INADs and Beginning the Review Process Larisa Rudenko, PhD, DABT.
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Transcript of INADs and Beginning the Review Process Larisa Rudenko, PhD, DABT.
INADs and Beginning the Review Process
Larisa Rudenko, PhD, DABT
GE Animal: Investigational Use
Outlines obligations and responsibilitiesOpens path for confidential communications21 CFR § 511.1b
INAD = file; not authorizationAllows 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
The NADA/INAD Review Process aka “Ziggy”
Hierarchical, weight-of-evidence, risk-based Satisfies statutory requirements for safety,
effectivenessFollows NADA regulations, with adaptations
for technology/expertise
y
x
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
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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
x
Our First Approval: GTC’s ATryn® Producing GE Goats
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
Approval Path
Describes the animal, construct, and proposed claim
Product Definition
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].
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.