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INADs and Beginning the Review Process

INADs and Beginning the Review Process. Larisa Rudenko, PhD, DABT. GE Animal: Investigational Use. Outlines obligations and responsibilities Opens path for confidential communications 21 CFR § 511.1b INAD = file; not authorization Allows for certain activities during development

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INADs and Beginning the Review Process

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  1. INADs and Beginning the Review Process Larisa Rudenko, PhD, DABT

  2. GE Animal: Investigational Use Outlines obligations and responsibilities Opens path for confidential communications 21 CFR § 511.1b INAD = file; not authorization Allows for certain activities during development • Animal (drug) shipments/labeling • Record keeping • Disposition • No investigational animals/products in food/feed supply without prior authorization • First look at environmental considerations for animal/product • Qualified investigators/collaborators

  3. x y The NADA/INAD Review Process aka “Ziggy” Hierarchical, weight-of-evidence, risk-based • Satisfies statutory requirements for safety, effectiveness • Follows NADA regulations, with adaptations for technology/expertise

  4. ? ? ? Early Interactions w Sponsor • Usually occurs right after opening INAD to ensure confidentiality • Sponsor provides some information prior to meeting • Generally starts with open seminar, then closed session with review team • Discusses nature of submissions; data/information to prepare • Follow up includes MOC

  5. x In House Review of Submissions • Group composition determined by subject area issues, availability • Convene Review Group • Group Discussion of issues  • Suitability, • Completeness • Assignment of reviews to subject area experts • Prepare preliminary review by in-depth reviewers • Peer review by group • Issue response to Sponsor y

  6. Our First Approval: GTC’s ATryn® Producing GE Goats

  7. ATryn Goat Approval (2/6/09) 2 Separate Legal Actions • CVM NADA approval • rDNA construct in GE goat to produce rh antithrombin in milk • CBER BLA approval for ATryn • Anticlotting agent for individuals with hereditary clotting disorders in high risk situations

  8. Approval Path

  9. Describes the animal, construct, and proposed claim Product Definition

  10. Product Definition • Broad statement identifying the GE animal, its proposed product or traits (Animal/rDNA construct + claim) • Suggested format: • An [x-ploid][n-zygous] [animal common name/breed, line] [genus, species] containing [copy number] copy/ies of the [construct name] construct at [genomic location] in the [animal breed/line] that [claim].

  11. GTC 155-92 Product Definition A specific hemizygous diploid line of domestic goats (Capra aegagrus hircus) containing 5 copies of the Bc6 transgene located at the GTC 155-92 site directing the expression of the human gene for antithrombin (which is intended for the treatment of humans) in the mammary gland of goats derived from Founder 155-92.

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