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Finding the Best Lab Partner for your IND Submission

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] 

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. Regulatory review: Regulators evaluate the IND application to ensure that preclinical data supports the proposed clinical trial, and ethical standards are met.
  6. 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.
  7. 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.

As a global company with operations across Asia, Europe, and North America, WuXi AppTec provides a broad portfolio of R&D and manufacturing services that enable the global pharmaceutical and life sciences industry to advance discoveries and deliver groundbreaking treatments to patients. Through its unique business models, WuXi AppTec’s integrated, end-to-end services include chemistry drug CRDMO (Contract Research, Development and Manufacturing Organization), biology discovery, preclinical testing and clinical research services, advanced therapies CTDMO (Contract Testing, Development and Manufacturing Organization), helping customers improve the productivity of advancing healthcare products through cost-effective and efficient solutions. WuXi AppTec received an AA ESG rating from MSCI for the third consecutive year in 2023 and its open-access platform is enabling more than 6,000 customers from over 30 countries to improve the health of those in need – and to realize the vision that “every drug can be made and every disease can be treated.

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