How do you prepare for a successful IND Program?
Did you know that it can take up to 18 months of preparation before starting your IND program? Many drug developers are unaware of the time required to identify and develop appropriate analytical methods and to produce and characterize batches of investigational new drugs that are suitable and in sufficient quantities for preclinical safety testing. 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 to correctly identify the safety assessment studies needed to support first-in-human trials.
Prior to asking for a quote for your investigational new drug program, there are critical questions that need answering. Your preclinical and clinical strategies should be aligned to facilitate adjustments and changes along the way, and sufficient time should be allocated for preparation and preliminary testing before the launch of your pivotal IND program. Appropriate manufacturing and characterization planning for your test article is essential to conducting successful IND-enabling studies.
Explore 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?
- It is recommended that you identify a CMO/CDMO approximately 18 months prior to entering into preclinical development to allow for a determination of whether or not your test material will be GMP in time to start the toxicology program. Manufacturing GMP-ready test materials allow for a smoother transition from preclinical into clinical trials but can take longer to manufacture.
- Throughout the preclinical journey and while tracking your test materials, documentation of all batches is required to ensure consistency, purity, and potency.
- Your test article should have proven stability prior to executing GLP toxicology and safety assessment evaluations or alternately there should be a plan to support storage and sample stability.
Does the preclinical strategy align to the clinical strategy?
- This aligns with synthesis, batch production, manufacturing and scale up of your test material, but you will need to understand and know your clinical strategy to ensure adequate preparation.
- You will need to know your clinical dose quantities, dosing regimens, and administration methods as they will need to align in the preclinical and clinical phases. It is recommended that this is defined 6 months prior to the start of the toxicology program beginning. Dose-range finding studies will be conducted as part of the preclinical package to support the dosing plans.
- It is recommended to have a pre-IND meeting with regulatory agencies to gain feedback on the non-clinical approach.
What are the timelines for IND submission and start dates for clinical trials?
- In order to meet your IND submission targets and also your targeted first-in-human trial dates, we need to know those dates. As a partner, we can then work to outline studies to meet those deadlines.
- It is recommended that you identify a clinician to support your clinical trials 18 months prior to starting your safety toxicology program.
- Throughout your preclinical program, the pharmacokinetic, pharmacology, and tolerability data will help to define the clinical dose strategy.
Custom IND Studies
Together with our vast and unique range of services and leading expertise, we help clients create, launch, and complete their IND-enabling programs on time and within budget. We work with clients to customize each exploratory IND-enabling study program based upon the type of drug, intended route of administration, and its clinical indication. We can also provide advice and guidance with the steps leading up to the program’s implementation, including the drug metabolism and pharmacokinetic evaluations to help determine lead candidates and justify species selection for safety assessment.
As the success of an investigational new drug program relies as much upon the planning as the execution, every program is overseen and implemented by scientists and program management professionals from both discovery and development. This allows your lead candidate selection to flow seamlessly into development. With a deep understanding of investigational new drug programs and a complementary portfolio of services our teams can create custom solutions for our clients. Start outlining your IND program with our IND Toolbox.
Capabilities & Support
IND Program Support
- Accelerated IND-enabling studies and timelines
- Transporter Assays
- Candidate selection
- Drug metabolism and pharmacokinetics
- Analytical and bioanalytical assay development and validation
- Safety assessment
- Formulation analysis
- Immunogenicity testing
- Screening and preliminary toxicology
- Repeat-dose toxicology
- Safety pharmacology
- Genetic toxicology
- Therapeutic Area Expertise
- Support Services
Charles River has proven experience with IND-enabling studies and with getting our clients’ investigational new drugs to market. With a unique range of services and best-in-class expertise, we help clients successfully initiate and complete their IND-enabling program on time and within budget. As a global CRO, we can leverage this same experience to design suitable studies or programs for submission to regulatory authorities around the world.
Need Guidance on Your IND-Enabling Program?
Frequently Asked Questions (FAQs) about IND-Enabling Studies
What is an Investigational New Drug or IND Program?
The purpose of IND-enabling studies is to secure approval to conduct the first-in-human clinical trials with a new drug. An IND application contains information on pharmacology and toxicology, manufacturing (e.g., composition, production, stability, etc.), human clinical study protocols, and investigator information. At Charles River, we focus primarily on the pharmacology and toxicology testing, which is designed to provide evidence that the drug has its intended effect and that the proposed human dose levels are safe.
Why is an IND application required?
The United States Food and Drug Administration (FDA) requires that an IND application be submitted in order to determine if the efficacy and safety profile, the proposed manufacturing process, and the clinical trial designs of a new drug are acceptable to allow for studies in humans. An IND program and application compiles all this information, which facilitates regulatory review. Once an IND application is submitted, the FDA has 30 calendar days to review the package. Unless the FDA indicates otherwise, the IND sponsor is free to initiate the proposed human studies once the 30 days have elapsed.
What studies are required as part of an IND program?
To support IND-enabling studies, nonclinical (i.e., “non-human”) studies are conducted to evaluate the efficacy and safety of the drug. The pharmacology studies most often consist of in vitro (cellular) and in vivo (whole animal) studies that demonstrate that the new drug binds to its intended target and has the desired effect. This is often done in animal models that mimic the human disease. Once proof-of-concept is demonstrated in the pharmacology studies, the nonclinical safety studies (i.e., the toxicology studies) evaluate the safety profile of the drug. This includes profiling the drug’s effect on DNA (genotoxicity), critical organ systems (i.e., cardiovascular, respiratory, and central nervous system effects through safety pharmacology), and general toxicity (through animal studies in rodent and nonrodent species). During the IND-enabling studies, the collected data will demonstrate systemic exposure to the drug, the exposures and nature of adverse effects at high dose levels, and the safety margin (i.e., the margin between doses/exposures associated with efficacy and doses/exposures associated with toxicity).
What is SEND?
SEND stands for the Standard Exchange of Nonclinical Data and is an implementation of the CDISC Study Data Tabulation Model (SDTM) that provides a framework for the standardized, electronic representation of individual animal study data. SEND is intended to increase the effectiveness and efficiency of data review for regulatory submissions. These SEND datasets are required when submitting your IND program to agency.