Madhu,
If you are planning a pre-IND meeting, make it as comprehensive as possible and get as many issues and topics on the table. The advise provided below is sound and discussion of the clinical protocol is key as the GLP tox study(ies) are relevant in identifying toxicities that might be expected in humans based on the relevant animal species (Monkey or rat) depending on the molecule. If you see anything concerning, cardiovascular, GI, liver function, etc, these are the types of issues that will need to be presented and plans for keeping the study subjects safe identified. Schedule the pre-IND meeting early enough so the responses matter and you have time to revise the pivotal tox studies if requested and consider any comments to the clinical protocol.
If you write a comprehensive and clear briefing document once the meeting is "granted" by FDA and in my experience FDA has requested a t-con rather than face-to-face and on one of my INDs responded to our questions in writing and we cancelled the t-con.
If you have something really novel, new target, complicated manufacturing process or tox signals that might be concerning, then it is even more important to generate a clear dossier.
My only comment on the EU question is that scientific advise is strictly for scientific advise. If you need a regulatory question answered the SAWP is not the forum. I would suggest regional discussion is necessary for example, MHRA or TGA, as scientific advise meetings are not free and if a question is addressed in a guidance or regulation, the meeting will not be granted.
Hope this adds some additional information,
Dar
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Darlene Rosario, BS, RAC, MBA
Oxnard CA
United States
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Original Message:
Sent: 07-04-2012 22:54
From: Danielle Littee
Subject: Timing of preIND/CTA meeting
Dear Madu,
There does not appear to be a specific timetable but yes certain tox and manufacturing data needs to be available prior to starting in the first in human clinical trial.
For the meetings, a helpful guidance document is:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM153222.pdf
There is also a regulation for the pre-IND meeting, which is a Type B meeting (scheduled 60 days after a formal request is sent to the FDA), 21 CFR 312.82 which states, "Prior to the submission of the initial IND, the sponsor may request a meeting with FDA-reviewing officials. The primary purpose of this meeting is to review and reach agreement on the design of animal studies needed to initiate human testing. The meeting may also provide an opportunity for discussing the scope and design of phase 1 testing, plans for studying the drug product in pediatric populations, and the best approach for presentation and formatting of data in the IND".
For EU, it would appear that the equivalent would be a meeting for Scientific Advice with the Scientific Advice Working Party (SAWP): this is a great guidance Q&A: http://www.emea.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/10/WC500004089.pdf
HealthCanada (Canadian FDA) has a pre-CTA meeting procedure and specific meeting package process: http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/clini/cta_pre_application-eng.php
Good luck, hope these help!
Danielle
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Danielle Littee
Boston MA
United States
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Original Message:
Sent: 07-04-2012 18:30
From: Madhu Singh
Subject: Timing of preIND/CTA meeting
Dear All,
In your experience what is the best time to hold this meeting for an initial IND. I have seen it happen prior to start of GLP toxicology studies ie once there is animal efficacy data, good idea of manufacturing process/specifications/analytical methods. The rest is proposed.
Also, what is the equivalent of a preIND meeting in Europe?
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Madhu