Pre-IND meetings with the FDA are quite advantageous for many reasons as seen in

the article. However, prior to a pre-IND meeting, it is important for the sponsors to be
familiar with the Code of Federal Regulations and International Conference on
Harmonization guidance documents (Black,et al 1999). Going through these documents
will help the sponsor gain clarity and confidence when asking the FDA if the guidance
documents have been correctly interpreted or implemented in the development process.
A successful meeting would make the FDA aware of sponsors developmental concerns
and without pressure, can be debated and resolved without the 30-day deadline or
holds. This allows open communication between teams in the framework and allows
teamwork during the drug development process and helps the drug sponsor be on track
for the development set dates.
A pre-IND meeting will also ensure the FDA is aware of the reasons and thinking of the
sponsor that guides the development decisions made, as we see in the article. Once
this is done, suggestions and comments can be presented which will be beneficial to the
sponsor and provide regulatory guidance from past experiences that can further aid the
process to ensure end stage approval.
This meeting will also help the sponsor voice any concerns regarding toxicity in the
product and how it may influence the clinical trial design.
Helps address contaminants in the drug development process and final product,
providing ways to address them. This will ensure the safety and efficacy of the product
is maintained and in line with regulatory requirements.
Timing of and submission of preclinical studies as well as disease endpoints in clinical
trials may be discussed in the meeting as well. This also is advantageous in addressing
questions including fast-track development and orphan drug status and other issues
that may come up or affect the planning process (Black, et al, 1999).
The FDA can also give their own opinion on the design of the IND supporting (Good
Laboratory Practice) GLP studies and assess the benefit/risk ratio and the toxicity
findings during animal studies and determine the safety margin for treatment in human
populations. Control Manufacturing and chemistry processes, clinical trial design and
other necessary requirements can assist the sponsor develop a good strategy.
From this article, it is clear and evident that pre-IND meetings are quite advantageous to
the drug sponsor/company developing.
Reference. B1 LACK, ALISON M. B2 ENDELE, RAY A. B3ENDELE,
LAUREN E. BLACK, A. M (1999) Regulatory Decision Strategy for Entry of a Novel
Biologic Therapeutic with a Clinically Unmonitorable Toxicity into Clinical Trials: Pre-IND
Meetings and a Case Example22-26.