Research Committee

Nikolay Delev has been serving as an Executive Medical Director, Immunology Clinical Development Team Lead at Bristol Myers Squibb (BMS) since 2020. He is overseeing the global development strategy and execution of programs across the BMS early to late-stage rheumatology portfolio. He is leading a team across US and EU, focusing on broad spectrum of autoimmune and inflammatory conditions such as lupus, arthritis, Sjogren’s and scleroderma, among others. His team is actively engaged in the development of novel treatment modalities, such as targeted small molecules, biologics and gene/cell therapies. He also sits on the BMS site leadership team, based in Boudry, Switzerland. Prior to BMS, Nikolay held several roles of increasing responsibility at Parexel, Novartis and Celgene. He was closely involved in the development and approval of Cosentyx, Otezla and Sotyktu brands, along with several business development deals. Nikolay volunteered for over 10 years as a clinician-rheumatologist at Overlook Medical Center in New Jersey and is passionate about applying many novel treatment modalities he developed as a researcher in rheumatology practice and patients globally. Nikolay received his M.D. degree from Sofia Medical School in Bulgaria, and completed Internal Medicine and Rheumatology Fellowship training at Johns Hopkins University in Baltimore, USA. He is well versed in the US healthcare system, and his in-depth experience and expertise are in autoimmune diseases, clinical research and global drug development, international corporate and business relations.

Gary Koretzky, M.D., Ph.D. obtained his M.D. and Ph.D. (Immunology) degrees at the University of Pennsylvania (’84). He then pursued clinical training in Internal Medicine and Rheumatology at the University of California at San Francisco. He went on to re-enter the laboratory at UCSF as a post-doctoral fellow, examining the molecular events associated with immune cell activation. Dr. Koretzky later moved to the University of Iowa in 1991, continuing his research examining the biochemistry and molecular biology of signal transduction in hematopoietic cells. In 1999, Koretzky joined the faculty at the University of Pennsylvania in the Department of Pathology and Laboratory Medicine and as Director of the Signal Transduction Program of the Abramson Family Cancer Research Institute. At Penn, he was an Associate Director of the M.D./Ph.D. program, served as Chief of the Division of Rheumatology from 2006-2008, and as the Francis C. Wood Professor of Medicine and Vice Chair for Research and Chief Scientific Officer in the Penn Department 2008-2013. In 2013, Dr. Koretzky moved to Weill Cornell Medical College as the Vice Dean for Research and the Dean of Weill Cornell Graduate School. In 2017, Dr. Koretzky moved to Ithaca as Vice Provost for Academic Integration to build research programs between the Ithaca and New York City campuses and as the inaugural Director of the Cornell Center for Immunology.

Anca D. Askanase M.D., M.P.H. is a Professor of Medicine at Columbia University. She is the Founder and Director of the Columbia University Lupus Center, Director of Rheumatology Clinical trials at Columbia University, and Associate Rheumatology Division Director. Dr. Askanase is a clinician, diagnostician, and researcher specializing in complex Systemic Lupus Erythematosus (SLE). Her research in lupus encompasses multiple areas including, lupus epidemiology including cohort and registry studies to allow for in depth characterization of disease phenotype and comorbidities; outcomes research to identify biomarkers and develop objective and novel instruments to more accurately diagnose lupus, track disease activity, and define treatment response; and clinical trials to increase treatment options. Much of Dr. Askanase’ research is conducted in collaboration with national and international lupus researchers.  She founded the CUIMC Lupus cohort (n=450) and is an active participant in the SLE registries managed by SLE international Collaborating Clinics (SLICC) and the Lupus Clinical Investigators Network (LuCIN), managed by the Lupus Research Alliance clinical research affiliate Lupus Therapeutics. Ongoing projects include the use of optical tomography to evaluate lupus arthritis, development of virtual lupus disease activity measures for use in clinical research, and lupus outreach to disparate populations in NYC.  Dr. Askanase earned her medical degree from Instit De Medicina Si Farmacie Carol Davila and Master’s of Public Health from Columbia University School of Public Health. 

Catherine Barbey, Ph.D. is a Senior Medical in the MS-Immunology Development Unit at Biogen. She has been in the pharmaceutical industry for almost 20 years, with a successful track record in Global Medical Information, Global Medical Affairs and Global Clinical Development in the areas of dermatology and rheumatology, particularly in lupus. Prior to joining the pharmaceutical industry, she spent 15 years as an immunologist researcher, conducting research at the University of Lausanne, the University of British Columbia-Canada, and various clinical departments at the University Hospital of Geneva and Lausanne and the Ludwig Institute for Cancer Research.

S. Louis Bridges, Jr., MD, PhD is Physician-in-Chief and Chair of the Department of Medicine at Hospital for Special Surgery (HSS) and Chief of the Division of Rheumatology at HSS and at Weill Cornell Medical College. He is Past President of the Rheumatology Research Foundation and a former Chair of the Committee on Research of the American College of Rheumatology. He received a Bachelor of Science degree from the University of Notre Dame, and an Medical degree from LSU School of Medicine in New Orleans. After serving as Chief Medical Resident at the University of Texas Medical Branch, he completed a fellowship in Rheumatology at the University of Alabama at Birmingham (UAB), where he also obtained a PhD in Microbiology/Immunology. For 12 years, he was UAB Director of the UAB Division of Clinical Immunology and Rheumatology. Dr. Bridges has been named to Best Doctors in America, and the 2023 New York Super Doctors list. He is former Co-Editor of Arthritis & Rheumatology and past Chair of the NIAMS Arthritis, Musculoskeletal, and Skin Study Section. Dr. Bridges has authored more than 185 manuscripts, many book chapters, and served as editor of three books. He will serve as Editor in Chief of Arthritis & Rheumatology, an official journal of the American College of Rheumatology from 2025 to 2030.

Alvina is a practicing rheumatologist with a 15-year career in the clinical development of therapeutic products for immunologic conditions and hematologic malignancies. Alvina holds a longstanding commitment to basic, translational, and clinical research in lupus and began her industry career clinically evaluating a treatment for systemic lupus erythematosus.

Alvina holds a Bachelor of Science degree from Stanford University and a Doctor of Medicine degree from the University at Buffalo School of Medicine. She completed an internal medicine residency at the University of Chicago Hospitals and a rheumatology fellowship at Stanford University Medical Center, where she continues to teach and care for patients.

Jennifer Cooper, M.D. is a pediatric rheumatologist, clinical pharmacologist, and clinical/translational researcher at the University of Colorado. She completed dual fellowship training in pediatric rheumatology and clinical pharmacology at UCSF in 2017. Dr. Cooper has been an active member of the Childhood Arthritis & Rheumatology Research Alliance (CARRA) SLE committee and Lupus Nephritis Workgroup since 2015. She published a key paper evaluating the use of standardized treatment protocols for pediatric lupus nephritis at 10 CARRA sites and is actively working to plan a larger comparative effectiveness trial. She is also Co-PI on a project to develop a standardized core dataset to harmonize data collection for pediatric SLE research internationally. Her individual research efforts are focused on pairing translational immunology and pharmacokinetics to develop precision treatment strategies for children with SLE. She also serves as Co-Director of the Children’s Hospital Colorado Pediatric Lupus Program, which provides pediatric rheumatology care for a five-state region.

Maria Dall’Era is the Jean S. Engleman Distinguished Professor of Medicine and Chief of the Division of Rheumatology at the University of California, San Francisco (UCSF). She is Director of the UCSF Rheumatology Clinical Research Center and Director of the Lupus Clinic. She is a steering committee member of the Lupus Academy, the Lupus Forum, and the Lupus 21st Century annual conference. She currently serves as Co-Chair of the Lupus Therapeutics Board of Directors. Her research is focused on understanding the epidemiology, mechanisms, treatment, and outcomes of SLE and lupus nephritis. She is the PI of a CDC-funded population- based longitudinal lupus cohort in the San Francisco Bay Area called the California Lupus Epidemiology Study and the PI on clinical trials focused on SLE and lupus nephritis. She is a member of the core leadership team developing the American College of Rheumatology Guidelines for the Treatment of SLE and lupus nephritis.

She received her undergraduate degree in Immunology from the University of California, Berkeley, and completed her Medical Degree from UCSF, where she later completed her Internship, Residency, and Chief Residency in Internal Medicine. She completed her Fellowship in Rheumatology at UCSF. She has authored numerous publications in the areas of SLE and lupus nephritis. She received the Edmund L. Dubois Memorial Lectureship Award from the American College of Rheumatology and the Evelyn V. Hess award from the Lupus Foundation of America.

Richard Furie, M.D. is the Chief of the Division of Rheumatology at Northwell Health. He is a rheumatologist whose activities for the last several decades have focused on patient care, physician education, and clinical research in the area of anti-rheumatic drug development. He directs The Program in Novel Therapeutics, the Health System’s clinical research program in musculoskeletal disease. He also directs the Hospital’s SLE and Autoimmune Disease Treatment Center, which has become internationally recognized for its role in the development of new therapies for SLE. Regarded as one of the senior rheumatologists in the New York metropolitan area, he has served as a volunteer for the Arthritis Foundation, the Lupus Foundation of America, the Lupus Research Alliance, and Lupus Therapeutics. For over twenty years, he served on many committees of the American College of Rheumatology and was named a Master of the College in 2018.

Rachel Glaser, M.D. is the Associate Director for Therapeutic Review and the Acting Deputy Director for Safety, in the Division of Rheumatology and Transplant Medicine at the FDA. She is also a practicing rheumatologist in Rockville, MD. She received her medical degree from The Johns Hopkins University School of Medicine. Dr. Glaser subsequently completed her training in internal medicine at New York-Presbyterian Hospital/Weill Cornell, and a fellowship in rheumatology at the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH. She was previously an Instructor in Medicine at Weill Cornell Medical College and worked in private practice prior to joining the FDA. At the FDA, Dr. Glaser is responsible for the regulatory review of small molecules, biologics, and biosimilars developed for the treatment of adult and pediatric rheumatologic diseases. She serves on multiple internal and external committees and working groups in these areas.

Amit Golding, M.D. is a Senior Physician in the Division of Rheumatology and Transplant Medicine (DRTM) in FDA/CDER/OND/Office of Immunology and Inflammation. After completing clinical training in Internal Medicine (Johns Hopkins Bayview), Rheumatology Fellowship (Johns Hopkins University SOM), and post-doctoral research in the laboratory of Dr. Ethan Shevach (NID/NIAID/LI/Cellular Immunology), Dr. Golding joined the University of Maryland School of Medicine Division of Rheumatology and Clinical Immunology as a tenure-track Assistant Professor. He received a five-year Career Development Award grant from the V.A. to conduct research on the regulatory T cells in Veterans with autoimmune disorders, including systemic lupus erythematosus (SLE) and rheumatoid arthritis (R.A.). He has published numerous first and last-authored manuscripts on the cellular biology of human regulatory T cells in the context of autoimmune disease as well as a new method for identifying hyperactivated B cells in SLE. Dr. Golding has been a full-time FDA employee since September 2019 and has presented on behalf of the FDA at the annual ACR Convergence meetings.

Ellen Goldmuntz, M.D., Ph.D. is the Acting Chief of the Autoimmunity and Mucosal Immunology Branch in the Division of Allergy, Immunology and Transplantation, NIAID. She completed her residency at Children’s National Medical Center, followed by a pediatric rheumatology fellowship in a combined program with the Children’s National Medical Center and NIH. Dr. Goldmuntz attended Albert Einstein College of Medicine, where she received an M.D. and a Ph.D. through the Medical Scientist Training Program. She joined the Division of Allergy, Immunology and Transplantation in 2003 to work on clinical trials in autoimmunity. Prior to joining NIAID, Dr. Goldmuntz was an Assistant Professor of Pediatrics in the Division of Rheumatology at Children’s National Medical Center in Washington, DC.

Elena Hsieh, M.D. earned her M.D. from the University of California San Francisco in 2008. She completed a residency in pediatrics at the University of California Los Angeles in 2011 and a fellowship in Allergy and Immunology at Stanford University in 2014. After one year stay at Stanford University as an Instructor, in 2015 Dr. Hsieh joined the faculty at the University of Colorado School of Medicine, jointly affiliated with the Children’s Hospital of Colorado. Dr. Hsieh’s lab addresses mechanistic and translational questions in human immunology, focusing on classical pediatric autoimmune disorders such as lupus and type 1 diabetes, and genetic immune dysregulation disorders. She is currently leading consortium studies that aim to identify novel inborn errors of immunity (IEI) that present with autoimmunity/inflammation, atopy, and/or malignancy (Sanford Children’s Genomic Medicine Consortium). She is the Director of the Jeffrey Modell Center for Primary Immunodeficiency and co-directs the Severe Combined Immunodeficiency Newborn Screen Program. Dr. Hsieh also directs the high-dimensional single-cell tissue interrogation section of the Human Immune Shared Resource under the Human Immunology and Immunotherapy Initiative, which seeks to promote basic science and translational immunology research.

J. Michelle Kahlenberg, M.D., Ph.D. is the Giles G. Boles MD and Dorothy Mulkey MD Research Professor of Rheumatology, Professor of Internal Medicine and Dermatology, and Vice Chair of Research for the Department of Internal Medicine at the University of Michigan. She is also the Director of the Michigan Lupus Program. She completed her undergraduate degree at Denison University, her M.D., Ph.D., and Internal Medicine training at Case Western Reserve University, and her fellowship in Rheumatology at the University of Michigan. She has been running her own laboratory at UM since 2013. Her clinical work is centered on the care of complicated lupus patients, including those with refractory skin disease. Her research laboratory combines translational approaches using patient samples and murine models to uncover the mechanisms that drive lupus and other autoimmune diseases. In particular, she is focused on unraveling the pathogenic mechanisms in cutaneous lupus, the factors that drive photosensitivity, and how skin inflammation can influence systemic lupus activity.

Mariana Kaplan, M.D. is Senior Investigator, Chief of the Systemic Autoimmunity and Deputy Scientific Director at NIAMS/NIH. Before her appointment, she was a Professor of Medicine in the Division of Rheumatology at the University of Michigan. Dr. Kaplan did her Rheumatology Fellowship and post-doctoral training at the University of Michigan, where she was a member of the faculty for 15 years and an active member of their Multidisciplinary Lupus Clinic. In addition to her research activities, Dr. Kaplan is an active clinician and teacher. She sees lupus patients in the NIH Clinical Research Center and is involved in the development of various clinical trials for patients with autoimmune diseases at NIH. She has served in numerous roles at the ACR/REF, the American Association of Immunologists, the Lupus Foundation of America, and the Lupus Research Alliance. Dr. Kaplan received the 2015 Evelyn V. Hess Award from the Lupus Foundation of America in recognition of her significant contributions to lupus research, diagnosis, and treatment.

Matt Linnik, Ph.D. is Vice President, Immunology at the Lilly Biotechnology Center in San Diego, where his responsibilities span discovery and clinical research. Matt received his Ph.D. in Pharmacology at Southern Illinois University School of Medicine and was post-doc and instructor at Harvard Medical School. His clinical work focuses on translational medicine while his research lab focuses on multifunctional molecules, including antibody-drug conjugates for autoimmune diseases. At Lilly, Matt has contributing to multiple autoimmune compounds, including baricitinib, ixekizumab, and tabalumab. Matt joined Lilly in 2011 from Biogen Idec where he was Distinguished Medical Research Scientist and Head of Translational Medicine for Immunology. At Biogen, Matt was responsible for rituximab and ocrelizumab in autoimmune diseases, including SLE, lupus nephritis and rheumatoid arthritis. Prior to Biogen, he was Chief Scientific Officer and Executive Vice President at La Jolla Pharmaceutical Co where his responsibilities included leading phase 3 trials in lupus nephritis (abetimus sodium) and driving a discovery research platform for B cell toleragens. Matt has served as Co-Chair of Lupus Industry Council for Lupus Research Alliance.

Franziska Matzkies, MD, is a rheumatologist and Global Program Head/ Vice President at Novartis, Basel. She earned her medical degree and doctorate in Immunology from the University of Erlangen, Germany, and conducted postdoctoral research in Immunology at Stanford and UCSF. She completed her Internship and Residency in Internal Medicine at Cedars-Sinai, Los Angeles, and a Rheumatology Fellowship at UCSF.  Before joining the biopharmaceutical industry, Franziska was an academic rheumatologist at UCSF with a focus in B-cell biology and B-cell driven diseases. She has led development programs for small molecules and monoclonal antibodies, bringing expertise in patient care, translational research, and drug development.

Joan T. Merrill, M.D. is a Professor in the Arthritis & Clinical Immunology Program at the Oklahoma Medical Research Foundation, OMRF Professor of Medicine and Adjunct Professor of Pharmacy at the University of Oklahoma, and Adjunct Professor of Medicine at New York University Medical Center. She is the Principal Investigator of the Oklahoma Lupus Cohort which has collected a repository of clinical information and matched biospecimens obtained from more than 650 patient volunteers. With 320 publications on the immunologic disorders that characterize SLE and the safety and efficacy of treatments, as well as decades of experience in the design and implementation of government and biotech-sponsored clinical trials for lupus, Dr. Merrill has developed novel approaches to testing new treatments, identifying immunologic profiles in patients most likely to respond to a given targeted approach, and improving the quality and interpretability of clinical trial outcomes. A particular interest has been research aimed at finding pitfalls in lupus disease activity measures that create noise which obscures the results of trial data, and refining trial protocols to minimize the impact of these bugs. She is an emeritus member of the Systemic Lupus International Collaborating Clinics, Chief Advisor for Clinical Development at the Lupus Foundation of America, and a Master of the American College of Rheumatology. Dr. Merrill is a graduate of Vassar College and Cornell University Medical School.

Judith Mills, M.B.S. is a biomedical scientist, a TEDx speaker, and adjunct professor at Kean University specializing in alopecia, disability, health, and lupus advocacy. She was diagnosed with lupus after three years with symptoms like fatigue, loss of appetite, body aches, and hair loss.

Seeking support, Judith first contacted the local New Jersey chapter of the Lupus Foundation of America (LFA) while pursuing a B.S. in Biology. She organized a student support group for individuals with disabilities and fundraising clubs for lupus.

In 2003, Judith formed Team MSU at Montclair State University for a local LFA walk. She also joined the now Lupus Research Alliance (LRA), supporting the NJ Walk with Us to Cure Lupus and participated in its Multicultural Task Force.

In 2011, she founded the nonprofit Butterfly Walkers Inc. while working towards a graduate degree in Biomedical Science. She has generated lupus awareness on television shows, serves with the Montclair Township Council, and has secured mayoral proclamations for lupus awareness in several NJ cities. Judith’s dedication has earned several awards from the LFA and the LRA.

Judith serves on the Lupus ABC to collaborate with fellow researchers and add her perspective as a person with lupus. She hopes Lupus ABC prioritizes precision medicine and encourages development of medications with minimal side effects.

Despite shattered dreams as a track star, Judith remains a runner, “not for track and field, but for the race of life.”

Eric Morand, M.D. graduated from Monash University and trained in rheumatology in Australia and the Royal National Hospital for Rheumatic Diseases, U.K. His laboratory research focuses on glucocorticoid-induced proteins in the immune system and his clinical research is on systemic lupus erythematosus. He founded the Asia Pacific Lupus Collaboration, which developed and validated the Lupus Low Disease Activity State (LLDAS) endpoint and lead the TULIP2 trial of anifrolumab, resulting in regulatory approval of anifrolumab in the U.S., Japan, Australia, and E.U. Dr. Morand is also a founding member of the Australian Lupus Registry & Biobank and a founder of the Monash Lupus Clinic, Australia’s largest research-grounded clinic for patients with SLE.

Dr. Raj Nair is a Division Director for Rheumatology and Transplant Medicine (DRTM) at FDA. He trained at the University of Alabama-Birmingham as a research fellow under the direction of Dr. Kenneth Saag and subsequently completed a clinical fellowship in Rheumatology at the Thurston Arthritis Center, University of North Carolina-Chapel Hill. He joined Washington Hospital Center where he served as an attending physician. During this time he obtained certification with musculoskeletal ultrasound through the American College of Rheumatology (RhMSUS). He started as a full time FDA employee in 2013 and was promoted to clinical team leader within the Division of Rheumatology and Transplant Medicine in 2021. He has been a speaker at the national American College of Rheumatology annual meetings and additional meetings specific to regulatory policy, patient perspective, and specific diseases.

Dr. Nikolay P. Nikolov is a board-certified Internist and Rheumatologist who joined FDA in 2009 as a Medical Officer and is currently the Director of the Office of Immunology and Inflammation, CDER.  He completed his Internal Medicine residency at Lincoln Medical Center, Bronx, NY and then joined National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), NIH, where he completed his rheumatology fellowship, participated in clinical investigational protocols and studied cellular and molecular mechanisms of autoimmunity in animal models at NIAMS.  Then, Dr. Nikolov joined the Sjögren’s Syndrome Group at the NIH, as a clinical investigator where he conducted clinical and translational protocols in systemic lupus erythematosus (SLE) and Sjögren’s syndrome. At the FDA Dr. Nikolov is involved in the regulatory review of immuno-modulatory therapies, including small molecules, biologics and biosimilars, for the treatment of pediatric and adult rheumatologic diseases.  He participates in the development of the Agency’s policies in these areas. 

Dr. Popat is Board certified in Internal Medicine, Endocrinology and Clinical Informatics. She joined FDA in 2008 and worked as a reviewer in CDER, and subsequently worked as a founding director of the Biomedical Informatics program in the office of New Drugs/CDER/for 7 years where she led safety analytics and informatics including data standards, data integrity/data quality, and Clinical reviewer training & mentoring activities. Currently she is the branch chief of general medicine branch 3 in CBER, working on Rheumatologic, Orthopedic, Endocrine, Pulmonary, ID, psychiatric and Trauma/Dental/Surgery indications and manages pre-IND, IND, BLA, IDE and variety of other regulatory submissions.

Dr. Brad H. Rovin is the Lee A. Hebert Professor of Nephrology. Dr. Rovin received his Bachelor of Science in Chemical Engineering from Northwestern University in Evanston Illinois and his Doctor of Medicine from the University of Illinois Medical School in Chicago, Illinois. He completed a residency in Internal Medicine at Barnes Hospital in St. Louis Missouri, and a Fellowship in Nephrology at Washington University School of Medicine, St. Louis.

Dr. Rovin has had several committee and leadership roles in the American Society of Nephrology, including the annual meeting program committee, running the Glomerular Diseases Pre-Course and Co-Editing NephSAP-Glomerular Diseases, a continuing education program of the Society. He serves as deputy Editor of Kidney International, the flagship journal of the International Society of Nephrology, and he is Co-Chair for glomerular disease guideline development for the Kidney Disease Improving Global Outcomes effort. Most recently he received the Evelyn Hess Award from the Lupus Foundation of America for research contributions to improve the understanding of lupus nephritis.

Jorge Terres, M.D. is the Senior Global Medical Director, Nephrology and Rheumatology at Genentech. He received his medical degree from Universidad Anáhuac Mexico Norte.

Dr. Amit Saxena is an associate professor of medicine in the division of rheumatology at NYU Langone Health. He completed his rheumatology fellowship and Master of Science in Clinical Investigation at NYU and transitioned to specializing in the care of lupus patients after completing a Pfizer fellowship in Rheumatology/Immunology focused on the disease. Dr. Saxena is the director for lupus clinical trials and has been the site principal investigator in multiple industry, NIH sponsored and investigator initiated interventional and observational trials. He is also the director of the Clinical Trials Design course for the NYU Master of Science of Clinical Investigation program. He is currently leading a collaborative clinical trial to evaluate the safety of the Herpes Zoster subunit vaccine (Shingrix) in patients with systemic lupus.

Dr. Zahi Touma, M.D, Ph.D.is an Associate Professor of Medicine, Clinician-Scientist with the University of Toronto and Scientist with the Schroeder Arthritis Institute and Krembil Research Institute. Dr. Touma  is Director of the Lupus Program and Staff Rheumatologist with the University Health Network (UHN)/Mount Sinai Hospital, and Adjunct Scientist with the Institute for Work and Health. Appointed the inaugural Dr. Murray B. Urowitz Chair in Lupus Research at UHN, his research is focused on patients with SLE and measurement science with a particular interest in the assessment of disease activity, patient reported outcomes and cognitive function. One of his most significant contributions has been the development of the SLE disease activity indices – the SLEDAI Responder Index-50 (S2K RI-50) and SLEDAI-2K Glucocorticoids Index (SGI). 

Dr. Touma is a Co-Chair of the Criteria Subcommittee of the Quality-of-Care Committee of the American College of Rheumatology (ACR) for the development of classification and response criteria for rheumatic diseases. He established the NeuroLupus Program with the goal of developing improved methods of identifying cognitive impairment in SLE and understanding its course over time and impact on health-related quality of life and productivity. Dr. Touma also is a co-chair of the SLE OMERACT (Outcome Measures in Rheumatology) Working Group and  sits on the Advisory Boards of Lupus Ontario and the Lupus Foundation of America. He has been appointed as the inaugural Dr. Murray B. Urowitz Chair in Lupus Research at UHN.

Veronica Vargas Lupo is a Managing Director at Consello. She is renowned for spearheading business transformations, partnering with C-level executives, and digitally transforming business capabilities and operational processes based on smarter, data-driven decision making.

Prior to joining Consello, Veronica spent 12 years at IBM serving in various leadership roles throughout the organization, including Associate Partner in IBM Consulting, Strategy & Transformation and Operations leader. Before joining IBM, Veronica worked as a buyer and planner for Dillard’s department stores.

Veronica has lived with lupus for 18 years. She has been an active member of the Lupus Research Alliance Young Leadership Board since its inception in 2010 and was honored in 2018 at our annual Handbag Luncheon as our “Woman of Achievement’. Veronica is originally from Venezuela, where she grew up until moving to the U.S. as a teenager. Lupus is dear to her not only because she has lived with it but also because her mother has lupus.

Why Veronica says she is serving on the Lupus Voices Council: “Lupus ABC will, for the first time, truly give people who live with lupus and their caregivers a platform where they can be heard and involved in the treatment development process directly with all stakeholders. As someone who has lived with the disease for many years and knowing the wide range of symptoms that those of us with lupus experience, having a voice in this process is immensely important. It is so critical for our perspectives to be considered when designing clinical trials and measuring outcomes to develop tailored therapies in lupus.”

Professor Ronald F. van Vollenhoven is a rheumatologist at the Department of Rheumatology and Clinical Immunology, Amsterdam UMC and Director of the Amsterdam Rheumatology Center in Amsterdam, the Netherlands. He received his MD and PhD degrees from the University of Leiden in The Netherlands. After graduating, he pursued immunology research at Cornell Medical College in New York, followed by specialty training at the State University of New York at Stony Brook and at Stanford University, leading to American Board of Internal Medicine certification in Internal Medicine and Rheumatology. He later went on to serve at both Stanford University and Karolinska Institute. Dr. van Vollenhoven’s research interests focus on the development and systematic evaluation of biological and immunomodulatory treatments for the rheumatic diseases. With his co-workers, he established the Stockholm registry for biological therapies (the STURE database) which supported research projects relating to clinical efficacy, pharmacology, outcomes and pharmacoeconomics. He has been principal investigator in many clinical trials and contributed to a number of important investigator-initiated trials including the SWEFOT, ADMIRE, and DOSERA trials. Professor Van Vollenhoven is Editor-in-Chief of the on-line journal Lupus Science & Medicine. He is also the Chair of the EULAR Research Committee, past-chair of the Swedish Rheumatology Society Professors’ Council, and (co-)initiator of the CERERRA registries collaboration, the NORD-STAR collaboration for Nordic trials in the rheumatic diseases, and the Treat-to-Target-in-SLE and DORIS initiatives.

Eduardo Vianna, PhD, is Global Program Head for enpatoran at EMD Serono. Eduardo has obtained his PharmD in Sao Paulo, Brazil followed by PhD from the University of Iowa, US. He also holds an MBA from the Open University, UK. Eduardo has more than 10 years experience in the pharmaceutical industry and has successfully driven decision making for molecules to meet their next milestone in drug development as well as submitting to Health Authorities and launching drugs in the market. Prior to joining Merck, he was part of the founder team of Novago Therapeutics in Switzerland where he raised a Series A financing round and led the program from a scientific concept to the clinic first in stroke and later in diabetic retinopathy. Previously at Roche, Eduardo participated in several programs with increasing responsibility within the Late Stage Development group. In his free time, he enjoys outdoor cooking and grilling with friends and skiing with his family.

Victoria Werth, M.D. is a Professor of Dermatology and Medicine at the Perelman School of Medicine at the University of Pennsylvania and Chief of the Division of Dermatology at the Philadelphia VAMC. Dr. Werth earned her medical degree from Johns Hopkins University School of Medicine. She completed a residency in internal medicine at Northwestern Memorial Hospital and a dermatology residency and immunodermatology fellowship at NYU, funded by the NIH and Dermatology Foundation. Dr. Werth joined the faculty at Penn in 1989 and has developed an internationally recognized program in autoimmune skin diseases. She is a co-founder of the Rheumatologic Dermatology Society and the previous president of the group. She has a longstanding interest in clinical and translational research pertaining to autoimmune skin diseases, including cutaneous lupus erythematosus, dermatomyositis, and autoimmune blistering diseases, with a focus on improving the outcomes of autoimmune dermatologic diseases. Her laboratory studies include cutaneous lupus and dermatomyositis that relate to pathogenesis and heterogeneity of response to treatment and ultraviolet light effects on skin. Her work has been funded by the Dermatology Foundation, NIH, Department of Defense, the Veterans Administration, the Lupus Research Alliance, the Lupus Foundation of America, the Myositis Association, the International Pemphigus and Pemphigoid Foundation, CARRA, and industry.

Nic Wisniacki, M.D., Ph.D. is a Physician Scientist who gained his PhD at the University of Liverpool and has completed Higher Medical Training in Pharmaceutical Medicine.

He has been working in Drug Discovery and Development for over 20 years starting his career at Centocor, sanofi-aventis and subsequently at Biogen focusing on immunology and early development programmes.

He joined GSK in June 2014 as Head of Translational Medicine within the Experimental Medicine Unit where he led the implementation of experimental medicine within the Immuno-Inflammation therapeutic area. He subsequently led the Experimental Medicine Unit Discovery Performance Unit and more recently the Discovery Medicine group within Research, leading the group of clinicians and clinical scientists responsible for providing clinical and translational leadership and expertise across the Research portfolio. Nic is currently Head of Clinical Research for Immunology and Emerging therapies within the Respiratory and Immunology Research Unit.

Janet Woodcock recently completed a long career at FDA. She served as Director of the Center for Drug Evaluation and Research for over twenty years in several stretches. Most recently she served as Principal Deputy Commissioner and prior to that as Acting FDA Commissioner. She held multiple other senior positions at FDA including at the Center for Biologics Evaluation and Research. She was the therapeutics lead for “Operation Warp Speed” during the COVID pandemic. Her most recent effort was spearheading a major reorganization of FDA’s foods program and the Office of Regulatory Affairs. Dr. Woodcock completed many major regulatory initiatives during her FDA tenure. She was instrumental in getting the biosimilars legislation enacted and worked to ensure adoption in the clinical community. Additionally, she worked with industry and Congress to bring about the first GDUFA. After passage of the legislation, she oversaw an extensive reorganization of the generic drug review program at CDER, that successfully met the aggressive targets of the legislation and led to eventual reauthorizing, with elimination of backlogs and approval of thousands of generic drugs.

Sule Yavuz is a rheumatologist with a deep understanding of Systemic Lupus Erythematosus (SLE) and Systemic Sclerosis. Her expertise extends across patient care, translational research in B cell biology and the type I interferon pathway, and late-stage drug development.
Sule is the Global Program Clinical Lead at AstraZeneca, where she oversees the CLE and other LCM indications. Previously, she worked at Takeda, leading the clinical development of inflammation pipeline assets in SLE and Phase 3 ITP.

She earned her medical degree from Istanbul University. Following her rheumatology fellowship training at UT Southwestern in Dallas, she pursued postdoctoral research at the Autoimmunity Branch of the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Prior to joining the pharmaceutical industry, Sule was an academic rheumatologist at University of Uppsala with a research focus in SLE, participating in multi-center clinical studies.