ABOUT THE EXPERT
MD, MACR, FACP
Adjunct Clinical Professor, Division of Immunology/Rheumatology
Stanford University School of Medicine
Palo Alto, CA
Vibeke Strand, MD, MACR, FACP, serves as a consultant in clinical research and regulatory affairs to pharmaceutical and biotech companies. She has been a clinical rheumatologist for 40 years—in subspecialty practice in San Francisco, as a clinical investigator, and subsequently senior director of clinical research at 3 pharmaceutical/biotech companies. She has served as an adjunct clinical professor, Division of Immunology and Rheumatology, at Stanford University since September 2000. She was clinical associate professor from March 1993 and assistant and associate clinical professor at the University of California, San Francisco (1981-1993).
Since 1991, Dr Strand has consulted regarding the translation of basic research into rational design of randomized controlled trials, analysis of their results, and regulatory strategy, presentation of novel products for approval to the US Food and Drug Administration (FDA) and the European Medicines Agency. She has assisted in the preparation of briefing documents, analyses, and data presentation for defense of New Drug Applications and Biologic License Applications in rheumatoid arthritis, systemic lupus erythematosus, psoriatic arthritis, spondyloarthritis, systemic sclerosis, uveitis, osteoarthritis, gout, fibromyalgia syndrome, and the first and subsequent monoclonal antibody biosimilars. She has been an invited member of FDA Arthritis Advisory Committee meetings discussing Guidance Documents.
She established and cochaired the biyearly Innovative Therapies in Autoimmune Disease meetings co-sponsored by the American College of Rheumatology (ACR), the National Institutes of Health, and the FDA (1988-2007). She has served as a founding member of the Executive Committee of the international Outcome Measures in Rheumatology (OMERACT) consensus conferences (1992-present). She is a founding member and steering committee member of Group for Research and Assessment of Psoriatic Arthritis (GRAPPA) and a member of the International Dermatology Outcome Measures (IDEOM) Board of Directors. She is a member of the ACR RA Clinical Trials Task Force (2011-2018); Board of Directors (2005-2013) and Medical and Scientific Committee of the Northern California Chapter of the Arthritis Foundation (2005-present); Board of Directors of CORRONA (2002-2008); and Scientific Advisory Board (2010-present) and Board of Advisors for Analgesic, Anesthetic, and Addiction Clinical Trial Translations, Innovations, Opportunities, and Networks (ACTTION).
She has authored/coauthored more than 440 original publications and is a fellow of the American College of Physicians (1982), Master of the ACR (2015), and a member of the Cosmos Club (1994) and its Substitute Board of Managers (2013-2017).