Life Science Leader Magazine

JAN 2012

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Regulatory Compliance/FDA Avoiding A Failed NDA Submission Via A Third-Party Gatekeeper By Diane Mauriello and William Cairns C 44 ompanies specializing in the development, registration, and manufacture of pharmaceuticals will require no less than flawless management of data and tacti- cal tasks to meet stringent FDA NDA (new drug application) submission require- ments. In the supercharged business and highly regulated life sciences industry, your company must engage the best skills and most highly experienced profes- sionals who offer end-to-end solutions to assure that your new products will be brought to market as rapidly as possible, well managed, and with minimal risk. YOUR IN-HOUSE TEAM WEARS TOO MANY HATS Your staff is responsible for numerous day- to-day global housekeeping activities. They do not have the time, focus, or experience to manage all aspects of a submission success- fully. Submitting an NDA is the conclusion of 10 to 15 years of R&D;, clinical development, and scientific discovery, and the cost is in the millions of dollars. Outsourcing these services to industry experts is the best alter- native — not only because of the savings involved in every area, but because of the expert subcontractor's in-depth understand- ing and day-to-day use of the procedures, protocols, and techniques required to reach a successful submission end point. LifeScienceLeader.com However, there are negatives and unseen risks. Many people do not do due diligence and spend enough time identifying the correct outsourced expertise and do not work on how to manage the resource. They are mainly concerned with signing a check. Unfortunately, when they get the deliverables, they start to see the prob- lems and deficiencies. You must consider whom you will engage, how to qualify a prospective expert, how to insert that resource/team into your company, how to keep project management centralized, how to monitor work and quality, and so on. The most successful method for avoiding a failed submission is the engagement of a third- January 2012 party gatekeeper. This is the high-level project management individual or team who details a comprehensive road map in the form of a master project plan- ner, which includes all components to the project. The gatekeeper serves as the communicator, the leader, the team effort overseer, sponsor, and project par- ticipant. They lead the team and manage the issues, timelines, and durations linked to all near-term or down- stream activities but not the relationships. It is essential to monitor and QC (quali- ty control) all actions. It is not enough to moni- tor without quality checks and

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