An Investigational New Drug (IND) program is the first step towards conducting clinical trials with a new drug. The submission of an Investigational New Drug (IND) application to the Food and Drug Administration (FDA) must include animal pharmacology and toxicology studies, manufacturing information, clinical protocols, and investigator information. Renejix, with 2 sites in NY offers comprehensive Chemistry, Manufacturing, and Controls (CMC) support for your IND application. Additionally we have a integrated network in Asia and in the USA for GLP toxicology, pharmacology testing, and API synthesis. Our expertise ranges from toxicology studies to process chemistry and drug substance manufacturing sourcing to formulation development and drug product manufacturing.
Preparing for a Successful Investigational New Drug (IND) program
- Timeframe: It can take up to 18 months of preparation before starting your IND program. This includes time to identify and develop appropriate analytical methods, and to produce and characterize batches of investigational new drugs that are suitable and sufficient in quantity for preclinical testing.
- Understanding the Therapeutic Target: The success of an IND program also depends on having a good understanding of the human therapeutic target, likely treatment schedule, disease indication, and clinical trial design. This information is crucial to correctly identify the safety assessment studies needed to support first-in-human trials.
- Alignment of Strategies: Your preclinical and clinical strategies should be aligned to facilitate adjustments and changes along the way. This ensures that the transition from preclinical to clinical stages is smooth and efficient.
- Preparation and Preliminary Testing: Sufficient time should be allocated for preparation and preliminary testing before the launch of your pivotal IND program. This includes manufacturing and characterization planning for your test article, which is essential to conducting successful IND-enabling studies.
- Interactive Questions: Consider these critical interactive questions that will aid you in planning for IND-enabling studies:
- Is there enough test article at each stage of development to not be a rate limiting factor?
- Does the preclinical strategy align to the clinical strategy?
- What are the timelines for IND submission and start dates for clinical trials?
- Preparing for a successful IND program involves careful planning, a deep understanding of the therapeutic target and disease indication, and a strong alignment between preclinical and clinical strategies.
- Custom IND Studies: Work with a CDMO that offers a vast and unique range of services and leading expertise can help you create, launch, and complete your IND-enabling programs on time and within budget. We can work with you to customize each exploratory IND-enabling study program based upon the type of drug, intended route of administration, and its clinical indication.
Why an IND Application is Necessary
- The United States Food and Drug Administration (FDA) requires an IND application to assess the efficacy, safety, manufacturing process, and clinical trial designs of a new drug before human studies can begin. This application facilitates regulatory review, and once submitted, the FDA has 30 days to review it. Unless the FDA indicates otherwise, the sponsor can proceed with proposed human studies after this period.
Studies Required for an IND Program
Nonclinical studies are essential for IND-enabling programs. Pharmacology studies, both in vitro and in vivo, demonstrate the drug’s intended effect. Safety studies evaluate the drug’s impact on DNA, organ systems, and overall toxicity. These studies provide data on systemic exposure, adverse effects, and safety margins, guiding dose selection for human trials.
What is SEND?
SEND (Standard Exchange of Nonclinical Data) is a standardized way to represent individual animal study data electronically. It follows the CDISC Study Data Tabulation Model (SDTM) and streamlines data review for regulatory submissions. SEND datasets are required for IND submissions, ensuring efficient data exchange with regulatory agencies.
Process Chemistry
Process chemistry involves the development of synthetic processes that are efficient, scalable, and cost-effective. Renejix’s team of experts collaborates to ensure that your molecule has the best chance at success. They work on synthetic process development and scalable processes, ensuring that the drug substance manufacturing process is robust and reliable.
Pre-formulation
Before a drug can be formulated, it’s essential to understand its physical and chemical properties. Renejix conducts polymorph/salt screening, solubility/physical characterization, and excipient compatibility studies. These studies provide valuable insights that guide the formulation development process.
Formulation Development
Formulation development involves creating a dosage form that is effective, safe, and stable. Renejix can develop a variety of dosage forms, including API in a bottle or capsule, and formulated tablets or capsules.
Drug Product Manufacturing
Once the formulation has been developed, it needs to be manufactured on a larger scale. Renejix has the capabilities to manufacture hundreds of thousands of dosage units. They also handle packaging and labeling, ensuring that the final product is ready for clinical trials.
Analytical Services
Throughout the entire process, Renejix’s analytical team provides quality analysis of your program to ensure you meet your milestones. They offer a range of analytical services, including material characterization, impurity identification, method development and qualification, and release and stability testing.
To help you meet strict IND requirements and accelerate the filing process, Renejix provides all supporting analytical data (specifications and release data) for raw materials, intermediates, and APIs. They also provide all master batch records, as well as a certificate of GMP stating that they manufacture their APIs according to industry standards.
Related Services
FAQs
Here are some frequently asked questions about IND Enabling Studies
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IND Enabling Studies are a suite of preclinical services designed to support the preparation of an Investigational New Drug (IND) application. These studies typically include pharmacology and toxicology assessments, manufacturing information, clinical protocols, and investigator information. At Renejix, we provide comprehensive support to ensure your drug meets regulatory milestones.
Renejix offers a full range of services to support your IND application, including process chemistry, synthetic process development, scalable processes, and GMP drug substance manufacturing. We ensure that your molecule has the best chance of success from pre-formulation to clinical manufacturing.
At Renejix, we pride ourselves on our technology-driven approach and our ability to provide cost-effective solutions. Our expertise in formulation development for complex dosage forms and our state-of-the-art facilities ensure that we deliver quality and efficiency at every step of your drug’s journey.
Yes, we can. Renejix is equipped with over 300+ state-of-the-art equipment and facilities that can seamlessly adapt to your needs, from early development stages to large-scale production, ensuring scalability and flexibility for your project.
Absolutely. We offer strategic regulatory planning and quality assurance to ensure global compliance, streamline approvals, and support the product lifecycle. Our team is dedicated to guiding you through the regulatory landscape.
Quality is at the core of what we do. Renejix employs over 150+ analytical scientists to provide comprehensive analytical testing and method development. We ensure compliance with stringent industry standards, guaranteeing product integrity and timely market entry.
Renejix’s services are ideal for a wide range of drugs, including orphan drugs, blockbuster drugs, generics, and consumer health brand extensions. Our expertise spans across small molecule oral dosage development, ensuring we can cater to diverse pharmaceutical needs.
We have a dedicated team of scientists, engineers, and quality personnel who specialize in pharmaceutical technology transfers. We address potential challenges from development to manufacturing from the outset, ensuring consistent quality and regulatory compliance.
The first step is to reach out to us with your project details. Our client-centric business development team will work closely with you to understand your requirements and provide a customized proposal that aligns with your goals for quality, insight, timely delivery, and competitive pricing.