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Case Studies

Regulatory Expertise Eases the Way for Company’s First IND Submission

A young biopharmaceutical company developing a pipe-line of preclinical cancer immunotherapy treatments was preparing to file its first investigational new drug (IND) application with the…

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Case Studies

Professional Plan and Execution Results in On-Time IND Submission and Clinical Program Initiation

Project Background A mid-size biotechnology company with multiple development candidates in their pipeline lacked an overarching strategy for moving a lead compound from selection to…

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