Dr. J. Randall Curtis is the recipient of the 2023 Edward Livingston Trudeau Medal. Dr. Curtis who is a former ATS president also served as a pulmonary, critical care, and palliative care physician at Harborview Medical Center at the University of Washington. He also holds the A. Bruce Montgomery – American Lung Association Endowed Chair in Pulmonary and Critical Care Medicine and he is the founding Director of the Cambia Palliative Care Center of Excellence at UW Medicine.

Erin K. Kross, MD, is an Associate Professor of Medicine in the Division of Pulmonary, Critical Care, and Sleep Medicine at the University of Washington and Director of the Cambia Palliative Care Center of Excellence at UW Medicine in Seattle, Washington. Dr. Kross received her undergraduate degree in psychology from Wellesley College, and her medical degree from the University of Iowa College of Medicine. She completed her training in internal medicine at the University of Iowa followed by training in pulmonary and critical care medicine at the University of Washington. She joined the faculty at the University of Washington after completion of her fellowship.

Dr. Kross is a clinician, scientist, and educator. Her clinical work is at Harborview Medical Center, the safety-net hospital affiliated with UW Medicine. There, she attends in the medical and neurosciences ICUs, on inpatient pulmonary and palliative care consult services, and sees patients in a general outpatient pulmonary clinic. She directs a research program focused on improving palliative care for patients with serious illness and their families, with funding from the National Heart, Lung, and Blood Institute (NHLBI) and that National Institute on Aging (NIA). She is program director for a T32 from NHLBI focused on post-doctoral research training in palliative care and mentors many junior faculty, fellows, and trainees. She is an educator in pulmonary, critical care, and palliative care for students, residents, fellows, practicing physicians, and members of the interprofessional team.

Dr. Kross has been a member of the ATS, with primary membership in the Behavioral Sciences and Health Services Assembly, since 2007. She has served as a member of the Members in Training and Transition Committee, the Health Policy Committee, and the BSHSR Nominating Committee, and has served as chair of the BSHSR Planning Committee and Program Committee.

Zea Borok, MD is a physician-scientist and Helen M. Ranney Professor of Medicine and Chair of the Department of Medicine at the University of California San Diego. A graduate of the University of Cape Town, South Africa, she completed internship and residency at the University of Pittsburgh. She completed postdoctoral training in critical care medicine at the University of Pittsburgh and pulmonary medicine at Pulmonary Branch at the National Institutes of Health. Prior to joining UC San Diego, she was Chief of the Division of Pulmonary, Critical Care and Sleep Medicine and inaugural Director of the Hastings Center for Pulmonary Research at the University of Southern California. She also served as Director of the Fellowship Training Program in Pulmonary and Critical Care Medicine (2000-2013) and established a Center for Gender Equity in Medicine and Science (GEMS), of which she was the inaugural director.

Dr. Borok’s contributions to the American Thoracic Society (ATS) are extensive. She has held several leadership roles including Chair of the Program Committee, Chair of the Assembly on Respiratory Cell and Molecular Biology (RCMB) and Chair of the International Conference Committee. She has also served on other RCMB Assembly and ATS committees including, until recently, the Awards committee.

The focus of Dr. Borok’s laboratory is on alveolar epithelial cell biology and plasticity in the context of lung injury repair and fibrosis. Her work has contributed to paradigm shifts in the field based on early demonstrations of plasticity of alveolar epithelial type II and type I cell phenotypic transitions and epithelial-mesenchymal plasticity, which served as the basis for the now accepted, but initially controversial, notion of a central role of the alveolar epithelium in pulmonary fibrosis.

Dr. Borok directs an NIH-funded research program and has been continuously funded by the National Insititutes of Health since 1993. She received both a MERIT award (2010) and a R35 Outstanding Investigator Award (2017) from NIH. She is an elected member of the Association of American Physicians and recipient of the ATS Recognition Award for Scientific Accomplishment (2014). She has mentored many fellows and junior faculty in research and career development, and was recognized for her contributions to pulmonary, critical care and sleep medicine and as a mentor by the ATS Elizabeth Rich Award in 2017. She has served as both an ad hoc and permanent member of the Lung Injury and Repair NIH Study Section.

Dr. Sharron Crowder is a Clinical Associate Professor and Special Assistant to the Dean for Health Policy Initiatives at Indiana University School of Nursing (IUSON). She has developed innovative models for health policy education with demonstrable impact on nursing students, faculty, and clinicians, including nurses of color. Her models catalyzed many nurses’ engagement in policy work on asthma disparities, the maternal health crisis, opioid epidemic, mental health, veterans’ health, and other healthcare issues. Those models also include the influential IUSON Legislative Fellowship and Eagles Health Policy Mentoring Program. To build capacity for more nurses and other healthcare professionals to impact health policy, Dr. Crowder launched an IUSON faculty program that supports integration of health policy into teaching, research, and service.

She was selected as a 2019 Robert Wood Johnson Foundation Health Policy Fellow and assigned to the U. S. House of Representatives’ Committee on Education and Labor. She made history, in the 48 years of the fellowship, she is one of only 32 nurse fellows, and first nurse, first African American from Indiana.

Dr. Crowder has been an active member of the American Thoracic Society (ATS) since 2009 and currently serves as the co-chair of the health policy committee. Her health policy committee membership and leadership have contributed to government relations, the Executive Committee, and the organization as a whole in addressing key health policy issues and advocacy response efforts. Her leadership roles in the Nursing Assembly include current program committee chair and previously early career working group chair.

She is committed to using her expertise to broaden the array of healthcare professionals engaged in health policy roles. She is a policy resource to her university’s government relations, schools replicating her models, notable national nursing and interprofessional organizations. She is fostering faculty health policy initiatives through her leadership of the Robert Wood Johnson Health Policy Fellows Faculty Network and the Association of Black Nursing Faculty’s (ABNF) Leadership and Health Policy Mentoring Program.

Dr. Crowder’s national influence has been enhanced through presentations and publications, and recognized with major honors and awards such as induction as a Fellow in the American Academy of Nursing, highlighted by the American Association of Colleges of Nursing in contributions of Black nurses, Indiana University President’s Bicentennial Medal and ABNF’s Lifetime Achievement in Teaching Award.

Dr. Crowder’s BSN is from the University of Arkansas for Medical Sciences, MN from Emory University, and PhD from Indiana University.

Dr. Taylor-Cousar is a tenured professor of adult and pediatric pulmonary medicine at National Jewish Health, where she serves as the Medical Director of Clinical Research Services, President of the Medical Executive Committee, Co-Director of the Adult CF Program and Director of the CF Therapeutics Development Network (TDN) center. She received her undergraduate degree in Human Biology from Stanford University, and completed her doctorate in medicine, combined residency in internal medicine and pediatrics, and combined fellowship in adult and pediatric pulmonary medicine at Duke University. She obtained her Master of Clinical Science from the University of Colorado.

Dr. Taylor-Cousar is an internationally recognized clinician-investigator. Through her expertise in clinical research design and conduct, she played a pivotal role in the development and approval of the highly effective CFTR modulator therapies that are vastly improving the lives of 90% of the U.S. CF population. She continues to effectively partner with the CF TDN and industry collaborators to find a genetic cure for CF. Through her investigator-initiated research, she is co-leading the first multicenter, prospective study of pregnancy in women with CF, and is co-investigator on a CFF/NIH funded multi-center study to understand the effects of parenthood on CF health. She is an elected member of the American Society for Clinical Investigation.

Dr. Taylor-Cousar shares her clinical research knowledge on national decision-making committees including the CF TDN’s Clinical Research Executive Committee, the Emily’s Entourage Scientific Advisory Board, and on the ATS Scientific Grant Review Committee; she was recently invited to serve a term on the NIH/NHLBI Clinical Trials Review study section. She has also served on the ATS Health Policies and Respiratory Health Awards committees, and Chaired the Clinical Year in Review and Clinical Problems Programming Committees. Finally, she is the adult CF care center representative to the CFF Board of Trustees.

Dr. Taylor-Cousar is a stalwart advocate for the patient voice, a recognized leader in advancing diversity, equity inclusion and justice, and mentor for trainees and junior faculty. She is a member of the CFF’s Board and Racial Justice Working Group, the ATS Workshop on Research Priorities in Pediatric Asthma: Addressing Systemic Racism, and an advisory member for the NIH P30 Georgia CF Core Center focus on Achieving Health Equity in CF. She collaborated with patient Terry Wright to develop an online resource to prevent missed CF diagnosis, and received the ATS Patient Advisory Roundtable William J. Martin Distinguished Achievement Award.

Dr. Ferrante is an Assistant Professor of Medicine in the Section of Pulmonary, Critical Care, and Sleep Medicine at the Yale School of Medicine and Director of the Operations Core at the Yale Claude D. Pepper Older Americans Independence Center. Her research program is centered at the interface of critical care medicine and geriatrics, with the overarching goal of understanding and improving the functional outcomes of critically ill older adults. Dr. Ferrante is currently funded by a Paul B. Beeson Emerging Leaders in Aging Career Development Award and an upcoming R01, the LANTERN study, both from the National Institute on Aging. Her work has been recognized most recently with the American Thoracic Society (ATS) Critical Care Early Career Achievement Award (2022) and the AGS Outstanding Junior Investigator of the Year Award (2021). Dr. Ferrante co-chairs the Aging in Critical Care Interest Group of the American Thoracic Society and the Medical & Surgical Specialties Section of the American Geriatrics Society. Clinically, she is an attending physician in the Medical Intensive Care Unit (MICU) at Yale-New Haven Hospital and cares for patients with persistent symptoms after COVID-19 infection in the Yale Post-COVID Recovery Program.

Dr. Ferrante trained in internal medicine at Columbia University Medical Center in New York City before moving to Yale for postdoctoral fellowship. At Yale, she concurrently completed a clinical fellowship in Pulmonary & Critical Care Medicine, a research fellowship in Geriatric Clinical Epidemiology, and a Master of Health Science degree before joining the Yale faculty.

Chris Garvey FNP, MSN, MPA, MAACVPR is a nurse practitioner who leads the ATS Pulmonary Rehabilitation (PR) Reimbursement working group which is charged with addressing access to PR as well as PR awareness and payment inequities. The working group membership includes all major US pulmonary societies and patient organizations. Their efforts include developing a comprehensive open access US PR database of over 1700 PR programs and an annual multi-society social media campaign to foster awareness and amplify the rationale for PR as a priority given it’s significant effectiveness and cost savings in persons with lung disease. Members of the working group recently averted a dramatic reduction in Medicare payment for Outpatient Respiratory Services needed by many patients receiving PR services.

Ms. Garvey’s contributions to clinical care and scholarly publication have focused on exercise prescription, hypoxemia, oxygen use, PR in interstitial lung disease and virtual PR. Her contribution to research include virtual PR and ambulatory ventilation. She helped lead the development and implementation of the American Association of Cardiovascular and Pulmonary Rehabilitation (AACVPR) national PR registry and recent update of the Pulmonary Rehabilitation Reimbursement Toolkit, and co-authored the AACVPR PR outcome resource guide. Chris has authored numerous guidelines, manuscripts and chapters. 

Chris is a former co-chair of the ATS PR Section which preceded the PR Assembly, and chaired the PR section’s Program Committee. She is currently a member of the ATS PR Assembly Executive Committee and PR Planning Committee, and a former member of the ATS PR Nominating Committee.

She is a recipient of the ATS PR Assembly Recognition Award, AACVPR Kent Smith National Award for Excellence and Presidential Award, and past president of the California Thoracic Society. Her clinical background includes PR and sleep disorders most recently at University of California San Francisco. She has twice received the Research Fellowship Award from the American Respiratory Care Foundation.

Chris received a Masters of Science in Nursing as a Family Nurse Practitioner from Holy Name University and a Masters in Public Administration from University of San Francisco. She has an honorary Masters from AACVPR.

Obianuju (Uju) Ozoh is an Associate Professor of Medicine at the College of Medicine of the University of Lagos and the Head of the Respiratory Unit at the Lagos University Teaching Hospital, Lagos Nigeria. She is the Editor in Chief of the Journal of the Pan African Thoracic Society. Dr. Ozoh thrives in her endeavor to improve lung health and utilizes her extensive educational background to mentor others to do so as well. She obtained her Medical Degree from the University of Nigeria Nsukka, completing a residency in Internal medicine and a fellowship in Pulmonology from the National Postgraduate Medical College of Nigeria. She had further clinical training at the Tygerberg Academic Hospital in Cape Town South Africa, a Clinical Observership at Mount Sinai Hospital in New York, and obtained her MSc in Global Health from Liverpool School of Tropical Medicine in Liverpool, United Kingdom.

Her research interests are in non-communicable respiratory diseases including the health impacts of air pollution. Dr. Ozoh led the first national surveys on asthma prevalence and asthma management and the availability and affordability of asthma and COPD medicines in Nigeria. She has used task shifting to implement and scale a structured asthma educational program and is currently working with other researchers to develop a chronic respiratory disease observatory for Africa. This observatory aims to compile comprehensive and reliable data on the burden of asthma and COPD in Africa.

Dr. Ozoh makes it her mission to mentor and build research capacities in her region with her involvement as Co-Director for the PATS MECOR program, and an executive member of the Pan African Thoracic Society and the Nigerian Thoracic Society. She tirelessly conducts community-based events in her country to improve the quality of healthcare services delivered to those with respiratory diseases. Recent events include workshop for health professionals to increase care for TB survivors, road shows for asthma awareness, free spirometry testing events, workshops on asthma for students and school nurses, fitness classes for the elderly and a “Healthy Lung for Life” event to raise awareness of the harmful health impacts of traffic pollution.

Dr. Obianuju B. Ozoh, is a passionate clinician, highly proficient researcher, a mentor to those in her region and beyond, a superb educator, and an unremitting advocate for people disproportionally affected by health disparities.

Dr. Burns graduated from medical school (University of Western Ontario) in London, Canada where she pursued training in Internal Medicine, and Pulmonary and Critical Care Medicine. She completed a fellowship in lung transplantation (University of Pittsburgh, USA) and subsequently a Master’s Degree in Clinical Epidemiology (McMaster University, Canada).

Dr. Burns is a pulmonologist, intensivist, and epidemiologist. She practices critical care medicine at Unity Health Toronto - St. Michael’s Hospital in Toronto, Canada. She is a Professor of Medicine and Clinician Scientist at the University of Toronto. She holds a Scientist appointment with the Li Ka Shing Knowledge Institute (Toronto, Canada) and part-time faculty in the Department of Research Methods, Evidence, and Impact at McMaster University. Her research program focuses on characterizing practice variation in liberating critically ill adults from invasive ventilation and evaluating mechanical ventilation support strategies. As a clinician scientist and clinical researcher, she utilizes various research methodologies (national and international surveys, large-scale observational studies, systematic reviews and meta-analyses, and randomized trials) to address important research questions within her program of research. Most studies within her research program have been conducted under the auspices of the Canadian Critical Care Trials Group (CCCTG). She is the past Chair of the Women in Critical Care interest group of the American Thoracic Society, a member of the Executive of the CCCTG, and current President of the Canadian Critical Care Society.

Joseph P. Mizgerd, ScD, ATSF, is the Jerome S. Brody, MD, Professor of Pulmonary Medicine and Director of the Pulmonary Center at the Boston University (BU) Chobanian & Avedisian School of Medicine. He received his BA in Biology from Amherst College, and then completed research training and served on the faculty at the Harvard School of Public Health. His doctoral studies of lung phagocytes were mentored by Dr. Joseph D. Brain, and his postdoctoral fellowship studying neutrophil recruitment was mentored by Dr. Claire M. Doerschuk. Motivating and training lung scientists is a major mission. In addition to being an active research mentor, he has been MPI of an NHLBI-funded T32 training program in lung biology, for MD and PhD postdoctoral and predoctoral researchers, since 2010. Dr. Mizgerd’s research is funded by the NHLBI and NIAID, including an Outstanding Investigator Award from the NHLBI. His research program focuses on lung immunology and respiratory infection with broad goals of elucidating pathways that determine pneumonia susceptibility and outcome. He began his career as principal investigator with investigations of the transcriptional and post-transcriptional regulation of immune responses to lung infection, helping to delineate mechanisms of immune resistance (eliminating microbes) and tissue resilience (bolstering the organ) that together protect an infected lung. More recent findings emphasize how recovery from respiratory infections, which everyone experiences, changes the immune system localized within the lung, including resident memory lymphocytes and trained innate immunity. A newer and growing ambition is to define sub-phenotypes of pneumonia involving disparate pulmonary pathophysiologies resulting from distinct and potentially targetable host responses.

Dr. Ana Mora is Professor at the Division of Pulmonary, Critical Care and Sleep Medicine at the Ohio State University and Director for Pulmonary Research of the Davis Heart Lung Research Institute. She was born in Colombia and received her MD and Immunology training at the Universidad Nacional de Colombia in Bogotá. She did postdoctoral training at Vanderbilt University and moved in 2002 as independent investigator to Emory University. In 2010, she joined the Division of Pulmonary at the University of Pittsburgh, where she was member of the Vascular Medicine Institute and Director of Education of the Aging Institute.

For more than two decades, Ana’s work has largely focused on the pathogenic mechanisms of lung fibrosis. Her early work at Emory University established a novel model of virus induced lung fibrosis, that helped to define the critical role of subtypes of macrophages in fibrotic responses. In addition, Ana is one of the pioneers of the study the molecular aspects of the aging lung and the pathogenesis of age-related lung diseases, such as IPF. Her work has shown novel aspects of the aging lung including the susceptibility of lung epithelial cells to ER stress, and the elucidation of the critical role of mitochondrial homeostasis in the vulnerability to lung injury and activation of fibrotic responses. She has received awards by the American Association of Immunologists, the Pulmonary Fibrosis Foundation, and by the Helmholtz Zentrum München in Germany. She has been member of ATS RCMB assembly since 2002, and in 2012 participated as a founding member of the RCBM Aging Group. She has been member of the RCMB Program Committee, elected member for the RCMB Nominating Committee, and currently is the elected chair of the Program Committee for RCMB. She serves as a member of the Editorial Board of the American Journal of Respiratory Cell and Molecular Biology.

Ana has published 100 peer review journal articles, and reviews, in addition of several chapter books. She has been an ad hoc reviewer of several NIH study sections and is permanent member of the Lung Injury Repair and Remodeling (LIRR) study section. She has received support for her research from ALA, AHA, and by NIH.

Dr. Xin Sun, PhD is a Professor of Pediatrics and Professor of Cell and Developmental Biology at University of California, San Diego. A graduate of Fudan University in China, she obtained her doctoral degree at Yale University and completed postdoctoral training at UC, San Francisco. Prior to joining UC San Diego, she was Professor of Genetics at University of Wisconsin-Madison (2002-2016). She served as co-Director (2011-2014) of the Cold Spring Harbor Mouse Development, Stem Cells and Cancer summer course, a flagship course on using mouse as a model organism.

Dr. Sun and her team are recognized for their original, rigorous and paradigm-shifting studies in a wide spectrum of subjects, including lung development, stem cells, injury repair, lung-nervous system interactions, and mechanisms of pediatric and adult lung diseases. Over the years, her work cemented our understanding of the role of a wide spectrum of factors in processes from lung initiation to maturation. Knowledge gained was instrumental in guiding the successful differentiation of iPSCs into lung cell types, as well as the understanding of how prematurity leads to bronchopulmonary dysplasia. Using CRISPR/Cas9 to model human disease variants in mice, she and her team delineated diverse mechanisms underlying multiple lung-associated congenital disorders. She led the in vivo demonstration that pulmonary neuroendocrine cells are critical sensors in lung. Despite their rarity, they are essential for amplifying allergen induced asthmatic responses, and modulate endothelium barrier and excess fluid in lung. Since pulmonary neuroendocrine cells are a frequent target for nerve innervation in lung, her team is pushing the boundary of lung biology into lung interoception, the discipline of how the lung sends signals to the nervous system and how the nervous system controls lung function.

Dr. Sun leads a research team within the NIH LungMAP and HuBMAP consortia that generates open-source single cell transcriptome and epigenomic datasets for the field. She co-led the construction of Lung CellCards, an annotated resource for the study of lung cell types (LungMAP.net/Cell-Cards). She is an instigator of the cross-consortium and community-wide effort to harmonize lung cell type signature and nomenclature. She was the recipient of the Donald Y. M. Leung AAAAI-JACI investigator award (2017). She has served on the ATS RCMB programming committee and lectured in multiple postgraduate courses. She served as regular member of the NIH Lung Injury Repair and Remodeling study section. She is the co-Chair of the upcoming Lung Gordon Research Conference (August 2023).

Dr. Rosen is a professor emerita at Case Western Reserve University (CWRU) School of Medicine since July 2020. She is board certified in Pediatrics, Pediatric Pulmonology, and Sleep Medicine and serves on the American Academy of Sleep Medicine’s Board of Directors. She also consults on two NIH projects: the “wrap-up” of the PATS randomized control trial assessing health outcomes after adenotonsillectomy in snoring children and a new study looking at sleep disparities in adolescent fatigue and functioning.

She attended medical school at the University of Illinois in Chicago, did pediatric residency training at Washington University (St. Louis Children’s Hospital) and Baylor College of Medicine (Texas Children’s Hospital) in Houston, Texas, then did pediatric pulmonary fellowship training at Baylor College of Medicine in Houston Texas with additional mid-career research training at Columbia College of Physicians and Surgeons in New York City.

She has been a member of the pediatric pulmonary faculties at Baylor College of Medicine, Yale University School of Medicine, and CWRU School of Medicine (20+ years), working with numerous pediatric pulmonary and sleep medicine trainees over those years.

Her clinical and research interests include diagnostic testing strategies for sleep-disordered breathing in children and adults, best practices for the management of sleep apnea in children, sleep-disordered breathing in sickle cell anemia, pediatric insomnia, pediatric narcolepsy, sleepiness/fatigue in children and teens, sleep health in children, and the impact of pediatric sleep disorders on health outcomes. She is a popular invited speaker at professional educational activities and a public spokesperson on various sleep health topics.

Ramon Farré (RF), PhD in Physics, is a Full Professor of Physiology at the Biophysics and Bioengineering Unit of the Faculty of Medicine and Health Sciences of the University of Barcelona (UB), and a Fellow of the ATS and of the ERS. He has had different managing positions at the Department, School, and University levels, and is now the Head of Studies of the Degree in Biomedical Engineering. He has coordinated research at different national institutions and has been an officer in research Groups of the European Respiratory Society and was a member of the committee of strategic planning of the Assembly “Sleep and Respiratory Neurobiology” of the ATS. He was an Associate Editor of the European Respiratory Journal, a member of the Strategic Committee of Education of EIT Health (European Institute of Innovation and Technology), and the Director of Education of its Spanish node. RF’s research is aimed at deepening our understanding of the mechanical behavior of the respiratory system to improve the diagnosis and treatment of respiratory diseases. He uses a multiscale perspective and a translational approach in a multidisciplinary framework involving close cooperation with respiratory clinical research groups. At the organ level, he studies the mechanical properties of the respiratory tract and lung tissues and the alterations in mechanical function associated with respiratory diseases. At the cellular level, he focuses his research on analyzing how the biomechanics of the cellular microenvironment modulates the cell-matrix crosstalk in respiratory diseases. Innovation and translation are essential activities in the career of RF. He has signed contracts with different companies for evaluating and improving devices for the diagnosis and treatment of respiratory diseases. Currently, RF is most focused on the design and publication of open-source, low-cost medical devices for facilitating technology transfer to low- and middle-income regions.

Dr. Kevin Gibson is currently Professor Medicine, Clinical and translational Science at the University of Pittsburgh, School of Medicine, and Medical Director of the Dorothy P. and Richard P. Simmons Center for Interstitial Lung Disease. Dr. Gibson completed his medical degree Rutgers Medical School, medical Residency at Emory University Affiliated Hospitals, and pulmonary and critical care fellowship at the University of Pittsburgh. He joined the faculty in the school of Medicine in 1987 with a joint appointment in cell biology and physiology after receiving a NHLBI physician scientist award in 1987. After a almost a decade as a physician scientist, his focused turned to more clinical research activities. In 2002 he was a co-founder of the Dorothy P. and Richard P. Simmons Center for Interstitial Lung disease along with Naftali Kaminski and Kathy Lindell, which over the next decade grew to become one the largest centers for ILD in the US. Dr. Gibson has received numerous awards for his accomplishments. He received the University’s of Pittsburgh Innovator Award for two licensed patents for biomarkers in ILD. He has received teaching awards for training of fellows from our fellowship program. He has received funding for research in IPF and sarcoidosis and has served on a number of NIH study sections for NHLBI and department of Defense. In addition, he has co-authored more than 100 manuscripts. He has served as principle investigator in more the 20 clinical trials in IPF and sarcoidosis. His current interests focus on clinical and translational trials in IPF and sarcoidosis, and in advancing novel therapies for these diseases through participation in clinical trials.