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IQ Presents: Update on Progress toward ICH S1 Rodent Carcinogenicity Testing Guidance Revision

IQ Presents: Update on Progress toward ICH S1 Rodent Carcinogenicity Testing Guidance Revision

March 31, 2016


Progress Update on the Prospective Evaluation of Proposed Changes to the ICH S1 Regulatory Testing Paradigm of Rodent Carcinogenicity Testing

The ICH S1 EWG launched in August 2013 a prospective evaluation period to evaluate the ability to predict when a 2 yr rat carcinogenicity study may not be needed to assess pharmaceutical carcinogenicity risk to humans, when a single rodent carcinogenicity study, usually a TgRasH2 transgenic mouse 6-month study, would suffice.

Over the past 2 years sponsors have voluntarily submitted Carcinogenicity Assessment Documents (CADs) to Drug Regulatory Authorities (DRAs) to document and justify these predictions, and the halfway target point has been met.  At the December S1 ICH Meeting, the S1 EWG convened to review this progress.  DRAs have encountered several factors relating to adequacy and clarity in reviewing the CADs and discrepancies in categorizations between sponsors and DRAs have surfaced.  As a result of this experience, changes were made to the Regulatory Notice Document and these changes along with a summary explanation of suggestions to sponsors on how to maximize CAD submission success have been posted to the ICH Website.

The goals of this webinar are to: 1) explain the changes made to the Regulatory Notice Document detailing revised CAD submission guidance; 2) provide a status update of the first 25 CAD submissions with a focus on advice for sponsors to consider toward improving success in the final round of CADs to be submitted; 3) review recent industry experience with the TgRasH2 transgenic mouse in supporting pharmaceutical carcinogenicity assessments; and 4) provide participants with the opportunity to ask questions of DRA, industry, and S1 EWG member scientists.

Webinar Agenda:

  1. Purpose, Introductions, and Webinar Agenda:  Frank Sistare/Merck (5 min)
  2. Significant Changes to the ICH S1 Regulatory Notice Document agreed to at the Dec 2015 Jacksonville ICH Meeting: Mike Graziano/BMS (20 min)
  3. Status Update of the ICH S1 Prospective Evaluation Period, and Summary of the first 25 CAD Submissions – Strengths, Weaknesses, Expectations to Maximize CAD Success: Jan Willem van der Laan/EMA (20 min)
  4. The TgRasH2 Transgenic Mouse Model - Summary of Recent Industry Experience: Zaher Radi/Pfizer (20 min)
  5. Round Table Discussion (Amar Thyagarajan/Taconic to summarize QC of the TgRasH2 model; Todd Bourcier/FDA to be available for Q&A) and open Q&A




The IQ Consortium DruSafe Leadership Group is seeking a speaker or speakers to join its webinar and roundtable discussion of ICH S1 during the week of March 28th, 2016.  We seek a speaker or speakers with experience in breeding and ensuring the genetic stability of the TgRasH2 mouse, and with experience supplying them commercially worldwide to the pharmaceutical industry to conduct 6-month TgRasH2 transgenic mouse carcinogenicity studies used to support pharmaceutical marketing registrations.

Please email your name, affiliation, contact information and your relevant experiences to by COB March 14, 2016.