Vibeke Strand, MD, FACP, FACR

Biopharmaceutical Consultant Adjunct Clinical Professor Division of Immunology and Rheumatology Stanford University School of Medicine Portola Valley, California

Dr Strand is an adjunct clinical professor in the division of immunology and rheumatology at Stanford University School of Medicine in Palo Alto, California, and a consultant in clinical research and regulatory affairs to pharmaceutical and biotech companies. She has been a clinical rheumatologist for 26 years, as a clinical research investigator, member of IRBs and directed clinical research at 3 pharmaceutical and biotech companies. Her professional interests include development of clinical trial methodology, planning regulatory strategy and clinical studies leading to approval of new agents for treatment of autoimmune diseases, including rheumatoid arthritis [RA], osteoarthritis [OA] and systemic lupus erythematosus [SLE].

Since 1991, Dr. Strand has led a consulting practice offering clinical research and regulatory strategy 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 EMEA. She has assisted in preparation of applications, briefing documents and data presentation for defense of NDA and BLA applications, including: Ganciclovir™ in CMV Retinitis, CD5 Plus™ in GvHD, Neoral™ in RA, Ontak™ in CTCL, Arava™ in RA, Celebrex™ in RA and OA, Remicade™ in RA, Kineret™ in RA, Humira™ in RA, Supartz™ in OA and additional labeling claims for the above products, as well as Prastera [DHEA] and Riquent [Abetimus sodium] in SLE.

Her commitment to promoting forums for the discussion of rational product development among industry, FDA and academia led to her establishing and co-chairing the biyearly “Innovative Therapies in Autoimmune Disease” meetings (1988-2005), serving as a member of the executive organizing committee of the international Outcomes in Rheumatology Clinical Trials (OMERACT 1-9) consensus conferences (1992-2008), co-chairing the OMERACT 7 meeting in 2004. She helped found and co-chairs the Clinical Immunology Society Spring Fellows School (2004-2008). 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 pain (1996 – 2004). Since 2005 she has served as a member of the board of the Northern California chapter of the Arthritis Foundation and a member of their Medical and Scientific Committee.

She has authored over 160 original publications and reviews, 35 chapters, co-edited several books and multiple proceedings. She is a Fellow of the American College of Physicians (1982), a Fellow of the American College of Rheumatology (1986), serves on the editorial board of multiple journals, and is a member of the Cosmos Club (1994).

Return to Program Information