Company: NOTV
Filing Date: 2025-12-05
Form Type: 10-K
Source: 0001628280-25-055483
Chunk: 86

Company: Inotiv, Inc.
Filing Date: 2025-12-05
Form: 10-K
Item: Item 1
Chunk 86
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. Teklad offers a variety of bedding and enrichment products to support model breeding, weaning, and general husbandry.

Research Model Services: We also offer a variety of services designed to support our clients' use of research models in basic research and product development. These services include specialized surgical modifications such as cannulation, implants, and the creation of surgically derived disease-state models. Further, we provide services, including contract breeding, contract colony management, health monitoring, the creation of new transgenic research models specific to individual clients’ needs, quarantine, cryopreservation, rederivation and revitalization services, and antibody development and production, as well as transportation services. 

The Company’s Role in the Drug Discovery and Development Process

Inotiv provides research support, through provision of its products and services, for the identification and development of new chemical and biological entities from discovery through clinical development. For both efficacy and safety evaluations, our DSA segment provides a wide range of supporting services and our RMS segment offers relevant, high-quality animal research models. 

1.The discovery phase of new product development includes the identification and validation of potential targets for therapeutic intervention, the latter of which may involve studying a disease’s molecular pathway by genetically altering one or more of the molecules in that pathway in cell lines or in murine models. Inotiv’s molecular biology group provides such murine models for our clients and, where appropriate, can then support clients in the use of those models to study the pharmacokinetic and potential efficacy profiles of new therapeutic entities.

In addition to generation of new models for studying potential pharmacokinetics and efficacy at the request of our clients, Inotiv also has a broad range of off-the-shelf standard, and disease-bearing models, that may be used for the same purposes. Our discovery services group uses these animals, and other model systems, to perform a range of early discovery tests to better characterize potential new therapeutic molecules for mode of action, potential efficacy, and predicted safety and metabolism profiles.

2.After a new drug candidate is identified and carried through this preliminary discovery screening, the development process for new drugs has three distinct phases: the nonclinical phase, the clinical phase and the post approval phase. The nonclinical phase includes safety testing to prepare an Investigational New Drug ("IND") application for submission to the FDA. The IND must be allowed to go into effect by the FDA before the drug candidate can be initially tested in humans. Once a pharmacologically active molecule is fully analyzed to confirm its potential utility, the initial dosage form for clinical