A successful Investigational New Drug (IND) application is imperative for research involving human participants ingesting or applying a drug product. Sponsors can take several potential regulatory pathways, but all pose unique challenges and requirements. The right laboratory testing partner can ease this process, avoiding longer timelines and bloated budgets. Drug sponsors should consider these three key areas before selecting a lab partner.
Clear communication
Sponsors should ensure they work with a full-service lab testing partner boasting an integrated communication management approach. The right partner will stay in close contact via video chat capabilities, offer regular reporting, and use SEND data packages to compile relevant information in the format regulators prefer, to ensure submissions stay on track.
From creating the study strategy to drafting the submission, integrated communication can save time, reduce miscommunication when transferring documents between departments and testing sites, and ensure the study is set up to succeed from the beginning.
Regulatory relationships
Regulations vary around the world, and the right lab testing partner can ensure appropriate and complete data is compiled throughout IND-enabling studies and help with territories outside the United States as well.
As sponsors consider partners, they should look for those with a strong reputation and collaborative relationships with regulatory bodies. This includes undergoing frequent government inspections, which they should be able to share with you.
Understanding the IND process
The right laboratory testing partner can ease the burden and stress of navigating the many nuances of the regulatory landscape, ensuring the safety and success of new therapeutics in human trials. The right partner can support the IND submission every step of the way:[KH1]
- Early development and discovery: Before beginning an IND-enabling study, the drug discovery and early development phase identifies potential drug candidates through laboratory research and preclinical testing.
- Nonclinical development: IND-enabling studies bridge the gap between early discovery and clinical trials. Comprehensive pharmacological and toxicological assessments of the drug candidate are completed in laboratory animals during this phase.
- Objective of IND-enabling studies: The main goal of IND-enabling studies is to garner sufficient data to support the safety and feasibility of testing the drug candidate in humans during clinical trials.
- Regulatory submission: Researchers compile the data and submit an IND application to regulators. The application includes comprehensive information on the drug candidate, study protocols, preclinical data, and plans for clinical trials.
- Regulatory review: Regulators evaluate the IND application to ensure that preclinical data supports the proposed clinical trial, and ethical standards are met.
- Clinical trials: Phase I trials evaluate the investigational drug’s safety, tolerability, and pharmacokinetics in a small cohort of healthy volunteers. Subsequent phases continue testing the drug in human subjects to further evaluate safety, dosage, efficacy, and side effects.
- Post-approval activities: Successful completion of clinical trials may lead to a New Drug Application (NDA) submission for regulatory approval. Post-approval activities include ongoing safety monitoring, additional studies, and market launch.
IND studies play a vital role in the drug development process, bridging the gap between nonclinical research and clinical practice. With the right laboratory testing partner, drug developers can rely on a partner to navigate the regulations and unexpected hurdles, ensuring the IND process runs smoothly.
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