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It is no secret that the pharmaceutical industry is filled with a litany of unique challenges and regulations. In our experience — having chiseled away an expertise in this arena — we’ve uncovered a process for successfully accelerating new drug development via our breakthrough project methodology.

Insigniam’s approach — which entails revealing, unhooking, and implementing a series of critical success factors — ensures that pharmaceutical companies can lead successful breakthrough projects — and healthcare innovations — for new drug applications (the process in which companies propose new medicines for sale and marketing, by way of FDA approval) and clinical submissions (the regulated series of tests and reviews needed during drug development).

So, where do pharmaceutical companies begin when they want to bring a new drug to market faster, more efficiently, and with less internal/external resistance? The answer: with an undeniable commitment to the goal or project timeline.

Ensuring Alignment

Often, early in the process of working with a pharmaceutical company, Insigniam will meet with a project leader who will declare, “We must do ___ in ___ amount of time,” — typically faster than first intended. So while the leader’s colleagues will often nod their heads in agreement, there often lacks a real, authentic alignment with the goal.

Alarmingly, we’ve found that up to 70 percent of teams are not aligned to the goal from the outset of the project. Unless there is an irrefutable commitment to the goal and timeline — from every person who touches the submission, in the case of NDA’s — projects will often fail spectacularly.

Enrolling Commitment

In order to solidify an authentic commitment, we must first reveal and examine the breakdowns. To begin, we talk to those involved with the project in an effort to uncover the undercurrents about what is going on in the background of a team. We focus on the things that aren’t being said, but are loudly heard.

Once uncovered, we can begin to design a process for addressing background concerns and enroll all parties involved in an authentic, unwavering commitment to the goal. In order for this to happen, we depend on strong, decisive, bold inspirational leadership — from everyone — which is the topic of Part II: A Rx for Bold Leadership.