Overview of USP Efforts to Identify Naming Schemes for Tissues and Tissue-Based Products

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1 Quality Standards for Medicines, Supplements, and Food Ingredients throughout the World Overview of USP Efforts to Identify Naming Schemes for Tissues and Tissue-Based Products Darin Weber, Ph.D., Vice-Chair USP Biologics & Biotechnology: Cell, Gene, and Tissue Therapies Expert Committee (BB CGT EC) USP Nomenclature Expert Committee, Member United States Adopted Names (USAN) Council, USP Representative ISCT SCT 2008, Bethesda, MD

2 Outline Why the USP has a need for a naming scheme for Tissues and Tissue-Based Products Example of current lack of harmonization among stakeholder organizations Desired attributes of a naming scheme Next steps

3 Why the USP has a need for a naming scheme for Tissues and Tissue-Based Products Monographs are being developed for a number of tissues and tissue-based products Industry wants a USP monograph for each of their products 361 tissues Medical devices containing animal or human tissue CMS requires a USP monograph for purposes of reimbursement

4 Purpose of a USP Monograph Allows the setting of a public standard for pharmaceutical and biopharmaceutical products marketed in the U.S. Describes tests to assess the quality of a product anytime during its life cycle, includes specifications and requirements for the product to meet The monograph title is the non-proprietary name, it is the name that will appear when the monograph is published in USP-NF A single monograph title is intended to cover all products that meet the monograph requirements

5 Monographs vs. General Chapters Monographs Product-specific Requirement for the product to meet General Chapters with number <1000 Test methods chapters Methods referenced in product monographs Example: <71> Sterility Tests General Chapters with number >1000 Informational Used as a guidance Example: <1043> Ancillary Materials

6 Current USP Approach for Naming Tissues and Tissue-Based Products Monographs reviewed by CGT EC Names are proposed by sponsor and approved by the EC Final approval by the USP Nomenclature EC Results: Lack of consistency in naming Tissue monographs Similar products in different sections of USP-NF Request from USP Nomenclature EC to develop standard approach

7 Five USP Official Monographs for Tissues and Tissue-Based Products Bovine Acellular Dermal Matrix Graftskin Current Monograph Titles Small Intestinal Submucosa Wound Matrix Cryopreserved Human Fibroblast- Derived Dermal Substitute Human Fibroblast-Derived Temporary Skin Substitute Proprietary Name & Manufacturer Oasis Wound Matrix; Surgisis Soft Tissue Graft (Cook) PriMatrix; Tissuemend (TEI) Dermagraft (Advanced BioHealing, Inc.) TransCyte (Advanced BioHealing, Inc.) Apligraf (Organogenesis, Inc.)

8 USP Tissue & Tissue-Based Products Monographs Under Development Human Acellular Dermal Matrix Platelet-Rich Fibrin Matrix Acellular Non-Crosslinked Bovine Collagen Matrix Equine Biomatrix Wound Dressing Collagen Nerve Conduit Bovine Tendon Collagen Collagen Nerve Guide Crosslinked Collagen-GAG bilayer Scaffold Crosslinked Collagen-GAG Scaffold Crosslinked Collagen-Chondroitin Sulfate

9 Desirable Attributes in Naming Scheme for Tissues and Tissue-Based Products Scheme to cover all tissue monographs under CGT EC Harmonize monograph names irrespective of regulatory status Medical devices vs. 361 HCT/Ps Scheme should allow similar product to appear next to one another in USP-NF The current Ad Hoc naming approach does not meet USP needs.

10 Naming Schemes developed by other Stakeholders FDA Stake Holder Scheme for 361 Tissues or Tissue-Based Products? No USAN/INN AMA Current Procedural Terminology (CPT) CMS Healthcare Common Procedural Coding System (HCPCS) ASTM ICCBBA No Yes Yes Yes Yes

11 USP, CMS & AMA Approaches Not Harmonized Current USP Bovine Acellular Dermal Matrix AMA CPT Decellularized nonhuman connective tissue CMS HCPCS Dermal (substitute/replacement ) tissue of nonhuman origin, without metabolically active elements (Tissuemend), per cm 2 Cryopreserved Human Fibroblast- Derived Dermal Substitute Cultured allogeneic neonatal dermal fibroblasts Dermal (substitute/replacement ) tissue of human origin with metabolically active elements, per cm

12 USP, ASTM & ICCBBA Approaches USP draft naming approach: [Defining Characteristic] [Animal Source] [secondary characteristic] [tissue Source] [physical form, if needed] ASTM F 2311 Approach for Skin Substitutes {cellular component(s) or acellular or blank} {in or blank} {scaffold(s) or blank} { format }, { sterility } For cell containing products captures: { [viability] [process] [sex] [species] [tissue origin] [type] } ICCBBA (ISBT 128): [Classes], [Modifiers], [Attributes (core conditions or optional variables)]

13 USP, ASTM & ICCBA Approaches Not Harmonized USP ASTM ICCBA Bovine Acellular Dermal Matrix Matrix, Bovine, Acellular, Dermal* Cryopreserved Human Fibroblast- Derived Dermal Substitute Graft, human, dermal fibroblasts in polyglactin scaffold* Acellular bovine dermis scaffold sheet, sterile Viable cultured allogeneic dermis fibroblasts in polyglactin woven fiber scaffold sheet, sterile Non-human tissues not described in ISBT 128 Engineered tissues with synthetic components not currently described in ISBT 128 *Potential new USP tissue naming scheme approach

14 Next Steps Identify or develop tissue nomenclature scheme to cover all monographs under CGT EC that meets needs of USP Harmonize monograph names irrespective of regulatory status Medical devices vs.361 HCT/Ps vs. combination products If possible harmonize with efforts outside of USP Develop a USP Chapter to describe a scheme for naming these products

15 Summary Developing a logical naming system for tissues and tissue-based products is an important issue for USP It is also important for Industry for CMS reimbursement For a more complete view of USP s activities in this area see slides from: Tissues and Tissue-Based Products Workshop Tuesday May 13, Committee html

16 Quality Standards for Medicines, Supplements, and Food Ingredients throughout the World