FDA Symposium Biosketches
Julie Johnson, PharmD, Director of the Clinical and Translational Science Institute, Principal Investigator of the Clinical and Translational Science Award
Julie A. Johnson, PharmD, is the Dr. Samuel T. and Lois Felts Mercer Professor of Medicine and Pharmacology at The Ohio State University’s Colleges of Medicine and Pharmacy. She is the Director of Ohio State’s Clinical and Translational Science Institute, Associate Dean for Research (Medicine) and Associate Vice President for Research at Ohio State. Dr. Johnson’s research focuses on pharmacogenomics discovery and implementation and outcome documentation of precision medicine in clinical practice. She is an internationally recognized leader in clinical pharmacology, pharmacogenomics and genomic medicine, with over 340 peer reviewed original publications and over $55M in research funding as principal investigator, excluding the CTSA award.
From 2015-2018 she was named a Clarivate Analytics Highly Cited Researcher, an accomplishment of about 1 in 1000 scientists globally. Dr. Johnson has received numerous awards and honors, including election to the National Academy of Medicine and elected as fellow of the American Association for the Advancement of Science, and three other societies. She was recently appointed to the National Academies’ Forum on Drug Discovery, Development and Translation. She has received the top research award from numerous organizations. She has received teaching awards from the University of Tennessee and the University of Florida and mentoring awards from the American Society for Clinical Pharmacology and Therapeutics and the American Heart Association.
Michelle Bright, M.A., CCRP, Director Operations, Center for Clinical Research Management, The Ohio State University, College of Medicine
Ms. Bright serves as the Director of Clinical Research Operations for The Ohio State University College of Medicine Center for Clinical Research Management (CCRM), bringing nearly 25 years of extensive expertise in managing clinical research trial operations across the entire spectrum of human subject research. As a clinical exercise physiologist, Michelle has channeled her deep passion for cardiovascular health into overseeing phases I-IV clinical trials focused on cardiac and pulmonary diseases.
As Director of Operations for the CCRM, Michelle has expanded her oversight to encompass a diverse range of non-oncology medical disciplines, including fields such as dermatology, pathology, neurosurgery, and many others. Renowned for her proficiency, she is a sought-after expert in study implementation, budget development, strategies for participant recruitment and retention, adherence to research compliance and the execution of robust quality data management practices.
Michelle's leadership role has also involved directly overseeing and actively participating in 10 FDA inspections of clinical research trials, along with assisting in four additional inspections. She values the unique learning opportunities that each FDA inspection has offered, using them as steppingstones for continuous improvement in research operations. Her commitment to advancing clinical research is evident in her dedication to ensuring excellence and fostering innovation in every aspect of study management.
Angel Cinco, MD, MPH, Regulatory Specialist, Office of Regulatory Affairs (ORRA), Nationwide Children’s Hospital
Angel Cinco, MPH, MD, joined the Office of Research Regulatory Affairs in 2022 as a regulatory specialist. He manages the neuro-oncology INDs as well as many of our expanded access filings. Previously, Dr. Cinco worked at Charleston Area Medical Center as a research review specialist and then at OhioHealth as a human subjects’ protections consultant working close with the organization’s Institutional Review Board (IRB). Dr. Cinco holds bachelor’s degrees in journalism and biology from West Virginia University, a Master of Public Health degree from Walden University and a medical degree from the Gullas College of Medicine.
Subinoy Das, M.D., FACS, FARS, U.S. Institute for Advanced Sinus Care and Research
Subinoy Das, MD, FACS, is the Chief Executive Officer for the U.S. Institute for Advanced Sinus Care and Research, a Co-Founder of Zotarix, LLC and Chief Medical Officer for Soundtrace, LLC. He is the former Director of The Ohio State University Sinus and Allergy Center. In addition, he was a research associate of the Center of Microbial Pathogenesis at the Research Institute, Nationwide Children’s Hospital. He was an inaugural recipient of a KL2 award from the Ohio State Center for Clinical and Translational Science and his NIH-funded research was awarded the 2013 Edmund Prince Fowler Award (top basic science research award in otolaryngology) for his work on detecting the cause of sinus infections. His patents from this research were licensed to ENTVantage Dx, Inc.
Dr. Das was born in Atlanta, Georgia. He received his bachelor's degree at the University of Virginia and received the Edwin Pullen Full Merit Scholarship to attend the University of Virginia School of Medicine, where he was elected president of his class, received Alpha Omega Alpha Honors and received the Richard Bowman Scholarship for the top clinical performance. He attended the University of North Carolina for residency and completed a fellowship in advanced sinus/skull base surgery at the Medical College of Georgia.
He has received a Presidential Citation for his service to the American Rhinologic Society and his former company, Tivic Health, has produced the ClearUP Sinus Pain Relief system, a medical device that won Time Magazine’s 2019 Top Inventions of the Year Award.
Jessica Fritter, DHSc, MACPR, ACRP-CP, Associate Clinical Professor, College of Nursing, The Ohio State University
Jessica Fritter is an Associate Clinical Professor at The Ohio State University, College of Nursing and Director for the Master of Clinical Research, Clinical Research Management Graduate Certificate and Clinical Trials Sciences Undergraduate Certificate programs where she teaches and creates courses that are fundamental to clinical research education. She is involved in the workforce development efforts for The Ohio State’s Clinical Translational Science Institute.
Through her years in clinical research, she has overseen very robust and always evolving infrastructures and has managed multimillion dollar infrastructures and clinical trial budgets along with overseeing a core of regulatory affairs, clinical research training, compliance, business operations, clinical trial management systems, feasibility and program management. Jessica currently serves as Chapter President for the ACRP Ohio Chapter and Vice President for the Consortium of Academic Programs in Clinical Research. She has multiple publications around workforce development and clinical research operations.
April Green, MACPR, CCRC, Regulatory Program Manager, Clinical and Translational Science Institute, The Ohio State University
April Green is the Regulatory Program Manager for Ohio State’s Clinical and Translational Science Institute (CTSI). She has over 14 years of clinical research experience and holds a master’s in clinical and preclinical research (MACPR). She started her clinical research journey as a Clinical Research Coordinator in Ohio State's Cerebrovascular and Neurocritical Care Division working in both in-patient (ED, NCCU, step down) and out-patient settings. She has a special focus on research regulations and has extensive experience with managing and leading large regulatory portfolios.
April was involved in the implementation of two 21 CFR 11 compliant systems (Ohio State's Advarra eReg and Ohio State's REDCap Black electronic data capture and signature platform) and providing regulatory Master’s degree in Clinical and Preclinical Research guidance to obtain FDA IND approval for a First in Human Drug study at Ohio State. April has provided foundational research training and education to over 250 new clinical research professionals within the OSU Comprehensive Cancer Center. In her current role, she provides regulatory support across OSU’s campus, including protocol and informed consent development, navigation of regulatory submissions to the FDA, IRB and NCATS, ClinicalTrials.gov registration and results reporting, essential document development and maintenance and serves as an ex officio Program Manager for the CTSI Data Safety Monitoring Board (DSMB).
Lindsay Hanes, BS, CCRC, Clinical Research Manager, Department of Anesthesiology, Spine Research Institute, The Ohio State University
Lindsay Hanes is a Clinical Research Manager at The Ohio State University Wexner Medical Center in the Department of Anesthesiology. Her team was established through a collaborative effort between medicine and engineering, primarily working with the Spine Research Institute on device, multi-site and military investigator-initiated trials focused on spine disorders. Previously, Lindsay worked at The James Cancer Center managing industry-sponsored trials.
As an experienced clinical research professional, she oversees a team of research professionals, ensures regulatory compliance and upholds adherence to FDA and ICH GCP standards. Her expertise spans recruitment strategies, regulatory documentation and clinical trial coordination. She is also pursuing a Master of Clinical Research at The Ohio State University to continue advancing her skills and contribute to the future of clinical research.
Timothy Huerta, PhD, Chief Research Information Officer (CRIO) and Associate Dean of Research for the Wexner Medical Center and the College of Medicine at The Ohio State University
Timothy R. Huerta is the Chief Research Information Officer (CRIO) and Associate Dean of Research for the Wexner Medical Center and the College of Medicine at The Ohio State University, the Director of Biomedical Informatics for the NCATS-sponsored Clinical and Translational Science Institute (CTSI), and a professor in the Departments of Biomedical Informatics as well as the Department of Family and Community Medicine.
He co-founded the Center for the Advancement of Team Science, Analytics and Systems Thinking in Health Services Research and Implementation Science. He is focused on quantitative analytics in health services delivery. He is responsible for the research infrastructure that supports our University’s biomedical mission and includes the governance and technical infrastructure required to support research across Ohio State's seven health colleges
Carolynn Jones, DNP, MSPH, CRN-BC, FAAN, Clinical Professor, College of Nursing Director, Master of Clinical Research, College of Nursing Co-Director of Workforce Development- Clinical Translational Science Institute, The Ohio State University
Carolynn Jones is Clinical Professor and former Director of the Master of Clinical Research Program at the College of Nursing, The Ohio State University. She is also co-director of workforce development for The Ohio State University Clinical Translational Science Institute (CTSI). She has over 35 years of experience in clinical research, with a focus on clinical translational science, research management and workforce development. She is an originating member of the Joint Task Force for Clinical Research Core Competency and the CRP SIG with the Association of Clinical Translational Science. She additionally serves as the consultant Executive Director of the Mycoses Study Group Education and Research Consortium, working with global key opinion leaders on study development, epidemiology and continuing education.
Lang Li, PhD, Clinical and Translational Science Research Program Co-Lead
Dr. Lang Li, PhD, is Professor and Chair in the Department of Biomedical Informatics (DBMI) in the College of Medicine at The Ohio State University. He has developed and specialized translational research in drug interaction and personalized medicine. Using system pharmacology models, statistical methods and informatics approaches, Dr. Li’s lab translates molecular mechanisms of drug interactions and pharmacogenetics into pharmaco-epidemiology studies and vice versa. Dr. Li successfully identified loratadine/simvastatin interaction induced myopathy in mining both PubMed literature and electronic medical records. Further in vitro studies demonstrated that loratadine/simvastatin interaction induced myopathy is likely due to the direct muscle myocyte toxicity.
Recently, using large language models and literature-based text mining, Dr. Li and his lab develop several knowledge bases for clinical and translational research in phase I cancer clinical trials (DrugCombo) and pediatric/maternal (MPRINT-KP) patient populations. D. Li’s research is funded by NLM, NCI, NICHD and NCATS.
Kristy L. Ott, CCRP, CCA, Team Lead- Clinical Research Business Operations, Nationwide Children’s Hospital
Kristy is the Team Lead for Clinical Research Business Operations for Nationwide Children’s Hospital within the Clinical Research Services Department. Her Feasibility team is responsible for budgetary reviews of both new and ongoing studies, including all phases of research. The types of studies include interventional drug and device, investigator initiated, observational and retrospective studies. Her Operations team manages the Clinical Trial Management System (CTMS)-OnCore, which is utilized for research subject tracking and EPIC/financial billing reconciliation. Additionally, this team has developed and maintains Smartsheet for tracking the status of the hospital’s portfolio of clinical research studies from inception to finalization. Overall, she has over 15 years of experience at Nationwide Children’s including project management, regulatory compliance, quality assurance, Phase I FDA submissions, oncology studies and various CTMS. Prior to her time at NCH, she worked at the Ohio Department of Agriculture testing for Avian Influenza. She is a proud graduate of The Ohio State University with a degree in Molecular Genetics.
Grace Wentzel, CCRP, CHRC, Deputy Director- Operations, State of Ohio Adversity and Resilience Study (S.O.A.R.), Department of Psychiatry and Behavioral Health, The Ohio State University
Grace Wentzel is Deputy Director of SOAR (State of Ohio Adversity and Resilience) which is a comprehensive research effort to understand factors that contribute to risk and resilience at the biological, psychological and social levels to inform and guide new strategies for prevention, treatment, recovery and resilience. Prior to her current role, Grace spent 32 years at Nationwide Children’s Hospital, a large pediatric academic medical center, overseeing their centralized clinical research infrastructure. Grace is dually certified with SOCRA and HCCA and continues to be heavily focused on leadership, patient access and engagement and training and education for clinical research professionals. Grace loves to spend as much time as she can with her grandson, family and their charcoal lab at their lake house, boating, watching the sunset and reading a good book.
Jennifer Zvosec, MCR, CCRP
Jennifer received their Bachelor of Science degree in Nutrition from The Ohio State University, where they recently completed my Master's in Clinical Research with a specialization in clinical research management. Jennifer began their career at Ohio State in the Medical Information Management department, where they worked as a Medical Information Management Specialist and Medical Records Coding Specialist.
Jennifer began their clinical research career in the Clinical Trials Office (CTO) as a Clinical Research Assistant and continued my career as a Clinical Research Coordinator and Senior Clinical Research Coordinator, working primarily on chronic lymphocytic leukemia trials. Jennifer is currently the Quality Assurance Manager for the CTO, where they coordinate all sponsor audits and FDA inspections from scheduling through CAPA development and implementation.