U.S. BIOPHARMACOPEIA™ Registry of Biopharmaceutical Products

                     Draft short proposal, 11/12/2011
Background:  The Biotechnology Information Institute seeks to facilitate the development and refinement of the basic information paradigms, taxonomies, terminology and nomenclature concerning biopharmaceuticals - how we think of, define, classify, name and regulate these products.  Specifically, new nomenclature and registry systems are needed for biopharmaceuticals, particularly biosimilars.  Current systems and names were designed for chemical substances and drugs and are simply inadequate for biopharmaceuticals, particularly in the context of biosimilars/biogenerics/biobetters. 
Goals:  The BIOPHARMACOPEIA™ project will prospose unique and generic (similar) nomenclature for biopharmaceutical products and active agents from a U.S.-centric perspective, and will integrate this with other nomenclature and identifiers at a public Registry Web site.  Candidate official unique and (bio)generic nomenclature will be provided for products and active agents for selective adoption by regulatory agencies, formularies, other reference sources, industry analysts, etc. 
Impact: Through its development of taxonomies and nomenclature from basic chemical/pharmaceutical information principles; provision of candidate official and other nomenclature; and the public Web site providing the most authoritative product and active agent nomenclature, the BIOPHARMACOPEIA™ Registry will be the dominant information resource in its field, and will help establish the core paradigms for how we define, characterize and think of biopharmaceuticals and biosimilars.  The BIOPHARMACOPEIA™ Registry will also be a potent force influencing the regulatory and scientific/medical communities and public perceptions concerning biopharmaceuticals and biosimilars.  Depending on sponsorship, the Registry could include outreach, educational and advocacy/lobbying efforts.  In many respects, the BIOPHARMACOPEIA™ project may be similar to the CTFA/PCPC Dictionary, with the main U.S. cosmetics trade association publishing names almost always adopted by FDA for cosmetic ingredient labeling.
Sponsorship: Ideally, this will be funded on a long-term basis as an independent unbiased scientific institution by one or more biopharmaceutical companies, trade associations or other source(s).  If this is not attainable, it may be funded as a for-hire, consulting project, in which case it will likely reflect the interests of its sponsors (e.g., innovator or biosimilar companies). 
Bottom Line:  The BIOPHARMACOPEIA™ Registry will profoundly affect the information infrastructure, perceptions, marketing and regulation of biopharmaceuticals and biosimilars.  Sponsorship will provide high impact, visibility and be highly cost-effective.  If you have significant vested interests in biopharmaceuticals, you cannot afford to miss this opportunity to make sure your views are represented.  Please contact us regarding your interests in this project.