Case 1

The Client

A publically traded, global biopharmaceutical company developing treatments for patients with serious, chronic conditions.

The Situation

The client had a talented and senior staff, but was lacking the hands-on experience needed to draft Regulatory Target Product Profiles (TPP) for each of its development programs.

TPPs are an FDA-recommended format for summarizing a drug development program. The idea is to “begin with the goal in mind,” with sponsors specifying labeling concepts, documenting supporting studies and, overall, creating a constructive dialogue with the FDA.

Clients without experience in this area, however, may be reluctant to commit this to paper, out of concern that it will limit their flexibility down the road. In practice, though, an FDA-complaint, efficient TPP process reduces (bad) surprises, keeps all disciplines on track and coordinated and (again, according to the FDA), may decrease drug development time.

Our Work

Working across disciplines – marketing, clinical, nonclinical, regulatory, manufacturing and others – an MLC expert consultant populated the template and managed the TPP process, consistent with the FDA guidance document and based on extensive prior experience in this area.

The End Result

Thanks to our effective involvement, our consultant is now implementing TPPs for all products across the company. In addition, she has been asked to join the NDA team as a group leader, and two other MLC consultants have been selected to assist with CMC and Quality efforts.