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Strategic Submission Preparation Redefines Product Value


A biotech company targeted a new oncology indication with an improved delivery technology of an already-approved drug. Because the API had been previously approved, the company believed it could leverage the 505(b)(2) pathway to seek FDA approval for the new indication, but arising issues with the FDA threatened to derail the project.


Intending to tap in-house drug development experience, the biotech company began nonclinical trials. Because there is no standard approach to achieving a 505(b)(2) NDA, the client’s in-house team began having trouble addressing multiple issues with the FDA. They feared that one wrong move could cause permanent damage to their program.


When the client approached Camargo, Camargo leveraged its frequent exposure and long-standing relationship with the division in the FDA, developed a strategy which would enable an efficient path through approval, and compiled evidence advocating the safety and efficacy of the drug. Utilizing Camargo’s cross-functional teams, the biotech’s program gained careful examination from each angle of the drug development program, with the goal of program optimization. Camargo’s cross-functional team corrected and rewrote the deficient modules. The team crafted the nonclinical data into a meaningful story, covering essential pharmacokinetics, toxicology, nonclinical testing strategy, pharmacodynamics, and toxicokinetics, as well as compiling relevant nonclinical study reports.


Properly assembled, not only did the NDA package show outstanding results, but also revealed the patients’ unprecedented success with the drug, resulting in remission and longer lives. Once presented as a high-value, viable, and realistic drug product with imminent regulatory success, a parent company acquired the originating biotech company for a substantial sum. The drug gained approval, and has the potential to become a new “gold standard” treatment in oncology.