As a Sponsor navigates through the drug development process, their objectives include completion of nonclinical studies that will advance a drug product from Discovery to Preclinical Development to Clinical Trials. Before studies can be conducted in humans, products must be tested in the nonclinical/preclinical stage of development. Often times, Sponsors make the decision to run multiple studies in parallel to meet their timelines. However, management of nonclinical studies and prioritizing which studies are necessary for the drug product requires careful consideration. The review process for nonclinical study reports was established by the Food and Drug Administration (FDA) in the late 1970s. Today, the FDA requires that nonclinical studies conducted in support of Investigational New Drug Applications (IND) and New Drug Applications (NDA) must be compliant with Good Laboratory Practices (GLP).

What are Good Laboratory Practices?

In the late 1970s, the FDA drafted regulations called Code of Federal Regulations Title 21 part 58 Good Laboratory Practice for Nonclinical Laboratory Studies or 21 CFR Part 58. GLP regulations established minimum standards for nonclinical laboratory study reports that ensured the quality and integrity of data that supported INDs or NDAs. These regulations required Sponsors and testing facilities to keep records of key personnel, quality assurance, data collection and storage, equipment maintenance, SOPs, and more. The goals for GLP-compliance are to regulate key aspects of nonclinical studies. The practices, at a minimum, improved data collection during the nonclinical phase of drug development. Ideally, when implemented correctly, GLP compliance makes data readily available to the FDA during Bioresearch Monitoring Program inspections.

However, not all Sponsors are equipped to transform their laboratories into GLP-compliant facilities that can utilize internal personnel for nonclinical animal studies. Luckily, Sponsors can outsource such activities to a contract research organization (CRO) that can conduct IND-enabling animal studies that are GLP/non-GLP compliant.

What nonclinical animal studies can be conducted prior to GLP-compliant studies?

Non-GLP compliant animal studies are typically exploratory studies (Pre-IND) that can be conducted with a CRO. These studies include:

  • Pharmacokinetics
    • PK Blood Sampling
    • Metabolic Stability
    • Dose Response Curve
  • Biologics Survivability & Fate
  • Spiking Studies
  • Tumorigenicity
  • Efficacy Studies
  • Absorption, Distribution, Metabolism and Excretion (ADME) Studies

These early studies allow Sponsors to determine key factors such as understanding effective dosages and in-life parameters to measure for future studies and IND-enabling studies. These exploratory stages can save a Sponsor significant funds further down the pipeline by assessing in-life parameters that will be relevant in support of the FDA applications. AniLocus specializes in developing the appropriate, short-term exploratory phase assays that precede IND-enabling studies.

What are IND-enabling studies?

By the time a Sponsor has collected their exploratory data from our in vivo team, we progress to IND-enabling studies that are more specific studies and essential components that support the IND application. These studies include:

Conclusions

Our team understands that this stage of the FDA application process is crucial. We conduct pre-IND studies and IND-enabling studies for drugs and biologics. Let’s discuss what works best for your product development. Contact us to learn more.

References

  1. 21 CFR Part 58—Good Laboratory Practice for Nonclinical Laboratory Studies. Food and Drug Administration. < https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-58 >.
  2. Organisation for Economic Co-operation and Development (OECD) Principles of Good Laboratory Practice (GLP). < https://www.oecd.org/chemicalsafety/testing/good-laboratory-practiceglp.htm >.
  3. IND Application Procedures: Overview. Food and Drug Administration. < https://www.fda.gov/drugs/investigational-new-drug-ind-application/ind-application-procedures-overview >.
  4. Pre-IND Consultation Program. Food and Drug Administration. < https://www.fda.gov/drugs/investigational-new-drug-ind-application/pre-ind-consultation-program >.
  5. Good Laboratory Practice Regulations Questions and Answers (March 1998). Food and Drug Administration. < https://www.fda.gov/regulatory-information/search-fda-guidance-documents/good-laboratory-practice-regulations-questions-and-answers >.
  6. FDA Bioresearch Monitoring Program Information. < fda.gov/inspections-compliance-enforcement-and-criminal-investigations/fda-bioresearch-monitoring-information/bioresearch-monitoring-program-information >.