Achieving IND Filing Success
IND filing is an exciting milestone for any life science firm to achieve. Reaching this goal, however, can be challenging as it requires perfectly timed and executed preclinical development activities. GLP toxicology studies are one of the critical components for an IND package and require precise scheduling and frequent communication amongst different technical teams for each toxicology study.
Pharmaron has helped our partners with dozens of IND filings – and one thing we learned is that each one is unique. Rgenix’s recent IND filing in 2016 was no exception. The company conducted three GLP toxicology studies in parallel: two in rodent species and one in non-rodent, as well as toxicokinetic analysis, slide processing, expedited histopathology evaluation and report generation. In a 6-month period, our team initiated, conducted and submitted audited reports for all three GLP studies ensuring Rgenix had the needed information. Their IND was successfully filed on time and the drug is now in clinical trials.
Written with permission by Rgenix.
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