Pre-IND meetings present a valuable opportunity to minimize the potential risks that could arise from misaligned plans or expectations. At this stage there are often questions regarding minimum requirements for the quality and manufacturing of a new drug for trial—whether the proposed toxicology studies are sufficient to support the dose and duration of drug treatment, as well as the selection of patients for a first in human (FIH) study.
These meetings are also an opportunity to discuss the qualifications for expedited programs or accelerated development. Carefully constructed questions and meeting packages can facilitate meaningful responses beyond the typical advice to review guidance documents or a boiler plate answer, like it is premature to discuss. For instances in which a companion diagnostic will be used for patient identification or outcome assessment, plan the discussion around timing and validation to gain clarity on how best to proceed.
Goals for granting and conduct of meetings have been established, and the FDA has issued a formal (albeit still draft) guidance in 2017 describing the process for “requesting, preparing, scheduling, conducting, and documenting” such meetings.
A pre-IND meeting request is typically made 60 days prior to the proposed meeting date.
The briefing package for the meeting is due 30 days prior to the meeting date.
It is important to have sufficient data to allow FDA to answer the questions that are being asked.
The timing for when to request a pre-IND meeting should be determined by when there is enough information to allow FDA to respond to the questions being asked, while still being early enough for the sponsor to implement advice from the FDA. Having a well-organized, reviewer-friendly meeting package helps facilitate discussion and establish a positive working relationship with the review division. Obtaining meaningful feedback for a program can accelerate the pathway to initiation of the clinical trial.
The Center for Biologics Evaluation and Research (CBER) offers an earlier stage meeting program called INTERACT (INitial Targeted Engagement for Regulatory Advice on CBER producTs). These are informal (non-PDUFA) meetings intended to provide preliminary guidance for innovative programs posing unique challenges that are not yet at the IND stage. A similar format no longer exists within the Center for Drug Evaluation and Research (CDER).
Additionally, Precision’s regulatory experts can support your IND and BLA submissions, as well as the development of a comprehensive regulatory strategy and documentation.
For more information on how Precision’s regulatory experts can support your upcoming program, contact us.
Vann Parker is the Head of Regulatory Consultancy (North America) for Precision for Medicine. He received his PhD in Molecular Biology from The California Institute of Technology and spent the past 30 years supporting biopharmaceutical and drug development. He currently focuses on strategies for clinical development and interactions with FDA and other regulatory agencies. In addition to support of pre-IND activities, Vann has supported sponsors throughout the drug development process including applications for Fast Track, Breakthrough Therapy and Orphan Designations, formal meetings with FDA and full NDA/BLA submissions.
Precision for Medicine is part of the Precision Medicine Group, an integrated team of experts that extends Precision for Medicine’s therapeutic development capabilities beyond approval and into launch strategies, marketing communication, and payer insights. As one company, the Precision Medicine Group helps pharmaceutical and life-sciences clients conquer product development and commercialization challenges in a rapidly evolving environment.
