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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.
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