Inotiv, Inc. (Inotiv) operates as a contract research organization (‘CRO’) dedicated to providing nonclinical and analytical drug discovery and development services primarily to the pharmaceutical and medical device industries, and to selling a range of research-quality animals and diets to the same industries, as well as to academia and government clients.
The company's products and services focus on bringing new drugs and medical devices through the discovery and preclinical phases of develop...
Inotiv, Inc. (Inotiv) operates as a contract research organization (‘CRO’) dedicated to providing nonclinical and analytical drug discovery and development services primarily to the pharmaceutical and medical device industries, and to selling a range of research-quality animals and diets to the same industries, as well as to academia and government clients.
The company's products and services focus on bringing new drugs and medical devices through the discovery and preclinical phases of development, all while focusing on increasing efficiency, improving data, and reducing the cost of discovering and taking new drugs and medical devices to market. Inotiv is committed to supporting discovery and development objectives, as well as helping researchers realize the full potential of their critical research and development projects, all while working together to build a healthier and safer world. The company is dedicated to practicing high standards of laboratory animal care and welfare.
As a result of the company's strategic acquisition of Envigo RMS Holding Corp. (‘Envigo’) in November 2021, which added a complementary research model platform, the company's full spectrum solutions now span two segments: Discovery and Safety Assessment (‘DSA’) and Research Models and Services (‘RMS’).
Through the company's DSA segment, the company supports the discovery, nonclinical development, and clinical development needs of researchers and clinicians for primarily small molecule drug candidates, as well as biotherapeutics and biomedical devices. The company's scientists have skills in analytical instrumentation development, chemistry, computer software development, histology, pathology, physiology, surgery, analytical chemistry, drug metabolism, pharmacokinetics, and toxicology to make the services and products it provides increasingly valuable to its clients. The company's principal clients are companies whose scientists are engaged in analytical chemistry, drug safety evaluation, clinical trials, drug metabolism studies, pharmacokinetics, and basic research, from small start-up biotechnology companies to some of the largest global pharmaceutical companies.
Through the company's RMS segment, the company offers access to a wide range of small and large purpose-bred animal research models for basic research and drug discovery and development, as well as specialized models for specific diseases and therapeutic areas, in addition to diet and bedding. The company provides deep animal husbandry expertise and expanded access to scientists across the discovery and preclinical continuum, which can reduce nonclinical lead times and provide enhanced project delivery. In conjunction with the DSA business, the company has the ability to run selected nonclinical studies directly on-site at closely located research model facilities and provide access to innovative genetically engineered models and services solutions. The company's principal clients include biopharmaceutical companies, CROs, and academic and government organizations.
DSA segment
The DSA segment comprises two principal areas of services: Discovery and Translational Sciences (‘Discovery’) and Safety Assessment.
Discovery and Translational Sciences
Analytical Method Development and Validation: Analytical methods are developed and validated in a manner designed to ensure that data generated are accurate, precise, reproducible, and reliable and are used consistently throughout the drug development process and in later product support. Both early-stage, fit-for-purpose discovery methods and fully Good Laboratory Practice (‘GLP’)-validated methods are generated to provide appropriate and timely responses to the client's situation.
In Vivo Pharmacology: The company provides preclinical in vivo efficacy services. In vivo pharmacology is strengthened by the combination of the company's genetically-modified rodent production capability, which provides animals with specific genetic modifications necessary for evaluation of new molecular targets, and by its ability to use advanced proteomic technologies to characterize the pharmacological target and the model's responses to intervention.
Exploratory Pharmacokinetics and Toxicology: The company evaluates the initial pharmacokinetics of drug candidates to determine oral bioavailability, dose proportionality of exposure, gender differences, and time-dependent changes in exposure in its laboratories. In addition, the company provides initial safety evaluation of drug candidates through the conduct of single and repeated dose exploratory toxicology studies designed to identify tolerability and target organ toxicity and to provide guidance for dosing of more extensive pivotal studies, which are intended to support human clinical trials.
Analytical Products: Analytical products consist of the company's liquid chromatographic and electrochemical instruments with associated accessories. The critical component of these products is the Epsilon electrochemical platform. This platform incorporates all the hardware capabilities needed for most electrochemical experiments but can be modified through software development. The market for the company's analytical products is involved principally of academic institutions and industrial research companies.
In Vivo Sampling Products: In vivo sampling products consist of the Culex family of automated in vivo sampling and dosing instruments. These instruments are used by pharmaceutical researchers to dose animals and collect biological samples (blood, bile, urine, microdialysate, feces, or any bio-fluid) from the animals. Since dosing and sample collections are automated, animals are not manually handled, reducing stress on the animals and producing more representative pharmacological data. Behavior and other physiological parameters can also be monitored simultaneously. Compared to manual methods, the Culex products offer significant reduction in test model use and comparable reduction in labor. The line also includes in vivo sampling devices sold to drug developers and medical research centers to assist in the study of a number of medical conditions, including stroke, depression, Alzheimer’s and Parkinson’s diseases, diabetes, and osteoporosis.
Safety Assessment
Non-clinical Toxicology and Pathology Services: The company provides safety testing in studies ranging from acute safety evaluation of drugs and medical devices to chronic, multi-year oncogenicity studies, and safety evaluation focused on developmental and reproductive toxicology. The company also provides services in toxicologic pathology and evaluation of tissues from animal efficacy models, surgical modeling, and focused evaluation of biomedical devices, as well as cardiovascular safety evaluation in radiotelemetry-implanted animals.
Stability Testing: The company tests stability of nonclinical drug dosing formulations and collects bioanalysis samples designed to ensure the integrity of all solutions used in nonclinical and clinical studies and post-study analyses. Results from sample shipping and storage studies assist its clients in maintaining sample integrity throughout the process from collection to analysis.
Drug Metabolism, Bioanalysis, and Pharmacokinetics Testing: The company analyzes samples from in vitro, preclinical, and clinical studies to identify and measure drug and metabolite concentrations in complex biological matrices, including drug metabolism, bioanalysis, and pharmacokinetics studies.
Archiving Services: The company provides climate-controlled archiving services for its clients’ data and samples at all of its facilities.
New Service Offerings
During the twelve months ended September 30, 2024, the company spent $3.3 million on startup costs for new service offerings that it is building internally, including biotherapeutics and genetic toxicology.
Research Models and Services segment
The RMS segment comprises Research Models, Diet, Bedding and Enrichment, and Research Model Services.
Research Models
The company's research models business comprises the commercial production and sale of laboratory animals and research models for use by scientific researchers, principally purpose-bred small animal models (primarily mice and rats) and large animal models (non-human primates (‘NHP’) and rabbits). The company provides these models to numerous clients around the world, including many academic institutions, government agencies, biopharmaceutical companies, and CROs, and it has a global footprint with production facilities strategically located in three countries.
The company's research models include standard stocks and strains, immunocompromised models (which are useful for oncology research), disease models (which are in demand as early-stage research tools), and genetically-engineered models (‘GEMS’) (which are often created for specific research projects).
Small Animal Research Models
The company's rodent species have been and continue to be among the most-used research models in the world, largely as a result of its geographic footprint and commitment to quality and client service. The company's small animal research models are bred and maintained in controlled environments, which are designed to ensure that the models are free of specific viral and bacterial agents, and other contaminants that can disrupt research operations and distort research results. With its production capabilities, the company strives to consistently deliver high-quality research models worldwide.
RMS rodent research models include outbred, which are purposefully bred for heterogeneity; inbred, which are bred to be genetically identical; spontaneous mutant, which contain a naturally occurring genetic mutation (such as immune deficiency); hybrid, which are the offspring of two different inbred parents; and GEMS.
Certain of the company's models are proprietary, disease-specific rodent models used to research treatments for diseases, such as diabetes, obesity, cardiovascular, and kidney disease.
Large Research Models
The company's large animal portfolio includes NHPs and rabbits. NHPs are generally imported into the U.S. and Europe from Asia and Africa, with limited breeding in the U.S. The company operates two quarantine facilities in the U.S. to house and clear these imported animals before onward shipment to clients. NHPs are used by the company's clients primarily for the safety testing of new biological therapies. Rabbits are bred in both the U.K. and the U.S.; and utilized primarily for the reproductive safety testing of potential new therapies.
Diet, Bedding and Enrichment
Through the company’s Teklad product line (‘Teklad’), RMS produces and sells laboratory animal diet, bedding, and enrichment products. With primary manufacturing operations in the U.S. and a primarily company-owned and/or managed distribution network throughout the U.S., the U.K., and Europe, the company distributes Teklad products globally. The company also maintains contract-manufacturing relationships with companies in the U.K. and Italy.
Teklad offers a full line of off-the-shelf formulations, as well as custom diets to meet its clients’ specific research needs. A team of nutritionists, including several PhDs, work with the company's clients to determine the best diet for their research objectives. If a custom diet is required, the company's nutritionists define the appropriate formula, and its custom diet manufacturing line produces the feed. The company's manufacturing facilities are ISO 9001:2015 certified.
Teklad diets are manufactured from natural ingredients and use fixed formulas. In conjunction with strict quality standards for raw materials, this approach helps to ensure quality and consistency by minimizing variability of both nutrients and certain natural chemicals in the diet, which might affect a research study. Teklad offers a variety of bedding and enrichment products to support model breeding, weaning, and general husbandry.
Research Model Services
The company also offers a variety of services designed to support its 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. The company also provides contract breeding, contract colony management, health monitoring, quarantine, cryopreservation, rederivation, and revitalization services, as well as antibody development and production. Lastly, through the GEMS business, the company offers the creation of new transgenic research models specific to individual clients’ needs.
Role in the Drug 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, the company's DSA segment provides a wide range of supporting services, and its RMS segment offers relevant, high-quality animal research models.
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 creates such murine models for its 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 its clients, Inotiv also has a broad range of off-the-shelf standard, and disease-bearing models, that may be used for the same purposes. The company's 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.
The company's bioanalytical services group utilizes its depth of expertise in liquid chromatography with detection by mass spectrometry to support research, nonclinical, and clinical programs. The company also offers bioanalytical services that utilize electrochemistry, spectrophotometric (UV/Vis or fluorescence), and Corona Discharge detection as options. The company has invested in robotics and mass spectrometry systems. Application of this technology allows the company to rapidly develop and validate methods for new compounds and obtain information suitable for regulatory submission.
The company's services supporting clinical development include evaluation of bioequivalence and bioavailability to monitor the rate and extent to which a drug is available in the body and to demonstrate that the availability is consistent between formulations. The company also offers in-vitro bioequivalence testing for poorly absorbed topical and oral drugs. The company offers support and testing services in clinical sample development, release, and stability.
The company also provides services during the post-approval phase, including bioequivalence studies of new formulations, line extensions, new disease indications, and drug interaction studies. The company's ability to offer Good Manufacturing Process (‘GMP’) electrochemical detection services has provided increased business opportunities for release testing.
Clients
The company provides its services and products to organizations engaged in basic research, biomedical device and pharmaceutical research and development. During the twelve months ended September 30, 2024, the company made sales to over 2,200 companies, ranging from emerging biopharmaceutical companies up to some of the largest pharmaceutical companies in the world. The company's business development efforts focus on both expanding existing client relationships and acquiring new clients.
Contractual Arrangements
The company’s DSA contracts typically establish an estimated fee to be paid for a proposed set of services designed in consultation with the client. In most cases, some percentage of the contract fee is paid in advance. While the company is performing a contract, clients sometimes adjust the scope of services to be provided based on interim project results. The company's RMS product contracts are typically short-term in nature and based upon purchase orders submitted by clients to satisfy specific requirements for their research.
Sales and Marketing
The company promotes its services through centralized business development and marketing efforts, and scientist-to-scientist communications. The company recognizes that its growth depends upon its ability to continually improve client satisfaction in order to deepen existing and establish new client relationships.
In November of 2019, the company rebranded its contract research services business as ‘Inotiv’. Adoption of the trade name Inotiv symbolized the expansion and supplementation of the company’s legacy contract research service operations through significant business acquisitions, as well as internal growth. Since the rebranding, the company has marketed and otherwise managed its contract research services operations under the name Inotiv. The company’s research equipment manufacturing division continues to operate under the name BASi Research Products.
The company acquired Envigo RMS Holding Corp in November of 2021. After its acquisition, the research models business of Envigo has continued to operate under the Envigo brand as ‘an Inotiv company’ and comprises the majority of the RMS segment of Inotiv. Since March of 2023, the company has worked to consolidate all DSA and RMS products and services under the Inotiv trademark, as evidenced by the launch of a unified website under the Inotiv domain.
The company's commercial initiatives include integrated campaigns designed to help differentiate and promote its products and services. Through trade events, digital and print advertising, direct communication, newsletters, scientific webinars, social media, and its website, the company provides its perspective on current industry challenges and developments to create an ongoing dialogue with its clients and to promote its industry expertise, quality, technology, and innovation.
The company encourages and sponsors the participation of its scientific and technical personnel in a variety of professional endeavors, including in-person (seminar) and virtual (webinar) speaking engagements, the presentation of papers at national and international professional trade meetings, and the publication of scientific articles in medical and pharmaceutical journals. These resources are located in both North America and the U.K./Europe to serve major research markets.
Industry Support and Animal Welfare
Inotiv is committed to delivering high-level health and genetic quality, operational performance, and client service. High standards of animal welfare are vital to delivering on each of these objectives and are a principal focus of Inotiv.
Inotiv is an advocate for implementation of Replacement, Reduction, and Refinement (‘3Rs’). Members of Inotiv's scientific and technical care staff undertake continuing professional development in the field of laboratory animal science, with special focus on animal welfare and the 3Rs, and they are encouraged to publish and present within the scientific community.
Inotiv has formed internal Institutional Animal Care and Use Committees, comprising staff from many disciplines within the DSA and RMS segments, in addition to external representation, to implement applicable regulations and provide strict oversight of animal welfare matters. The majority of Inotiv’s animal production facilities are accredited by the Association for Assessment and Accreditation of Laboratory Animal Care International (‘AAALAC’), a private, non-profit, international accrediting organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment programs. Its facilities are also routinely inspected by government agencies tasked with enforcing animal welfare regulations.
Inotiv is firmly committed to the 3Rs and to reducing the number of animals used in research by emphasizing health and genetic integrity to decrease study data variability. Whenever possible, technological advances, such as new diagnostic tests for screening pathogens in laboratory rodents, micro-sampling, and in vitro assays, are used.
The company works with the scientific community to improve its understanding and promote best practice in the care and welfare of research animals.
Regulatory Matters
The company is subject to extensive regulatory requirements and held to related and additional FDA expectations, all designed to ensure the quality and integrity of its data and products and to bioresearch monitoring (BIMO), including government inspections and audits related thereto and clinical trial monitoring. These regulations and related expectations include those promulgated under the Federal Food, Drug and Cosmetic Act, as amended from time to time, and issued by FDA in guidances for industry (‘GFI’), covering good laboratory practice (‘GLP’), current good manufacturing practice (‘CGMP’), bioequivalence (‘BE’), and good clinical practice (‘GCP’).
The company is subject to federal, state, and foreign healthcare and other regulations, including anti-bribery and anti-corruption laws (such as the U.S. Foreign Corrupt Practices Act of 1977). Its facilities and operations are subject to various federal, state, and local laws and regulations relating to protection of human health and the environment, including those governing the discharge of pollutants into the environment and the storage, handling, use, treatment, disposal, and recycling of hazardous substances and wastes, as well as relating to the humane treatment of animals in its custody, as further described below. Such laws include, without limitation, the Clean Air Act, the Clean Water Act, the Toxic Substances Control Act, the Animal Welfare Act, and the Resource Conservation and Recovery Act.
Most of the company's contract research services are subject to government standards for laboratory practices that are embodied in regulations for GLP, CGMP, BE, and GCP. The company must also maintain reports for each study for specified periods for auditing by the study sponsor and by the FDA or similar regulatory authorities in other parts of the world.
The company's animal research facilities are subject to a variety of federal and state laws and regulations, including rules and regulations enforced by the National Institutes of Health (‘NIH’) and the United States Department of Agriculture (‘USDA’), such as the Animal Welfare Act (‘AWA’). These regulations establish the standards for the humane treatment, care and handling of animals by breeders, dealers, and research facilities. The company’s animal research facilities maintain detailed standard operating procedures and other documentation designed to comply with applicable regulations for the humane treatment of animals in its custody.
The RMS segment is subject to licensing and registration requirement standards set by the USDA and similar agencies in other countries for the care and use of regulated species. The company's operations in Europe are subject to the standards as stipulated by Directive 2010/63/EU on the Protection of Animals Used for Scientific Purposes, as amended in 2019 by Regulation (EU) 2019/1010, including new reporting and transparency requirements, and mandated collection of data and publication of statistics by Member States. Stipulations within that Directive were transposed into national legislations within Europe in 2013. The company is regularly consulted and inspected by the relevant national authorities in each nation in which it operates.
Some of the company's development and testing activities are subject to the Controlled Substances Act administered by the Drug Enforcement Agency (‘DEA’), which strictly regulates all narcotic and habit-forming substances. The company maintains restricted-access facilities and heightened control procedures for projects involving such substances due to the level of security and other controls required by the DEA.
The company's laboratories are subject to licensing and regulation under federal, state, and local laws relating to hazard communication and employee right-to-know regulations, the handling and disposal of medical specimens and hazardous waste, as well as the safety and health of laboratory employees. All of the company's laboratories are subject to applicable federal and state laws and regulations relating to the storage and disposal of laboratory specimens, including regulations of the Environmental Protection Agency, the Department of Transportation, the National Fire Protection Agency, and the Resource Conservation and Recovery Act.
The company's laboratories must also comply with the International Air Transport Association regulations, which govern international shipments of laboratory specimens.
The company’s services and products are primarily marketed globally to pharmaceutical, medical research and biotechnology companies and institutions (academic and governmental) engaged in drug research and development.
Solution
The company addresses the needs of the pharmaceutical and biotechnology industries, as well as academic, non-profit, and government organizations, for drug discovery and development by providing integrated products and services to help its clients maximize the return on their research and development investments.
Intellectual Property
The company's issued patents are protected for durations ranging from October of 2031 to February of 2034. The company also holds various U.S. registered copyrights and trademarks.
History
The company was founded in 1974. The company was incorporated in 1974. It was formerly known as Bioanalytical Systems, Inc. and changed its name to Inotiv, Inc. in 2021.
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