Scientific Advisory Board

Blisibimod

Dr Jonathan Barratt is a Reader in the Department of Infection Immunity & Inflammation at the University of Leicester and an Honorary Consultant Nephrologist in the John Walls Renal Unit, Leicester General Hospital. He qualified from Manchester University Medical School in 1992 with Honors and undertook his clinical training in Manchester, Leeds and Leicester. His PhD focused on the interaction between IgA and the glomerular mesangial cell and his postdoctoral research has characterized a number of important pathogenic pathways in IgA nephropathy. Dr Barratt’s research group has interests in lymphocyte homing and B cell activation, IgA1 O-glycosylation, elucidation of the 3-dimensional structure of IgA1 and development of tubulointerstitial scarring in IgA nephropathy. He is on the steering committee and treasurer of the International IgA Nephropathy Network and was a member of the group that developed the Oxford Classification of IgA Nephropathy. Dr Barratt is also actively involved in clinical trials in kidney disease and is a member of the UK Glomerulonephritis Clinical Study Group, UK Kidney Research Consortium and NIHR UK Clinical Research Network Renal Specialty Group.
Professor Isenberg graduated from St Bartholomew’s Hospital in 1973. Trained in General Medicine, Rheumatology, Neurology, Psychiatry and Gastroenterology becoming a Research Fellow at UCL/the Middlesex Hospital in 1979.  Awarded an MD Thesis (in 1984), based on studies of myositis.  During a year of research at Tufts University, Boston, he became interested in autoantibody structure/function and origin.  Appointed Consultant Rheumatologist in November 1984 becoming a professor in 1991 and was given the Arthritis Research UK’s Diamond Jubilee chair of Rheumatology at UCL London in 1996.  Has been elected to Fellowships of both the Royal College of Physicians and the Academy of Medical Sciences.  His specialist involvement is in autoimmune rheumatic diseases, notably Systemic Lupus Erythematosus. Sjögren’s Syndrome, Myositis and the Anti-phospholipid antibody syndrome. His principal clinical interests have been in the development of disease activity and damage assessment tools in patients with lupus.   Chair of the British Isles Assessment Group and also the Chair (1998-2003) of the Systemic Lupus International Collaborating Clinics group (SLICC).

Has undertaken many roles for the Arthritis Research UK in the past 20 years and is the past president of the British Society for Rheumatology (2004-2006) and is currently chairing the Society’s Biologics Register Committee. He is the 2010 recipient of the Evelyn Hess Prize from the Lupus Foundation of America for his contribution to lupus research and treatments and 2012 recipient of the Roger Demers award for his contribution to International Rheumatology.

Dr. Kalunian is a Professor in the Division of Rheumatology, Allergy and Immunology at the University of California, San Diego School of Medicine. He serves as the Associate Director of the UCSD Center for Innovative Therapy. Dr. Kalunian completed fellowships at the Lutheran General Hospital for arthroscopic surgery and the University of California, Los Angeles for rheumatology. He has authored over 50 peer-reviewed papers and serves on several committees, including the Collective Data Analysis Initiative for the Lupus Foundation, serving as the Chair.
Dr. Diane Kamen is an Associate Professor of Medicine and Director of Clinical Research in the Division of Rheumatology. She completed her undergraduate training at Northwestern University. She graduated from the University of Kansas School of Medicine in 1999 and completed her Internal Medicine residency and a three-year rheumatology fellowship at the Medical University of South Carolina in June 2005. In 2004, she completed a two-year Master of Science in Clinical Research program and joined the faculty at MUSC in July 2005.
Dr. Merrill has been involved in design, implementation and execution of clinical trials of immune modulating treatments for SLE for over 20 years. She is the Director of the Oklahoma Lupus Cohort which includes a prospective collection of biologic materials, patient information and disease activity measures with more than 600 lupus patient volunteers. She has participated in more than 30 registrational trials for SLE, and has been the PI of several multicenter studies, as well as a number of investigator-initiated trials to test novel, efficient approaches formulated to increase the potential discriminatory capacity of targeted biologics, several of which have been implemented in recent years in early phase pilot studies by biotechnology companies.

As the Medical Director of the Lupus Foundation of America, she led the development of an online lupus assessment training website (www.lfa-point) which is now the gold standard in scoring complex outcome measures for trials, helped to launch a combined data analysis initiative, pooling data from completed clinical trials from multiple companies, and is currently working in a collaborative group of stakeholders to test and validate a new, simplified outcome measure for lupus, LFA-REAL (Rapid Evaluation of Activity in Lupus). She is a member of the Systemic Lupus International Collaborating Clinics, and has lectured about progress in lupus diagnosis, monitoring and treatment to physicians and patients around the world. She has more than 190 peer-reviewed publications.

Dr. Petri is a Professor of Medicine at the Johns Hopkins University School of Medicine. She is also the Director of the Hopkins Lupus Cohort, a longitudinal study of morbidity and mortality in SLE. In addition, she serves as the Co-Director of the Hopkins Lupus Pregnancy Center. Previously, she completed two fellowship programs at the University of California, San Francisco in allergy and immunology and rheumatology.
Dr. Strand serves a consultant in clinical research and regulatory affairs to pharmaceutical and biotech companies. She graduated from Swarthmore College with honors, attended the University of California, San Francisco School of Medicine and returned there to complete her subspecialty Rheumatology Fellowship. She was one of eight in the first Primary Care Internal Medicine Residency at Michigan State University. She has been a clinical rheumatologist for 30 years – in subspecialty practice in San Francisco, as a clinical investigator, as an IRB member and subsequently as the director of clinical research at 3 pharmaceutical and biotech companies. She is a member of the clinical faculty at Stanford University, serving as Clinical Professor, Adjunct, Division of Immunology and Rheumatology since September 2000; Clinical Associate Professor since March 1993, and previously as Assistant and Associate Clinical Professor at University of California San Francisco (1981-1993). Her professional interests include development of outcome measures methodology, and clinical and regulatory strategies leading to approval of new agents for treatment of autoimmune diseases, including rheumatoid arthritis [RA], osteoarthritis [OA], fibromyalgia [FMS], gout, systemic lupus erythematosus [SLE] and systemic sclerosis [SSc].

Since 1991, Dr. Strand has led a consulting practice offering clinical research and regulatory expertise. Her focus is to help translate basic research into rational design of randomized controlled trials, evaluate their results and defend approval of novel products to FDA and EMA. She has assisted in preparation of applications, briefing documents and data presentation for defense of NDA and BLA applications in HIV, BMTx, CTCL, uveitis, RA, OA, FMS, gout and SLE. She has been an invited speaker at FDA Arthritis Advisory Committee meetings discussing Guidance Documents for RA, OA, SLE, JRA, radiographic analyses in RA and outcome measures in pain, FMS and gout.

Professor Ronald F. van Vollenhoven is Chief of the Unit for Clinical Therapy Research, Inflammatory Diseases (ClinTRID) at the Karolinska Institute, and of the Clinical Trials Unit Rheumatology at the Karolinska University Hospital.
He received his MD and PhD degrees from the University of Leiden in The Netherlands. After graduating in 1984 he pursued immunology research at Cornell Medical College in New York, followed by residency (specialty training) in Internal Medicine at the State University of New York at Stony Brook, and a fellowship in Rheumatology at Stanford University in Palo Alto following which he received American Board of Internal Medicine certification in both Internal Medicine and Rheumatology.

From 1993 to 1998 Dr van Vollenhoven held a faculty appointment as Assistant Professor of Medicine in the Division of Immunology and Rheumatology at Stanford University, and from 1995 he was the Medical Services Chief and Fellowship Director in that division.

In 1998 Dr van Vollenhoven moved to Stockholm, Sweden, where he worked as a Senior Physician and Chief of the Clinical Trials Unit in the Department of Rheumatology at the Karolinska University Hospital and Associate Professor of Rheumatology; and in 2010, he was appointed in his current position as Professor and Unit Chief at the Karolinska Institute.

Dr van Vollenhoven’s research interests focus around the development and systematic evaluation of biological and immunomodulatory treatments for the rheumatic diseases. With his co-workers, he has established the Stockholm registry for biological therapies (the STURE database) for this purpose, which has supported research projects relating to clinical efficacy, pharmacology, outcomes and pharmacoeconomics. He has been principal investigator in many clinical trials of novel therapies in rheumatic diseases and has contributed to a number of important investigator-initiated trials including the recently published SWEFOT trial. He has published over 220 original papers, book chapters and reviews, and is editor of the textbook Targeted Treatment of the Rheumatic Diseases and associate-editor of Dubois’ Lupus Erythematosus. In 2004, Dr van Vollenhoven was awarded the Scandinavian Research Foundation Prize for excellence in clinical research in rheumatology, and he is an honorary member of several rheumatological societies. He is the Editor-in-Chief of Lupus Science & Medicine, chair-elect of the EULAR Standing Committee on Clinical Affairs, member of many editorial boards, past-chair of the Swedish Rheumatology Society Professors’ Council, co-founder of the IRBIS registry for biologics in SLE, the CERERRA registries collaboration and the NORD-STAR collaboration for Nordic trials in the rheumatic diseases, and the initiator of the Treat-to-Target-in-SLE initiative. Prof. van Vollenhoven lives just north of Stockholm with his wife and children aged 18 and 15. Outside his professional life he is an avid classical pianist.

Dr. Wofsy received his undergraduate degree from Harvard (1968), his MD from the University of California, San Diego (1974), and his medical residency training and rheumatology fellowship training from the University of California, San Francisco. He joined the UCSF faculty in 1980. He currently Professor of Medicine and Microbiology/Immunology at UCSF. Dr. Wofsy also serves as Associate Dean for Admissions for the UCSF School of Medicine. He has served on numerous NIH study sections, and on the Arthritis Advisory Committee of the Food and Drug Administration. Dr. Wofsy is a past-President of the American College of Rheumatology. Dr. Wofsy’s research program is devoted to the development of novel therapies for autoimmune diseases, particularly systemic lupus erythematosus (SLE). For many years, his research focused on the cellular and molecular mechanisms that lead to autoimmunity in murine models for SLE. These therapies are designed to block pathologic immune responses without damaging the entire immune system. One of the therapies that was pioneered by Dr. Wofsy’s group involves the B7 family of molecules on antigen-presenting cells (APC). These molecules play a pivotal role in the generation of T-cell help. Specifically, the interaction of B7 molecules on APC with their ligand (designated CD28) on T cells provides an important signal for T-cell activation. Dr. Wofsy first showed that selective inhibition of the B7-CD28 interaction retards autoimmunity in murine lupus. He subsequently showed that this beneficial effect could be enhanced substantially in two ways: (i) by combining blockade of B7-CD28 with blockade of other receptor-ligand pairs (CD40-CD40L) on the surface of T cells and APC; and (ii) by combining blockade of B7-CD28 with cyclophosphamide therapy. In each case, combination therapy provided a prolonged benefit without sustained generalized immune suppression. This work laid the foundation for translational studies that resulted in FDA approval of a new treatment for rheumatoid arthritis. Dr.Wofsy’s current research is focused on establishing whether this therapy can be life-saving in people with kidney disease due to SLE.

Sollpura

Drucy S Borowitz is an internationally recognized expert in nutrition and the involvement of the intestine and lung in cystic fibrosis. Through most of her 27-year career at the University at Buffalo, the physician-scientist also directed the Cystic Fibrosis Center at Women and Children’s Hospital of Buffalo (WCHOB). Dr. Borowitz has been a leading researcher of enzyme replacement therapy to correct digestive abnormalities in cystic fibrosis patients. She has pioneered research using novel agents and dietary supplements to address the challenges her patients face with colonopathy and pulmonary function.
Michael W. Konstan, MD is the Vice Dean for Translational Research at the Case Western Reserve University School of Medicine and Vice Chair for Clinical Research for the Department of Pediatrics. He received his B.A. and M.D. degrees from CWRU. After completing his internship and residency in pediatrics at The Children’s Hospital of Buffalo, he returned to CWRU and Rainbow for fellowship training in Pediatric Pulmonology. He is currently a professor of pediatrics at CWRU, where he also serves as the co-director of CWRU’s Cystic Fibrosis Research Center.

Dr. Konstan’s academic career has focused on developing new therapies for the lung disease of cystic fibrosis (CF), with a special interest in anti-inflammatory therapies and clinical trial design. His research has been supported by grants from the Cystic Fibrosis Foundation, National Institutes of Health, and the Food and Drug Administration. He has led numerous national and international clinical trials of potentially new therapies for CF, including trials of pancreatic enzyme products, and is regarded as an international expert in this disease. Dr. Konstan has published extensively, serves on many advisory boards and committees related to advancing the treatment of CF, and continues to care for a devoted cadre of patients with CF.

Dr. Konstan has received several national awards for his accomplishments, including the Richard C. Talamo Distinguished Clinical Achievement Award from the Cystic Fibrosis Foundation, and the “All Stars Among Us” award for community service from Major League Baseball and People Magazine.

Dr. Jeffrey Wagener is a pediatric pulmonologist in Aurora, Colorado and is affiliated with multiple hospitals in the area, including Children’s Hospital Colorado and University of Colorado Hospital. He received his medical degree from University of Colorado Denver School of Medicine and has been in practice for 40 years.
Professor Michael Wilschanski was born in London, England and graduated from the University of London (Royal Free Medical School) in 1985. He completed his Pediatric residency at Shaare Zedek Hospital in Jerusalem and following this a 3 year Fellowship in Pediatric Gastroenterology at The Hospital for Sick Children in Toronto, Canada. He returned to Israel and worked as a senior Pediatric Gastroentrologist at Shaare Zedek before being appointed Director of the Pediatric Gastroenterology Unit at the Hadassah University Hospitals (Ein Kerem and Mount Scopus) in 2003.

Apart from his clinical and research interest in Cystic Fibrosis, Professor Wilschanski has published on numerous aspects of pediatric gastroenterology including Inflammatory Bowel Disease, Celiac Disease, probiotics in neonatology and pediatrics and abdominal pain including Helicobacter pylori infection in children. He has a current research project on recurrent pancreatitis in children.

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