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Case Study 3:
Providing General Regulatory Strategy and Preparing for a Meeting with FDA

A pharmaceutical development company had acquired patent rights to a drug for various uses. The client had also acquired rights to two U.S. INDs for the drug, and had scheduled a meeting with FDA to discuss the clinical development plan. At the time, the drug was marketed in Europe for a single indication; however, no sponsor had ever received approval from the FDA to market the drug in the U.S. Roughly two months prior to the meeting with the FDA, this client approached Umen & Co. for assistance in preparing for the meeting. The project involved significant challenges including the client's lack of rights to reference original data, the pursuit of multiple indications (each different from the indication for which the product was marketed in Europe), potential serious safety issues, limited personnel, and limited funding.

Our first step in assisting this client was to conduct a comprehensive review of the existing INDs, the drug (i.e., the science), the history of the development program, the therapeutic areas, and any regulatory precedents that could provide useful insight. We proceeded to work with the client and its team of expert medical consultants in the targeted therapeutic areas to formulate a revised clinical development plan and questions for the FDA meeting. We then drafted an Information Package for the meeting and briefed the client in advance of the meeting by identifying potential FDA concerns and preparing a response/rationale to address each issue.

Despite the short notice, this client was able to successfully submit a complete Information Package to the Agency in the required time frame. Further, based on the comprehensive preparation, the client was fully prepared during the meeting. Ultimately, the client received favorable feedback from the Agency, was able to amend the existing INDs, and proceeded with the agreed upon clinical development plan.

Umen & Co.  The Leader in NDA Preparation Since 1981