About the Infant Botulism Treatment and Prevention Program (IBTPP)
The IBTPP is a high-visibility Departmental activity of national scope and impact because it serves as the nationally (and internationally) recognized center of expertise in infant botulism that is the sole source world-wide for the public service orphan drug BabyBIG®. The IBTPP was established as a fee-supported program by Ch. 674, Statutes of 1995, now codified as Heath & Safety Code §123700-123709.
After an approximately 15-year development period by CDHS/CDPH, BabyBIG® was licensed by FDA in October 2003 and provides the Program’s fee support. BabyBIG® (human Botulism Immune Globulin) has become the standard-of-care for paralyzed, critically-ill patients with infant botulism as well as a recognized treatment for any domestic bioterrorist attack that uses botulinum toxin as a weapon. BabyBIG® is the only treatment available for the orphan (rare) disease known as infant botulism.
Under its chartering statute, the IBTPP is also responsible for laboratory diagnostic services, surveillance, consultation, research and prevention of infant botulism statewide. An original and current principal programmatic focus is to identify and prevent cases of Sudden Infant Death Syndrome (SIDS, crib death) that result from unrecognized, abrupt-onset infant botulism. The Program carries out much of its activities through contracts and collaborations. Parenthetically, production of the next lot of BabyBIG® is being transitioned to a new manufacturer, Baxter BioSciences (Thousand Oaks, CA), and source plasma collection will begin in 2008.
The high national profile of the program is also a consequence of its interactions with the U.S. Food and Drug Administration (FDA), the federal Centers for Disease Control and Prevention (CDC), the National Institute of Allergy and Infectious Diseases (NIAID), Lawrence Livermore National Laboratory (LLNL), Los Alamos National Laboratory (LANL), Biomedical Advanced Research and Development Authority (BARDA), U.S. Department of Health and Human Services, the Johns Hopkins (now University of Pittsburg) Center for Civilian Biodefense, all California local Health Departments, and approximately 200 major university, children’s and community hospitals nationwide. The IBTPP participates in and represents CDPH in the NIAID-funded Pacific Southwest Regional Center of Excellence (RCE) for Emerging Infections and Biodefense Preparedness headquartered at the University of California Irvine.
The Program consists of a small group of highly committed, energetic individuals dedicated to improving the treatment and prevention of infant botulism and those cases of SIDS (crib death) that result from it. The Program was founded by Dr. Arnon in 1976 coincident with the recognition and naming of infant botulism and has been headed by him ever since.