including the Institutional Review Board, Institutional Animal Care and Use Committee, Stem Cell Research Oversight, and Conflict of Interest. Her responsibilities also encompass providing regulatory support for clinical trials, managing IND/IDEs, clinicaltrials.gov registration, coordinating research misconduct programs, and facilitating responsible conduct of research training. Sridhar is the co-lead of the CTSA workforce development core, a member of the Texas Medical Center Clinical Research Education committee and serves as a site visitor for the Association for Accreditation of Human Research Protection Programs.
Shari Messinger, M.E., Ph.D.
Professor and Director, Division of Biostatistics and Bioinformatics
Director, Biostatistics Collaboration and Consulting Core
Department of Public Health Sciences
University of Miami Miller School of Medicine
Shari Messinger, tenured Professor and Director of the Division of Biostatistics and Bioinformatics, Department Public Health Sciences of the Miller School of Medicine, and Director of the University of Miami Biostatistics Collaboration and Consulting Core (BCCC). DR. Messinger serves as Director of the Biostatistics, Epidemiology and Research Design Program of the Miami Clinical and Translational Sciences Institute (CTSI.) She has extensive knowledge and experience in application of appropriate statistical methodologies and is responsible for overseeing the biostatistics support for bench to bedside translation in her role as Director of the BCCC where she leads all collaboration and consulting activities provided by MS and PhD level BCCC staff statisticians. She teaches graduate courses and advises MS and Ph.D. students in Biostatistics. She has extensive knowledge and experience in the development, application, and education of appropriate statistical methodology for the analysis of clinical and translational investigations at every stage of research.
Jennifer McCafferty-Fernandez, PhD
Managing Partner
Critical Path Advisors, LLC
Dr. McCafferty-Fernandez is the Managing Partner for Critical Path Advisors, LLC, a boutique healthcare consulting firm offering tailored strategic consulting services aimed at guiding healthcare organizations through complex challenges and opportunities. They collaborate closely with their clients on the development of robust strategic plans that align with their mission and vision including short- and long-range strategic planning, organizational development, board governance, brand strategy and public relations. They also draw on more than twenty years of experience navigating regulatory requirements and ethical considerations in healthcare including comprehensive health care, privacy and research compliance program development and evaluation.
Before launching Critical Path Advisors, Dr. McCafferty-Fernandez spent 10 years at Nicklaus Children’s Health System where she last served as the Senior Vice President and Chief of Staff at Nicklaus Children’s Health System, overseeing marketing and communications, government and community affairs, corporate governance and board support services as well as the patient and consumer experience activities for the System. Prior to Nicklaus, she was assistant provost and chief medical compliance & HIPAA privacy officer, among other roles, at the University of Miami and the Miller School of Medicine. She received Ph.D. in molecular and cellular pharmacology from the University of Miami, completed post-doctoral training at the Sylvester Comprehensive Cancer Center, and bachelor’s degree in chemistry from Maryville College. Proud mama of 4 amazing children and blessed to share her life with husband, Rudy Fernandez. In free time, Dr. McCafferty-Fernandez participates in community organizations like the South Florida YMCA, Live Like Bella Pediatric Cancer Foundation, and the United Way. Avid reader, love to bake and enjoys all the fantastic outdoor things that South Florida has to offer – especially college and professional sports (Go Canes, Heat, Dolphins, Marlins, Panthers, InterMiami, and her hometown Reds and Bengals)!
Kenneth W. Goodman, PhD, FACMI, FACE
Director, Institute for Bioethics and Health Policy
Director, University of Miami Ethics Programs
Kenneth W. Goodman, Ph.D., FACMI, is founder and director of the University of Miami Miller School of Medicine’s Institute for Bioethics and Health Policy and its World Health Organization Collaborating Center in Ethics and Global Health Policy. He is a Professor of Medicine with appointments in the Department of Philosophy and others. He directs the Florida Bioethics Network and is responsible for ethics services for University of Miami Hospital, the UM Hospital and Clinics and the Jackson Health System. His research has emphasized issues in health information technology, including the use of computers in clinical care, research and public health. He has served on several institutional review boards, conflict-of-interest committees and research ethics review panels.
Laura Kozma
Associate Vice President
Office of Research Administration
University of Miami
Laura Kozma, Associate Vice President for the Office of Research Administration, joined the University in September 2020. She provides leadership for sponsored administration which includes proposal review, processing, contract negotiations, award funding, expenditure, and compliance monitoring, and serves as audit liaison for the Institution for sponsored awards. In this same capacity, she is also responsible for sponsored cash management, university-wide reporting, and regulatory education and training programs. In addition, Ms. Kozma leads the facilities and administrative (indirect cost) rate calculation and negotiations and is responsible for the financial review and set-up of recharge centers.
Previously Laura served as the Executive Director of Sponsored Program Services and Faculty Services at the University of Connecticut overseeing the office responsible for all sponsored awards under the Office of the Vice President for Research including the development of a new shared service department to improve and enhance administrative support for faculty related to sponsored awards. Prior to the University of Connecticut, Laura spent over ten years at Yale University in several roles including serving at the Assistant Director in the office of Grant and Contract Administration. Laura graduated cum laude from the University of Connecticut and obtained her Master of Arts degree from Southern Connecticut State University. Laura has been active in both NCURA and SRA, is a member of the Federal Demonstration Partnership (FDP) and serves as UM’s lead representative on the Council on Governmental Relations (COGR).
Nicole S. McCullough, MS, CCRP
Director, Regulatory Support
Investigator Initiated Trial Services at the U (IITS-U)
Office of the Executive Dean for Research
University of Miami Miller School of Medicine
Nicole McCullough is currently the Director of the Investigator Initiated Trial Services unit at the University of Miami Miller School of Medicine. The unit provides support to University of Miami investigator-initiated clinical trials conducted under an IND or IDE for FDA submissions, monitoring, safety management, data management and project management.
Prior to re-joining the University of Miami in May 2022, Nicole worked at Nicklaus Children’s Health System where in her final three years she served as the Director of the Research Institute.
Nicole has 24 years of research experience in the following areas: clinical research (protocol writing, operations/ coordination, regulatory, monitoring and compliance), laboratory research, and grants management (applications/pre-award and post-award financial management).
Nicole earned a BS in Microbiology and a Master of Science in Molecular Biology from Louisiana State University. She has been a Certified Clinical Research Professional since 2005.
Dr. Leigh Nattkemper, PhD
Associate Professor
Director of Clinical Trials
Dr. Phillip Frost Department of Dermatology & Cutaneous Surgery
Miami Itch Center
University of Miami
Dr. Leigh Nattkemper is a Research Associate Professor and Director of Clinical Trials at the University of Miami Dr. Phillip Frost Department of Dermatology and Cutaneous Surgery. She received her bachelor’s degree in microbiology and master’s degree in molecular medicine from the University of South Florida, then her Ph.D. in Neuroscience from Temple University. Her current research focus is to better understand the pathobiology of chronic pruritus, and to develop and test targeted treatments that will be effective for a wide array of diseases that suffer from chronic itch.
Philip A. Arlen, PhD
Executive Director, Clinical Research Services Sylvester Comprehensive Cancer Center
University of Miami
Dr. Arlen is Executive Director of Clinical Research Services at the University of Miami Sylvester Comprehensive Cancer Center, the only NCI-designated cancer center in South Florida. The Sylvester CRS supports interventional and non-interventional research studies, with a current portfolio of more than 300 open protocols and 3,000 research participants.
Prior to joining the University of Miami, Dr. Arlen managed strategic alliances and partnerships on behalf of the Conrad Prebys Center for Chemical Genomics, the premier academic drug discovery program housed at Sanford Burnham Prebys Medical Discovery Institute. He then joined Diverse Biotech, Inc., an early-stage biotechnology company, where he headed R&D and led therapeutic development efforts.
Dr. Arlen earned a BS in Biology from Cornell University and PhD in Microbiology, Immunology, and Molecular Genetics from the University of California, Los Angeles. His graduate research in HIV pathogenesis led to important discoveries in viral latency and therapeutic efficacy. After a post-doctoral fellowship in chloroplast transformation for the production of vaccines and pharmaceutical agents, he joined the MD Anderson Cancer Center as an assistant professor. There, he directed the Early-Stage Interventions Laboratory, which studied the relationship between cancer and the immune system, with specific areas of focus in cancer vaccines, tumor biomarkers, and immunodiagnostics. That research led to his first spin-out, Pandora Genomics, which developed novel strategies and tools for predicting treatment responses.
Kenia Viamonte, MA
Director, Human Subject Research
University of Miami
Kenia Viamonte is the Director for the Human Subject Research Office (HSRO) and oversees the review of human subject research studies, the regulatory team that conducts HSR reviews, the five Institutional Review Boards (IRBs), and several compliance initiatives. She started at the University in 2002 at Medical Human Resources, where she was the recruiter for temporary staffing, and joined HSRO in 2005. She is well versed in the areas of IRB Operations, Research Compliance, Personnel Matters, Conflict Resolution, and Project Management. Kenia is the accreditation contact for the University through the Association for the Accreditation of Human Research Protection Programs (AAHRPP). She earned her Undergraduate and Graduate degrees from the University.
Guillermo (Willy) Prado, PhD
Executive Vice President for Academic Affairs & Provost
University of Miami
Guillermo (Willy) Prado is the University of Miami's chief academic officer, serving as interim provost and executive vice president for academic affairs. Prado is professor of Nursing and Health Studies, Public Health Sciences, and Psychology at the University of Miami. He is a pioneer in health disparities and behavioral interventions for the prevention of substance use, sexual risk behaviors, and depressive symptoms in Hispanic families. He has received approximately $30 million of continuous NIH and CDC funding since his doctoral studies as PI and over $100 million as Co-I, mentor, or collaborator. His research has led to over 200 peer-reviewed articles and chapters. For significantly advancing knowledge in the behavioral interventions, health disparities, and adolescent health literature, he has received numerous awards and honors, including the Lifetime Achievement Award from the National Hispanic Science Network; the Community, Culture, and Prevention Science Award from the Society for Prevention Research; and election to the prestigious National Academy of Medicine. His research has been featured in multiple media outlets including the Miami Herald, NBC, Univision, and CNN en Español. He has also been invited to serve as a witness to the U.S. House Select Committee on Economic Disparities and Fairness in Growth to speak about prevention science and health disparities.
Stephen D. Nimer, MD
Professor of Medicine, Biochemistry and Molecular Biology
Director, Sylvester Comprehensive Cancer Center
Executive Dean for Research, Miller School of Medicine
Professor of Chemical, Environmental & Materials Engineering
Stephen D. Nimer, M.D., is the director of the National Cancer Institute (NCI)-designated Sylvester Comprehensive Cancer Center. He is also the executive dean for research and a professor of medicine, biochemistry and molecular biology at the University of Miami Miller School of Medicine. Dr. Nimer's career spans more than 30 years in clinical care, research, administration and leadership.
Before joining the Miller School of Medicine in 2012, Dr. Nimer held several positions at Memorial Sloan-Kettering Cancer Center for almost 20 years. There, he served as the Alfred P. Sloan Chair in Cancer Research, head of the division of hematologic oncology, vice chairman for faculty development and chief of the Hematology Service. Under Dr. Nimer's leadership, Sylvester Comprehensive Cancer Center, which serves more than six million people in its catchment area and sits at the “gateway” to the Caribbean and Latin America, became an NCI-designated center in July 2019. It is the only NCI-designated cancer center in South Florida and the second youngest among all NCI-designated cancer centers. In 2022, U.S. News & World Report recognized Sylvester as a top-ranked cancer hospital in the nation. As a member of the University of Miami and the American Society of Hematology task forces that aim to address health disparities in different cultures, Dr. Nimer underscores the value of Sylvester, which offers a vastly multiethnic patient base — a veritable microcosm of what U.S. demographics are projected to be in 50+ years.
Dr. Nimer leads Sylvester’s research and experience with diverse community partnerships to create model approaches that address challenges and generate opportunities—all to prepare the cancer center for the future. Dr. Nimer shares this unique perspective through his service on external advisory boards for several NCI-designated cancer centers. Through key engagements and on-site advocacy, Dr. Nimer ensures cancer research remains at the forefront of efforts at the state and federal levels in contributing to meaningful cancer-related policies, innovative community care models and funding priorities. Since 2018 he has been a member of the Association of American Cancer Institutes, Nominating Committee and in 2020, he became a member of the Science Policy and Government Affairs Committee (SPGAC) of the American Association for Cancer Research.
Throughout his career, Dr. Nimer has cared for patients with myelodysplastic syndromes (MDS), acute myelogenous leukemia (AML), multiple myeloma and lymphoma and has decades of service to non-profits in their efforts to advance patient science and clinical care. He has chaired foundations including the MDS Foundation, the Leukemia & Lymphoma Society and the AAMDSIF. Moreover, he is the chairman of the Gabrielle’s Angel Foundation and Myelodysplastic Syndromes Foundation (MDSF), two organizations that award funding for early and senior career investigators, where Dr. Nimer performs oversight including grant reviews and convening board meetings.
Outside of his committee and foundation duties, Dr. Nimer has been continuously funded by the NIH for three decades and has served as PI on Leukemia and Lymphoma Society multi-project Specialized Center of Research awards. In his lab, Dr. Nimer focuses on understanding the genes involved in the development and progression of MDS and AML to identify novel therapeutic approaches to make hematologic cancers more responsive to treatment. Dr. Nimer holds two patents for the treatment of leukemia.
A physician-scientist in the field of hematology-oncology and cancer research, Dr. Nimer has authored more than 300 scientific publications and holds numerous awards including the Oscar de La Renta Endowed Chair in Cancer Research, the Irma T. Hirschl Career Scientist Award and he received the E. Donnall Thomas Award in 2015 from the Bone Marrow Foundation. In April 2021, the Academy of Science, Engineering and Medicine of Florida inducted Dr. Nimer to recognize his outstanding contributions to the scientific community. Similarly, the American Society of Clinical Investigators and the Association of American Physicians elected him to highlight his influential role in shaping the field of oncology. Dr. Nimer is also a Fellow of the American College of Physicians, further demonstrating his dedication to patient care and clinical excellence.
Maria Luisa Alcaide, MD
Vice Provost for Research and Scholarship
Professor of Medicine, Infectious Diseases
University of Miami
Dr. Maria Alcaide is the Vice Provost for Research and Scholarship at the University of Miami. Dr. Alcaide is an Infectious Diseases physician scientist, Professor of Medicine, OB/GYN, and Public Health Sciences at the University of Miami Miller School of Medicine. Through these roles, she provides guidance and recommendations on the conduction and strategic plan for research at the Miller School of Medicine, and scientific and administrative oversight to multiple multidisciplinary research studies focused on HIV and other emerging infections.
Dr. Alcaide received her medical degree at the Universidad Autonoma de Madrid and completed her residency in internal medicine and fellowship in Infectious Diseases at the University of Miami/Jackson Memorial Hospital in 2007. Dr. Alcaide has been continuously funded by NIH since 2009 and is among the top funded investigators at the University of Miami. She conducts large NIH funded multidisciplinary clinical and epidemiological studies in infectious diseases the US and international settings.
Karrelyn Gindy Wetherington
Sr. Clinical Trial Disclosure (CTD) Associate
Karre Wetherington is a Sr. Clinical Trial Disclosure Associate in the Regulatory Affairs and Assessment (RAA) within the Office of Vice Provost of Research and Scholarship (OVPRS) at the University of Miami. She has over 20 years of experience in sponsored research with pre and post-award administration as well as all facets of clinical research roles in clinical research coordination, Lead Clinical Research Associate for Children’s Oncology Group (COG), project management for contract research organizations, quality assurance, regulatory affairs, Medicare coverage analysis (MCA) and clinical research billing compliance, contract and clinical trial budget negotiation, and clinical trials disclosure. She graduated from the University of Florida in 1997 with a Bachelor of Health Science (BHS) degree. In addition, she maintains memberships with the Clinical Trial Registration and Result Reporting National Taskforce and SOCRA. She hopes to use her experience and knowledge to contribute to the success of clinical research as well as support the success of her team at 2RISE.
